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Reyataz (Atazanavir Sulfate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

REYATAZ® (atazanavir sulfate) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from controlled studies of 48 weeks duration in antiretroviral-naive and antiretroviral-treatment-experienced adult and pediatric patients at least 6 years of age.

The following points should be considered when initiating therapy with REYATAZ:

  • In Study AI424-045 REYATAZ/ritonavir and lopinavir/ritonavir were similar for the primary efficacy outcome measure of time-averaged difference in change from baseline in HIV RNA level. This study was not large enough to reach a definitive conclusion that REYATAZ/ritonavir and lopinavir/ritonavir are equivalent on the secondary efficacy outcome measure of proportions below the HIV RNA lower limit of detection [see Clinical Studies ].
  • The number of baseline primary protease inhibitor mutations affects the virologic response to REYATAZ/ritonavir [see Clinical Pharmacology ].

DOSAGE AND ADMINISTRATION

General Dosing Recommendations:

  • REYATAZ Capsules must be taken with food.
  • 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 ].
  • When coadministered with didanosine buffered or enteric-coated formulations, REYATAZ should be given (with food) 2 hours before or 1 hour after didanosine.
  • REYATAZ without ritonavir is not recommended for treatment-experienced patients with prior virologic failure [see Clinical Studies ].
  • Efficacy and safety of REYATAZ with ritonavir in doses greater than 100 mg once daily have not been established. The use of higher ritonavir doses might alter the safety profile of atazanavir (cardiac effects, hyperbilirubinemia) and, therefore, is not recommended. Prescribers should consult the complete prescribing information for NORVIR® (ritonavir) when using this agent.

Recommended Adult Dosage

Dose Recommendations for Therapy-Naive Patients

  • For treatment-naive patients, the recommended dosage is REYATAZ 300 mg with ritonavir 100 mg once daily (all as a single dose with food).
                                                OR
  • For treatment-naive patients who are unable to tolerate ritonavir, the recommended dosage is REYATAZ 400 mg (without ritonavir) once daily taken with food.

Concomitant Therapy:

  • REYATAZ 300 mg with ritonavir 100 mg once daily (all as a single dose with food) if combined with any of the following:
      tenofovir
    • H2-receptor antagonist: The H2-receptor antagonist dose should not exceed a dose comparable to famotidine 40 mg twice daily. REYATAZ 300 mg and ritonavir 100 mg should be administered simultaneously with, and/or at least 10 hours after, the dose of the H2-receptor antagonist. For patients unable to tolerate ritonavir, REYATAZ 400 mg once daily with food should be administered at least 2 hours before and at least 10 hours after the H2-receptor antagonist. For these patients, no single dose of the H2-receptor antagonist should exceed a dose comparable to famotidine 20 mg, and the total daily dose should not exceed a dose comparable to famotidine 40 mg.
    • proton-pump inhibitors: The proton-pump inhibitor dose should not exceed a dose comparable to omeprazole 20 mg and must be taken approximately 12 hours prior to the REYATAZ 300 mg and ritonavir 100 mg dose.
    • If REYATAZ is combined with efavirenz, REYATAZ 400 mg (two 200-mg capsules) with ritonavir 100 mg should be administered once daily all as a single dose with food, and efavirenz should be administered on an empty stomach, preferably at bedtime.

Dose Recommendations for Therapy-Experienced Patients

REYATAZ 300 mg with ritonavir 100 mg once daily (all as a single dose with food).

Concomitant Therapy:

  • Whenever an H2-receptor antagonist is given to a patient receiving REYATAZ with ritonavir, the H2-receptor antagonist dose should not exceed a dose comparable to famotidine 20 mg twice daily, and the REYATAZ and ritonavir doses should be administered simultaneously with, and/or at least 10 hours after, the dose of the H2-receptor antagonist.
      REYATAZ 300 mg with ritonavir 100 mg once daily (all as a single dose with food) if taken with an H2-receptor antagonist.
    • REYATAZ 400 mg (two 200-mg capsules) with ritonavir 100 mg once daily (all as a single dose with food) if taken with both tenofovir and an H2-receptor antagonist.
  • Proton-pump inhibitors should not be used in treatment-experienced patients receiving REYATAZ.
  • Efavirenz: Do not coadminister REYATAZ with efavirenz in treatment-experienced patients due to decreased atazanavir exposure.

[For these drugs and other antiretroviral agents for which dosing modification may be appropriate, see Drug Interactions (7) .]

Recommended Pediatric Dosage

The recommended dosage of REYATAZ for pediatric patients (6 to less than 18 years of age) is based on body weight and should not exceed the recommended adult dosage. REYATAZ Capsules must be taken with food. The data are insufficient to recommend dosing of REYATAZ for any of the following: (1) patients less than 6 years of age, (2) without ritonavir in patients less than 13 years of age, and (3) treatment-experienced pediatric patients with body weight less than 25 kg.

