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

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 Co-administered with either H2RA or Tenofovir DFb

In combination with either H2RA or tenofovir DF

400 mg

100 mg

a See Drug Interactions (7) for instructions concerning co-administration 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.

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 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 co-administration 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

Atazanavir Capsules:

  • Atazanavir capsules, 100 mg are supplied as size ‘2’ hard gelatin capsules having imprinted ‘Amneal 100 mg’ on blue opaque cap with white ink and ‘1135’ on white opaque body with blue ink, filled with off-white to yellow granular powder.
  • Atazanavir capsules, 150 mg are supplied as size ‘1’ hard gelatin capsules having imprinted ‘Amneal 150 mg’ on blue opaque cap with white ink and ‘1136’ on powder blue opaque body with blue ink, filled with off-white to yellow granular powder.
  • Atazanavir capsules, 200 mg are supplied as size ‘0’ hard gelatin capsules having imprinted ‘Amneal 200 mg’ on blue opaque cap and ‘1137’on blue opaque body with white ink, filled with off-white to yellow granular powder.
  • Atazanavir capsules, 300 mg are supplied as size ‘00’ hard gelatin capsules having imprinted ‘Amneal 300 mg’ on red opaque cap and ‘1138’ on blue opaque body with white ink, filled with off-white to yellow granular powder.

4 CONTRAINDICATIONS

Atazanavir is 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 co-administered 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 co-administered with drugs that strongly induce CYP3A and may lead to lower exposure and loss of efficacy of atazanavir (see Table 6).

Table 6 displays drugs that are contraindicated with atazanavir.

Table 6: Drugs that are Contraindicated with Atazanavir (Information in the table applies to Atazanavir with or without ritonavir, unless otherwise indicated)

Drug Class

Drugs within class that are contraindicated with Atazanavir

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 is co-administered with ritonavir.

Pimozide

Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.

Benzodiazepines

Triazolam, orally administered midazolama

Triazolam and orally administered midazolam are extensively metabolized by CYP3A4. Co-administration of triazolam or orally administered midazolam with atazanavir 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

May increase the risk of ALT elevations due to a significant increase in grazoprevir plasma concentrations.

Glecaprevir/pibrentasvir May increase the risk of ALT elevations due to an increase in glecaprevir and pibrentasvir concentrations.

Herbal Products

St. John’s wort (Hypericum perforatum)

Co-administration of St. John’s wort and atazanavir 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

Sildenafilb 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 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.

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.

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