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These highly and moderately emetogenic chemotherapy regimens increase the risk of CINV.

Breast Cancer1,2

AC (doxorubicin + cyclophosphamide)TAC (docetaxel + doxorubicin + cyclophosphamide)TC (docetaxel + cyclophosphamide)CMF (cyclophosphamide + methotrexate + fluorouracil)TCH (docetaxel + carboplatin + trastuzumab)

Lymphoma1,5

ABVD (doxorubicin + bleomycin + vinblastine + dacarbazine) CHOP (cyclophosphamide + doxorubicin + vincristine +

prednisone) rituximabCVP (cyclophosphamide + vincristine + prednisone)

Lung Cancer1,3

Carbo-Tax (carboplatin + paclitaxel)Cisplatin + vinorelbineCisplatin + gemcitabineCisplatin + pemetrexed

Colorectal Cancer1,6,7

FOLFOX (oxaliplatin + leucovorin + 5-fluorouracil) FOLFIRI (irinotecan + leucovorin + 5-fluorouracil)CapeOX (capecitabine + oxaliplatin)IrinotecanCisplatin-based regimens

Head and Neck Cancer1,4

Cisplatin-based regimensCarboplatin-based regimens

Ovarian Cancer1,8

Carbo-Tax (carboplatin + paclitaxel) IP cis (intraperitoneal cisplatin)Cisplatin

Help stop CINV before it starts, with a regimen including EMEND, a 5-HT3 antagonist, and a corticosteroid

EMEND, in combination with other antiemetic agents, is indicated in adults for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin; and for prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. EMEND has not been studied for treatment of established nausea and vomiting. Chronic continuous administration of EMEND is not recommended.

Selected Important Safety InformationEMEND should be used with caution in patients receiv ing c o n c o m i t a n t m e d i c a t i o n s , i n c l u d i n g c h e m o t h e r a p y agents, that are pr imar i ly metabol ized through CYP3A4. Inhib i t ion of CYP3A4 by EMEND could result in e levated plasma concentrations of these concomitant medications. Conversely, when EMEND is used concomitantly with another CYP3A4 inhibitor, aprepitant plasma concentrations could be elevated. When EMEND is used concomitantly with medications that induce CYP3A4 activity, aprepitant plasma concentrations could be reduced, and this may result in decreased efficacy of aprepitant.Chemotherapy agents that are known to be metabolized by CYP3A4 include docetaxel, paclitaxel, etoposide, irinotecan, ifosfamide, imatinib, vinorelbine, vinblastine, and vincristine.In clinical studies, EMEND 125 mg /80 mg was administered commonly with etoposide, vinorelbine, or paclitaxel. The doses of these agents were not adjusted to account for potential drug interactions. In separate pharmacokinetic studies, EMEND 125 mg / 80 mg did not inf luence the pharmacokinetics of docetaxel or vinorelbine.Because a small number of patients in clinical studies received the CYP3A4 substrates vinblastine, vincristine, or ifosfamide, particular caution and careful monitoring are advised in patients receiving these agents or other chemotherapy agents metabolized primarily by CYP3A4 that were not studied.The efficacy of hormonal contraceptives may be reduced during coadministration with EMEND and for 28 days after the last

dose of EMEND. Alternative or backup methods of contraception should be used during treatment with EMEND and for 1 month after the last dose of EMEND.Coadministration of EMEND with warfarin (a CYP2C9 substrate) may result in a clinically significant decrease in international normalized ratio (INR) of prothrombin time. In patients on chronic warfarin therapy, the INR should be closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of EMEND with each chemotherapy cycle.Chronic continuous use of EMEND for prevention of nausea and vomiting is not recommended because it has not been studied and because the drug interaction profile may change during chronic continuous use.In clinical trials of EMEND, the most common adverse events reported at a frequency greater than with standard therapy, and at an incidence greater than 10%, in patients receiving highly emetogenic chemotherapy were asthenia/fatigue (17.8% EMEND vs 11.8% standard therapy), nausea (12.7% vs 11.8%), hiccups (10.8% vs 5.6%), diarrhea (10.3% vs 7.5%), and anorexia (10.1% vs 9.5%).In clinical trials of EMEND, the most common adverse events reported at a frequency greater than with standard therapy in patients receiving moderately emetogenic chemotherapy were alopecia (12.4% EMEND vs 11.9% standard therapy) , dyspepsia (5.8% vs 3.8%), nausea (5.8% vs 5.1%), neutropenia (5.8% vs 5.6%), asthenia (4.7% vs 4.6%), and stomatit is (3.1% vs 2.7%).In clinical trials, EMEND increased the AUC of dexamethasone, a CYP3A4 substrate, by approximately 2.2-fold; therefore, the dexamethasone dose administered in the regimen with EMEND should be reduced by approximately 50% to achieve exposures of dexamethasone similar to those obtained without EMEND. See PRECAUTIONS, Drug Interactions, in the Prescribing Information for EMEND for additional information on dosage adjustment for methylprednisolone when coadministered with EMEND.Please read the Brief Summary of the Prescribing Information for EMEND on the following pages.

References: 1. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: antiemesisV.1.2011. www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed January 5, 2011. 2. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: breast cancerV.2.2011. www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed January 5, 2011. 3. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: non-small cell lung cancerV.2.2011. www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed January 5, 2011. 4. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: head and neck cancersV.2.2010. www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed January 5, 2011. 5. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: Hodgkin lymphomaV.2.2010. www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed January 5, 2011. 6. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: colon cancerV.2.2011. www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed January 5, 2011. 7. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: rectal cancerV.2.2011. www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed January 5, 2011. 8. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: ovarian cancerV.2.2011. www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed January 5, 2011.

Have you included

EMEND from Cycle 1?

CINV=chemotherapy-induced nausea and vomiting.

Copyright 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. 21050812(2)(901)-EME emend.com

An antiemetic regimen including

Brief Summary of the Prescribing Information for INDICATIONS AND USAGEPrevention of Chemotherapy-Induced Nausea and Vomiting (CINV): EMEND, in combination with other antiemetic agents, is indicated for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC), including high-dose cisplatin; and for prevention of nausea and vomiting associated with

initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

Prevention of Postoperative Nausea and Vomiting (PONV): EMEND is indicated for prevention of postoperative nausea and vomiting.

Limitations of Use: EMEND has not been studied for treatment of established nausea and vomiting.Chronic continuous administration is not recommended.

CONTRAINDICATIONSEMEND is contraindicated in patients who are hypersensitive to any component of the product.

EMEND is a dose-dependent inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4). EMEND should not be used concurrently with pimozide, terfenadine, astemizole, or cisapride. Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions [see Drug Interactions].

WARNINGS AND PRECAUTIONSCYP3A4 Interactions: EMEND, a dose-dependent inhibitor of CYP3A4, should be used with caution in patients receiving concomitant medications that are primarily metabolized through CYP3A4. Moderate inhibition of CYP3A4 by aprepitant, 125-mg/80-mg regimen, could result in elevated plasma concentrations of these concomitant medications.

Weak inhibition of CYP3A4 by a single 40-mg dose of aprepitant is not expected to alter the plasma concentrations of concomitant medications that are primarily metabolized through CYP3A4 to a clinically signifi cant degree.

When aprepitant is used concomitantly with another CYP3A4 inhibitor, aprepitant plasma concentrations could be elevated. When EMEND is used concomitantly with medications that induce CYP3A4 activity, aprepitant plasma concentrations could be reduced and this may result in decreased effi cacy of EMEND [see Drug Interactions].

Chemotherapy agents that are known to be metabolized by CYP3A4 include docetaxel, paclitaxel, etoposide, irinotecan, ifosfamide, imatinib, vinorelbine, vinblastine, and vincristine. In clinical studies, EMEND (125-mg/80-mg regimen) was administered commonly with etoposide, vinorelbine, or paclitaxel. The doses of these agents were not adjusted to account for potential drug interactions.

In separate pharmacokinetic studies no clinically signifi cant change in docetaxel or vinorelbine pharmacokinetics was observed when EMEND (125-mg/80-mg regimen) was coadministered.

