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)].
|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|
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)].
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.
|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.
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.
|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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