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)].
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.
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.
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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