Due to the small number of patients in clinical studies who received the CYP3A4 substrates vinblastine, vincristine, or ifosfamide, particular caution and careful monitoring are advised in patients receiving these agents or other chemotherapy agents metabolized primarily by CYP3A4 that were not studied [see Drug Interactions].

Coadministration With Warfarin (a CYP2C9 substrate): Coadministration of EMEND with warfarin may result in a clinically signifi cant decrease in international normalized ratio ( INR) of prothrombin time. In patients on chronic warfarin therapy, the INR should be closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of the 3-day regimen of EMEND with each chemotherapy cycle, or following administration of a single 40-mg dose of EMEND for prevention of postoperative nausea and vomiting [see Drug Interactions].

Coadministration With Hormonal Contraceptives: Upon coadministration with EMEND, the effi cacy of hormonal contraceptives during and for 28 days following the last dose of EMEND may be reduced. Alternative or backup methods of contraception should be used during treatment with EMEND and for 1 month following the last dose of EMEND [see Drug Interactions].Patients With Severe Hepatic Impairment: There are no clinical or pharmacokinetic data in patients with severe hepatic impairment (Child-Pugh score >9). Therefore, caution should be exercised when EMEND is administered in these patients.

Chronic Continuous Use: Chronic continuous use of EMEND for prevention of nausea and vomiting is not recommended because it has not been studied and because the drug interaction profi le may change during chronic continuous use.

ADVERSE REACTIONSThe overall safety of aprepitant was evaluated in approximately 5300 individuals.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not refl ect the rates observed in clinical practice.

Clinical Trials Experience: Chemotherapy-Induced Nausea and Vomiting: Highly Emetogenic Chemotherapy: In 2 well-controlled clinical trials in patients receiving highly emetogenic cancer chemotherapy, 544 patients were treated with aprepitant during Cycle 1 of chemotherapy and 413 of these patients continued into the Multiple-Cycle extension for up to 6 cycles of chemotherapy. EMEND was given in combination with ondansetron and dexamethasone.

In Cycle 1, clinical adverse experiences were reported in approximately 69% of patients treated with the aprepitant regimen compared with approximately 68% of patients treated with standard therapy. Following are the percentage of patients receiving highly emetogenic chemotherapy in Cycle 1 with clinical adverse experiences reported at an incidence of 3% for the aprepitant regimen (n=544) and standard therapy (n=550), respectively:Body as a whole/Site unspecifi ed: asthenia/fatigue: 17.8, 11.8; dizziness: 6.6, 4.4; dehydration: 5.9, 5.1; abdominal pain: 4.6, 3.3; fever: 2.9, 3.5; mucous membrane disorder: 2.6, 3.1

Digestive system: nausea: 12.7, 11.8; constipation: 10.3, 12.2; diarrhea: 10.3, 7.5; vomiting: 7.5, 7.6; heartburn: 5.3, 4.9; gastritis: 4.2, 3.1; epigastric discomfort: 4.0, 3.1

Eyes, ears, nose, and throat: tinnitus: 3.7, 3.8

Hemic and lymphatic system: neutropenia: 3.1, 2.9

Metabolism and nutrition: anorexia: 10.1, 9.5

Nervous system: headache: 8.5, 8.7; insomnia: 2.9, 3.1

Respiratory system: hiccups: 10.8, 5.6

In addition, isolated cases of serious adverse experiences, regardless of causality, of bradycardia, disorientation, and perforating duodenal ulcer were reported in highly emetogenic CINV clinical studies.

Moderately Emetogenic Chemotherapy: During Cycle 1 of 2 moderately emetogenic chemotherapy studies, 868 patients were treated with the aprepitant regimen and 686 of these patients continued into extensions for up to 4 cycles of chemotherapy. In the combined analysis of Cycle 1 data for these 2 studies, adverse experiences were reported in approximately 69% of patients treated with the aprepitant regimen compared with approximately 72% of patients treated with standard therapy.

In the combined analysis of Cycle 1 data for these 2 studies, the adverse-experience profi le in both moderately emetogenic chemotherapy studies was generally comparable to the highly emetogenic chemotherapy studies. Following are the percentage of patients receiving moderately emetogenic chemotherapy in Cycle 1 with clinical adverse experiences reported at an incidence of 3% for the aprepitant regimen (n=868) and standard therapy (n=846), respectively:

Blood and lymphatic system disorders: neutropenia: 5.8, 5.6

Metabolism and nutrition disorders: anorexia: 6.2, 7.2

Psychiatric disorders: insomnia: 2.6, 3.7

Nervous system disorders: headache: 13.2, 14.3; dizziness: 2.8, 3.4

Gastrointestinal disorders: constipation: 10.3, 15.5; diarrhea: 7.6, 8.7; dyspepsia: 5.8, 3.8; nausea: 5.8, 5.1; stomatitis: 3.1, 2.7

Skin and subcutaneous tissue disorders: alopecia: 12.4, 11.9

EMEND (aprepitant) capsules

General disorders and general administration site conditions: fatigue: 15.4, 15.6; asthenia: 4.7, 4.6

In a combined analysis of these 2 studies, isolated cases of serious adverse experiences were similar in the 2 treatment groups.

Highly and Moderately Emetogenic Chemotherapy: The following additional clinical adverse experiences (incidence >0.5% and greater than standard therapy), regardless of causality, were reported in patients treated with the aprepitant regimen in either HEC or MEC studies:

Infections and infestations: candidiasis, herpes simplex, lower respiratory infection, oral candidiasis, pharyngitis, septic shock, upper respiratory infection, urinary tract infection

Neoplasms benign, malignant, and unspecifi ed (including cysts and polyps): malignant neoplasm, nonsmall-cell lung carcinoma

Blood and lymphatic system disorders: anemia, febrile neutropenia, thrombocytopenia

Metabolism and nutrition disorders: appetite decreased, diabetes mellitus, hypokalemia

Psychiatric disorders: anxiety disorder, confusion, depression

Nervous system: peripheral neuropathy, sensory neuropathy, taste disturbance, tremor

Eye disorders: conjunctivitis

Cardiac disorders: myocardial infarction, palpitations, tachycardia

Vascular disorders: deep venous thrombosis, fl ushing, hot fl ush, hypertension, hypotension

Respiratory, thoracic, and mediastinal disorders: cough, dyspnea, nasal secretion, pharyngolaryngeal pain, pneumonitis, pulmonary embolism, respiratory insuffi ciency, vocal disturbance

Gastrointestinal disorders: abdominal pain upper, acid refl ux, deglutition disorder, dry mouth, dysgeusia, dysphagia, eructation, fl atulence, obstipation, salivation increased

Skin and subcutaneous tissue disorders: acne, diaphoresis, pruritus, rash

Musculoskeletal and connective tissue disorders: arthralgia, back pain, muscular weakness, musculoskeletal pain, myalgia

Renal and urinary disorders: dysuria, renal insuffi ciency

Reproductive system and breast disorders: pelvic pain

General disorders and administrative site conditions: edema, malaise, pain, rigors

Investigations: weight loss

Stevens-Johnson syndrome was reported as a serious adverse experience in a patient receiving aprepitant with cancer chemotherapy in another CINV study.

Laboratory Adverse Experiences: Following are the percentage of patients receiving highly emetogenic chemotherapy in Cycle 1 with laboratory adverse experiences reported at an incidence of 3% for the aprepitant regimen (n=544) and standard therapy (n=550), respectively:

Proteinuria: 6.8, 5.3

ALT increased: 6.0, 4.3

Blood urea nitrogen increased: 4.7, 3.5

Serum creatinine increased: 3.7, 4.3

AST increased: 3.0, 1.3

The following additional laboratory adverse experiences (incidence >0.5% and greater than standard therapy), regardless of causality, were reported in patients treated with the aprepitant regimen: alkaline phosphatase increased, hyperglycemia, hyponatremia, leukocytes increased, erythrocyturia, leukocyturia.

The adverse-experience profi les in the Multiple-Cycle extensions of HEC and MEC studies for up to 6 cycles of chemotherapy were generally similar to that observed in Cycle 1.

Postoperative Nausea and Vomiting: In well-controlled clinical studies in patients receiving general anesthesia, 564 patients were administered 40-mg aprepitant orally and 538 patients were administered 4-mg ondansetron IV.

