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EPZICOM® (Abacavir and Lamivudine) Tablets, for Oral Use • Because EPZICOM Is a Fixed-Dose Tablet and Cannot Be Dose Adjusted, Initial U.S

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EPZICOM® (Abacavir and Lamivudine) Tablets, for Oral Use • Because EPZICOM Is a Fixed-Dose Tablet and Cannot Be Dose Adjusted, Initial U.S -------------------------- DOSAGE AND ADMINISTRATION -------------------------- HIGHLIGHTS OF PRESCRIBING INFORMATION • Before initiating EPZICOM, screen for the HLA-B*5701 allele because These highlights do not include all the information needed to use EPZICOM contains abacavir. (2.1) EPZICOM safely and effectively. See full prescribing information for • Adults: One tablet orally once daily. (2.2) EPZICOM. • Pediatric patients weighing at least 25 kg: One tablet daily. (2.3) EPZICOM® (abacavir and lamivudine) tablets, for oral use • Because EPZICOM is a fixed-dose tablet and cannot be dose adjusted, Initial U.S. Approval: 2004 EPZICOM is not recommended in patients requiring dosage adjustment or patients with hepatic impairment. (2.4, 4) WARNING: HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, and ---------------------- DOSAGE FORMS AND STRENGTHS------------------------- EXACERBATIONS OF HEPATITIS B Tablets: 600 mg of abacavir and 300 mg of lamivudine. (3) See full prescribing information for complete boxed warning. ------------------------------- CONTRAINDICATIONS --------------------------------- Hypersensitivity Reactions • Presence of HLA-B*5701 allele. (4) • Serious and sometimes fatal hypersensitivity reactions have occurred • Prior hypersensitivity reaction to abacavir or lamivudine. (4) with abacavir-containing products. (5.1) • Moderate or severe hepatic impairment. (4, 8.7) • Hypersensitivity to abacavir is a multi-organ clinical syndrome. (5.1) ------------------------ WARNINGS AND PRECAUTIONS -------------------------- • Patients who carry the HLA-B*5701 allele are at a higher risk of • Hepatic decompensation, some fatal, has occurred in HIV-1/HCV experiencing a hypersensitivity reaction to abacavir. (5.1) co-infected patients receiving combination antiretroviral therapy and • EPZICOM is contraindicated in patients with a prior hypersensitivity interferon alfa with or without ribavirin. Discontinue EPZICOM as reaction to abacavir and in HLA-B*5701-positive patients. (4) medically appropriate and consider dose reduction or discontinuation of • Discontinue EPZICOM as soon as a hypersensitivity reaction is interferon alfa, ribavirin, or both. (5.4) suspected. Regardless of HLA-B*5701 status, permanently discontinue • Immune reconstitution syndrome and redistribution/accumulation of body EPZICOM if hypersensitivity cannot be ruled out, even when other fat have been reported in patients treated with combination antiretroviral diagnoses are possible. (5.1) therapy. (5.5, 5.6) • Following a hypersensitivity reaction to EPZICOM, NEVER restart EPZICOM or any other abacavir-containing product. (5.1) ------------------------------- ADVERSE REACTIONS --------------------------------- The most commonly reported adverse reactions of at least moderate intensity Lactic Acidosis and Severe Hepatomegaly with Steatosis (incidence greater than 5%) in an adult HIV-1 clinical trial were drug • Lactic acidosis and severe hepatomegaly with steatosis, including fatal hypersensitivity, insomnia, depression/depressed mood, headache/migraine, cases, have been reported with the use of nucleoside analogues. (5.2) fatigue/malaise, dizziness/vertigo, nausea, and diarrhea. (6.1) Exacerbations of Hepatitis B To report SUSPECTED ADVERSE REACTIONS, contact ViiV • Severe acute exacerbations of hepatitis B have been reported in patients Healthcare at 1-877-844-8872 or FDA at 1-800-FDA-1088 or who are co-infected with hepatitis B virus (HBV) and human www.fda.gov/medwatch. immunodeficiency virus (HIV-1) and have discontinued lamivudine, a component of EPZICOM. Monitor hepatic function closely in these ------------------------------- DRUG INTERACTIONS---------------------------------- patients and, if appropriate, initiate anti-hepatitis B treatment. (5.3) • Methadone: An increased methadone dose may be required in a small number of patients. (7.1) ------------------------------ RECENT MAJOR CHANGES ------------------------------ Warnings and Precautions, Related Products that are Not Removed ------------------------ USE IN SPECIFIC POPULATIONS -------------------------- Recommended (5.8) 03/2017 • Lactation: Women infected with HIV should be instructed not to breastfeed due to potential for HIV transmission. (8.2) ------------------------------ INDICATIONS AND USAGE ------------------------------- EPZICOM, a combination of abacavir and lamivudine, both nucleoside See 17 for PATIENT COUNSELING INFORMATION and Medication analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination Guide. with other antiretroviral agents for the treatment of HIV-1 infection. (1) Revised: 03/2017 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: HYPERSENSITIVITY REACTIONS, LACTIC 7 DRUG INTERACTIONS ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, 7.1 Methadone AND EXACERBATIONS OF HEPATITIS B 8 USE IN SPECIFIC POPULATIONS 1 INDICATIONS AND USAGE 8.1 Pregnancy 2 DOSAGE AND ADMINISTRATION 8.2 Lactation 2.1 Screening for HLA-B*5701 Allele prior to Starting 8.4 Pediatric Use EPZICOM 8.5 Geriatric Use 2.2 Recommended Dosage for Adult Patients 8.6 Patients with Impaired Renal Function 2.3 Recommended Dosage for Pediatric Patients 8.7 Patients with Impaired Hepatic Function 2.4 Not Recommended Due to Lack of Dosage Adjustment 10 OVERDOSAGE 3 DOSAGE FORMS AND STRENGTHS 11 DESCRIPTION 4 CONTRAINDICATIONS 12 CLINICAL PHARMACOLOGY 5 WARNINGS AND PRECAUTIONS 12.1 Mechanism of Action 5.1 Hypersensitivity Reactions 12.3 Pharmacokinetics 5.2 Lactic Acidosis and Severe Hepatomegaly with Steatosis 12.4 Microbiology 5.3 Patients with Hepatitis B Virus Co-infection 13 NONCLINICAL TOXICOLOGY 5.4 Use with Interferon- and Ribavirin-Based Regimens 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.5 Immune Reconstitution Syndrome 13.2 Animal Toxicology and/or Pharmacology 5.6 Fat Redistribution 14 CLINICAL STUDIES 5.7 Myocardial Infarction 14.1 Adults 6 ADVERSE REACTIONS 14.2 Pediatric Subjects 6.1 Clinical Trials Experience in Adult Subjects 16 HOW SUPPLIED/STORAGE AND HANDLING 6.2 Clinical Trials Experience in Pediatric Subjects 17 PATIENT COUNSELING INFORMATION 6.3 Postmarketing Experience *Sections or subsections omitted from the full prescribing information are not listed. 1 Reference ID: 4072066 FULL PRESCRIBING INFORMATION WARNING: HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, and EXACERBATIONS OF HEPATITIS B Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir, a component of EPZICOM (abacavir and lamivudine). Patients who carry the HLA-B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir; although, hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele [see Warnings and Precautions (5.1)]. EPZICOM is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients [see Contraindications (4), Warnings and Precautions (5.1)]. All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with EPZICOM or reinitiation of therapy with EPZICOM, unless patients have a previously documented HLA-B*5701 allele assessment. Discontinue EPZICOM immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible [see Contraindications (4), Warnings and Precautions (5.1)]. Following a hypersensitivity reaction to EPZICOM, NEVER restart EPZICOM or any other abacavir-containing product because more severe symptoms, including death, can occur within hours. Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity [see Warnings and Precautions (5.1)]. Lactic Acidosis and Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues and other antiretrovirals. Discontinue EPZICOM if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur [see Warnings and Precautions (5.2)]. Exacerbations of Hepatitis B Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine, which is a component of EPZICOM. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue EPZICOM and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.3)]. 2 Reference ID: 4072066 1 INDICATIONS AND USAGE EPZICOM, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. 2 DOSAGE AND ADMINISTRATION 2.1 Screening for HLA-B*5701 Allele prior to Starting EPZICOM Screen for the HLA-B*5701 allele prior to initiating therapy with EPZICOM [see Boxed Warning, Warnings and Precautions (5.1)]. 2.2 Recommended Dosage for Adult Patients The recommended dosage of EPZICOM for adults is one tablet taken orally once daily, in combination with other antiretroviral agents, with or without food. 2.3 Recommended Dosage for Pediatric Patients The recommended oral dose of EPZICOM for pediatric patients weighing at least 25 kg is one
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