Wakix▼(pitolisant) 4.5mg and 18mg film-coated tablets (United Kingdom)

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Wakix▼(pitolisant) 4.5mg and 18mg film-coated tablets (United Kingdom)

Wakix (pitolisant) is indicated in adults for the treatment of narcolepsy with or without cataplexy.  Pitolisant is a potent, orally active histamine H3-receptor antagonist/inverse agonist which, via its blockade of histamine auto-receptors enhances the activity of brain histaminergic neurons, a major arousal system with widespread projections to the whole brain. Pitolisant also modulates various neurotransmitter systems, increasing acetylcholine, noradrenaline and dopamine release in the brain.  Treatment should be initiated by a physician experienced in the treatment of sleep disorders.

Further information regarding Wakix can be viewed in the SPC via the link below:

Wakix 4.5mg/18mg Combined SPC

Wakix is a prescription-only medication.

Abbreviated Prescribing Information (Please refer to the Summary of Product Characteristics (SmPC) before prescribing Wakix.)

Wakix 4.5 mg Film-coated Tablets Wakix 18 mg Film-coated Tablets 

Pitolisant: Each 4.5 mg tablet contains 5 mg pitolisant hydrochloride equivalent to 4.45 mg pitolisant. Each 18 mg tablet contains 20 mg pitolisant hydrochloride equivalent to 17.8 mg pitolisant. 

Indication: Treatment of narcolepsy in adults, with or without cataplexy. 

Dosage and administration: For oral use. Treatment should be initiated by a physician experienced in the treatment of sleep disorders. Use at the lowest effective dose, up to a maximum 36 mg/day. Start at 9 mg/day in week 1 and titrate depending on dose response. Dose may be increased to 18 mg/day in week 2 and 36 mg/day in week 3. Dose may be adjusted at any time between 4.5 to 36 mg/day. Total daily dose should be administered as a single dose in the morning. Maximum daily dose should not exceed 18mg in those with renal impairment or moderate hepatic impairment.

Contraindications: Hypersensitivity to any of the ingredients, severe hepatic impairment (Child-Pugh C), breastfeeding. 

Warnings and Precautions: Use caution in patients with a history of psychiatric disorders (e.g. severe anxiety, severe depression with suicidal ideation risk), patients with renal or moderate hepatic impairment, acid related gastric disorders or medicines causing gastric irritation, patients with significant weight change, severe obesity or severe anorexia. Carefully monitor in cases of severe epilepsy, cardiac disease, or concomitant medication known to prolong the QT interval, increase the risk of repolarization disorders or increase plasma pitolisant. May reduce the effectiveness of hormonal contraceptives. Advise affected patients to use alternative methods of contraception. Avoid combination with CYP3A4 substrates or products with a narrow therapeutic margin. Monitor treatment discontinuation. 

Interactions: Avoid combination with oral contraceptives. Pitolisant efficacy may be impaired by tri- or tetra-cyclic antidepressants, antihistamines. See also warnings on drugs affecting QT interval and repolarisation. Enzyme inducers and CYP2D6 inhibitors may affect pitolisant metabolism. Pitolisant may affect the metabolism of CYP3A4, CYP2B6 and OCT1 substrates. Pitolisant may be used with modafinil or sodium oxybate. 

Pregnancy and lactation: May reduce the effectiveness of hormonal contraceptives. Advise affected patients to use alternative methods of contraception. Pregnancy: Do not use unless the benefits outweigh the potential risks. Breastfeeding: Contraindicated. 

Effects on ability to drive and use machines: Caused dizziness, vertigo and tremor. Patients with excessive daytime sleepiness should avoid driving and other potentially dangerous activity. 

Common and serious undesirable effects (refer to SmPC for full list of side effects): Common side effects: Insomnia, headache, nausea, anxiety, irritability, dizziness, depression, tremor, sleep disorder, fatigue, vomiting, vertigo, dyspepsia Uncommon serious side effects: suicidal ideation, dyskinesia, cataplexy, dystonia, epilepsy, bradycardia, increased hepatic enzymes, ECG QT prolonged Rare serious side effects: anorexia, depressed mood, loss of consciousness, enterocolitis, toxic skin eruption, spontaneous abortion, increased creatine phosphokinase, ECG repolarisation abnormality, ECG T wave inversion.

Legal Category: POM 

Pack size: 4.5 mg: 1 bottle x30 tablets £310 18 mg: 1 bottle x30 tablets £310 

MA Number: EU/1/15/1068/001-002, PLGB: 26351/0005-6

MA Holder: Bioprojet Pharma, 9, rue Rameau, 75002 Paris, France

UK Distributor: Bioprojet UK Ltd, Unit B Stanley Court, Glenmore Business Park, Telford Road, Salisbury SP2 7GH

Date of preparation: January 2021 Unique ID: WakPI/UK/024/21 

Adverse events should be reported. Reporting forms and information can be found at http://yellowcard.mhra.gov.uk/. Adverse events should also be reported via Jenson Group on 01271 334 609 or  via email (click link)