Clinical adverse experiences were reported in approximately 60% of patients treated with 40-mg aprepitant compared with approximately 64% of patients treated with 4-mg ondansetron IV. Following are the percentage of patients receiving general anesthesia with clinical adverse experiences reported at an incidence of 3% in the combined studies for aprepitant 40 mg (n=564) and ondansetron (n=538), respectively:

Infections and infestations: urinary tract infection: 2.3, 3.2

Blood and lymphatic system disorders: anemia: 3.0, 4.3

Psychiatric disorders: insomnia: 2.1, 3.3

Nervous system disorders: headache: 5.0, 6.5

Cardiac disorders: bradycardia: 4.4, 3.9

Vascular disorders: hypotension: 5.7, 4.6; hypertension: 2.1, 3.2

Gastrointestinal disorders: nausea: 8.5, 8.6; constipation: 8.5, 7.6; fl atulence: 4.1, 5.8; vomiting 2.5, 3.9

Skin and subcutaneous tissue disorders: pruritus: 7.6, 8.4

General disorders and general administration site conditions: pyrexia: 5.9, 10.6

The following additional clinical adverse experiences (incidence >0.5% and greater than ondansetron), regardless of causality, were reported in patients treated with aprepitant:

Infections and infestations: postoperative infection

Metabolism and nutrition disorders: hypokalemia, hypovolemia

Nervous system disorders: dizziness, hypoesthesia, syncope

Vascular disorders: hematoma

Respiratory, thoracic, and mediastinal disorders: dyspnea, hypoxia, respiratory depression

Gastrointestinal disorders: abdominal pain, abdominal pain upper, dry mouth, dyspepsia

Skin and subcutaneous tissue disorders: urticaria

General disorders and administrative site conditions: hypothermia, pain

Investigations: blood pressure decreased

Injury, poisoning, and procedural complications: operative hemorrhage, wound dehiscence

Other adverse experiences (incidence 0.5%) reported in patients treated with aprepitant 40 mg for postoperative nausea and vomiting included:

Nervous system disorders: dysarthria, sensory disturbance

Eye disorders: miosis, visual acuity reduced

Respiratory, thoracic, and mediastinal disorders: wheezing

Gastrointestinal disorders: bowel sounds abnormal, stomach discomfort

There were no serious adverse drug-related experiences reported in the postoperative nausea and vomiting clinical studies in patients taking 40-mg aprepitant.

Laboratory Adverse Experiences: One laboratory adverse experience, hemoglobin decreased (40-mg aprepitant 3.8%, ondansetron 4.2%), was reported at an incidence 3% in a patient receiving general anesthesia.The following additional laboratory adverse experiences (incidence >0.5% and greater than ondansetron), regardless of causality, were reported in patients treated with aprepitant 40 mg: blood albumin decreased, blood bilirubin increased, blood glucose increased, blood potassium decreased, glucose urine present.

The adverse experience of increased ALT occurred with similar incidence in patients treated with aprepitant 40 mg (1.1%) as in patients treated with ondansetron 4 mg (1.0%).

Other Studies: In addition, 2 serious adverse experiences were reported in postoperative nausea and vomiting (PONV) clinical studies in patients taking a higher dose of aprepitant: 1 case of constipation, and 1 case of subileus.

CAPSULES

Angioedema and urticaria were reported as serious adverse experiences in a patient receiving aprepitant in a non-CINV/non-PONV study.

Postmarketing Experience: The following adverse reactions have been identifi ed during postmarketing use of aprepitant. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to the drug.

Skin and subcutaneous tissue disorders: pruritus, rash, urticaria

Immune system disorders: hypersensitivity reactions including anaphylactic reactions

DRUG INTERACTIONS Aprepitant is a substrate, a weak-to-moderate (dose-dependent) inhibitor, and an inducer of CYP3A4. Aprepitant is also an inducer of CYP2C9.

Effect of Aprepitant on the Pharmacokinetics of Other Agents: CYP3A4 substrates: Weak inhibition of CYP3A4 by a single 40-mg dose of aprepitant is not expected to alter the plasma concentrations of concomitant medications that are primarily metabolized through CYP3A4 to a clinically signifi cant degree. However, higher aprepitant doses or repeated dosing at any aprepitant dose may have a clinically signifi cant effect.

As a moderate inhibitor of CYP3A4 at a dose of 125 mg/80 mg, aprepitant can increase plasma concentrations of concomitantly administered oral medications that are metabolized through CYP3A4 [see Contraindications]. The use of fosaprepitant may increase CYP3A4 substrate plasma concentrations to a lesser degree than the use of oral aprepitant (125 mg).

5-HT3 antagonists: In clinical drug interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of ondansetron, granisetron, or hydrodolasetron (the active metabolite of dolasetron).

Corticosteroids: Dexamethasone: EMEND, when given as a regimen of 125 mg with dexamethasone coadministered orally as 20 mg on Day 1, and EMEND when given as 80 mg/day with dexamethasone coadministered orally as 8 mg on Days 2 through 5, increased the AUC of dexamethasone, a CYP3A4 substrate, by 2.2-fold on Days 1 and 5. The oral dexamethasone doses should be reduced by approximately 50% when coadministered with EMEND (125-mg/80-mg regimen), to achieve exposures of dexamethasone similar to those obtained when it is given without EMEND. The daily dose of dexamethasone administered in clinical chemotherapy-induced nausea and vomiting studies with EMEND refl ects an approximate 50% reduction of the dose of dexamethasone. A single dose of EMEND (40 mg) when coadministered with a single oral dose of dexamethasone 20 mg, increased the AUC of dexamethasone by 1.45-fold. Therefore, no dose adjustment is recommended.

Methylprednisolone: EMEND, when given as a regimen of 125 mg on Day 1 and 80 mg/day on Days 2 and 3, increased the AUC of methylprednisolone, a CYP3A4 substrate, by 1.34-fold on Day 1 and by 2.5-fold on Day 3, when methylprednisolone was coadministered intravenously as 125 mg on Day 1 and orally as 40 mg on Days 2 and 3. The IV methylprednisolone dose should be reduced by approximately 25% and the oral methylprednisolone dose should be reduced by approximately 50% when coadministered with EMEND (125-mg/80-mg regimen) to achieve exposures of methylprednisolone similar to those obtained when it is given without EMEND. Although the concomitant administration of methylprednisolone with the single 40-mg dose of aprepitant has not been studied, a single 40-mg dose of EMEND produces a weak inhibition of CYP3A4 (based on midazolam interaction study) and it is not expected to alter the plasma concentrations of methylprednisolone to a clinically signifi cant degree. Therefore, no dose adjustment is recommended.

Chemotherapeutic agents: [see Warnings and Precautions] Docetaxel: In a pharmacokinetic study, EMEND (125-mg/80-mg regimen) did not infl uence the pharmacokinetics of docetaxel.

Vinorelbine: In a pharmacokinetic study, EMEND (125-mg/80-mg regimen) did not infl uence the pharmacokinetics of vinorelbine to a clinically signifi cant degree.

CYP2C9 substrates (warfarin, tolbutamide): Aprepitant has been shown to induce the metabolism of S() warfarin and tolbutamide, which are metabolized through CYP2C9. Coadministration of EMEND with these drugs or other drugs that are known to be metabolized by CYP2C9, such as phenytoin, may result in lower plasma concentrations of these drugs.

Warfarin: A single 125-mg dose of EMEND was administered on Day 1 and 80 mg/day on Days 2 and 3 to healthy subjects who were stabilized on chronic warfarin therapy. Although there was no effect of EMEND on the plasma AUC of R(+) or S() warfarin determined on Day 3, there was a 34% decrease in S() warfarin (a CYP2C9 substrate) trough concentration accompanied by a 14% decrease in the prothrombin time (reported as international normalized ratio or INR) 5 days after completion of dosing with EMEND. In patients on chronic warfarin therapy, the prothrombin time (INR) should be closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of the 3-day regimen of EMEND with each chemotherapy cycle, or following administration of a single 40-mg dose of EMEND for prevention of postoperative nausea and vomiting.

Tolbutamide: EMEND, when given as 125 mg on Day 1 and 80 mg/day on Days 2 and 3, decreased the AUC of tolbutamide (a CYP2C9 substrate) by 23% on Day 4, 28% on Day 8, and 15% on Day 15, when a single dose of tolbutamide 500 mg was administered orally prior to the administration of the 3-day regimen of EMEND and on Days 4, 8, and 15.

