Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Bioprojet Pharma, 9, rue Rameau, 75002 Paris, France, Tel: +33 (0)1 47 03 66 33, Fax: +33 (0)1 47 03 66 30, e-mail: contact@bioprojet.com
Wakix is indicated in adults for the treatment of narcolepsy with or without cataplexy (see also section 5.1).
Treatment should be initiated by a physician experienced in the treatment of sleep disorders.
Wakix should be used at the lowest effective dose, depending on individual patient response and tolerance, according to an up-titration scheme, without exceeding the dose of 36 mg/day:
At any time the dose can be decreased (down to 4.5 mg per day) or increased (up to 36 mg per day) according to the physician assessment and the patient’s response.
The total daily dose should be administered as a single dose in the morning during breakfast.
As long-term efficacy data are limited (see section 5.1), the continued efficacy of treatment should be regularly evaluated by the physician.
Limited data are available in elderly. Therefore, dosing should be adjusted according to their renal and hepatic status.
In patients with renal impairment, the maximum daily dose should be 18 mg.
In patients with moderate hepatic impairment (Child-Pugh B) two weeks after initiation of treatment, the daily dose can be increased without exceeding a maximal dose of 18 mg (see section 5.2). Pitolisant is contra-indicated in patients with severe hepatic impairment (Child-Pugh C) (see section 4.3).
No dosage adjustment is required in patients with mild hepatic impairment.
The safety and efficacy of pitolisant in children aged from 0 to 18 years old have not yet been established. No data are available.
By comparison to CYP2D6 extensive metabolisers, higher systemic exposure (up to 3 fold) is observed in CYP2D6 poor metabolisers. In the up-titration scheme, dose increment should take into account this higher exposure.
For oral use.
Symptoms of Wakix overdose may include headache, insomnia, irritability, nausea and abdominal pain.
In case of overdose, hospitalisation and monitoring of the vital functions are recommended. There is no clearly identified antidote.
Wakix 4.5 mg tablet: 3 years.
Wakix 18 mg tablet: 3 years.
This medicinal product does not require any special storage conditions.
High density polyethylene (HDPE) bottle with a tamper evident, child-resistant, polypropylene screw cap fitted with desiccant (silica gel).
Bottle of 30 or 90 film-coated tablets.
Wakix 4.5 mg: Available in packs containing 1 bottle of 30 tablets.
Wakix 18 mg: Available in packs containing 1 bottle of 30 tablets or packs containing 1 bottle of 90 tablets or multi-packs containing 90 (3 bottles of 30) tablets.
Not all pack sizes may be marketed.
No special requirements.
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