Atazanavir Sulfate

ATAZANAVIR SULFATE — atazanavir sulfate capsule
NorthStar Rx LLC

1 INDICATIONS AND USAGE

Atazanavir capsule is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for 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/ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].

2 DOSAGE AND ADMINISTRATION

2.1 Overview

  • 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 H2 -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.

2.2 Testing Prior to Initiation and During Treatment with Atazanavir Capsules

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)].

2.3 Dosage of Atazanavir Capsules in Adult Patients

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 H2 -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.

Table 1: Recommended Atazanavir Capsules and Ritonavir Dosage in Adultsa
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

2.4 Dosage of Atazanavir Capsules in Pediatric Patients

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).

Table 2: Recommended Dosage of Atazanavir Capsules and Ritonavir in Pediatric Patients (6 to less than 18 years of age)a,b
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-Experiencedc
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 ritonavirc
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.

2.6 Dosage Adjustments in Pregnant Patients

Table 4 includes the recommended dosage of atazanavir capsules and ritonavir in treatment-naive and treatment-experienced pregnant patients. In these patients, atazanavir capsules must be administered with ritonavir. There are no dosage adjustments for postpartum patients (see Table 1 for the recommended atazanavir capsules dosage in adults) [see Use in Specific Populations (8.1)].

Table 4: Recommended Dosage of Atazanavir Capsules and Ritonavir in Pregnant Patientsa
a 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).b Atazanavir capsules are not recommended for treatment-experienced pregnant patients during the second and third trimester taking atazanavir capsules with both tenofovir DF and H2RA.
Atazanavir Capsules Once Daily Dosage Ritonavir Once Daily Dosage
Treatment-Naive and Treatment-Experienced
Recommended Regimen 300 mg 100 mg
Treatment-Experienced During the Second or Third Trimester When Coadministered with either H2RA or Tenofovir DFb
In combination with either H2RA or tenofovir DF 400 mg 100 mg

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