Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
NITISINONE (UNII: K5BN214699) (NITISINONE - UNII:K5BN214699)
Swedish Orphan Biovitrum AB (publ)
nitisinone
nitisinone 4 mg in 1 mL
ORAL
PRESCRIPTION DRUG
ORFADIN ® is 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
Capsules: White capsules marked in black with "NTBC" and identified as 2 mg, 5 mg, 10 mg or 20 mg strengths of nitisinone. The capsules are packed in a high density (HD) polyethylene container with a tamper-resistant low density (LD) polyethylene snap-on cap. Each bottle contains 60 capsules. Oral suspension: White, slightly viscous opaque suspension. 1 mL contains 4 mg of nitisinone. The suspension is provided in a 100 mL brown bottle (type III glass) with a white child resistant HDPE screw cap with sealing and tamper evidence. Each bottle contains 90 mL oral suspension.
New Drug Application
ORFADIN- NITISINONE SUSPENSION SWEDISH ORPHAN BIOVITRUM AB (PUBL) ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ORFADIN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ORFADIN. ORFADIN (NITISINONE) CAPSULES, FOR ORAL USE ORFADIN (NITISINONE) ORAL SUSPENSION INITIAL U.S. APPROVAL: 2002 RECENT MAJOR CHANGES Warnings and Precautions ( 5.1) 05/2019 INDICATIONS AND USAGE ORFADIN 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. In patients 5 years of age and older who have undetectable serum and urine succinylacetone concentrations after a minimum of 4 weeks on a stable dosage of nitisinone, the total daily dose may be given once 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. Preparation and Administration Instructions ( 2.2) : For instructions on preparing, measuring and administering the oral suspension, see the full prescribing information. Maintain dietary restriction of tyrosine and phenylalanine Take ORFADIN capsules at least one hour before, or two hours after a meal For patients who have difficulties swallowing capsules and who are intolerant to the oral suspension, the capsules may be opened and the contents suspended in a small amount of water, formula or apple sauce immediately before use. Take ORFADIN oral suspension without regard to meals. DOSAGE FORMS AND STRENGTHS Capsules: 2 mg, 5 mg, 10 mg, 20 mg. ( 3) Oral suspension: 4 mg/mL ( 3) CONTRAINDICATIONS None ( 4) WARNINGS AND PRECAUTIONS Elevated Plasma Tyrosine Levels, Ocular Symptoms, Developmental Delay and Hyperkeratotic Plaques: Inadequate restriction of Soma hati kamili