Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
PITOLISANT HYDROCHLORIDE (UNII: YV33CH63HI) (PITOLISANT - UNII:4BC83L4PIY)
Harmony Biosciences, LLC
ORAL
PRESCRIPTION DRUG
WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. WAKIX is contraindicated in patients with: - known hypersensitivity to pitolisant or any component of the formulation. Anaphylaxis has been reported in patients treated with WAKIX [see Adverse Reactions (6.2)] . - severe hepatic impairment. WAKIX is extensively metabolized by the liver and there is a significant increase in WAKIX exposure in patients with moderate hepatic impairment [see Use in Specific Populations (8.6)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. Patients should be encouraged to enroll in the WAKIX pregnancy registry if they become pregnant. To enroll or obtain information from the registry, patients can call 1-800-833-7460. Risk Summary Available case reports from clinical trials and postmarketing reports with WAKIX use in pregnant women have not determined a d
WAKIX (pitolisant) tablets are available as: 4.45 mg: white, round, biconvex film-coated tablet, 3.7 mm diameter, marked with “S” on one side and plain on the other side. NDC 72028-045-03 – Bottles of 30 17.8 mg: white, round, biconvex film-coated tablet, 7.5 mm diameter, marked with “H” on one side and plain on the other side. NDC 72028-178-03 – Bottles of 30 Store at 20° C to 25° C (68° F to 77° F); excursions permitted between 15° C to 30° C (59° F to 86° F) [see USP Controlled Room Temperature].
New Drug Application
WAKIX- PITOLISANT HYDROCHLORIDE TABLET, FILM COATED HARMONY BIOSCIENCES, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE WAKIX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR WAKIX. WAKIX (PITOLISANT) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2019 INDICATIONS AND USAGE WAKIX is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy (1) DOSAGE AND ADMINISTRATION Administer once daily in the morning upon wakening. The recommended dosage range is 17.8 mg to 35.6 mg daily. Titrate dosage as follows: Week 1: Initiate with 8.9 mg once daily Week 2: Increase dosage to 17.8 mg once daily Week 3: May increase to the maximum recommended dosage of 35.6 mg once daily (2.1) Hepatic impairment (2.2, 8.6, 12.3): Moderate hepatic impairment: Initial dosage is 8.9 mg once daily. Titrate to a maximum dosage of 17.8 mg once daily after 14 days Renal impairment (2.3, 8.7, 12.3): Moderate and severe impairment: Initial dosage is 8.9 mg once daily. Titrate to maximum dosage of 17.8 mg once daily after 7 days End−stage renal disease (ESRD): Not recommended Poor Metabolizers of CYP2D6: Maximum recommended dosage is 17.8 mg once daily (2.5) DOSAGE FORMS AND STRENGTHS Tablets: 4.45 mg and 17.8 mg (3) CONTRAINDICATIONS Known hypersensitivity to pitolisant or any component of the formulation (4) Severe hepatic impairment (4) WARNINGS AND PRECAUTIONS _QT Interval Prolongation_: Increases in QT interval. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval. Monitor patients with hepatic or renal impairment for increased QTc (5.1) ADVERSE REACTIONS The most common adverse reactions (≥5% and at least twice placebo) for WAKIX were insomnia, nausea, and anxiety (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HARMONY BIOSCIENCES AT 1-800-833- 7460 OR FDA AT 1-800-FDA-1088 OR _WWW. Lesen Sie das vollständige Dokument