"The US Food and Drug Administration (FDA) has approved atazanavir and cobicistat (Evotaz, Bristol-Myers Squibb) for treatment of adults with human immunodeficiency virus (HIV-1) infection.
Atazanavir/cobicistat is a fixed-dos"...
Limitations of Use
DOSAGE AND ADMINISTRATION
- 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 DRUG INTERACTIONS].
- REYATAZ capsules without ritonavir are not recommended for treatment-experienced adult or pediatric patients with prior virologic failure [see Clinical Studies].
- REYATAZ oral powder must be taken with ritonavir and is not recommended for use in children who weigh less than 10 kg or who weigh 25 kg or more. [See Dosage And Administration Of REYATAZ Oral Powder In Pediatric Patients]
- 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.
Dosage 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
|REYATAZ Once Daily Dosage||Ritonavir Once Daily Dosage|
|Treatment-Naive Adult Patients|
|recommendedregimen||300 mg||100 mg|
|unable to tolerate ritonavir||400 mg||N/A|
|in combination with efavirenz||400 mg||100 mg|
|Treatment-Experienced Adult Patients|
|recommendedregimen||300 mg||100 mg|
|in combination with both H2RA and tenofovir||400 mg||100 mg|
|a See DRUG INTERACTIONS for instructions concerning coadministration of acid reducing medications (eg, H2RA or proton pump inhibitors [PPIs]), and other antiretroviral drugs (eg, efavirenz, tenofovir, and didanosine).|
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
|Body weight||REYATAZ Daily Dosage||Ritonavir Daily Dosage|
|Treatment-Naive and Treatment-Experiencedc|
|Less than 15 kg||Capsules not recommended||N/A|
|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|
|Treatment-Naive, at least 13 years old and cannot tolerate ritonavirc|
|At least 40 kg||400 mg||N/A|
|a Administer REYATAZ capsules and ritonavir
simultaneously with food.
bThe same recommendations regarding the timing and maximum doses of concomitant PPIs and H2RAs in adults also apply to pediatric patients. See DRUG INTERACTIONS for instructions concerning coadministration of acid reducing medications (eg, H2RA or PPIs), and other antiretroviral drugs (eg, efavirenz, tenofovir, and didanosine).
c In treatment-experienced patients, REYATAZ capsules must be administered with ritonavir.
Dosage And Administration Of REYATAZ Oral Powder In Pediatric Patients
REYATAZ oral powder is for use in treatment-naive or treatment-experienced pediatric patients who are at least 3 months of age and weighing at least 10 kg and less than 25 kg. REYATAZ oral powder must be mixed with food or beverage for administration and ritonavir must be given immediately afterwards. Table 3 displays the recommended dosage of REYATAZ oral powder and ritonavir.
Table 3: Recommended Dosage of REYATAZ Oral Powder and
Ritonavir in Pediatric Patients (at least 3 months of age and weighing at least
10 kg and less than 25 kg)a
|Body Weight||Daily Dosage of REYATAZ Oral Powder||Daily Dosage of Ritonavir Oral Solution|
|10 kg to less than 15 kg||200 mg (4 packets)b||80 mg|
|15 kg to less than 25 kg||250 mg (5 packets)b||80 mg|
|a The same recommendations regarding the
timing and maximum doses of concomitant PPIs and H2RAs in adults also apply to
pediatric patients. See DRUG INTERACTIONS for instructions concerning
coadministratrion of acid reducing medications (eg, H2RA or PPIs), and other
antiretroviral drugs (eg, efavirenz, tenofovir, and didanosine).
bEach packet contains 50 mg of REYATAZ.
Instructions for Mixing REYATAZ Oral Powder
[see FDA-approved Instructions for Use]
- It is preferable to mix REYATAZ oral powder with food such as applesauce or yogurt. Mixing REYATAZ oral powder with a beverage (milk, infant formula, or water) may be used for infants who can drink from a cup. For young infants (less than 6 months) who cannot eat solid food or drink from a cup, REYATAZ oral powder should be mixed with infant formula and given using an oral dosing syringe. Administration of REYATAZ and infant formula using an infant bottle is not recommended because full dose may not be delivered.
- Determine the number of packets (4 or 5 packets) that are needed.
- Prior to mixing, tap the packet to settle the powder. Use a clean pair of scissors to cut each packet along the dotted line.
