Source: European Medicines Agency (EU) Revision Year: 2022 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
Ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by, or who have not tolerated, OSA primary therapy, such as continuous positive airway pressure (CPAP).
Treatment should be initiated by a healthcare professional experienced in the treatment of OSA and cardiovascular risk. OSA disease should be annually reassessed.
Ozawade is not a therapy for the underlying airway obstruction in patients with OSA. Primary OSA therapy should be maintained or periodically rechallenged in patients not tolerating primary OSA therapy.
Pitolisant 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 18 mg/day:
Week 1: initial dose of 4.5 mg (one 4.5 mg tablet) per day.
Week 2: the dose may be increased to 9 mg (two 4.5 mg tablets) per day.
Week 3: the dose may be increased to 18 mg (one 18 mg tablet) per day or decreased to 4.5 mg (one 4.5 mg tablet) per day.
At any time the dose can be decreased (down to 4.5 mg per day) or increased (up to 18 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 individual response and tolerance. Insomnia has been reported in higher rate in the elderly and dosing should be adjusted accordingly (see section 4.8).
No dose adjustment is necessary.
No dosage adjustment is required in patients with mild hepatic impairment.
In patients with moderate hepatic impairment (Child-Pugh B), the titration period should be two weeks up-titration steps instead of one after initiation of treatment, due to expected longer half-life and higher exposure, and a dosage adjustment in patients with moderate hepatic impairment could eventually be considered depending on individual response and tolerance (see section 5.2).
Pitolisant is contraindicated in patients with severe hepatic impairment (Child-Pugh C) (see section 4.3).
There is no relevant use of Ozawade in the paediatric population in Obstructive Sleep Apnoea (OSA).
By comparison to CYP2D6 extensive metabolizers, higher systemic exposure (up to 3 fold) is observed in CYP2D6 poor metabolizers and lower exposure (by 0.8-fold) is observed in CYP2D6 ultra-rapid metabolizers. No differences in systemic exposure is observed between CYP2D6 extensive and intermediate metabolizers.
In the up-titration scheme, dose increment should take into account the higher exposure in CYP2D6 poor metabolizers, and a dosage adjustment in patients with known poor CYP2D6 metabolizer genotype could be considered depending on individual response and tolerance (see section 5.2). Furthermore, no dose recommendation can currently be given for CYP2D6 ultra-rapid metabolizers taking a CYP3A inducer, because the PK is currently unknown in this subpopulation.
For oral use.
Symptoms of pitolisant 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.
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).
Ozawade 4.5 mg: Available in packs containing 1 bottle of 30 tablets.
Ozawade 18 mg: Available in packs containing 1 bottle of 30 tablets or 1 bottle of 90 tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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