NITISINONE capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

NITISINONE (UNII: K5BN214699) (NITISINONE - UNII:K5BN214699)

Tillgänglig från:

Par Pharmaceutical, Inc.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Nitisinone capsules are indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. None. Risk Summary Limited available data with nitisinone use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. Animal reproduction studies have been conducted for nitisinone. In these studies, nitisinone was administered to mice and rabbits during organogenesis with oral doses of nitisinone up to 20 and 8 times respectively, the recommended initial dose of 1 mg/kg/day. In mice, nitisinone caused incomplete skeletal ossification of fetal bones and decreased pup survival at doses 0.4 times the recommended initial dose, and increased gestational length at doses 4 times the recommended initial dose. In rabbits, nitisinone caused maternal toxicity and incomplete skeletal ossification of fetal bones at doses 1.6 times the recommended initial dose [see Data]. The b

Produktsammanfattning:

Nitisinone Capsules 2 mg for oral administration containing 2 mg of nitisinone, are supplied as follows: White Opaque Hard gelatin capsule shell Size #3, imprinted with black ink as "008" on cap and "Novitium 2 mg" on body, filled with white to off white powder blend. NDC 0254-3020 -02             Bottles of 60 capsules with child-resistant closure and tamper resistant induction sealing Nitisinone Capsules 5 mg for oral administration containing 5 mg of nitisinone, are supplied as follows: White Opaque Hard gelatin capsule shell Size #3, imprinted with black ink as "009" on cap and "Novitium 5 mg" on body, filled with white to off white powder blend. NDC 0254-3021 -02             Bottles of 60 capsules with child-resistant closure and tamper resistant induction sealing Nitisinone Capsules 10 mg for oral administration containing 10 mg of nitisinone, are supplied as follows: White Opaque Hard gelatin capsule shell Size #3, imprinted with black ink as "010" on cap and "Novitium 10 mg" on body, filled with white to off white powder blend. NDC 0254-3022 -02             Bottles of 60 capsules with child-resistant closure and tamper resistant induction sealing Store at room temperature between  20°C to 25°C (68°F to 77°F), excursions permitted to 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

NITISINONE- NITISINONE CAPSULE
PAR PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NITISINONE CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NITISINONE CAPSULES.
NITISINONE CAPSULES, FOR ORAL USE.
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Warnings and Precautions (5.1) 05/2019
INDICATIONS AND USAGE
Nitisinone is a hydroxy-phenylpyruvate dioxygenase inhibitor indicated
for the treatment of adult and pediatric patients
with hereditary tyrosinemia type 1 (HT-1) in combination with dietary
restriction of tyrosine and phenylalanine. (1)
DOSAGE AND ADMINISTRATION
Recommended Dosage (2.1):
The recommended starting dosage is 0.5 mg/kg orally twice daily.
Titrate the dosage based on biochemical and/or clinical response, as
described in the full prescribing information.
The maximum total daily dosage is 2 mg/kg orally.
Administration (2.2):
Maintain dietary restriction of tyrosine and phenylalanine
Take Nitisinone capsules at least one hour before, or two hours after
a meal
For patients who have difficulties swallowing capsules, the capsules
may be opened and the contents suspended in a
small amount of water, formula or apple sauce immediately before use.
DOSAGE FORMS AND STRENGTHS
Capsules: 2 mg, 5 mg, 10 mg. (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay
and Hyperkeratotic Plaques: Inadequate
restriction of tyrosine and phenylalanine intake can lead to
elevations in plasma tyrosine, which at levels above 500
micromol/L can result in symptoms, intellectual disability and
developmental delay or painful hyperkeratotic plaques on
the soles and palms; do not adjust nitisinone dosage in order to lower
the plasma tyrosine concentration. Obtain slit-
lamp examination prior to treatment, regularly during treatment;
Reexamine patients if symptoms develop or tyrosine
levels are > 500 micromol/L. Assess plasma tyrosine levels in patients
w