ZIAGEN 20 mg/mL
abacavir sulfate · SOLUTION · ViiV Healthcare Company
ZIAGEN is a solution containing abacavir sulfate at 20 mg/mL, taken oral. Manufactured by ViiV Healthcare Company.
Key Facts
- Brand Name
- ZIAGEN
- Generic Name
- abacavir sulfate
- NDC Code (Product)
49702-222- Manufacturer
- ViiV Healthcare Company
- Strength
- 20 mg/mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- NDA020978
- Marketing Start
- 01/28/1999
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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. ZIAGEN, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Before initiating ZIAGEN, screen for the HLA-B*5701 allele. ( 2.1 ) • Adults: 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily. ( 2.2 ) • Pediatric Patients Aged 3 Months and Older: Administered either once or twice daily. Dose should be calculated on body weight (kg) and should not exceed 600 mg daily. ( 2.3 ) • Patients with Hepatic Impairment: Mild hepatic impairment – 200 mg twice daily. ( 2.4 ) 2.1 Screening for HLA-B*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 availab…
Contraindications
4 CONTRAINDICATIONS ZIAGEN 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 )]. • Presence of HLA-B*5701 allele. ( 4 ) • Prior hypersensitivity reaction to abacavir. ( 4 ) • Moderate or severe hepatic impairment. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Methadone: An increased methadone dose may be required in a small number of patients. ( 7.1 ) • Riociguat: The riociguat dose may need to be reduced. ( 7.2 ) 7.1 Methadone In a trial of 11 HIV‑1–infected subjects receiving methadone‑maintenance therapy with 600 mg of ZIAGEN twice daily (twice the currently recommended dose), oral methadone clearance increased [see Clinical Pharmacology ( 12.3 )] . This alteration will not result in a methadone dose modification in the majority of patients; however, an increased methadone dose may be required in a small number of patients. 7.2 Riociguat Coadministration with fixed-dose abacavir/dolutegravir/lamivudine resulted in increased riociguat exposure, which may increase the risk of riociguat adverse reactions [see Clinical Pharmacology ( 12.3 )] . The riociguat dose may need to be reduced. See full prescribing information for ADEMPAS (riociguat).
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: • Serious and sometimes fatal hypersensitivity reactions [see Boxed Warning, Warnings and Precautions ( 5.1 )] . • Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions ( 5.2 )] . • Immune reconstitution syndrome [see Warnings and Precautions ( 5.3 )] . • Myocardial infarction [see Warnings and Precautions ( 5.4 )] . • The most commonly reported adverse reactions of at least moderate intensity (incidence greater than or equal to 10%) in adult HIV-1 clinical trials were nausea, headache, malaise and fatigue, nausea and vomiting, and dreams/sleep disorders. ( 6.1 ) • The most commonly reported adverse reactions of at least moderate intensity (incidence greater than or equal to 5%) in pediatric HIV-1 clinical trials were fever and/or chills, nausea and vomiting, skin rashes, and ear/nose/throat infections. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience in Adult Subjects Because clinical trials are conducted under widely varying condit…
Frequently Asked Questions
What is ZIAGEN used for?
ZIAGEN contains abacavir sulfate. It is a solution taken oral. Consult your doctor for specific uses.
Is ZIAGEN a controlled substance?
ZIAGEN is not classified as a controlled substance by the DEA.
What is the generic name for ZIAGEN?
The generic name for ZIAGEN is abacavir sulfate. There are 7 other brand versions of abacavir sulfate.
What is the NDC code for ZIAGEN 20 mg/mL?
The NDC (National Drug Code) for ZIAGEN 20 mg/mL is 49702-222, listed by ViiV Healthcare Company.