ZIAGEN

ZIAGEN- abacavir sulfate tablet, film coated
A-S Medication Solutions

WARNING: HYPERSENSITIVITY REACTIONS, and LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY

Hypersensitivity Reactions

Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with ZIAGEN® (abacavir).

Patients who carry the HLA‑B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir; although, hypersensitivity reactions have occurred in patients who do not carry the HLA‑B*5701 allele . [see Warnings and Precautions (5.1)]

ZIAGEN is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA‑B*5701-positive patients . All patients should be screened for the HLA‑B*5701 allele prior to initiating therapy with ZIAGEN or reinitiation of therapy with ZIAGEN, unless patients have a previously documented HLA‑B*5701 allele assessment. Discontinue ZIAGEN immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible . [see Contraindications (4), Warnings and Precautions (5.1)] [see Contraindications (4), Warnings and Precautions (5.1)]

Following a hypersensitivity reaction to ZIA GEN , NE VER restart ZIA GEN or any other abacavir‑containing product because more severe symptoms, including death can occur within hours. Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity . [see Warnings and Precautions (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 and other antiretrovirals. Discontinue ZIAGEN if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur . [see Warnings and Precautions (5.2)]

1 INDICATIONS AND USAGE

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

2 DOSAGE AND ADMINISTRATION

2.2 Recommended Dosage for Adult Patients

The recommended dosage of ZIAGEN 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 Patients

The recommended dosage of ZIAGEN 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.

ZIAGEN 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 ZIAGEN tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow ZIAGEN tablets, the oral solution formulation should be prescribed. The recommended oral dosage of ZIAGEN tablets for HIV-1-infected pediatric patients is presented in Table 1.

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

Weight

(kg)

Once-daily Dosing Regimen a

Twice-daily Dosing 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)]

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