EMEND, when given as a 40-mg single oral dose on Day 1, decreased the AUC of tolbutamide (a CYP2C9 substrate) by 8% on Day 2, 16% on Day 4, 15% on Day 8, and 10% on Day 15, when a single dose of tolbutamide 500 mg was administered orally prior to the administration of EMEND 40 mg and on Days 2, 4, 8, and 15. This effect was not considered clinically important.

Oral contraceptives: Aprepitant, when given once daily for 14 days as a 100-mg capsule with an oral contraceptive containing 35 mcg of ethinyl estradiol and 1 mg of norethindrone, decreased the AUC of ethinyl estradiol by 43%, and decreased the AUC of norethindrone by 8%.

In another study, a daily dose of an oral contraceptive containing ethinyl estradiol and norethindrone was administered on Days 1 through 21, and EMEND was given as a 3-day regimen of 125 mg on Day 8 and 80 mg/day on Days 9 and 10 with ondansetron 32 mg IV on Day 8 and oral dexamethasone given as 12 mg on Day 8 and 8 mg/day on Days 9, 10, and 11. In the study, the AUC of ethinyl estradiol decreased by 19% on Day 10 and there was as much as a 64% decrease in ethinyl estradiol trough concentrations during Days 9 through 21. While there was no effect of EMEND on the AUC of norethindrone on Day 10, there was as much as a 60% decrease in norethindrone trough concentrations during Days 9 through 21.

In another study, a daily dose of an oral contraceptive containing ethinyl estradiol and norgestimate (which is converted to norelgestromin) was administered on Days 1 through 21, and EMEND 40 mg was given on Day 8. In the study, the AUC of ethinyl estradiol decreased by 4% and 29% on Day 8 and Day 12, respectively, while the AUC of norelgestromin increased by 18% on Day 8 and decreased by 10% on Day 12. In addition, the trough concentrations of ethinyl estradiol and norelgestromin on Days 8 through 21 were generally lower following coadministration of the oral contraceptive with EMEND 40 mg on Day 8 compared to the trough levels following administration of the oral contraceptive alone.

The coadministration of EMEND may reduce the effi cacy of hormonal contraceptives (these can include birth control pills, skin patches, implants, and certain IUDs) during and for 28 days after administration of the last dose of EMEND. Alternative or backup methods of contraception should be used during treatment with EMEND and for 1 month following the last dose of EMEND.

Midazolam: EMEND increased the AUC of midazolam, a sensitive CYP3A4 substrate, by 2.3-fold on Day 1 and 3.3-fold on Day 5, when a single oral dose of midazolam 2 mg was coadministered on Day 1 and Day 5 of a regimen of EMEND 125 mg on Day 1 and 80 mg/day on Days 2 through 5. The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) should be considered when coadministering these agents with EMEND (125 mg/80 mg). A single dose of EMEND (40 mg) increased the AUC of midazolam by 1.2-fold on Day 1, when a single oral dose of midazolam 2 mg was coadministered on Day 1 with EMEND 40 mg; this effect was not considered clinically important.

In another study with intravenous administration of midazolam, EMEND was given as 125 mg on Day 1 and 80 mg/day on Days 2 and 3, and midazolam 2 mg IV was given prior to the administration of the 3-day regimen of EMEND and on Days 4, 8, and 15. EMEND increased the AUC of midazolam by 25% on Day 4 and decreased the AUC of midazolam by 19% on Day 8 relative to the dosing of EMEND on Days 1 through 3. These effects were not considered clinically important. The AUC of midazolam on Day 15 was similar to that observed at baseline.

An additional study was completed with intravenous administration of midazolam and EMEND. Intravenous midazolam 2 mg was given 1 hour after oral administration of a single dose of EMEND 125 mg. The plasma AUC of midazolam was increased by 1.5-fold. Depending on clinical situations (eg, elderly patients) and degree of

monitoring available, dosage adjustment for intravenous midazolam may be necessary when it is coadministered with EMEND for the chemotherapy-induced nausea and vomiting indication (125 mg on Day 1 followed by 80 mg on Days 2 and 3).

Effect of Other Agents on the Pharmacokinetics of Aprepitant: Aprepitant is a substrate for CYP3A4; therefore, coadministration of EMEND with drugs that inhibit CYP3A4 activity may result in increased plasma concentrations of aprepitant. Consequently, concomitant administration of EMEND with strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfi navir) should be approached with caution. Because moderate CYP3A4 inhibitors (eg, diltiazem) result in a 2-fold increase in plasma concentrations of aprepitant, concomitant administration should also be approached with caution.

Aprepitant is a substrate for CYP3A4; therefore, coadministration of EMEND with drugs that strongly induce CYP3A4 activity (eg, rifampin, carbamazepine, phenytoin) may result in reduced plasma concentrations of aprepitant that may result in decreased effi cacy of EMEND.

Ketoconazole: When a single 125-mg dose of EMEND was administered on Day 5 of a 10-day regimen of 400 mg/day of ketoconazole, a strong CYP3A4 inhibitor, the AUC of aprepitant increased approximately 5-fold and the mean terminal half-life of aprepitant increased approximately 3-fold. Concomitant administration of EMEND with strong CYP3A4 inhibitors should be approached cautiously.

Rifampin: When a single 375-mg dose of EMEND was administered on Day 9 of a 14-day regimen of 600 mg/day of rifampin, a strong CYP3A4 inducer, the AUC of aprepitant decreased approximately 11-fold and the mean terminal half-life decreased approximately 3-fold.

Coadministration of EMEND with drugs that induce CYP3A4 activity may result in reduced plasma concentrations and decreased effi cacy of EMEND.

Additional Interactions: EMEND is unlikely to interact with drugs that are substrates for the P-glycoprotein transporter, as demonstrated by the lack of interaction of EMEND with digoxin in a clinical drug interaction study.

Diltiazem: In patients with mild to moderate hypertension, administration of aprepitant once daily, as a tablet formulation comparable to 230 mg of the capsule formulation, with diltiazem 120 mg 3 times daily for 5 days, resulted in a 2-fold increase of aprepitant AUC and a simultaneous 1.7-fold increase of diltiazem AUC. These pharmacokinetic effects did not result in clinically meaningful changes in ECG, heart rate, or blood pressure beyond those changes induced by diltiazem alone.

Paroxetine: Coadministration of once-daily doses of aprepitant, as a tablet formulation comparable to 85 mg or 170 mg of the capsule formulation, with paroxetine 20 mg once daily, resulted in a decrease in AUC by approximately 25% and Cmax by approximately 20% of both aprepitant and paroxetine.

USE IN SPECIFIC POPULATIONSPregnancy: Teratogenic effects: Pregnancy Category B: Reproduction studies have been performed in rats at oral doses up to 1000 mg/kg twice daily (plasma AUC of 31.3 mcghr/mL, about 1.6 times the human exposure at the recommended dose) and in rabbits at oral doses up to 25 mg/kg/day (plasma AUC of 26.9 mcghr/mL, about 1.4 times the human exposure at the recommended dose) and have revealed no evidence of impaired fertility or harm to the fetus due to aprepitant. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers: Aprepitant is excreted in the milk of rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for possible serious adverse reactions in nursing infants from aprepitant and because of the potential for tumorigenicity shown for aprepitant in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness of EMEND in pediatric patients have not been established.Geriatric Use: In 2 well-controlled chemotherapy-induced nausea and vomiting clinical studies, of the total number of patients (N=544) treated with EMEND, 31% were 65 and over, while 5% were 75 and over. In well-controlled postoperative nausea and vomiting clinical studies, of the total number of patients (N=1120) treated with EMEND, 7% were 65 and over, while 2% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment in the elderly is not necessary.