- Mixing with food: Using a spoon, mix the recommended number of REYATAZ oral powder packets with a minimum of one tablespoon of food (such as applesauce or yogurt). Feed the mixture to the infant or young child. Add an additional one tablespoon of food to the small container, mix, and feed the child the residual mixture.
- Mixing with a beverage such as milk or water in a small drinking cup: Using a spoon, mix the recommended number of REYATAZ oral powder packets with a minimum of 30 mL of the beverage. Have the child drink the mixture. Add an additional 15 mL more of beverage to the drinking cup, mix, and have the child drink the residual mixture. If water is used, food should also be taken at the same time.
- Mixing with liquid infant formula using an oral dosing syringe and a small medicine cup: Using a spoon, mix the recommended number of REYATAZ oral powder packets with 10 mL of prepared liquid infant formula. Draw up the full amount of the mixture into an oral syringe and administer into either right or left inner cheek of infant. Pour another 10 mL of formula into the medicine cup to rinse off remaining REYATAZ oral powder in cup. Draw up residual mixture into the syringe and administer into either right or left inner cheek of infant.
- Administer ritonavir immediately following REYATAZ powder administration.
- Administer the entire dosage of REYATAZ oral powder (mixed in the food or beverage) within one hour of preparation (may leave the mixture at room temperature during this one hour period). Ensure that the patient eats or drinks all the food or beverage that contains the powder. Additional food may be given after consumption of the entire mixture.
Dosage Adjustments In Pregnant Patients
Table 4 includes the recommended dosage of REYATAZ capsules and ritonavir in treatment-naive and treatment-experienced pregnant patients. In these patients, REYATAZ must be administered with ritonavir. There are no dosage adjustments for postpartum patients (see Table 1 for the recommended REYATAZ dosage in adults). [See Use In Specific Populations]
Table 4: Recommended Dosage of REYATAZ and Ritonavir
in Pregnant Patientsa
|REYATAZ 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 Tenofovirb|
|In combination with either H2RA or tenofovir||400 mg||100 mg|
|a See DRUG INTERACTIONS for
instructions concerning coadministration of acid reducing medications (eg, H2RA
or PPIs), and other antiretroviral drugs (eg, efavirenz, tenofovir and
bREYATAZ is not recommended for treatment-experienced pregnant patients during the second and third trimester taking REYATAZ with both tenofovir and H2RA.
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]
Dosage Adjustments In Patients With Hepatic Impairment
Table 5 displays the recommended REYATAZ dosage in treatment-naive patients with hepatic impairment. The use of REYATAZ in patients with severe hepatic impairment (Child-Pugh Class C) is not recommended. The coadministration of REYATAZ with ritonavir in patients with any degree of hepatic impairment is not recommended.
Table 5: Recommended Dosage of REYATAZ Capsules in
Treatment-Naive Adults with Hepatic Impairment
|REYATAZ 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)||REYATAZ with or without ritonavir is not recommended|
Dosage Forms And Strengths
- 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.
REYATAZ Oral Powder
- 50 mg of atazanavir as an oral powder in a packet.
Storage And Handling
REYATAZ® (atazanavir) 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|
|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|
|* 150 mg atazanavir equivalent to 170.8 mg atazanavir sulfate. 200 mg atazanavir equivalent to 227.8 mg atazanavir sulfate. 300 mg atazanavir equivalent to 341.69 mg atazanavir sulfate.|
Store REYATAZ capsules at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].
REYATAZ Oral Powder
REYATAZ oral powder is an orange-vanilla flavored powder, packed in child-resistant packets. Each packet contains 50 mg of atazanavir equivalent to 56.9 mg of atazanavir sulfate in 1.5 g of powder. REYATAZ oral powder is supplied in cartons (NDC 0003-3638-10) of 30 packets each. [See DOSAGE AND ADMINISTRATION]
Store REYATAZ oral powder below 30°C (86°F). Once the REYATAZ oral powder is mixed with food or beverage, it may be kept at room temperature 20°C to 30°C (68°F-86°F) for up to 1 hour prior to administration. Store REYATAZ oral powder in the original packet and do not open until ready to use.
Distributed by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA. Issued: June 2014
Last reviewed on RxList: 6/16/2014
This monograph has been modified to include the generic and brand name in many instances.
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