ENDARI- glutamine powder, for solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

Glutamine (UNII: 0RH81L854J) (Glutamine - UNII:0RH81L854J)

Saadav alates:

Emmaus Medical, Inc.

INN (Rahvusvaheline Nimetus):

Glutamine

Koostis:

Glutamine 5 g

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Endari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. None Risk Summary There are no available data on Endari use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies were not conducted with Endari. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Risk Summary There are no data on the presence of Endari in human milk, the effect on the breastfed infant or the effect on milk production. The developmental and health benefits from breastfeeding should be considered along with the mother's clinical need for Endari and any potential advers

Toote kokkuvõte:

Endari is supplied in paper-foil-plastic laminate packets containing 5 grams of L-glutamine white crystalline powder. Store at 20°C to 25°C (68°F to 77°F) away from direct sunlight.

Volitamisolek:

New Drug Application

Toote omadused

ENDARI- GLUTAMINE POWDER, FOR SOLUTION
EMMAUS MEDICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ENDARI™ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ENDARI.
ENDARI (L-GLUTAMINE ORAL POWDER )
INITIAL U.S. APPROVAL: 2017
INDICATIONS AND USAGE
ENDARI is an amino acid indicated to reduce the acute complications of
sickle cell disease in adult and
pediatric patients 5 years of age and older. (1)
DOSAGE AND ADMINISTRATION
5 grams to 15 grams orally, twice daily based on body weight. (2)
Each dose of Endari should be mixed in 8 oz. (240 mL) of cold or room
temperature beverage or 4 oz.
to 6 oz. of food before ingestion. (2)
DOSAGE FORMS AND STRENGTHS
Oral Powder: 5 grams of L-glutamine powder per paper-foil-plastic
laminate packet. (3)
CONTRAINDICATIONS
None (4)
ADVERSE REACTIONS
Most common adverse reactions (incidence > 10%) are constipation,
nausea, headache, abdominal pain,
cough, pain in extremity, back pain, and chest pain. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT EMMAUS MEDICAL, INC. AT
1-877-420-
6493 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 10/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosage
2.2 Preparation of Product
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Endari is indicated to reduce the acute complications of sickle cell
disease in adult and
pediatric pat