Atazanavir Sulfate (Page 2 of 12)

2.6 Dosage Adjustments in Pregnant Patients

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

Table 4: Recommended Dosage of Atazanavir Sulfate Capsules and Ritonavir in Pregnant Patients 1

Atazanavir Sulfate 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 2

In combination with either H2RA

or tenofovir DF

400 mg

100 mg

1. 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).

2. Atazanavir sulfate capsules are not recommended for treatment-experienced pregnant patients during the second and third trimester taking atazanavir sulfate 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 sulfate capsules. Treatment-naive patients with end-stage renal disease managed with hemodialysis should receive atazanavir sulfate capsules 300 mg with ritonavir 100 mg. Atazanavir sulfate 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 sulfate capsule dosage in treatment-naive patients with hepatic impairment. The use of atazanavir sulfate capsules in patients with severe hepatic impairment (Child-Pugh Class C) is not recommended. The coadministration of atazanavir sulfate capsules with ritonavir in patients with any degree of hepatic impairment is not recommended.

Table 5: Recommended Dosage of Atazanavir Sulfate 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 sulfate capsules with or without ritonavir is not recommended

3 DOSAGE FORMS AND STRENGTHS

  • 150 mg capsule with light-turquoise-blue-opaque cap and aqua-blue-opaque body, imprinted “5526” on the body and “TEVA” on the cap.
  • 200 mg capsule with light-turquoise body and light-turquoise cap, imprinted “93” over “5527” on both the cap and the body.
  • 300 mg capsule with light-blue-opaque body and red-opaque cap, imprinted “93” over “5528” on both the cap and the body.

4 CONTRAINDICATIONS

Atazanavir sulfate 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 sulfate 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 sulfate (see Table 6).

Table 6 displays drugs that are contraindicated with atazanavir sulfate.

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

Drug Class

Drugs within class that are contraindicated with atazanavir sulfate

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

Pimozide

Potential for serious and/or life-threatening reactions if atazanavir sulfate is coadministered with ritonavir.

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

Benzodiazepines

Triazolam, orally administered midazolam 1

Triazolam and orally administered midazolam are extensively metabolized by CYP3A4. Coadministration of triazolam or orally administered midazolam with atazanavir sulfate 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)

Coadministration of St. John’s wort and atazanavir sulfate 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 2 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 sulfate 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.

1. See Drug Interactions, Table 16 ( 7) for parenterally administered midazolam.

2. See Drug Interactions, Table 16 ( 7) for sildenafil when dosed as VIAGRA ® for erectile dysfunction.

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