NONCLINICAL TOXICOLOGYCarcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity studies were conducted in Sprague-Dawley rats and in CD-1 mice for 2 years. In the rat carcinogenicity studies, animals were treated with oral doses ranging from 0.05 to 1000 mg/kg twice daily. The highest dose produced a systemic exposure to aprepitant (plasma AUC ) of 0.7 to 1.6 times the human exposure (AUC =19.6 mcghr/mL) at the recommended dose of 125 mg/day. Treatment with aprepitant at doses of 5 to 1000 mg/kg twice daily caused an increase in the incidences of thyroid follicular cell adenomas and carcinomas in male rats. In female rats, it produced hepatocellular adenomas at 5 to 1000 mg/kg twice daily and hepatocellular carcinomas and thyroid follicular cell adenomas at 125 to 1000 mg/kg twice daily. In the mouse carcinogenicity studies, the animals were treated with oral doses ranging from 2.5 to 2000 mg/kg/day. The highest dose produced a systemic exposure of about 2.8 to 3.6 times the human exposure at the recommended dose. Treatment with aprepitant produced skin fi brosarcomas at 125 and 500 mg/kg/day doses in male mice.

Aprepitant was not genotoxic in the Ames test, the human lymphoblastoid cell (TK6) mutagenesis test, the rat hepatocyte DNA strand break test, the Chinese hamster ovary (CHO) cell chromosome aberration test, and the mouse micronucleus test.

Aprepitant did not affect the fertility or general reproductive performance of male or female rats at doses up to the maximum feasible dose of 1000 mg/kg twice daily (providing exposure in male rats lower than the exposure at the recommended human dose and exposure in female rats at about 1.6 times the human exposure).

PATIENT COUNSELING INFORMATION[See FDA-Approved Patient Labeling.] Instructions: Physicians should instruct their patients to read the patient package insert before starting therapy with EMEND and to reread it each time the prescription is renewed.

Patients should be instructed to take EMEND only as prescribed. For prevention of chemotherapy-induced nausea and vomiting (CINV), patients should be advised to take their fi rst dose (125 mg) of EMEND 1 hour prior to chemotherapy treatment. For prevention of postoperative nausea and vomiting (PONV), patients should receive their medication (40-mg capsule of EMEND) within 3 hours prior to induction of anesthesia.

Allergic reactions, which may be serious, and may include hives, rash, and itching, and cause diffi culty in breathing or swallowing, have been reported in general use with EMEND. Physicians should instruct their patients to stop taking EMEND and call their doctor right away if they experience an allergic reaction.

EMEND may interact with some drugs including chemotherapy; therefore, patients should be advised to report to their doctor the use of any other prescription or nonprescription medication or herbal products.

Patients on chronic warfarin therapy should be instructed to have their clotting status closely monitored in the 2-week period, particularly at 7 to 10 days, following initiation of the 3-day regimen of EMEND 125 mg/80 mg with each chemotherapy cycle, or following administration of a single 40-mg dose of EMEND for prevention of postoperative nausea and vomiting.

Administration of EMEND may reduce the effi cacy of hormonal contraceptives. Patients should be advised to use alternative or backup methods of contraception during treatment with EMEND and for 1 month following the last dose of EMEND.

For detailed information, please read the Prescribing Information.Rx only

Copyright 2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.All rights reserved. 21050812(2)(901)-EME

EMEND (aprepitant) capsules

COMING SOON for your hemophilia A patients

*Clnicamente probado que minimiza los picos de glucosa en sangre comparado con otros productos nutricionales de uso general.Use los productos Glucerna bajo supervisin mdica como parte de su plan de alimentacin para la diabetes.

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el tiempo pueden ayudar a reducir los niveles de A1C.

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iPro Continuous Glucose Monitoring (CGM) can help you discover glycemic excursions not revealed by self-monitoring of blood glucose (SMBG) alone

The American Diabetes Association recommends that patients with diabetes using multiple insulin injections perform SMBG three or more times daily1

iPro CGM provides up to 12 glucose values per hour and up to 288 values per day,2 a rate unrealistic for patients to achieve with SMBG alone

Get the insights you need to make informed treatment decisions

Continuous Glucose Monitoring aided identi cation of unrecognized hypoglycemia in patients with type 1 diabetes3

Continuous Glucose Monitoring assisted in determining insulin therapy modi cations3

Indications for Use

iPro CGM is intended to continuously record interstitial glucose levels in persons with diabetes mellitus

This information is intended to supplement, not replace, blood glucose information obtained using standard home glucose monitoring devices

Please see Important Safety Information on adjacent page or request a copy of the iPro CGM user guides from your Medtronic sales representative.

For more information, please contact Medtronic at 1-888-350-3245.

Indications for Use

The CGMS iPro Digital Recorder is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace, blood glucose information obtained using standard home glucose monitoring devices. The information collected by the digital recorder may be downloaded and displayed on a computer and reviewed by healthcare professionals.

This information may allow identi cation of patterns of glucose-level excursions above or below the desired range, facilitating therapy adjustments which may minimize these excursions.

The CGMS iPro Digital Recorder:

Is intended for prescription use only.

Will not allow readings to be made available directly to patients in real time.

Provides readings that will be available for review by physicians after the recording interval (72 hours).

Is currently intended for occasional rather than everyday use.

Is to be used only as a supplement to, and not a replacement for, standard invasive measurement.

Is not intended to change patient management based on the numbers generated, but to guide future management of the patient based on response to trends noticed. That is, these trends or patterns may be used to suggest when to take ngerstick glucose measurements to better manage the patient.

The glucose sensor, tester, charger, and CGMS iProWand are intended for use with the CGMS iPro Digital Recorder. The Sen-serter device is indicated only for insertion of the Medtronic MiniMed glucose sensor.

Important Safety Information

Contraindication

Do not use magnetic mattress pads while wearing the CGMS iPro Digital Recorder.

Warning

Product contains small parts and may pose a choking hazard for young children.

Important Safety Information, continued

Sensor

The glucose sensor should be removed if redness, bleeding, pain, tenderness, irritation, or in ammation develops at insertion site, or if you experience unexplained fever. An optional occlusive dressing should be removed if irritation or reaction to the tape develops.

The glucose sensor may create special needs regarding your patients medical conditions or medications. Healthcare professionals should discuss this with their patients before they use the glucose sensor.

Wait 5 minutes after glucose sensor insertion before setting up the CGMS iPro Digital Recorder with Solutions CGMS iPro.

Make sure that the site is not bleeding before connection.

If bleeding occurs, apply steady pressure with a sterile gauze or clean cloth at the insertion site until bleeding stops. After bleeding stops, attach the digital recorder to the glucose sensor.

If bleeding persists after 3 minutes, remove the glucose sensor and discard. Insert a new glucose sensor in a different location.

Contact the 24 Hour HelpLine if you experience any adverse reactions associated with the digital recorder or glucose sensor.

Precautions

If performing multiple CGMS iPro Digital Recorder studies on the same patient, establish a rotation schedule for choosing new glucose sensor sites. Avoid sites that are constrained by clothing, have scar tissue, or are subject to rigorous movement during exercise.

For additional information, please consult the iPro CGM user guides.

iPro is a trademark of Medtronic MiniMed, Inc.Sen-serter is a registered trademark of Medtronic MiniMed, Inc.

References

1. American Diabetes Association. Diabetes Care. 2010;33(suppl 1):S11-S61.

2. Solutions Software for CGMS iPro Continuous Glucose Recorder User Guide.

3. Chico A, Vidal-Rios P, Subira M, Novials A. Diabetes Care. 2003;26:1153-1157.

9403750-011 20100708 Medtronic MiniMed, Inc. 2010. All rights reserved. HI66161 0810 PRINTED IN USA 2010, LILLY USA, LLC. ALL RIGHTS RESERVED.

But it first needs to fit your patients life.

Important Safety Information for Humalog, continued

Warnings and Precautions, continued differentorlesspronouncedunderconditionssuchaslong-standingdiabetes,diabeticnervedisease,useofmedicationssuchasbeta-blockers,orintensifieddiabetescontrol.Thesesituationsmayresultinseverehypoglycemiaandpossiblylossofconsciousnesspriortothepatientsawarenessofhypoglycemia.Severehypoglycemiamaybelifethreateningandcancauseseizuresordeath.

Usecautioninpatientswithhypoglycemiaunawarenessandwhomaybepredisposedtohypoglycemia.Thepatientsabilitytoconcentrateandreactmaybeimpairedasaresultofhypoglycemia.Rapidchangesinserumglucoselevelsmayinducesymptomssimilartohypoglycemiainpersonswithdiabetes,regardlessoftheglucosevalue.

