Atazanavir (Page 2 of 12)

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 (eg, H2RA or PPIs), and other antiretroviral drugs (eg, efavirenz, tenofovir DF, and didanosine).b Atazanavir capsulesare not recommended for treatment-experienced pregnant patients during the second and third trimester taking atazanavircapsuleswith 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 EITHERH2RA OR tenofovir DF 400 mg 100 mg

2.7 Dosage in Patients with Renal Impairment

For patients with renal impairment, including those with severe renal impairment who are not managed with hemodialysis, no dose adjustment is required for atazanavir capsules. Treatment-naive patients with end-stage renal disease managed with hemodialysis should receive atazanavir capsules 300 mg with ritonavir 100 mg. Atazanavir capsules are not recommended in treatment-experienced patients with HIV-1 infection who have end-stage renal disease managed with hemodialysis[see Use in Specific Populations (8.7)].

2.8 Dosage Adjustments in Patients with Hepatic Impairment

Table 5 displays the recommended atazanavir capsules dosage in treatment-naive patients with hepatic impairment. The use of atazanavir capsules in patients with severe hepatic impairment (Child-Pugh Class C) is not recommended. The coadministration of atazanavir capsules with ritonavir in patients with any degree of hepatic impairment is not recommended.

Table 5: Recommended Dosage of Atazanavir Capsules in Treatment-Naive Adults with Hepatic Impairment
Atazanavir Capsules Once Daily Dosage
Mild hepatic impairment (Child-Pugh Class A) 400 mg
Moderate hepatic impairment (Child-Pugh Class B) 300 mg
Severe hepatic impairment (Child-Pugh Class C) Atazanavir capsules with or without ritonavir is not recommended

3 DOSAGE FORMS AND STRENGTHS

  • 150 mg: Off-white to Pale yellow colored granular powder filled in size “1” empty hard gelatin capsule shell with Opaque green colored cap imprinted with AT150 in white ink and Opaque light green colored body.
  • 200 mg: Off-white to Pale yellow colored granular powder filled in size “0” empty hard gelatin capsule shell with Opaque green colored cap imprinted with AT200 in white ink and Opaque green colored body.
  • 300 mg: Off-white to Pale yellow colored granular powder filled in size “00” empty hard gelatin capsule shell with Opaque orange colored cap imprinted with AT300 in white ink and Opaque green colored body.

4 CONTRAINDICATIONS

Atazanavir capsules are 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 [see Warnings and Precautions (5.2)].
  • 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).
  • when coadministered with drugs that strongly induce CYP3A and may lead to lower exposure and loss of efficacy of atazanavir capsules (see Table 6).

Table 6 displays drugs that are contraindicated with atazanavir capsules.

Table 6: Drugs Contraindicated with Atazanavir Capsules (Information in the table applies to atazanavir capsules with or without ritonavir, unless otherwise indicated)
a See Drug Interactions, Table 16 (7)for parenterally administered midazolam.b See Drug Interactions, Table 16 (7)for sildenafil when dosed as VIAGRA® for erectile dysfunction.
Drug Class Drugs within class that are contraindicated with Atazanavir capsules
Alpha 1-adrenoreceptor antagonist Alfuzosin
Antiarrhythmics Amiodarone (with ritonavir), quinidine (with ritonavir)
Antimycobacterials Rifampin
Antineoplastics Irinotecan
Antipsychotics Lurasidone (with ritonavir), pimozide
Benzodiazepines Triazolam, orally administered midazolama
Ergot Derivatives Dihydroergotamine, ergotamine, ergonovine, methylergonovine
GI Motility Agent Cisapride
Hepatitis C Direct- Acting Antivirals Elbasvir/grazoprevir; glecaprevir/pibrentasvir
Herbal Products St. John’s wort (Hypericum perforatum)
Lipid-Modifying Agents: Lovastatin, simvastatin, lomitapide
Phosphodiesterase-5 (PDE-5) Inhibitor Sildenafilb when dosed as REVATIO® for the treatment of pulmonary arterial hypertension
Protease Inhibitors Indinavir
Non-nucleoside Reverse Transcriptase Inhibitors Nevirapine

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