REYATAZ- atazanavir capsule, gelatin coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

ATAZANAVIR SULFATE (UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S)

Saatavilla:

REMEDYREPACK INC.

INN (Kansainvälinen yleisnimi):

ATAZANAVIR SULFATE

Koostumus:

ATAZANAVIR 300 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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)] . REYATAZ is contraindicated:REYATAZ is contraindicated: - in patients with previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of REYATAZ capsules or REYATAZ oral powder [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 lif

Tuoteyhteenveto:

                                                                          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 cap body 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 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 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 (2.5) .] 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.

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

REYATAZ- ATAZANAVIR CAPSULE, GELATIN COATED
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
REYATAZ SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR REYATAZ.
REYATAZ (ATAZANAVIR) CAPSULES, FOR ORAL USE
REYATAZ (ATAZANAVIR) ORAL POWDER
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Dosage and Administration,
Testing Prior to Initiation and During Treatment with REYATAZ (2.2)
10/2017
Dosage of REYATAZ Capsules in Pediatric Patients (2.4) 5/2017
Dosage and Administration of REYATAZ Oral Powder in Pediatric Patients
(2.5) 5/2017
Contraindications (4) 3/2018
Warnings and Precautions
Chronic Kidney Disease (5.5) 10/2017
INDICATIONS AND USAGE
REYATAZ is a protease inhibitor indicated for use in combination with
other antiretroviral agents for the treatment of HIV-
1 infection for patients 3 months and older weighing at least 5 kg.
(1)
DOSAGE AND ADMINISTRATION
_Pretreatment testing:_ Renal laboratory testing should be performed
in all patients prior to initiation of REYATAZ and
continued during treatment with REYATAZ. Hepatic testing should be
performed in patients with underlying liver
disease prior to initiation of REYATAZ and continued during treatment
with REYATAZ. (2.2)
_Treatment-naive adults:_ REYATAZ 300 mg with ritonavir 100 mg once
daily with food or REYATAZ 400 mg once daily
with food. (2.3)
_Treatment-experienced adults:_ REYATAZ 300 mg with ritonavir 100 mg
once daily with food. (2.3)
_Pediatric patients:_ REYATAZ capsule dosage is based on body weight
not to exceed the adult dose and must be taken
with food. (2.4)
_REYATAZ oral powder:_ Must be taken with ritonavir and food and
should not be used in pediatric patients who weigh
less than 5 kg. (2.5)
_Pregnancy:_ REYATAZ 300 mg with ritonavir 100 mg once daily with
food, with dosing modifications for some
concomitant medications. (2.6)
_Dosing modifications:_ may be required for concomitant therapy (2.3,
2.4, 2.5, 2.6), renal impairment (2.7), and hepatic
impa