Abacavir Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for HIV Infection

300 mg orally twice a day or 600 mg orally once a day

Usual Adult Dose for Nonoccupational Exposure

(Not approved by FDA)

Centers for Disease Control and Prevention recommendations: 300 mg orally twice a day or 600 mg orally once a day

Duration: 28 days

Prophylaxis should be initiated as soon as possible, within 72 hours of exposure. The alternative regimens recommended for nonoccupational postexposure HIV prophylaxis include abacavir as part of nonnucleoside reverse transcriptase inhibitor (NNRTI)-based, protease inhibitor (PI)-based, or triple nucleoside reverse transcriptase inhibitor (NRTI) regimens.

Usual Pediatric Dose for HIV Infection

3 months or older:
Oral solution: 8 mg/kg orally twice a day, not to exceed 600 mg/day

Tablets:
14 to 21 kg: 150 mg orally twice a day
22 to less than 30 kg: 150 mg orally in the morning and 300 mg in the evening
30 kg or more: 300 mg orally twice a day

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild hepatic impairment (Child-Pugh 5 to 6): 200 mg orally twice a day
Moderate to severe hepatic impairment: Contraindicated

Precautions

Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir therapy and usually appear within the first 6 weeks of treatment. Patients with the HLA-B*5701 allele are at increased risk of hypersensitivity reaction to abacavir; therefore, screening for the HLA-B*5701 allele is recommended prior to starting abacavir treatment. Therapy with an abacavir-containing regimen is not recommended for HLA-B*5701-positive patients and should be considered only with close medical supervision under exceptional conditions where potential benefit outweighs the risk. Considerably less frequently, HLA-B*5701-negative patients may experience hypersensitivity reaction with abacavir. Frequently observed signs and symptoms include, but are not limited to, fever, skin rash, malaise, fatigue, achiness, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, dyspnea, and cough. Abacavir should be discontinued as soon as a hypersensitivity reaction is suspected and should not be restarted because more severe symptoms will occur within hours and may include life-threatening hypotension and death.

Severe or fatal hypersensitivity reactions can also occur within hours after restarting abacavir in patients who have no identified history or unrecognized symptoms of this reaction. Screening for the HLA-B*5701 allele is also recommended prior to restarting abacavir treatment in patients whose HLA-B*5701 status is unknown. Abacavir therapy should be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible, to minimize the risk of a life-threatening hypersensitivity reaction.

The manufacturer's Medication Guide and Warning Card with information about the abacavir hypersensitivity reaction must be dispensed with each new and refill prescription.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretroviral agents. Risk factors may include female gender, obesity, and prolonged nucleoside exposure. Caution is recommended in patients with risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with abacavir should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

Immune reconstitution syndrome has occurred during combination antiretroviral therapy. Patients responding to therapy may develop an inflammatory response to indolent or residual opportunistic infections and require evaluation and treatment.

Abacavir has not been shown to reduce the risk of HIV transmission to others through sexual contact or blood contamination.

Abacavir should always be used in combination with other antiretroviral agents. Abacavir should not be added as a single agent when antiretroviral regimens are changed due to the development of drug resistance and loss of virological response.

Safety and efficacy have not been established in pediatric patients less than 3 months of age.

Dialysis

Data not available

Other Comments

Abacavir may be taken with or without food.

Abacavir should always be used in combination with other antiretroviral agents.

If a patient is unable to reliably swallow an abacavir tablet, then the oral solution should be used.

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