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The US Food and Drug Administration (FDA) has approved a fixed-dose combination of the antiretroviral drug darunavir (800 mg) and the pharmacokinetic enhancer cobicistat (150 mg) for HIV"...
The following adverse reactions are discussed in other sections of the labeling:
- Hematologic toxicity, including neutropenia and anemia [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
- Symptomatic myopathy [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
- Lactic acidosis and severe hepatomegaly with steatosis [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
- Exacerbations of hepatitis B [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
- Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [see WARNINGS AND PRECAUTIONS].
- Exacerbation of anemia in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine [see WARNINGS AND PRECAUTIONS].
- Pancreatitis [see WARNINGS AND PRECAUTIONS].
- Immune reconstitution syndrome [see WARNINGS AND PRECAUTIONS].
- Fat redistribution [see WARNINGS AND PRECAUTIONS].
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Lamivudine plus Zidovudine Administered as Separate Formulations
In 4 randomized, controlled trials of EPIVIR 300 mg per day plus RETROVIR 600 mg per day, the following selected adverse reactions and laboratory abnormalities were observed (see Tables 1 and 2).
Table 1: Selected Clinical Adverse Reactions (Greater
than or Equal to 5% Frequency) in 4 Controlled Clinical Trials with EPIVIR 300
mg per day and RETROVIR 600 mg per day
|Adverse Reaction||EPIVIR plus RETROVIR
(n = 251)
|Body as a whole|
|Malaise & fatigue||27%|
|Fever or chills||10%|
|Nausea & vomiting||13%|
|Anorexia and/or decreased appetite||10%|
|Insomnia & other sleep disorders||11%|
|Nasal signs & symptoms||20%|
Pancreatitis was observed in 9 of the 2,613 adult subjects (0.3%) who received EPIVIR in controlled clinical trials [see WARNINGS AND PRECAUTIONS].
Selected laboratory abnormalities observed during therapy are listed in Table 2.
Table 2: Frequencies of Selected Laboratory
Abnormalities among Adults in 4 Controlled Clinical Trials of EPIVIR 300 mg per
day plus RETROVIR 600 mg per daya
|Test (Abnormal Level)||EPIVIR plus RETROVIR % (n)|
|Neutropenia (ANC < 750/mm³)||7.2% (237)|
|Anemia (Hgb < 8.0 g/dL)||2.9% (241)|
|Thrombocytopenia (platelets < 50,000/mm )||0.4% (240)|
|ALT ( > 5.0 x ULN)||3.7% (241)|
|AST ( > 5.0 x ULN)||1.7% (241)|
|Bilirubin ( > 2.5 x ULN)||0.8% (241)|
|Amylase ( > 2.0 x ULN)||4.2% (72)|
|ULN = Upper limit of normal.
ANC = Absolute neutrophil count.
n = Number of subjects assessed.
aFrequencies of these laboratory abnormalities were higher in subjects with mild laboratory abnormalities at baseline.
The following adverse reactions have been identified during postmarketing use. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as a Whole
Redistribution/accumulation of body fat [see WARNINGS AND PRECAUTIONS].
Endocrine and Metabolic
Oral mucosal pigmentation, stomatitis.
Hemic and Lymphatic
Hepatic and Pancreatic
Muscle weakness, CPK elevation, rhabdomyolysis.
Abnormal breath sounds/wheezing.
Read the Combivir (lamivudine, zidovudine) Side Effects Center for a complete guide to possible side effects
Agents Antagonistic with Zidovudine
Concomitant use of zidovudine with the following drugs should be avoided since an antagonistic relationship has been demonstrated in vitro:
- Nucleoside analogues e.g., ribavirin
Hematologic/Bone Marrow Suppressive/Cytotoxic Agents
Coadministration with the following drugs may increase the hematologic toxicity of zidovudine:
- Interferon alfa
- Other bone marrow suppressive or cytotoxic agents
Read the Combivir Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 10/8/2015
Additional Combivir Information
Combivir - User Reviews
Combivir User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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