Abacavir

ABACAVIR- abacavir sulfate solution
Pharmaceutical Associates, Inc.

BOXED WARNING

See full prescribing information for complete boxed warning.

Hypersensitivity Reactions
• Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir. (5.1)
• Hypersensitivity to abacavir is a multi-organ clinical syndrome. (5.1)
• Patients who carry the HLA-B*5701 allele are at higher risk of experiencing a hypersensitivity reaction to abacavir. (5.1)
• Abacavir is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA- B*5701-positive patients.(4)
• Discontinue abacavir as soon as a hypersensitivity reaction is suspected. Regardless of HLA-B*5701 status, permanently discontinue abacavir if hypersensitivity cannot be ruled out, even when other diagnoses are possible. (5.1)
• Following a hypersensitivity reaction to abacavir, NEVER restart abacavir oral solution or any other abacavir-containing product. (5.1)

Lactic Acidosis and Severe Hepatomegaly with Steatosis
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. (5.2)

1 INDICATIONS & USAGE

Abacavir oral solution in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection.

2 DOSAGE & ADMINISTRATION

2.1 Screening for HLA-B*5701 Allele prior to Starting Abacavir

Screen for the HLA-B*5701 allele prior to initiating therapy with abacavir [see Boxed Warning, Warnings and Precautions ( 5.1)].

2.2 Recommended Dosage for Adults patients

The recommended dosage of abacavir for adults is 600 mg daily, administered orally as either 300 mg twice daily or 600 mg once daily, in combination with other antiretroviral agents.

2.3 Recommended Dosage for Pediatric

The recommended dosage of abacavir oral solution in HIV-1-infected pediatric patients aged 3 months and older is 8 mg per kg orally twice daily or 16 mg per kg orally once-daily (up to a maximum of 600 mg daily) in combination with other antiretroviral agents.

Abacavir is also available as a scored tablet for HIV-1-infected pediatric patients weighing greater than or equal to 14 kg for whom a solid dosage form is appropriate. Before prescribing abacavir tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow abacavir tablets, the oral solution formulation should be prescribed. The recommended oral dosage of abacavir tablets for HIV-1-infected pediatric patients is presented in Table 1.

Table 1. Dosing Recommendations for Abacavir Scored Tablets in Pediatric Patients

Weight (Kg) Once-daily Dosing Regimen a Twice-daily Dosage Regimen
AM Dose PM Dose Total Daily Dose
14 to <20 1 tablet (300 mg) ½ tablet (150 mg) ½ tablet (150 mg) 300 mg
≥20 to <25 1½ tablets (450 mg) ½ tablet (150 mg) 1 tablet (300 mg) 450 mg
≥25 2 tablets (600 mg) 1 tablet (300 mg) 1 tablet (300 mg) 600 mg

a Data regarding the efficacy of once-daily dosing is limited to subjects who transitioned from twice-daily dosing to once-daily dosing after 36 weeks of treatment [see Clinical Studies ( 14.2)].

2.4 Recommended Dosage for Patients with Hepatic Impairment

The recommended dose of abacavir in patients with mild hepatic impairment (Child-Pugh Class A) is 200 mg twice daily. To enable dose reduction, abacavir oral solution (10 mL twice daily) should be used for the treatment of these patients. The safety, efficacy, and pharmacokinetic properties of abacavir have not been established in patients with moderate to severe hepatic impairment; therefore, abacavir is contraindicated in these patients.

3 DOSAGE FORMS & STRENGTHS

Abacavir Oral Solution, USP contains 20 mg per mL of abacavir as abacavir sulfate, USP. The solution is clear yellowish, strawberry-banana flavored liquid filled in unit dose cups.

4 CONTRAINDICATIONS

Abacavir oral solution is contraindicated in patients:
• who have the HLA-B*5701 allele [see Warnings and Precautions ( 5.1)].
• with prior hypersensitivity reaction to abacavir [see Warnings and Precautions ( 5.1)].
• with moderate or severe hepatic impairment [see Use in Specific Populations ( 8.6)].

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir. These hypersensitivity reactions have included multi-organ failure and anaphylaxis and typically occurred within the first 6 weeks of treatment with abacavir (median time to onset was 9 days); although abacavir hypersensitivity reactions have occurred any time during treatment [see Adverse Reactions ( 6.1)]. Patients who carry the HLA-B*5701 allele are at a higher risk of abacavir hypersensitivity reactions; although, patients who do not carry the HLA-B*5701 allele have developed hypersensitivity reactions. Hypersensitivity to abacavir was reported in approximately 206 (8%) of 2,670 patients in 9 clinical trials with abacavir-containing products where HLA-B*5701 screening was not performed. The incidence of suspected abacavir hypersensitivity reactions in clinical trials was 1% when subjects carrying the HLA-B*5701 allele were excluded. In any patient treated with abacavir, the clinical diagnosis of hypersensitivity reaction must remain the basis of clinical decision making.

Due to the potential for severe, serious, and possibly fatal hypersensitivity reactions with abacavir:
• All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with abacavir or reinitiation of therapy with abacavir, unless patients have a previously documented HLA- B*5701 allele assessment.
• Abacavir is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients.
• Before starting abacavir, review medical history for prior exposure to any abacavir-containing product. NEVER restart abacavir oral solution or any other abacavir-containing product following a hypersensitivity reaction to abacavir, regardless of HLA-B*5701 status.
• To reduce the risk of a life-threatening hypersensitivity reaction, regardless of HLA-B*5701 status, discontinue abacavir immediately if a hypersensitivity reaction is suspected, even when other diagnoses are possible (e.g., acute onset respiratory diseases such as pneumonia, bronchitis, pharyngitis, or influenza; gastroenteritis; or reactions to other medications).
• If a hypersensitivity reaction cannot be ruled out, do not restart abacavir oral solution or any other abacavir-containing products because more severe symptoms which may include life-threatening hypotension and death, can occur within hours.
• If a hypersensitivity reaction is ruled out, patients may restart abacavir. Rarely, patients who have stopped abacavir for reasons other than symptoms of hypersensitivity have also experienced life-threatening reactions within hours of reinitiating abacavir therapy. Therefore, reintroduction of abacavir oral solution or any other abacavir-containing product is recommended only if medical care can be readily accessed.
• A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill.

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