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Abacavir, Lamivudine and Zidovudine Tablets
  • Professionals
  • FDA PI

Abacavir, Lamivudine and Zidovudine Tablets

Generic name: abacavir sulfate, lamivudine and zidovudine
Dosage form: tablet
Drug class:Antiviral combinations

Medically reviewed by Drugs.com. Last updated on May 1, 2021.

WARNING: HYPERSENSITIVITY REACTIONS, HEMATOLOGIC TOXICITY, MYOPATHY, 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 Abacavir, Lamivudine and Zidovudine Tablets. 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)].

Abacavir, Lamivudine and Zidovudine Tablets are 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 Abacavir, Lamivudine and Zidovudine Tablets or reinitiation of therapy with Abacavir, Lamivudine and Zidovudine Tablets, unless patients have a previously documented HLA-B*5701 allele assessment. Discontinue Abacavir, Lamivudine and Zidovudine Tablets 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 Abacavir, Lamivudine and Zid...