tudy 934 (Table 3), Grade 3/4 laboratory abnormalities of increased bilirubin (greater than 2.5 × upper limit of normal (ULN)), increased pancreatic amylase (greater than 2.0 × ULN), increased or decreased serum glucose (less than 40 or greater than 250 mg/dL), and increased serum lipase (greater than 2.0 × ULN) occurred in up to 3% of subjects treated with emtricitabine or tenofovir DF with other antiretroviral agents in clinical trials.
Hepatic Events: In Study 934, 19 subjects treated with efavirenz, emtricitabine, and tenofovir DF and 20 subjects treated with efavirenz and fixed-dose zidovudine/lamivudine were hepatitis B surface antigen or hepatitis C antibody positive. Among these coinfected subjects, one subject (1/19) in the efavirenz, emtricitabine and tenofovir DF arm had elevations in transaminases to greater than five times ULN through 144 weeks. In the fixed-dose zidovudine/lamivudine arm, two subjects (2/20) had elevations in transaminases to greater than five times ULN through 144 weeks. No HBV and/or HCV coinfected subject discontinued from the trial due to hepatobiliary disorders [See Warnings and Precautions (5.10)].
The following adverse reactions have been identified during postapproval use of efavirenz, emtricitabine, or tenofovir DF. Because postmarketing 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.
Efavirenz:
Cardiac Disorders
Palpitations
Ear and Labyrinth Disorders
Tinnitus, vertigo
Endocrine Disorders
Gynecomastia
Eye Disorders
Abnormal vision
Gastrointestinal Disorders
Constipation, malabsorption
General Disorders and Administration Site Conditions
Asthenia
Hepatobiliary Disorders
Hepatic enzyme increase, hepatic failure, hepatitis. A few of the postmarketing reports of hepatic failure, including cases in patients with no pre-existing hepatic disease or other identifiable risk factors, were characterized by a fulminant course, progressing in some cases to transplantation or death.
Immune System Disorders
Allergic reactions
Metabolism and Nutrition Disorders
Redistribution/accumulation of body fat [See Warnings and Precautions (5.14)], hypercholesterolemia, hypertriglyceridemia
Musculoskeletal and Connective Tissue Disorders
Arthralgia, myalgia, myopathy
Nervous System Disorders
Abnormal coordination, ataxia, cerebellar coordination and balance disturbances, convulsions, hypoesthesia, paresthesia, neuropathy, tremor
Psychiatric Disorders
Aggressive reactions, agitation, delusions, emotional lability, mania, neurosis, paranoia, psychosis, suicide
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea
Skin and Subcutaneous Tissue Disorders
Flushing, erythema multiforme, photoallergic dermatitis, Stevens-Johnson syndrome
Emtricitabine: No postmarketing adverse reactions have been identified for inclusion in this section.
Tenofovir Disoproxil Fumarate:
Immune System Disorders
Allergic reaction, including angioedema
Metabolism and Nutrition Disorders
Lactic acidosis, hypokalemia, hypophosphatemia
Respiratory, Thoracic, and Mediastinal Disorders
Dyspnea
Gastrointestinal Disorders
Pancreatitis, increased amylase, abdominal pain
Hepatobiliary Disor |
