Ziagen

A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill. To facilitate reporting of hypersensitivity reactions and collection of information on each case, an Abacavir Hypersensitivity Registry has been established. Physicians should register patients by calling 1-800-270-0425. ZIAGEN may be taken with or without food. 2.1 Adult Patients

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

2.2 Pediatric Patients

The recommended oral dose of ZIAGEN Oral Solution in HIV-1-infected pediatric patients aged 3 months and older is 8 mg/kg twice daily (up to a maximum of 300 mg twice 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 Tablets in Pediatric Patients

Weight

(kg) Dosage Regimen Using Scored Tablet

Total

Daily Dose AM Dose PM Dose 14 to 21 ½ tablet (150 mg) ½ tablet (150 mg) 300 mg >21 to <30 ½ tablet (150 mg) 1 tablet (300 mg) 450 mg ≥30 1 tablet (300 mg) 1 tablet (300 mg) 600 mg 2.3 Patients with Hepatic Impairment

The recommended dose of ZIAGEN in patients with mild hepatic impairment (Child-Pugh score 5 to 6) is 200 mg twice daily. To enable dose reduction, ZIAGEN 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, ZIAGEN is contraindicated in these patients.

A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill. ZIAGEN may be taken with or without food.

 

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

 

The recommended oral dose of ZIAGEN Oral Solution in HIV-1-infected pediatric patients aged 3 months and older is 8 mg/kg twice daily (up to a maximum of 300 mg twice 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 Tablets in Pediatric Patients

Weight

(kg)

Dosage Regimen Using Scored Tablet

Total

Daily Dose

AM Dose

PM Dose

14 to 21

½ tablet (150 mg)

½ tablet (150 mg)

300 mg

>21 to <30

½ tablet (150 mg)

1 tablet (300 mg)

450 mg

≥30

1 tablet (300 mg)

1 tablet (300 mg)

600 mg

 

The recommended dose of ZIAGEN in patients with mild hepatic impairment (Child-Pugh score 5 to 6) is 200 mg twice daily. To enable dose reduction, ZIAGEN 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, ZIAGEN is contraindicated in these patients.

 

2.1 Screening for HLAB*5701 Allele prior to Starting ZIAGEN

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

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 Regimena

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

aData 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 ZIAGEN in patients with mild hepatic impairment (Child‑Pugh Class A) is 200 mg twice daily. To enable dose reduction, ZIAGEN 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, ZIAGEN is contraindicated in these patients.