WAKIX- pitolisant hydrochloride tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

PITOLISANT HYDROCHLORIDE (UNII: YV33CH63HI) (PITOLISANT - UNII:4BC83L4PIY)

Dostupno od:

Harmony Biosciences, LLC

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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

Proizvod sažetak:

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].

Status autorizacije:

New Drug Application

Svojstava lijeka

WAKIX- PITOLISANT HYDROCHLORIDE TABLET, FILM COATED
HARMONY BIOSCIENCES, LLC
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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.