"Nov. 27, 2012 -- Every month, 1,000 more young Americans ages 13 to 24 get an incurable infection that's deadly unless held at bay by daily doses of costly drugs -- and many of them don't even know it.
That infection is HIV, the virus"...
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 96 weeks duration in antiretroviral-naive and 48 weeks duration in 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.
- 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.
- 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 adult or pediatric 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
Table 1 summarizes the recommended REYATAZ dosing regimen in adults. All REYATAZ dosing regimens are to be administered as a single dose with food.
Table 1: REYATAZ Dosing Regimens
|Treatment-Naive Patients||REYATAZ 300 mg with ritonavir 100 mg once daily|
|If unable to tolerate ritonavir||REYATAZ 400 mg once daily|
|When combined with any of the following: Tenofovir||REYATAZ 300 mg with ritonavir 100 mg once daily|
The H2-receptor antagonist dose should not exceed a dose comparable to famotidine 40 mg twice daily. Administer REYATAZ and ritonavir simultaneously with, and/or at least 10 hours after the H2-receptor antagonist.
If unable to tolerate ritonavir, administer REYATAZ 400 mg once daily at least 2 hours before and at least 10 hours after the H2-receptor antagonist. 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.
The proton-pump inhibitor dose should not exceed a dose comparable to omeprazole 20 mg daily and must be taken approximately 12 hours prior to REYATAZ and ritonavir.
|When combined with efavirenz||REYATAZ 400 mg with ritonavir 100 mg once daily|
|Efavirenz should be administered on an empty stomach, preferably at bedtime.|
|Treatment-Experienced Patients||REYATAZ 300 mg with ritonavir 100 mg once daily|
|Do not coadminister with proton-pump inhibitors or efavirenz in treatment-experienced patients.|
|Do not coadminister with proton-pump inhibitors or efavirenz in treatment-experienced patients.||REYATAZ 300 mg with ritonavir 100 mg once daily|
|The H2-receptor antagonist dose should not exceed a dose comparable to famotidine 20 mg twice daily. Administer REYATAZ and ritonavir simultaneously with, and/or at least 10 hours after the H2-receptor antagonist.|
|When given with both tenofovir and an H2-receptor antagonist||REYATAZ 400 mg with ritonavir 100 mg once daily|
|The H2-receptor antagonist dose should not exceed a dose comparable to famotidine 20 mg twice daily. Administer REYATAZ and ritonavir simultaneously with, and/or at least 10 hours after the H2-receptor antagonist. [For these drugs and other antiretroviral agents for which dosing modification may be appropriate, see DRUG INTERACTIONS.]|
Recommended Pediatric Dosage
The recommended daily 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 any pediatric patient less than 13 years of age, and (3) patients less than 40 kg receiving concomitant tenofovir, H2-receptor antagonists, or proton-pump inhibitors.
The recommended dosage of REYATAZ with ritonavir in pediatric patients at least 6 years of age is shown in Table 2.
Table 2: Dosage for Pediatric
Patients (6 to less than 18 years of age) for REYATAZ Capsules with ritonavira
|Body Weight||REYATAZ dose||ritonavir dose|
|15 kg to less than 20 kg||150 mg||100 mg|
|20 kg to less than 40 kg||200 mg||100 mg|
|at least 40 kg||300 mg||100 mg|
|aThe REYATAZ and ritonavir dose should be taken together once daily with food.|
For treatment-naive patients at least 13 years of age and at least 40 kg, who are unable to tolerate ritonavir, the recommended dose is REYATAZ 400 mg (without ritonavir) once daily with food. For patients at least 13 years of age and at least 40 kg receiving concomitant tenofovir, H2receptor antagonists, or proton-pump inhibitors, REYATAZ should not be administered without ritonavir.
Dosing During Pregnancy and the Postpartum Period
- REYATAZ should not be administered without ritonavir.
- REYATAZ should only be administered to pregnant women with HIV-1 strains susceptible to atazanavir.
- For pregnant patients, no dose adjustment is required for
REYATAZ with the following exceptions:
- For treatment-experienced pregnant women during the second or third trimester, when REYATAZ is coadministered with either an H2-receptor antagonist or tenofovir, REYATAZ 400 mg with ritonavir 100 mg once daily is recommended. There are insufficient data to recommend a REYATAZ dose for use with both an H2-receptor antagonist and tenofovir in treatment-experienced pregnant women.
- No dose adjustment is required for postpartum patients. However, patients should be closely monitored for adverse events because atazanavir exposures could be higher during the first 2 months after delivery. [See Use In Specific Populations and CLINICAL PHARMACOLOGY.]
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-treatmentexperienced patients with end stage renal disease managed with hemodialysis. [See Use In Specific Populations.]
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.
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|
|100 mg||blue/white||BMS 100 mg (white)||3623 (blue)||60||0003-3623-12|
|150 mg||blue/powder blue||BMS 150 mg (white)||3624 (blue)||60||0003-3624-12|
|200 mg||blue/blue||BMS 200 mg (white)||3631 (white)||60||0003-3631-12|
|300 mg||red/blue||BMS 300 mg (white)||3622 (white)||30||0003-3622-12|
|* atazanavir equivalent as atazanavir sulfate.|
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].
Bristol-Myers Squibb Company, Princeton, NJ 08543 USA.
Last reviewed on RxList: 3/5/2012
This monograph has been modified to include the generic and brand name in many instances.
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