Therapy-Naive Pediatric Patients

The recommended dosage of REYATAZ with ritonavir in treatment-naive patients at least 6 years of age is shown in Table 1.

For treatment-naive patients at least 13 years of age and at least 39 kg, who are unable to tolerate ritonavir, the recommended dose is REYATAZ 400 mg (without ritonavir) once daily with food.

Table 1: Dosage for Treatment-Naive Pediatric Patients (6 to less than 18 years of age) for REYATAZ Capsules with ritonavir
Body Weight REYATAZ dosea,b ritonavir doseb
(kg) (lbs) (mg) (mg)
a The recommended dosage of REYATAZ can be achieved using a combination of commercially available capsule strengths.
b The dosage of REYATAZ and ritonavir was calculated as follows:
  • 15 kg to less than 20 kg: REYATAZ 8.5 mg/kg with ritonavir 4 mg/kg once daily with food.
  • at least 20 kg: REYATAZ 7 mg/kg with ritonavir 4 mg/kg once daily with food not to exceed REYATAZ 300 mg and ritonavir 100 mg.
c Ritonavir liquid.
d Ritonavir capsule or liquid.
15 to less than 2533 to less than 5515080c
25 to less than 3255 to less than 70200100d
32 to less than 3970 to less than 86250100d
at least 39at least 86300100d

Therapy-Experienced Pediatric Patients

The recommended dosage of REYATAZ with ritonavir in treatment-experienced patients at least 6 years of age is shown in Table 2.

Table 2: Dosage for Treatment-Experienced Pediatric Patients (6 to less than 18 years of age) for REYATAZ Capsules with ritonavir
Body Weight REYATAZ dosea,b ritonavir doseb
(kg) (lbs) (mg) (mg)
a The recommended dosage of REYATAZ can be achieved using a combination of commercially available capsule strengths.
b The dosage was calculated as REYATAZ 7 mg/kg with ritonavir 4 mg/kg once daily with food not to exceed REYATAZ 300 mg and ritonavir 100 mg.
c Ritonavir capsule or liquid.
25 to less than 3255 to less than 70200100c
32 to less than 3970 to less than 86250100c
at least 39at least 86300100c

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 REYATAZ. Treatment-naive patients with end stage renal disease managed with hemodialysis should receive REYATAZ 300 mg with ritonavir 100 mg. REYATAZ should not be administered to HIV-treatment-experienced patients with end stage renal disease managed with hemodialysis. [See Use in Specific Populations .]

Hepatic Impairment

REYATAZ should be used with caution in patients with mild-to-moderate hepatic impairment. For patients with moderate hepatic impairment (Child-Pugh Class B) who have not experienced prior virologic failure, a dose reduction to 300 mg once daily should be considered. REYATAZ should not be used in patients with severe hepatic impairment (Child-Pugh Class C). REYATAZ/ritonavir has not been studied in subjects with hepatic impairment and is not recommended. [See Warnings and Precautions and Use in Specific Populations . ]

DOSAGE FORMS AND STRENGTHS

  • 100 mg capsule with blue cap and white body, printed with white ink “BMS 100 mg” on the cap and with blue ink “3623” on the body.
  • 150 mg capsule with blue cap and powder blue body, printed with white ink “BMS 150 mg” on the cap and with blue ink “3624” on the body.
  • 200 mg capsule with blue cap and blue body, printed with white ink“BMS 200 mg” on the cap and with white ink “3631” on the body.
  • 300 mg capsule with red cap and blue body, printed with white ink“BMS 300 mg” on the cap and with white ink “3622” on the body.

HOW SUPPLIED/STORAGE AND HANDLING

REYATAZ® (atazanavir sulfate) Capsules are available in the following strengths and configurations of plastic bottles with child-resistant closures.

Product Strength* Capsule Shell Color (cap/body) Markings on Capsule
(ink color)
Capsules per Bottle NDC Number
cap body
* atazanavir equivalent as atazanavir sulfate.
100 mgblue/whiteBMS 100 mg
(white)
3623
(blue)
600003-3623-12
150 mgblue/powder blueBMS 150 mg
(white)
3624
(blue)
600003-3624-12
200 mgblue/blueBMS 200 mg
(white)
3631
(white)
600003-3631-12
300 mgred/blueBMS 300 mg
(white)
3622
(white)
300003-3622-12

REYATAZ (atazanavir sulfate) Capsules should be stored at 25° C (77° F); excursions permitted to 15–30° C (59–86° F) [see USP Controlled Room Temperature].

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