Atazanavir

What it is and how it works

Mechanism of Action Atazanavir is an HIV-1 antiretroviral drug .

Indications

Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus . Use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions . Atazanavir capsules are a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg.

Dosage and administration (summary)

Pretreatment testing: Renal laboratory testing should be performed in all patients prior to initiation of atazanavir capsules and continued during treatment with atazanavir capsules. Hepatic testing should be performed in patients with underlying liver disease prior to initiation of atazanavir capsules and continued during treatment with atazanavir capsules. Treatment-naive adults: Atazanavir capsules 300 mg with ritonavir 100 mg once daily with food or atazanavir capsules 400 mg once daily with food. Treatment-experienced adults: Atazanavir capsules 300 mg with ritonavir 100 mg once daily with food.

Contraindications

Atazanavir is contraindicated: in patients with previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of atazanavir capsules . when coadministered with drugs that are highly dependent on CYP3A or UGT1A1 for clearance, and for which elevated plasma concentrations of the interacting drugs are associated with serious and/or life-threatening events (see Table 6).

Warnings and precautions

Cardiac conduction abnormalities: PR interval prolongation may occur in some patients. ECG monitoring should be considered in patients with preexisting conduction system disease or when administered with other drugs that may prolong the PR interval. (5.1, 7.3 , 12.2 , 17 ) Severe Skin Reactions: Discontinue if severe rash develops. ( 5.2 , 17 ) Hyperbilirubinemia: Most patients experience asymptomatic increases in indirect bilirubin, which is reversible upon discontinuation. Do not dose reduce. If a concomitant transaminase increase occurs, evaluate for alternative etiologies.

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to atazanavir during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.

Storage and supply

Atazanavir capsules are available in the following strengths and configurations: 150 mg – capsules with light-turquoise-blue-opaque cap and aqua-blue-opaque body, imprinted “5526” on the body and “TEVA” on the cap, in bottles of 60 (NDC 0093-5526-06) with a child-resistant closure.

Source: Atazanavir Sulfate (Atazanavir Sulfate) — US FDA prescribing information, 2024-12-30, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.