EPZICOM Rx

Indications for EPZICOM:

HIV-1 infection, in combination with other antiretroviral agents.

Adults and Children:

<25kg: use individual components. ≥25kg: 1 tab daily. Mild hepatic or renal impairment (CrCl<50mL/min): not recommended; use individual components.

Contraindications:

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

Boxed Warning:

Hypersensitivity reactions. Exacerbations of hepatitis B.

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. 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. Suspend if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Possible risk of MI; minimize risk factors for coronary heart disease (eg, hypertension, hyperlipidemia, diabetes, smoking). Women. Obesity. Elderly. Pregnancy. Nursing mothers: not recommended.

Pharmacological Class:

Nucleoside analogues (reverse transcriptase inhibitors).

Interactions:

Avoid concomitant sorbitol-containing products. May antagonize methadone. Monitor for treatment-associated toxicities (esp. hepatic decompensation) with interferon-alpha with or without ribavirin.

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, lactic acidosis, severe hepatomegaly with steatosis.

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