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Rx Item-WAKIX Pitolisant 17.8MG TAB 30 BY HARMONY BIOSCIENCE

WAKIX 17.8MG TAB 30 BY HARMONY BIOSCIENCE Pitolisant hydrochloride tablet, film coated Item No.:RX72028-178-03 NDC No. 72028-178-03 72028-0178-03 72028017803 7202817803 UPC No.:3-72028-17803-

WAKIX 4.5MG TAB 30 BY HARMONY BIOSCIENCE Pitolisant hydrochloride tablet, film coated Item No.:RX72028-045-03 NDC No.72028-0045-03 72028-045-03 72028004503 7202804503 UPC No.:3-72028-04503-6 372028

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SUNOSI 75 MG TAB 30 By Jazz Pharma-Solriamfetol HCl ORAL TABLET Item No.:DEA885677 885677 NDC No.68727-0350-01 68727-350-01 6872735001 68727035001 UPC No.:1-03687-2735001-1 103687-27350011 10368727

Rx Item-WAKIX Pitolisant 17.8MG TAB 30 BY HARMONY BIOSCIENCE

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WAKIX 17.8MG TAB 30 BY HARMONY BIOSCIENCE Pitolisant hydrochloride tablet, film coated Item No.: RX72028-178-03 NDC No. 72028-178-03 72028-0178-03 72028017803 7202817803 UPC No.:3-72028-17803-1 372028-178031 372028178031 . MPN 17803 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item

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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) 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

WAKIX is contraindicated in patients with 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 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.fda.gov/medwatch.

DRUG INTERACTIONS

Strong CYP2D6 Inhibitors: Maximum recommended dosage is 17.8 mg once daily (2.4, 7.1)
Strong CYP3A4 Inducers: Decreased exposure of WAKIX; consider dosage adjustment (2.4, 7.1)
Sensitive CYP3A4 Substrates (including hormonal contraceptives): WAKIX may reduce effectiveness of sensitive CYP3A4 substrates. Use an alternative non-hormonal contraceptive method during treatment with WAKIX and for at least 21 days after discontinuation of treatment (7.1, 8.3)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 11/2019

WAKIX Pitolisant 17.8MG TAB 30
WAKIX 17.8MG TAB 30 BY HARMONY BIOSCIENCE Pitolisant hydrochloride tablet, film coated Item No.:RX72028-178-03 NDC No. 72028-178-03 72028-0178-03 72028017803 7202817803 UPC No.:3-72028-17803-

Pitolisant 4.5MG TAB 30
WAKIX 4.5MG TAB 30 BY HARMONY BIOSCIENCE Pitolisant hydrochloride tablet, film coated Item No.:RX72028-045-03 NDC No.72028-0045-03 72028-045-03 72028004503 7202804503 UPC No.:3-72028-04503-6 372028

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SUNOSI 75 MG TAB By Jazz Ph
SUNOSI 75 MG TAB 30 By Jazz Pharma-Solriamfetol HCl ORAL TABLET Item No.:DEA885677 885677 NDC No.68727-0350-01 68727-350-01 6872735001 68727035001 UPC No.:1-03687-2735001-1 103687-27350011 10368727

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