Timingofhypoglycemiausuallyreflectsthetime-actionprofileofadministeredinsulins.Otherfactorssuchas

Important Safety Information for Humalog, continued

Warnings and Precautions, continued changesinfoodintake,injectionsite,exercise,andconcomitantmedicationsmayaltertheriskofhypoglycemia.

(continuedonnextpage)

See Brief Summary of Prescribing Information on following pages.

Please see full user manual that accompanies the pen.

Important Safety Information for Humalog, continued

Warnings and Precautions, continuedAllergic Reactions:Severe,life-threatening,generalizedallergy,includinganaphylaxis,canoccurwithHumalog.

Hypokalemia:Humalogcancausehypokalemia,which,ifuntreated,mayresultinrespiratoryparalysis,ventriculararrhythmia,anddeath.Usecautioninpatientswhomaybeatriskforhypokalemia(eg,patientsusingpotassium-loweringmedicationsormedicationssensitivetoserumpotassiumconcentrations).

Renal or Hepatic Impairment:Frequentglucosemonitoringandinsulindosereductionmayberequiredinpatientswithrenalorhepaticimpairment.

Mixing of Insulins:HumalogforsubcutaneousinjectionshouldnotbemixedwithinsulinsotherthanNPHinsulin.IfHumalogismixedwithNPHinsulin,Humalogshouldbedrawnintothesyringefirst.Injectionshouldoccurimmediatelyaftermixing.

Subcutaneous Insulin Infusion Pump: Humalogshouldnotbedilutedormixedwhenusedinanexternalinsulinpump.ChangeHumaloginthereservoiratleastevery7days.Changetheinfusionsetandinsertionsiteatleastevery3days.

Malfunctionoftheinsulinpumporinfusionsetorinsulindegradationcanrapidlyleadtohyperglycemiaandketosis.Promptcorrectionofthecauseofhyperglycemiaorketosisisnecessary.InterimsubcutaneousinjectionswithHumalogmayberequired.Trainpatientsusinganinsulinpumptoadministerinsulinbyinjectionandtohavealternateinsulintherapyavailableincaseofpumpfailure.

Important Safety Information for Humalog, continued

Warnings and Precautions, continuedDrug Interactions: Somemedicationsmayalterglucosemetabolism,insulinrequirements,andtheriskforhypoglycemiaorhyperglycemia.Signsofhypoglycemiamaybereducedorabsentinpatientstakinganti-adrenergicdrugs.Particularlyclosemonitoringmayberequired.

Adverse ReactionsAdversereactionsassociatedwithHumalogincludehypoglycemia,hypokalemia,allergicreactions,injection-sitereactions,lipodystrophy,pruritus,rash,weightgain,andperipheraledema.

Use in Specific PopulationsPediatrics: Humaloghasnotbeenstudiedinchildrenwithtype1diabeteslessthan3yearsofageorinchildrenwithtype2diabetes.

Dosage and AdministrationHumalogshouldbegivenwithin15minutesbeforeorimmediatelyafterameal.

See Brief Summary of Prescribing Information on following pages.

Please see full user manual that accompanies the pen.

HIHCPISI08JUN2011

Humalog isaregisteredtrademarkofEliLillyandCompanyandisavailablebyprescriptiononly.

HI72766 0611 PRINTED IN USA Lilly USA, LLC 2011. All rights reserved.

Humalog (insulin lispro injection [rDNA origin]) Brief Summary: Consult the package insert for complete prescribing information.

INDICATIONS AND USAGE HUMALOG is an insulin analog indicated to improve glycemic control in adults and

children with diabetes mellitus.

CONTRAINDICATIONSHUMALOG is contraindicated:

during episodes of hypoglycemia in patients who are hypersensitive to HUMALOG or to any of its excipients.

WARNINGS AND PRECAUTIONSDose Adjustment and Monitoring Glucose monitoring is essential for patients receiving insulin therapy. Changes to an insulin regimen should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose. Concomitant oral antidiabetic treatment may need to be adjusted.

As with all insulin preparations, the time course of action for HUMALOG may vary in different individuals or at different times in the same individual and is dependent on many conditions, including the site of injection, local blood supply, or local temperature. Patients who change their level of physical activity or meal plan may require adjustment of insulin dosages.

Hypoglycemia Hypoglycemia is the most common adverse effect associated with insulins, including HUMALOG. The risk of hypoglycemia increases with tighter glycemic control. Patients must be educated to recognize and manage hypoglycemia. Hypoglycemia can happen suddenly and symptoms may be different for each person and may change from time to time. Severe hypoglycemia can cause seizures and may be life-threatening or cause death.

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulations. Other factors such as changes in food intake (e.g., amount of food or timing of meals), injection site, exercise, and concomitant medications may also alter the risk of hypoglycemia [see Drug Interactions].

As with all insulins, use caution in patients with hypoglycemia unawareness and in patients who may be predisposed to hypoglycemia (e.g., the pediatric population and patients who fast or have erratic food intake). The patients ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery.

Rapid changes in serum glucose levels may induce symptoms similar to hypoglycemia in persons with diabetes, regardless of the glucose value. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as longstanding diabetes, diabetic nerve disease, use of medications such as beta-blockers [see Drug Interactions], or intensified diabetes control. These situations may result in severe hypoglycemia (and, possibly, loss of consciousness) prior to the patients awareness of hypoglycemia.

Hypersensitivity and Allergic Reactions Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including HUMALOG [see Adverse Reactions].

Hypokalemia All insulin products, including HUMALOG, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Use caution in patients who may be at risk for hypokalemia (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).

Renal or Hepatic Impairment Frequent glucose monitoring and insulin dose reduction may be required in patients with renal or hepatic impairment.

Mixing of Insulins HUMALOG for subcutaneous injection should not be mixed with insulin preparations other than NPH insulin. If HUMALOG is mixed with NPH insulin, HUMALOG should be drawn into the syringe first. Injection should occur immediately after mixing.

Do not mix HUMALOG with other insulins for use in an external subcutaneous infusion pump.

Subcutaneous Insulin Infusion Pumps When used in an external insulin pump for subcutaneous infusion, HUMALOG should not be diluted or mixed with any other insulin. Change the HUMALOG in the reservoir at least every 7 days, change the infusion sets and the infusion set insertion site at least every 3 days. HUMALOG should not be exposed to temperatures greater than 98.6F (37C).

Malfunction of the insulin pump or infusion set or insulin degradation can rapidly lead to hyperglycemia and ketosis. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Interim subcutaneous injections with HUMALOG may be required. Patients using continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure [see Dosage and Administration and How Supplied/Storage and Handling].

Drug Interactions Some medications may alter insulin requirements and the risk for hypoglycemia or hyperglycemia [see Drug Interactions].

ADVERSE REACTIONSThe following adverse reactions are discussed elsewhere: Hypoglycemia [see Warnings and Precautions]. Hypokalemia [see Warnings and Precautions].

Clinical Trial Experience Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared with those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.

The frequencies of Treatment-Emergent Adverse Events during HUMALOG clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.

