EPZICOM Rx

Indications for EPZICOM:

HIV-1 infection.

Adult:

1 tab daily. Mild hepatic or renal impairment (CrCl<50mL/min): not recommended; consider other alternatives.

Children:

<25kg: use individual components. ≥25kg: 1 tab daily.

Contraindications:

Presence of HLA-B*5701 allele. Prior hypersensitivity reaction to any of the components (see full labeling). Moderate or severe hepatic impairment.

Warnings/Precautions:

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. Suspend if lactic acidosis or hepatotoxicity (eg, hepatomegaly and steatosis) occurs. Not for treating hepatitis B; monitor patients co-infected with HBV for at least several months after stopping treatment (discontinuing may exacerbate HBV infection). Coronary heart disease. Diabetes. Smoking. Women, obesity, prolonged nucleoside exposure: increased risk of toxicity. Elderly. Pregnancy. Nursing mothers: not recommended.

Interactions:

See full labeling. Do not combine with other nucleoside/nucleotide reverse transcriptase inhibitors as part of a triple-drug regimen. May antagonize methadone. May be potentiated by ethanol, TMP/SMX, nelfinavir. Monitor for treatment-associated toxicities (esp. hepatic decompensation) with interferon-alpha with or without ribavirin.

Pharmacological Class:

Nucleoside analogues (reverse transcriptase inhibitors).

Adverse Reactions:

Hypersensitivity reactions (may be fatal), insomnia, depression, headache/migraine, fatigue/malaise, dizziness, nausea, diarrhea; rash (may be severe, eg, Stevens-Johnson), pyrexia, immune reconstitution syndrome, fat redistribution, lactic acidosis, severe hepatomegaly with steatosis, post-treatment exacerbation of hepatitis B.

Note:

Register pregnant patients exposed to Epzicom by calling (800) 258-4263. Register patients who have had a hypersensitivity reaction to Epzicom by calling (800) 270-0425.

How Supplied:

Tabs—30