REYATAZ

REYATAZ- atazanavir sulfate capsule, gelatin coated
REYATAZ- atazanavir sulfate powder
E.R. Squibb & Sons, L.L.C.

1 INDICATIONS AND USAGE

REYATAZ® (atazanavir) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 3 months and older weighing at least 5 kg.

Limitations of Use:

REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus.
Use of REYATAZ/ritonavir 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 Overview

REYATAZ capsules and oral powder must be taken with food.
Do not open the capsules.
The recommended oral dosage of REYATAZ depends on the treatment history of the patient and the use of other coadministered drugs. When coadministered with H2 -receptor antagonists or proton-pump inhibitors, dose separation may be required [see Dosage and Administration (2.3, 2.4, 2.5, and 2.6) and Drug Interactions (7)].
REYATAZ capsules without ritonavir are not recommended for treatment-experienced adult or pediatric patients with prior virologic failure [see Clinical Studies (14)].
REYATAZ oral powder must be taken with ritonavir and is not recommended for use in children who weigh less than 5 kg [see Dosage and Administration (2.5)].
Efficacy and safety of REYATAZ with ritonavir when ritonavir is administered in doses greater than 100 mg once daily have not been established. The use of higher ritonavir doses may alter the safety profile of atazanavir (cardiac effects, hyperbilirubinemia) and, therefore, is not recommended. Prescribers should consult the complete prescribing information for ritonavir when using ritonavir.

2.2 Testing Prior to Initiation and During Treatment with REYATAZ

Renal laboratory testing should be performed in all patients prior to initiation of REYATAZ and continued during treatment with REYATAZ. Renal laboratory testing should include serum creatinine, estimated creatinine clearance, and urinalysis with microscopic examination [see Warnings and Precautions (5.5, 5.6)].

Hepatic laboratory testing should be performed in patients with underlying liver disease prior to initiation of REYATAZ and continued during treatment with REYATAZ [see Warnings and Precautions (5.4)].

2.3 Dosage of REYATAZ in Adult Patients

Table 1 displays the recommended dosage of REYATAZ capsules in treatment-naive and treatment-experienced adults. Table 1 also displays recommended dosage of REYATAZ and ritonavir when given concomitantly with other antiretroviral drugs and H2 -receptor antagonists (H2RA). Ritonavir is required with several REYATAZ dosage regimens (see the ritonavir complete prescribing information about the safe and effective use of ritonavir). The use of REYATAZ in treatment-experienced adult patients without ritonavir is not recommended.

Table 1: Recommended REYATAZ and Ritonavir Dosage in Adultsa,b
a See Drug Interactions (7) for instructions concerning coadministration of acid-reducing medications (eg, H2RA or proton pump inhibitors [PPIs]), and other antiretroviral drugs (eg, efavirenz, tenofovir DF, and didanosine).b For adult patients who cannot swallow the capsules, REYATAZ oral powder is taken once daily with food at the same recommended adult dosage as the capsules along with ritonavir.

REYATAZ Once Daily Dosage

Ritonavir Once Daily Dosage

Treatment-Naive Adult Patients

recommended regimen

300 mg

100 mg

unable to tolerate ritonavir

400 mg

N/A

in combination with efavirenz

400 mg

100 mg

Treatment-Experienced Adult Patients

recommended regimen

300 mg

100 mg

in combination with both H2RA and tenofovir DF

400 mg

100 mg

2.4 Dosage of REYATAZ Capsules in Pediatric Patients

The recommended daily dosage of REYATAZ capsules and ritonavir in pediatric patients (6 years of age to less than 18 years of age) is based on body weight (see Table 2).

Table 2: Recommended Dosage of REYATAZ Capsules and Ritonavir in Pediatric Patients (6 to less than 18 years of age)a,b
a Administer REYATAZ capsules and ritonavir simultaneously with food.b The same recommendations regarding the timing and maximum doses of concomitant PPIs and H2RAs in adults also apply to pediatric patients. 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).c In treatment-experienced patients, REYATAZ capsules must be administered with ritonavir.

Body weight

REYATAZ Daily Dosage

Ritonavir Daily Dosage

Treatment-Naive and Treatment-Experiencedc

Less than 15 kg

Capsules not recommended

N/A

At least 15 kg to less than 35 kg

200 mg

100 mg

At least 35 kg

300 mg

100 mg

Treatment-Naive, at least 13 years old and cannot tolerate ritonavirc

At least 40 kg

400 mg

N/A

When transitioning between formulations, a change in dose may be needed. Consult the dosing table for the specific formulation.

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.