Indications for TRIZIVIR:
HIV-1 infection, alone or in combination with other antiretroviral agents.
Limitations of Use:
Limited data with monotherapy in patients with baseline viral load >100,000 copies/mL.
Adults and Children:
<40kg: not recommended. ≥40kg: 1 tab twice daily. Mild hepatic or renal impairment (CrCl<50mL/min): not recommended; use individual components.
Presence of HLA-B*5701 allele. Prior hypersensitivity reaction to any of the components (see full labeling). Moderate or severe hepatic impairment.
Hypersensitivity reactions. Hematologic toxicity. Myopathy. Lactic acidosis and severe hepatomegaly with steatosis. Exacerbations of hepatitis B.
Screen for presence of HLA-B*5701 allele prior to starting therapy or reinitiation; if (+), abacavir is contraindicated. Discontinue immediately if hypersensitivity is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible. If hypersensitivity cannot be ruled out, do not restart. If stopped for reasons other than hypersensitivity, restart only if medical care can be readily accessed. Risk of hematologic toxicity/bone marrow suppression; monitor CBCs esp. in advanced HIV-1 disease; interrupt dose if anemia or neutropenia occurs. Myopathy with prolonged zidovudine use. Suspend if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Not for treating chronic HBV infection; closely monitor patients co-infected with HBV and HIV for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection); if appropriate, initiate anti-hepatitis B therapy may be warranted. Possible risk of MI; minimize risk factors for coronary heart disease (eg, hypertension, hyperlipidemia, diabetes, smoking). Monitor for lipoatrophy; use alternatives if suspected. Women. Obesity. Elderly. Pregnancy. Nursing mothers: not recommended.
Nucleoside analogues (reverse transcriptase inhibitors).
Avoid concomitant stavudine, doxorubicin, nucleoside analogues (eg, ribavirin), sorbitol-containing products. Increased hematologic toxicity with ganciclovir, interferon alfa, ribavirin, other bone marrow suppressants or cytotoxic drugs. Abacavir may antagonize methadone. Monitor for treatment-associated toxicities (eg, hepatic decompensation) with interferon-alpha with or without ribavirin.
Nausea, headache, malaise, fatigue, vomiting; hypersensitivity reactions (may be fatal), lactic acidosis, severe hepatomegaly with steatosis, anemia, neutropenia, myopathy, myositis, immune reconstitution syndrome, rash (may be severe, eg, Stevens-Johnson), lipoatrophy.
Register pregnant patients exposed to Trizivir by calling (800) 258-4263. Register patients who have had a hypersensitivity reaction to abacavir by calling (800) 270-0425.