Table 1: Treatment-Emergent Adverse Events in Patients with Type 1 Diabetes Mellitus (adverse events with frequency 5%)

Events, n (%) Lispro(n=81)

Regular human insulin (n=86)

Total(n=167)

Flu syndrome 28 (34.6) 28 (32.6) 56 (33.5)

Pharyngitis 27 (33.3) 29 (33.7) 56 (33.5)

Rhinitis 20 (24.7) 25 (29.1) 45 (26.9)

Headache 24 (29.6) 19 (22.1) 43 (25.7)

Pain 16 (19.8) 14 (16.3) 30 (18.0)

Cough increased 14 (17.3) 15 (17.4) 29 (17.4)

Infection 11 (13.6) 18 (20.9) 29 (17.4)

Nausea 5 (6.2) 13 (15.1) 18 (10.8)

Accidental injury 7 (8.6) 10 (11.6) 17 (10.2)

Surgical procedure 5 (6.2) 12 (14.0) 17 (10.2)

Fever 5 (6.2) 10 (11.6) 15 (9.0)

Abdominal pain 6 (7.4) 7 (8.1) 13 (7.8)

Asthenia 6 (7.4) 7 (8.1) 13 (7.8)

Bronchitis 6 (7.4) 6 (7.0) 12 (7.2)

Diarrhea 7 (8.6) 5 (5.8) 12 (7.2)

Dysmenorrhea 5 (6.2) 6 (7.0) 11 (6.6)

Myalgia 6 (7.4) 5 (5.8) 11 (6.6)

Urinary tract infection

5 (6.2) 4 (4.7) 9 (5.4)

Table 2: Treatment-Emergent Adverse Events in Patients with Type 2 Diabetes Mellitus (adverse events with frequency 5%)

Events, n (%) Lispro(n=714)

Regular human insulin (n=709)

Total(n=1423)

Headache 63 (11.6) 66 (9.3) 149 (10.5)

Pain 77 (10.8) 71 (10.0) 148 (10.4)

Infection 72 (10.1) 54 (7.6) 126 (8.9)

Pharyngitis 47 (6.6) 58 (8.2) 105 (7.4)

Rhinitis 58 (8.1) 47 (6.6) 105 (7.4)

Flu syndrome 44 (6.2) 58 (8.2) 102 (7.2)

Surgical procedure 53 (7.4) 48 (6.8) 101 (7.1)

Insulin initiation and intensification of glucose control Intensification or rapid improvement in glucose control has been associated with a

transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.

Lipodystrophy Long-term use of insulin, including HUMALOG, can cause lipodystrophy at the site of

repeated insulin injections or infusion. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption. Rotate insulin injection or infusion sites within the same region to reduce the risk of lipodystrophy [see Dosage and Administration].

Weight gain Weight gain can occur with insulin therapy, including HUMALOG, and has been

attributed to the anabolic effects of insulin and the decrease in glucosuria.

Peripheral Edema Insulin, including HUMALOG, may cause sodium retention and edema, particularly if

previously poor metabolic control is improved by intensified insulin therapy.

Adverse Reactions with Continuous Subcutaneous Insulin Infusion (CSII) In a 12-week, randomized, crossover study in adult patients with type 1 diabetes

(n 39), the rates of catheter occlusions and infusion site reactions were similar for HUMALOG and regular human insulin treated patients (see Table 3).

Table 3: Catheter Occlusions and Infusion Site Reactions

HUMALOG(n 38)

Regular human insulin(n 39)

Catheter occlusions/month

0.09 0.10

Infusion site reactions 2.6% (1/38) 2.6% (1/39)

In a randomized, 16-week, open-label, parallel design study of children and adolescents with type 1 diabetes, adverse event reports related to infusion-site reactions were similar for insulin lispro and insulin aspart (21% of 100 patients versus 17% of 198 patients, respectively). In both groups, the most frequently reported infusion site adverse events were infusion site erythema and infusion site reaction.

Allergic Reactions Local AllergyAs with any insulin therapy, patients taking HUMALOG may experience

redness, swelling, or itching at the site of the injection. These minor reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation of HUMALOG. In some instances, these reactions may be related to factors other than insulin, such as irritants in a skin cleansing agent or poor injection technique.

Systemic AllergySevere, life-threatening, generalized allergy, including anaphylaxis, may occur with any insulin, including HUMALOG. Generalized allergy to insulin may cause whole body rash (including pruritus), dyspnea, wheezing, hypotension, tachycardia, or diaphoresis.

In controlled clinical trials, pruritus (with or without rash) was seen in 17 patients receiving regular human insulin (n 2969) and 30 patients receiving HUMALOG (n 2944).

Localized reactions and generalized myalgias have been reported with injected metacresol, which is an excipient in HUMALOG [see Contraindications].

Antibody Production In large clinical trials with patients with type 1 (n 509) and type 2 (n 262) diabetes

mellitus, anti-insulin antibody (insulin lispro-specific antibodies, insulin-specific antibodies, cross-reactive antibodies) formation was evaluated in patients receiving both regular human insulin and HUMALOG (including patients previously treated with human insulin and naive patients). As expected, the largest increase in the antibody levels occurred in patients new to insulin therapy. The antibody levels peaked by 12 months and declined over the remaining years of the study. These antibodies do not appear to cause deterioration in glycemic control or necessitate an increase in insulin dose. There was no statistically significant relationship between the change in the total daily insulin dose and the change in percent antibody binding for any of the antibody types.

Postmarketing Experience The following additional adverse reactions have been identified during post-approval use of HUMALOG. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Medication errors in which other insulins have been accidentally substituted for HUMALOG have been identified during postapproval use.

DRUG INTERACTIONS A number of drugs affect glucose metabolism and may require insulin dose adjustment

and particularly close monitoring. Following are some of the examples:

Drugs That May Increase the Blood-Glucose-Lowering Effect of HUMALOG and Susceptibility to Hypoglycemia: Oral antidiabetic agents, salicylates, sulfonamide antibiotics, monoamine oxidase inhibitors, fluoxetine, pramlintide, disopyramide, fibrates, propoxyphene, pentoxifylline, ACE inhibitors, angiotensin II receptor blocking agents, and somatostatin analogs (e.g., octreotide).

Drugs That May Reduce the Blood-Glucose-Lowering Effect of HUMALOG: corticosteroids, isoniazid, niacin, estrogens, oral contraceptives, phenothiazines, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), somatropin, atypical antipsychotics, glucagon, protease inhibitors, and thyroid hormones.

Drugs That May Increase or Reduce the Blood-Glucose-Lowering Effect of HUMALOG: beta-blockers, clonidine, lithium salts, and alcohol. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.

Drugs That May Reduce the Signs of Hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine.

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category B. All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. In patients with diabetes or gestational diabetes insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential in these patients. Therefore, female patients should be advised to tell their physicians if they intend to become, or if they become pregnant while taking HUMALOG.

Although there are limited clinical studies of the use of HUMALOG in pregnancy, published studies with human insulins suggest that optimizing overall glycemic control, including postprandial control, before conception and during pregnancy improves fetal outcome.

In a combined fertility and embryo-fetal development study, female rats were given subcutaneous insulin lispro injections of 5 and 20 units/kg/day (0.8 and 3 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area, respectively) from

2 weeks prior to cohabitation through Gestation Day 19. There were no adverse effects on female fertility, implantation, or fetal viability and morphology. However, fetal growth retardation was produced at the 20 units/kg/day-dose as indicated by decreased fetal weight and an increased incidence of fetal runts/litter.

In an embryo-fetal development study in pregnant rabbits, insulin lispro doses of 0.1, 0.25, and 0.75 unit/kg/day (0.03, 0.08, and 0.24 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area, respectively) were injected subcutaneously on Gestation days 7 through 19. There were no adverse effects on fetal viability, weight, and morphology at any dose.

Nursing Mothers It is unknown whether insulin lispro is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HUMALOG is administered to a nursing woman. Use of HUMALOG is compatible with breastfeeding, but women with diabetes who are lactating may require adjustments of their insulin doses.

Pediatric Use HUMALOG is approved for use in children for subcutaneous daily injections and for subcutaneous continuous infusion by external insulin pump. HUMALOG has not been studied in pediatric patients younger than 3 years of age. HUMALOG has not been studied in pediatric patients with type 2 diabetes.

As in adults, the dosage of HUMALOG must be individualized in pediatric patients based on metabolic needs and results of frequent monitoring of blood glucose.

Geriatric Use Of the total number of subjects (n 2834) in eight clinical studies of HUMALOG, twelve percent (n 338) were 65 years of age or over. The majority of these had type 2 diabetes. HbA1c values and hypoglycemia rates did not differ by age. Pharmacokinetic/pharmacodynamic studies to assess the effect of age on the onset of HUMALOG action have not been performed.

OVERDOSAGE Excess insulin administration may cause hypoglycemia and hypokalemia. Mild episodes

of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

DOSAGE AND ADMINISTRATIONDosage Considerations When given subcutaneously, HUMALOG has a more rapid onset of action and a shorter duration of action than regular human insulin.

The dosage of HUMALOG must be individualized. Blood glucose monitoring is essential in all patients receiving insulin therapy.

The total daily insulin requirement may vary and is usually between 0.5 to 1 unit/kg/day. Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs.

