Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most commonly reported adverse reactions (incidence at least 10%) in clinical trials were nausea, headache, malaise and fatigue, and nausea and vomiting.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc.
at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
The following adverse reactions are discussed in other sections of the labeling: Serious and sometimes fatal hypersensitivity reactions [see BOXED WARNING , WARNINGS AND PRECAUTIONS ( 5.1 )] .
Hematologic toxicity, including neutropenia and anemia [see BOXED WARNING , WARNINGS AND PRECAUTIONS ( 5.2 )] .
Symptomatic myopathy [see BOXED WARNING , WARNINGS AND PRECAUTIONS ( 5.3 )] .
Lactic acidosis and severe hepatomegaly with steatosis [see BOXED WARNING , WARNINGS AND PRECAUTIONS ( 5.4 )] .
Exacerbations of hepatitis B [see BOXED WARNING , WARNINGS AND PRECAUTIONS ( 5.5 )] .
Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C [see WARNINGS AND PRECAUTIONS ( 5.6 )] .
Exacerbation of anemia in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine [see WARNINGS AND PRECAUTIONS ( 5.6 )] .
5 WARNINGS AND PRECAUTIONS Hepatic decompensation, some fatal, has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon alfa with or without ribavirin.
Discontinue abacavir, lamivudine and zidovudine tablets as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both.
( 5.6 ) Exacerbation of anemia has been reported in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine.
Coadministration of ribavirin and zidovudine is not advised.
( 5.6 ) Immune reconstitution syndrome and lipoatrophy have been reported in patients treated with combination antiretroviral therapy.
Like all medications, Abacavir, Lamivudine And Zidovudine can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: