DEFLAZACORT tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEFLAZACORT (UNII: KR5YZ6AE4B) (DEFLAZACORT - UNII:KR5YZ6AE4B)

Available from:

Aurobindo Pharma Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza TM (deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information . Deflazacort tablets are contraindicated in patients with known hypersensitivity to deflazacort or to any of the inactive ingredients. Instances of hypersensitivity, including anaphylaxis, have occurred in patients receiving corticosteroid therapy [see Warnings and Precautions (5.15) and Adverse Reactions (6.2)] . Risk Summary Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. There are no adequate and well-controlled studies with deflazacort in pregnant women to inform drug-associated risks. Corticosteroids, including deflazacort, readily cross the placenta. Adverse developmental outcomes, including orofacial clefts (cleft lip, with or without cleft palate) and intrauterine growth restriction, and decreased birth weight, have been reported with maternal use of corticosteroids, including deflazacort, during pregnancy. Some epidemiologic studies report an increased risk of orofacial clefts from about 1 per 1000 infants to 3 to 5 per 1000 infants; however, a risk for orofacial clefts has not been observed in all studies. Intrauterine growth restriction and decreased birth weight appear to be dose-related; however, the underlying maternal condition may also contribute to these risks (see Data). The estimated background risk of major birth defects and miscarriage for the indicated populations is 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. Animal reproduction studies have not been conducted with deflazacort. Animal reproduction studies conducted with other corticosteroids in pregnant mice, rats, hamsters, and rabbits using clinically relevant doses have shown an increased incidence of cleft palate. An increase in embryofetal death, intrauterine growth retardation, and constriction of the ductus arteriosus were observed in some animal species. Data Human Data Multiple cohort and case-controlled studies in humans suggest that maternal corticosteroid use during the first trimester increases the rate of cleft lip, with or without cleft palate, from about 1/1000 infants to 3 to 5/1000 infants. Two prospective case-controlled studies showed decreased birth weight in infants exposed to maternal corticosteroids in utero. Risk Summary Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for deflazacort and any potential adverse effects on the breastfed infant from deflazacort. There are no data on the effects on milk production. The safety and effectiveness of deflazacort for the treatment of DMD have been established in patients 5 years of age and older. Use of deflazacort in pediatric patients is supported by a multicenter, randomized, double-blind, placebo- and active-controlled study in 196 males 5 to 15 years of age [see Clinical Studies (14)] . Safety and effectiveness in pediatric patients below the age of 2 years have not been established. Juvenile Animal Toxicity Data Oral administration of deflazacort (0, 0.1, 0.3, and 1.0 mg/kg/day) to juvenile rats from postnatal day (PND) 21 to 80 resulted in decreased body weight gain and adverse effects on skeletal development (including decreased cellularity of growth plate and altered bone distribution) and on lymphoid tissue (decreased cellularity). A no-effect dose was not identified. In addition, neurological and neurobehavioral abnormalities were observed at the mid and/or high dose. Plasma 21-desDFZ exposure (AUC) at the lowest dose tested (0.1 mg/kg/day) was lower than that in humans at the recommended human dose of deflazacort (0.9 mg/kg/day). Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza TM (deflazacort) tablets. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information . DMD is largely a disease of children and young adults; therefore, there is no geriatric experience with deflazacort. No dose adjustment is required in patients with mild, moderate or severe renal impairment [see Clinical Pharmacology (12.3)] . No dose adjustment is required in patients with mild or moderate hepatic impairment [see Clinical Pharmacology (12.3)] . There is no clinical experience in patients with severe hepatic impairment, and a dosing recommendation cannot be provided for patients with severe hepatic impairment.

Product summary:

Deflazacort Tablets, 6 mg are white to off-white, uncoated round shaped biconvex tablets, debossed with “DL6” on one side and plain on other side. They are supplied as follows: Bottles of 100                          NDC 59651-599-01            Deflazacort Tablets, 18 mg are white to off-white, uncoated round shaped biconvex tablets, debossed with “DL18” on one side and plain on other side. They are supplied as follows: Bottles of 30                          NDC 59651-600-30           Deflazacort Tablets, 30 mg are white to off-white, uncoated oval shaped biconvex tablets, debossed with “DL30” on one side and plain on other side. They are supplied as follows: Bottles of 30                         NDC 59651-601-30            Deflazacort Tablets, 36 mg are white to off-white, uncoated oval shaped biconvex tablets, debossed with “DL36” on one side and plain on other side. They are supplied as follows: Bottles of 30                        NDC 59651-602-30  Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEFLAZACORT - DEFLAZACORT TABLET
AUROBINDO PHARMA LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEFLAZACORT TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DEFLAZACORT TABLETS.
DEFLAZACORT TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2017
INDICATIONS AND USAGE
Deflazacort is a corticosteroid indicated for the treatment of
Duchenne muscular dystrophy (DMD) in
patients 5 years of age and older (1)
DOSAGE AND ADMINISTRATION
• The recommended once-daily dosage is approximately 0.9 mg/kg/day
administered orally (2.2)
• Discontinue gradually when administered for more than a few days
(2.3)
DOSAGE FORMS AND STRENGTHS
• Tablets: 6 mg, 18 mg, 30 mg, and 36 mg (3)
CONTRAINDICATIONS
Hypersensitivity to deflazacort or any of the inactive ingredients in
deflazacort tablets (4)
WARNINGS AND PRECAUTIONS
•_ Alterations in Endocrine Function:_
Hypothalamic-pituitary-adrenal axis suppression, Cushing’s syndrome,
and hyperglycemia can occur; Monitor patients for these conditions
with chronic use of deflazacort (2.3,
5.1)
•_ Immunosuppression and Increased Risk of Infection:_ Increased
risk of new, exacerbation, dissemination,
or reactivation of latent infections, which can be severe and at times
fatal; Signs and symptoms of
infection may be masked (5.2)
• _Alterations in Cardiovascular/Renal Function:_ Monitor for
elevated blood pressure and sodium, and for
decreased potassium levels (5.3)
• _Gastrointestinal Perforation:_ Increased risk in patients with
certain GI disorders; Signs and symptoms
may be masked (5.4)
• _Behavioral and Mood Disturbances:_ May include euphoria,
insomnia, mood swings, personality changes,
severe depression, and psychosis (5.5)
• _Effects on Bones:_ Monitor for decreases in bone mineral density
with chronic use of deflazacort (5.6)
• _Ophthalmic Effects:_ May include cataracts, infections, and
glaucoma; Monitor intraocular pressure if
deflazacort is continued for more than 6 weeks (5.7)