Dispensing rules
Table of Contents
Maximum prescription period: 1 year.
For girls, adolescents, women of childbearing age and pregnant women
- Initial annual prescription reserved for psychiatrists.
- Dispensation is conditional on the presentation of an annual information certificate co-signed by the prescriber and the patient. This certificate replaces the care agreement form put in place before January 6, 2025. However, for patients already treated, it remains valid until the end of its year of validity.
- Renewals: prescription drawn up by any prescriber with presentation of the specialist’s initial prescription and the certificate of shared information. Both documents must be less than 1 year old.
For adolescents and men of childbearing potential
- Initial prescription reserved for psychiatrists.
- The dispensation is conditional on the presentation of an annual information certificate.
- Renewals: prescription drawn up by any prescriber with presentation of the specialist’s initial prescription, even if it is more than 1 year old, and the certificate of shared information dating back less than 1 year.
Return the patient card to detach from the box packaging and ensure that the contents are understood by the person concerned and/or their representative. The patient must keep this card.
Special case
In patients, in the event of definitive sterility: Sheet 1 of the information certificate must be completed only once by any doctor, it is then valid for the entire duration of the treatment (no mandatory annual renewal). The restricted prescription conditions do not apply in this situation.
Risks associated with treatment
The occurrence of disorders, sometimes serious, in the children of patients treated with Dépamide justifies the implementation of a pregnancy prevention plan. These are:
- major congenital malformations (failure to close the neural tube, craniofacial anomalies including cleft lip and palate, cardiovascular, renal and urogenital malformations, limb disorders including bilateral aplasia of the radius, polymalformative syndromes affecting various parts of the body). The risk is multiplied by 4 or even 5 compared to the general population;
- neurodevelopmental disorders (frequency and characterization not established to date) including in children born to men treated with valproate in the 3 months preceding conception.
Contraception
A plasma pregnancy test should be performed before initiating treatment.
Women and men of childbearing potential should use a highly effective method of contraception during treatment and until 1 month and 3 months, respectively, after taking the last tablet.
At least one effective method of contraception (intrauterine device, implant) or two complementary forms of contraception including a barrier method (condom or cervical cap) must be used.
