EVOTAZ

EVOTAZ- atazanavir sulfate and cobicistat tablet
E.R. Squibb & Sons, L.L.C.

1 INDICATIONS AND USAGE

1.1 Indications

EVOTAZ® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in the following populations [see Dosage and Administration (2.2,2.3)]:

Adult patients
Pediatric patients weighing at least 35 kg.

1.2 Limitations of Use

Use of EVOTAZ in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].

2 DOSAGE AND ADMINISTRATION

2.1 Laboratory Testing Prior to Initiation and During Treatment with EVOTAZ

Renal Testing

Renal laboratory testing should be performed in all patients prior to initiation of EVOTAZ and continued during treatment with EVOTAZ. Renal laboratory testing should include estimated creatinine clearance, serum creatinine, and urinalysis with microscopic examination [see Warnings and Precautions (5.5,5.6)]. Cobicistat decreases estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function [see Warnings and Precautions (5.3)].

When coadministering EVOTAZ with tenofovir disoproxil fumarate (tenofovir DF), assess estimated creatinine clearance, urine glucose, and urine protein at baseline and routinely monitor during treatment. In patients with chronic kidney disease, also monitor serum phosphorus[see Warnings and Precautions (5.4)].

Hepatic Testing

Hepatic laboratory testing should be performed in patients with underlying liver disease prior to initiation of EVOTAZ and continued during treatment with EVOTAZ [see Warnings and Precautions (5.7)].

2.2 Recommended Dosage

EVOTAZ is a fixed-dose tablet containing 300 mg of atazanavir and 150 mg of cobicistat. The recommended dosage of EVOTAZ is one tablet taken once daily orally with food [see Clinical Pharmacology (12.3)] in HIV-1-infected treatment-naïve and treatment-experienced:

Adult patients
Pediatric patients weighing at least 35 kg

Administer EVOTAZ in conjunction with other antiretroviral agents [see Drug Interactions (7)]. Dose separation may be required when taken with H2 -receptor antagonists or proton-pump inhibitors [see Drug Interactions (7.2, 7.3)].

2.3 Dosage in Patients with Renal Impairment

EVOTAZ is not recommended in treatment-experienced patients with HIV-1 infection who have end-stage renal disease managed with hemodialysis [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

EVOTAZ coadministered with tenofovir DF is not recommended in patients with estimated creatinine clearance below 70 mL/min. Coadministration of EVOTAZ and tenofovir DF in combination with concomitant or recent use of a nephrotoxic agent is not recommended [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)].

2.4 Not Recommended in Patients with Any Degree of Hepatic Impairment

EVOTAZ is not recommended in patients with any degree of hepatic impairment [see Warnings and Precautions (5.7), Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)].

2.5 Not Recommended During Pregnancy

EVOTAZ is not recommended for use during pregnancy and should not be initiated in pregnant individuals due to substantially lower exposures of cobicistat and consequently, lower exposures of atazanavir, during the second and third trimesters. An alternative regimen is recommended for individuals who become pregnant during therapy with EVOTAZ [see Use in Specific Populations (8.1) ] .

3 DOSAGE FORMS AND STRENGTHS

EVOTAZ tablets contain 342 mg atazanavir sulfate, equivalent to 300 mg of atazanavir, and 150 mg of cobicistat and are oval, biconvex, pink, film-coated, and debossed with “3641” on one side and plain on the other side.

4 CONTRAINDICATIONS

The concomitant use of EVOTAZ and the following drugs in Table 1, are contraindicated due to the potential for serious and/or life-threatening events or loss of therapeutic effect [see Warnings and Precautions (5.8, 5.9) , Drug Interactions (7) and Clinical Pharmacology (12.3) ] .

EVOTAZ 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 this product [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 5).
when coadministered with drugs that strongly induce CYP3A and may lead to lower exposure and loss of efficacy of EVOTAZ (see Table 1).
For additional information, including clinical comments and potential impact on exposure levels associated with drugs that are contraindicated with EVOTAZ, refer to Table 5 [see Drug Interactions (7.3)].
Table 1: Drugs Contraindicated with EVOTAZ
Drug Class Drugs within class that are contraindicated with EVOTAZ

Alpha 1-adrenoreceptor antagonist

alfuzosin

Antianginal

ranolazine

Antiarrhythmics

dronedarone

Anticonvulsants

carbamazepine, phenobarbital, phenytoin

Antigout

colchicine (when used in patients with hepatic and/or renal impairment)

Antimycobacterials

rifampin

Antineoplastics

irinotecan

Antipsychotics

lurasidone, pimozide

Ergot Derivatives

dihydroergotamine, ergotamine, methylergonovine

GI Motility Agent

cisapride

Hepatitis C Direct-Acting Antivirals

elbasvir/grazoprevir; glecaprevir/pibrentasvir

Herbal Products

St. John’s wort (Hypericum perforatum)

Hormonal Contraceptives

drospirenone/ethinyl estradiol

Lipid-modifying Agents

lomitapide, lovastatin, simvastatin

Non-nucleoside Reverse Transcriptase Inhibitor

nevirapine

Phosphodiesterase-5 (PDE-5) Inhibitor

sildenafil a when administered for the treatment of pulmonary arterial hypertension

Protease Inhibitors

indinavir

Sedative/hypnotics

triazolam, orally administered midazolam b

a Refer to Table 5 for sildenafil when administered for erectile dysfunction [see Drug Interactions (7.3) ]. b Refer to Table 5 for parenterally administered midazolam [see Drug Interactions (7.3)].

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.