Atazanavir Sulfate (Page 2 of 11)

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 Patients a
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 DF b
In combination with either H2RA 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 HIV-treatment-experienced patients with 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 Atazanavir Sulfate Dosage Forms and Strengths

  • 100 mg Capsules are blue/white size ‘2’ hard gelatin capsule filled with off-white to pale yellow granular powder and imprinted with ‘100 mg’ on blue cap with white edible ink and ‘T23’ on white body with black edible ink.
  • 150 mg Capsules are blue/powder blue size ‘1’ hard gelatin capsule filled with off-white to pale yellow granular powder and imprinted with ‘150 mg’ on blue cap and ‘T24’ on powder blue body with white edible ink.
  • 200 mg Capsules are blue/blue size ‘0’ hard gelatin capsule filled with off-white to pale yellow granular powder and imprinted with ‘200 mg’ on blue cap and ‘T25’ on blue body with white edible ink.
  • 300 mg Capsules are red/blue size ‘00’ hard gelatin capsule filled with off-white to pale yellow granular powder and imprinted with ‘300 mg’ on red cap and ‘T26’ on blue body with white edible ink.

4 CONTRAINDICATIONS

Atazanavir capsules are contraindicated:

  • in patients with previously demonstrated clinically significant hypersensitivity (e.g., 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 that are 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 Clinical Comment
Alpha 1-­Adrenoreceptor Antagonist Alfuzosin Potential for increased alfuzosin concentrations, which can result in hypotension.
Antimycobacterials Rifampin Rifampin substantially decreases plasma concentrations of atazanavir, which may result in loss of therapeutic effect and development of resistance.
Antineoplastics Irinotecan Atazanavir inhibits UGT1A1 and may interfere with the metabolism of irinotecan, resulting in increased irinotecan toxicities.
Antipsychotics Lurasidone Potential for serious and/or life-threatening reactions if atazanavir capsules are coadministered with ritonavir.
Pimozide Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Benzodiazepines Triazolam, orally administered midazolam a Triazolam and orally administered midazolam are extensively metabolized by CYP3A4. Coadministration of triazolam or orally administered midazolam with atazanavir capsules may cause large increases in the concentration of these benzodiazepines. Potential for serious and/or life-threatening events such as prolonged or increased sedation or respiratory depression.
Ergot Derivatives Dihydroergotamine, ergotamine, ergonovine, methylergonovine Potential for serious and/or life-threatening events such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
GI Motility Agent Cisapride Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Hepatitis C Direct-Acting Antivirals Elbasvir/grazoprevir Glecaprevir/pibrentasvir May increase the risk of ALT elevations due to a significant increase in grazoprevir plasma concentrations. May increase the risk of ALT elevations due to an increase in glecaprevir and pibrentasvir concentrations.
Herbal Products St. John’s wort ( Hypericum perforatum) Coadministration of St. John’s wort and atazanavir capsules may result in loss of therapeutic effect and development of resistance.
HMG-CoA Reductase Inhibitors Lovastatin, simvastatin Potential for serious reactions such as myopathy, including rhabdomyolysis.
PDE5 Inhibitor Sildenafil b when dosed as REVATIO ® for the treatment of pulmonary arterial hypertension Potential for sildenafil-associated adverse events (which include visual disturbances, hypotension, priapism, and syncope).
Protease Inhibitors Indinavir Both atazanavir capsules and indinavir are associated with indirect (unconjugated) hyperbilirubinemia.
Non-nucleoside Reverse Transcriptase Inhibitors Nevirapine Nevirapine substantially decreases atazanavir exposure which may result in loss of therapeutic effect and development of resistance. Potential risk for nevirapine- associated adverse reactions due to increased nevirapine exposures.

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