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WAKIX Is Contraindicated in Patients with Severe Hepatic Impairment (4) WAKIX® Safely and Effectively

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WAKIX Is Contraindicated in Patients with Severe Hepatic Impairment (4) WAKIX® Safely and Effectively ___________________ ____________________ HIGHLIGHTS OF PRESCRIBING INFORMATION CONTRAINDICATIONS These highlights do not include all the information needed to use WAKIX is contraindicated in patients with severe hepatic impairment (4) WAKIX® safely and effectively. See full prescribing information for _______________ _______________ WAKIX. WARNINGS AND PRECAUTIONS QT Interval Prolongation: Increases in QT interval. Avoid use with drugs that WAKIX® (pitolisant) tablets, for oral use also increase the QT interval and in patients with risk factors for prolonged Initial U.S. Approval: 2019 QT interval. Monitor patients with hepatic or renal impairment for increased QTc (5.1) __________________ _________________ INDICATIONS AND USAGE ____________________ ____________________ WAKIX is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for the ADVERSE REACTIONS treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy The most common adverse reactions (≥5% and twice placebo) for WAKIX (1) were insomnia, nausea, and anxiety (6.1) _______________ ______________ DOSAGE AND ADMINISTRATION To report SUSPECTED ADVERSE REACTIONS, contact Harmony • Administer once daily in the morning upon wakening. Biosciences at 1-800-833-7460 or FDA at 1-800-FDA-1088 or • The recommended dosage range is 17.8 mg to 35.6 mg daily. Titrate www.fda.gov/medwatch. dosage as follows: ____________________ ____________________ DRUG INTERACTIONS o Week 1: Initiate with 8.9 mg once daily • o Week 2: Increase dosage to 17.8 mg once daily Strong CYP2D6 Inhibitors: Maximum recommended dosage is 17.8 mg o Week 3: May increase to the maximum recommended dosage of once daily (2.4, 7.1) 35.6 mg once daily (2.1) • Strong CYP3A4 Inducers: Decreased exposure of WAKIX; consider • Hepatic impairment (2.2, 8.6, 12.3): dosage adjustment (2.4, 7.1) o Moderate hepatic impairment: Initial dosage is 8.9 mg once daily. • Sensitive CYP3A4 Substrates (including hormonal contraceptives): Titrate to a maximum dosage of 17.8 mg once daily after 14 days WAKIX may reduce effectiveness of sensitive CYP3A4 substrates. Use an • Renal impairment (2.3, 8.7, 12.3): alternative non-hormonal contraceptive method during treatment with o Moderate and severe impairment: Initial dosage is 8.9 mg once daily. WAKIX and for at least 21 days after discontinuation of treatment (7.1, Titrate to maximum dosage of 17.8 mg once daily after 7 days 8.3) o End stage renal disease (ESRD): Not recommended • Poor Metabolizers of CYP2D6: Maximum recommended dosage is See 17 for PATIENT COUNSELING INFORMATION 17.8 mg once daily (2.5) Revised: 08/2019 ______________ _____________ DOSAGE FORMS AND STRENGTHS Tablets: 4.45 mg and 17.8 mg (3) FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 8.2 Lactation 2 DOSAGE AND ADMINISTRATION 8.3 Females and Males of Reproductive Potential 2.1 Recommended Dosage 8.4 Pediatric Use 2.2 Dosage Modification and Recommendations in Patients with 8.5 Geriatric Use Hepatic Impairment 8.6 Hepatic Impairment 2.3 Dosage Modification and Recommendations in Patients with 8.7 Renal Impairment Renal Impairment and End Stage Renal Disease 8.8 CYP2D6 Poor Metabolizers 2.4 Dosage Recommendations for Concomitant Use with Strong 11 DESCRIPTION CYP2D6 Inhibitors and Strong CYP3A4 Inducers 12 CLINICAL PHARMACOLOGY 2.5 Use in Patients Who Are Known CYP2D6 Poor Metabolizers 12.1 Mechanism of Action (PMs) 12.2 Pharmacodynamics 3 DOSAGE FORMS AND STRENGTHS 12.3 Pharmacokinetics 4 CONTRAINDICATIONS 12.5 Pharmacogenomics 5 WARNINGS AND PRECAUTIONS 13 NONCLINICAL TOXICOLOGY 5.1 QT Interval Prolongation 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 6 ADVERSE REACTIONS 13.2 Animal Toxicology and/or Pharmacology 6.1 Clinical Trials Experience 14 CLINICAL STUDIES 6.2 Postmarketing Experience 16 HOW SUPPLIED/STORAGE AND HANDLING 7 DRUG INTERACTIONS 16.1 How Supplied 7.1 Drugs Having Clinically Important Interactions with WAKIX 16.2 Storage and Handling 7.2 Drugs Having No Clinically Important Interactions with 17 PATIENT COUNSELING INFORMATION WAKIX 8 USE IN SPECIFIC POPULATIONS *Sections or subsections omitted from the full prescribing information are not 8.1 Pregnancy listed. 1 Reference ID: 4477577 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy [see Clinical Studies (14)]. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage The recommended dosage range for WAKIX is 17.8 mg to 35.6 mg administered orally once daily in the morning upon wakening. Titrate dosage as follows: Week 1: Initiate with a dosage of 8.9 mg (two 4.45 mg tablets) once daily Week 2: Increase dosage to 17.8 mg (one 17.8 mg tablet) once daily Week 3: May increase to the maximum recommended dosage of 35.6 mg (two 17.8 mg tablets) once daily Dose may be adjusted based on tolerability. If a dose is missed, patients should take the next dose the following day in the morning upon wakening. It may take up to 8 weeks for some patients to achieve a clinical response. 2.2 Dosage Modification and Recommendations in Patients with Hepatic Impairment In patients with moderate hepatic impairment, initiate WAKIX at 8.9 mg once daily and increase after 14 days to a maximum dosage of 17.8 mg once daily [see Warnings and Precautions (5.1), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]. WAKIX is contraindicated in patients with severe hepatic impairment. WAKIX has not been studied in patients with severe hepatic impairment [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]. 2.3 Dosage Modification and Recommendations in Patients with Renal Impairment and End Stage Renal Disease In patients with moderate and severe renal impairment, initiate WAKIX at 8.9 mg once daily and increase after 7 days to a maximum dosage of 17.8 mg once daily [see Warnings and Precautions (5.1), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)]. WAKIX is not recommended in patients with end stage renal disease (ESRD) [see Warnings and Precautions (5.1), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)]. 2 Reference ID: 4477577 2.4 Dosage Recommendations for Concomitant Use with Strong CYP2D6 Inhibitors and Strong CYP3A4 Inducers Coadministration with Strong CYP2D6 Inhibitors For patients receiving strong CYP2D6 inhibitors, initiate WAKIX at 8.9 mg once daily and increase after 7 days to a maximum dosage of 17.8 mg once daily. For patients on a stable dose of WAKIX, reduce the WAKIX dose by half upon initiating strong CYP2D6 inhibitors [see Drug Interactions (7.1), Clinical Pharmacology (12.3)]. Coadministration with Strong CYP3A4 Inducers Concomitant use of WAKIX with strong CYP3A4 inducers decreases pitolisant exposure by 50%. Assess for loss of efficacy after initiation of a strong CYP3A4 inducer. For patients stable on WAKIX 8.9 mg or 17.8 mg once daily, increase the dose of WAKIX to double the original daily dose (i.e., 17.8 mg or 35.6 mg, respectively) over 7 days. If concomitant dosing of a strong CYP3A4 inducer is discontinued, decrease WAKIX dosage by half [see Drug Interactions (7.1), Clinical Pharmacology (12.3)]. 2.5 Use in Patients Who Are Known CYP2D6 Poor Metabolizers (PMs) In patients known to be poor CYP2D6 metabolizers, initiate WAKIX at 8.9 mg once daily and titrate to a maximum dose of 17.8 mg once daily after 7 days [see Use in Specific Populations (8.8), Clinical Pharmacology (12.5)]. 3 DOSAGE FORMS AND STRENGTHS • WAKIX 4.45 mg tablets: white, round, biconvex film-coated tablet, marked with “S” on one side and plain on the other side. Each tablet contains 5 mg of pitolisant hydrochloride equivalent to 4.45 mg of pitolisant. • WAKIX 17.8 mg tablets: white, round, biconvex film-coated tablet, marked with “H” on one side and plain on the other side. Each tablet contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant. 4 CONTRAINDICATIONS WAKIX is contraindicated in patients with 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)]. 5 WARNINGS AND PRECAUTIONS 5.1 QT Interval Prolongation WAKIX prolongs the QT interval. The use of WAKIX should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval [see Drug Interactions (7.1)]. WAKIX should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, 3 Reference ID: 4477577 including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval [see Clinical Pharmacology (12.2)]. The risk of QT prolongation may be greater in patients with hepatic or renal impairment due to higher concentrations of pitolisant. Monitor patients with hepatic or renal impairment for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment [see Dosage and Administration (2.2, 2.3)]. WAKIX is contraindicated in patients with severe hepatic impairment [see Contraindications (4)]. WAKIX is not recommended in patients with end stage renal disease (ESRD) [see Dosage and Administration (2.3), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)]. 6 Adverse Reactions The following adverse reactions are discussed in more detail in other sections of the labeling: • QT Interval Prolongation [see Warnings and Precautions (5.1)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
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