ATAZANAVIR SULFATE- atazanavir sulfate capsule
Atazanavir capsule is 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 [see Use in Specific Populations (8.4)].
- Use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)] .
- Atazanavir capsules must be taken with food.
- Do not open the capsules.
- The recommended oral dosage of atazanavir capsules depends on the treatment history of the patient and the use of other coadministered drugs. When coadministered with H 2 -receptor antagonists or proton-pump inhibitors, dose separation may be required [see Dosage and Administration (2.3, 2.4, and 2.6) and Drug Interactions (7)] .
- Atazanavir capsules without ritonavir are not recommended for treatment-experienced adult or pediatric patients with prior virologic failure [see Clinical Studies (14)] .
- Efficacy and safety of atazanavir capsules with ritonavir when ritonavir is administered in doses greater than 100 mg once daily have not been established. The use of higher ritonavir doses may alter the safety profile of atazanavir (cardiac effects, hyperbilirubinemia) and, therefore, is not recommended. Prescribers should consult the complete prescribing information for ritonavir when using ritonavir.
Renal laboratory testing should be performed in all patients prior to initiation of atazanavir capsules and continued during treatment with atazanavir capsules. Renal laboratory testing should include serum creatinine, estimated creatinine clearance, and urinalysis with microscopic examination [see Warnings and Precautions (5.5, 5.6)]. Hepatic laboratory testing should be performed in patients with underlying liver disease prior to initiation of atazanavir capsules and continued during treatment with atazanavir capsules [see Warnings and Precautions (5.4)].
Table 1 displays the recommended dosage of atazanavir capsules in treatment-naive and treatment-experienced adults. Table 1 also displays recommended dosage of atazanavir capsules and ritonavir when given concomitantly with other antiretroviral drugs and H 2 -receptor antagonists (H2RA). Ritonavir is required with several atazanavir capsules dosage regimens (see the ritonavir complete prescribing information about the safe and effective use of ritonavir). The use of atazanavir capsules in treatment-experienced adult patients without ritonavir is not recommended.
|a See Drug Interactions (7) for instructions concerning coadministration of acid-reducing medications (e.g., H2RA or proton pump inhibitors [PPIs]), and other antiretroviral drugs (e.g., efavirenz, tenofovir DF, and didanosine).|
|Atazanavir Capsules Once Daily Dosage||Ritonavir Once Daily Dosage|
|Treatment-Naive Adult Patients|
|recommended regimen||300 mg||100 mg|
|unable to tolerate ritonavir||400 mg||N/A|
|in combination with efavirenz||400 mg||100 mg|
|Treatment-Experienced Adult Patients|
|recommended regimen||300 mg||100 mg|
|in combination with both H2RA and tenofovir DF||400 mg||100 mg|
The recommended daily dosage of atazanavir capsules and ritonavir in pediatric patients (6 years of age to less than 18 years of age) is based on body weight (see Table 2).
|a Administer atazanavir capsules and ritonavir simultaneously with food. b The same recommendations regarding the timing and maximum doses of concomitant PPIs and H2RAs in adults also apply to pediatric patients. See Drug Interactions (7) for instructions concerning coadministration of acid-reducing medications (e.g., H2RA or PPIs), and other antiretroviral drugs (e.g., efavirenz, tenofovir DF, and didanosine). c In treatment-experienced patients, atazanavir capsules must be administered with ritonavir.|
|Body weight||Atazanavir Capsules Daily Dosage||Ritonavir Daily Dosage|
|Treatment-Naive and Treatment-Experienced c|
|Less than 15 kg||Capsules not recommended||N/A|
|At least 15 kg to less than 35 kg||200 mg||100 mg|
|At least 35 kg||300 mg||100 mg|
|Treatment-Naive, at least 13 years old and cannot tolerate ritonavir|
|At least 40 kg||400 mg||N/A|
When transitioning between formulations, a change in dose may be needed. Consult the dosing table for the specific formulation.
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