Subcutaneous Administration HUMALOG should be given within 15 minutes before a meal or immediately after a meal.

HUMALOG given by subcutaneous injection should generally be used in regimens with an intermediate- or long-acting insulin.

HUMALOG administered by subcutaneous injection should be given in the abdominal wall, thigh, upper arm, or buttocks. Injection sites should be rotated within the same region (abdomen, thigh, upper arm, or buttocks) from one injection to the next to reduce the risk of lipodystrophy [see Adverse Reactions].

Continuous Subcutaneous Infusion (Insulin Pump) HUMALOG may be administered by continuous subcutaneous infusion by an external insulin pump. Do not use diluted or mixed insulins in external insulin pumps. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy [see Adverse Reactions]. Change the HUMALOG in the reservoir at least every 7 days, change the infusion sets and the infusion set insertion site at least every 3 days.

The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen. Although there is significant variability among patients, approximately 50% of the total dose is usually given as meal-related boluses of HUMALOG and the remainder is given as a basal infusion. HUMALOG is recommended for use in pump systems suitable for insulin infusion such as MiniMed, Disetronic, and other equivalent pumps.

HOW SUPPLIED/STORAGE AND HANDLING

How SuppliedHUMALOG 100 units per mL (U-100) is available as:

10 mL vials NDC 0002-7510-01 (VL-7510)

3 mL vials NDC 0002-7510-17 (VL-7533)

5 x 3 mL cartridges1 NDC 0002-7516-59 (VL-7516)

5 x 3 mL prefilled pen NDC 0002-8725-59 (HP-8725)

5 x 3 mL Humalog KwikPen (prefilled) NDC 0002-8799-59 (HP-8799)

StorageDo not use after the expiration date.Unopened HUMALOG should be stored in a refrigerator (36 to 46F [2 to 8C]), but

not in the freezer. Do not use HUMALOG if it has been frozen. In-use HUMALOG vials, cartridges, pens, and HUMALOG KwikPen should be stored at room temperature, below 86F (30C) and must be used within 28days or be discarded, even if they still contain HUMALOG. Protect from direct heat and light. See table below:

Not In-Use (Unopened) Room

Temperature (Below 86F [30C])

Not In-Use (Unopened) Refrigerated

In-Use (Opened) Room Temperature, (Below 86F [30C])

10 mL vial 28 days Until expiration date 28 days, refrigerated/room temperature.

3 mL vial 28 days Until expiration date 28 days, refrigerated/room temperature.

3 mL cartridge 28 days Until expiration date 28 days, Do not refrigerate.

3 mL prefilled pen 28 days Until expiration date 28 days, Do not refrigerate.

3 mL Humalog KwikPen (prefilled)

28 days Until expiration date 28 days, Do not refrigerate.

Use in an External Insulin PumpChange the HUMALOG in the reservoir at least every 7 days, change the infusion sets and the infusion set insertion site at least every 3 days or after exposure to temperatures that exceed 98.6F (37C). A HUMALOG 3mL cartridge used in the D-Tron pumps should be discarded after 7 days, even if it still contains HUMALOG. However, as with other external insulin pumps, the infusion set should be replaced and a new infusion set insertion site should be selected at least every 3 days.

Diluted HUMALOG for Subcutaneous InjectionDiluted HUMALOG may remain in patient use for 28 days when stored at 41F (5C) and for 14 days when stored at 86F (30C). Do not dilute HUMALOG contained in a cartridge or HUMALOG used in an external insulin pump.

Preparation and HandlingDiluted HUMALOG for Subcutaneous InjectionHUMALOG may be diluted with Sterile

Diluent for HUMALOG for subcutaneous injection. Diluting one part HUMALOG to nine parts diluent will yield a concentration one-tenth that of HUMALOG (equivalent to U-10). Diluting one part HUMALOG to one part diluent will yield a concentration one-half that of HUMALOG (equivalent to U-50).

PATIENT COUNSELING INFORMATION: See FDA-approved patient labeling and Patient Counseling Information section of the Full Prescribing Information.

1 3 mL cartridge is for use in Eli Lilly and Company's HumaPen Memoir and HumaPen Luxura HD insulin delivery devices, Owen Mumford, Ltd.s Autopen 3-mL insulin delivery device and Disetronic D-TRON and D-TRON Plus pumps.

Autopen is a registered trademark of Owen Mumford, Ltd.

Humalog, Humalog KwikPen, HumaPen, HumaPen Memoir, HumaPen

Luxura and HumaPen Luxura HD are trademarks of Eli Lilly and Company.

Disetronic, D-Tron, and D-Tronplus are registered trademarks of Roche Diagnostics GmbH.

MiniMed are registered trademarks of MiniMed, Inc.

Other product and company names may be the trademarks of their respective owners.

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA

Copyright 1996, 2011, Eli Lilly and Company. All rights reserved.

Additional information can be found at www.humalog.com.

HI HCP BS 26MAY2011 PV5533

References: 1. Cryer PE. In: Fauci AS, Braunwald E, Kasper DL, et al, eds. Harrisons Principles of Internal Medicine. 17th ed. New York, NY: McGraw-Hill Medical; 2008 2305-2310. 2. Marwick TH, Hordern MD, Miller T, et al; on behalf of the Council on Clinical Cardiology, American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee; Council on Cardiovascular Disease in the Young; Council on Cardiovascular Nursing; Council on Nutrition, Physical Activity, and Metabolism; Interdisciplinary Counc l on Quality of Care and Outcomes Research. Circulation. 2009;119(25):3244-3262. 3. The Look AHEAD Research Group. Diabetes Care. 2007;30(6):1374-1383. 4. American Association of Clinical Endocrinologists (AACE) Diabetes Mellitus Clinical Practice Guidelines Task Force. http://www.aace.com/pub/guidelines/. Accessed January 31, 2011. 5. DeFronzo RA. Med Clin North Am. 2004;88(4):787-835. 6. Gerich JE. Diabetes Obes Metab. 2000;2(6):345-350. 7. Kasuga M. J Clin Invest. 2006;116(7):1756-1760. 8. Centers for Disease Control and Prevention. Atlanta, GA: US Department of Hea th and Human Services, Centers for Disease Control and Prevention; 2011. 9. Marsenic O. Am J Kidney Dis. 2009;53(5):875-883. 10. Rahmoune H, Thompson PW, Ward JM, Smith CD, Hong G, Brown J. Diabetes. 2005;54(12):3427-3434. 11. Wright EM, Hirayama BA, Loo DF. J Intern Med. 2007;261(1):32-43.

2011 Bristol-Myers Squibb MEUS11UBARO3903 05/11 1307103All rights reserved.

Many organs play a role in glucose homeostasisFasting glucose levels are controlled by the body within a range of 70-110 mg/dL.1 Lifestyle choices, including diet and exercise, are essential to help manage glucose levels.2-4 Maintaining glucose homeostasis is a multiorgan process involving the muscle, adipose tissue, liver, gastrointestinal (GI) tract, pancreas, brain, and kidney.5,6

The body handles glucose through both insulin-dependent and insulin-independent pathways5Insulin-dependent pathways located in the liver, muscle, and adipose tissue, and insulin-independent pathways, found mostly in the brain, kidney, GI tract, and liver, help create a complex interplay of processes essential for glucose management.5,6

Type 2 diabetes mellitus (T2DM) is characterized by core defects of impaired insulin secretion from the pancreas and increased insulin resistance in the muscle, liver, and adipose tissue.5,7 These defects contribute to chronically elevated glucose levels.7

Because type 2 diabetes is the leading cause of kidney failure, the kidney is often viewed as a victim of the disease.8 But emerging understanding of renal-glucose transporters helps illustrate the ways in which the kidney is an active contributor to the disease as well.9,10

Sodium-glucose cotransporters (SGLTs) 1 and 2 are expressed in the kidneys, along with facilitative glucose transporters (GLUTs) 1 and 2, where they promote reabsorption of fi ltered glucose from the renal tubules back into the bloodstream in an insulin-independent process9,10

In type 2 diabetes, the renal glucose transport system continues to reabsorb glucose even in the presence of high blood glucose, further worsening hyperglycemia9,11

Learn more: http://www.pathwaysinT2DM.com

Exploring glucose homeostasis and type 2 diabetes