Adult Dosing
Treatment of HIV-1 infection
- 1 tablet PO qd in combination with other antiretroviral agents
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
- <50 mL/min: Contraindicated (dose adjustment not possible with fixed-dose combination)
Hepatic Dose Adjustment
- Hepatic impairment: Contraindicated (dose adjustment not possible with fixed-dose combination)
- Hypersensitivity reactions, typically with multi-organ involvement may occur, and are often serious, even fatal [US Black Box Warning]
- Should evidence or suspicion of hypersensitivity reaction occur; discontinue therapy permanently [US Black Box Warning]
- Patients carrying the HLA-B*5701 allele are highly prone for experiencing a hypersensitivity reaction to abacavir. Prior to initiating therapy screen patients for the HLA-B*5701 allele; prior to reinitiation of abacavir, screen patients of unknown HLA-B*5701 status who have previously tolerated abacavir. HLA-B*5701-negative patients may develop a suspected hypersensitivity reaction to abacavir ([US Black Box Warning]
- Therapy is not recommended for HLA-B*5701-positive patients; consider therapy only with close medical supervision and under exceptional circumstances after assessing benefit/risk
- Skin patch testing is used as a research tool. Avoid using in the clinical diagnosis of abacavir hypersensitivity
- Discontinue therapy as soon as a hypersensitivity reaction is suspected. To minimize the risk of a life-threatening hypersensitivity reaction, permanently discontinue therapy
- Following a hypersensitivity reaction, never restart therapy or any other abacavir containing product as life-threatening hypotension and even death may occur [US Black Box Warning]
- Carefully evaluate the reason for discontinuation of therapy while considering initiating of therapy; screen patient of unknown HLA-B*5701 status
- If hypersensitivity cannot be ruled out avoid initiating of therapy even in the absence of the HLA-B*5701 allele
- Register patients in abacavir hypersensitivity reaction registry
- Severe hepatomegaly with steatosis may occur, including fatal cases; cease treatment immediately if clinical or laboratory findings suggest hepatotoxicity or lactic acidosis [US Black Box Warning]; obesity and prolonged nucleoside exposure are risk factors
- In patients co-infected with HIV/Hepatitis B, stopping this drug may lead to a severe acute exacerbation of hepatitis B; closely monitor hepatic function (laboratory and clinical) for at least several months. Initiate anti-hepatitis B therapy if needed [US Black Box Warning]
- Hypersensitivity reactions including anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, and death have occurred in patients
- Lymphadenopathy, mucous membrane lesions (conjunctivitis and mouth ulcerations), maculopapular or urticarial rash, erythema multiforme have occurred; hypersensitivity reactions have occurred without rash
- Elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, and lymphopenia have also occurred
- Discontinue therapy as soon as a hypersensitivity reaction is suspected. To minimize the risk of a life-threatening hypersensitivity reaction, permanently discontinue therapy
- Fatal hepatic decompensation has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin. Closely monitor patients receiving interferon alfa with or without ribavirin and abacavir/lamivudine for treatment-associated toxicities, especially hepatic decompensation, neutropenia, and anemia. Consider discontinuation of therapy as appropriate
- Avoid concomitant administration with the fixed-dose combination of lamivudine/zidovudine, abacavir and lamivudine, or emtricitabine and tenofovir; avoid concomitant use with abacavir, lamivudine, emtricitabine, or zidovudine
- Consider potential for cross-resistance between abacavir and other NRTIs when choosing new therapeutic regimens in therapy-experienced patients
- Safety and efficacy of lamivudine have not been established for treatment of chronic hepatitis B in patients infected with HIV-1 and HBV
- Immune reconstitution syndrome has occurred in patients treated with combination antiretroviral therapy
- Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance have occurred in patients
Cautions: Use cautiously in
- Risk of hepatic disease
- HBV co-infection
- Risk of cardiac disease
- Coronary artery disease
- Hypertension
- Hyperlipidemia
- Diabetes mellitus
- Obesity
- Smoking
- Female patients
- Myelosuppression
- Prolong nucleoside treatment
- Human leukocyte antigen *5701-positive
- Baseline viral load >100,000
- Granulocyte count <1,000 cells/mm3
- Hemoglobin <9.5 g/dL
Pregnancy Category:C
Breastfeeding: HIV-infected mothers should generally not breastfeed their infants. In countries in which no acceptable, feasible, sustainable and safe replacement feeding is available, exclusive breastfeeding for 6 months is recommended for HIV-infected mothers to reduce the risk of HIV transmission from the mother to the infant compared with mixed feeding. In these settings, abrupt weaning at 4 months does not reduce the risk of HIV transmission or produce an overall health benefit compared to continued breastfeeding, and increases the risk of infant death in HIV-infected infants. Extended antiretroviral prophylaxis in breastfed infants with antiretrovirals, reduces the rate of HIV transmission during breastfeeding by about half, but the optimal regimen and duration of prophylaxis has not yet been defined. Abacavir/lamivudine has been successfully used as part of a regimen that decreases mother-to-child transmission. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 10 January 2011). Centers for disease control and prevention recommends that mothers avoid breast-feeding their infants as risk for postnatal transmission of HIV-1 infection exists. Lamivudine is excreted in human milk. Manufacturer advises to instruct infected mothers to avoid breastfeeding during therapy because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants.
US Trade Name(s)
US Availability
Epzicom (abacavir/lamivudine)
Canadian Trade Name(s)
Canadian Availability
Kivexa (abacavir/lamivudine)
UK Trade Name(s)
UK Availability
Kivexa (abacavir/lamivudine)
Australian Trade Name(s)
Australian Availability
Kivexa (abacavir/lamivudine)
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Epzicom 600-300 MG TABS [Bottle] (VIIV HEALTHCARE)
30 mg = $1031.96
90 mg = $2972.02
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Epzicom (abacavir 600 MG / lamivudine 300 MG) Oral Tablet
Ingredient(s): Abacavir mixture with Lamivudine
Imprint: GS;FC2
Color(s): Orange
Shape: Oval
Size (mm): 20.00
Score: 1
Inactive Ingredient(s): magnesium stearate / cellulose, microcrystalline / sodium starch glycolate type a potato / fd&c yellow no. 6 / hypromellose / polyethylene glycol 400 / polysorbate 80 / titanium dioxide
Drug Label Author:
GlaxoSmithKline LLC
DEA Schedule:
Non-Scheduled