Depakene Warnings

Female children/Female adolescents/Women of childbearing potential/Pregnancy: Divalproex sodium/Valproate/Valproic Acid has a high teratogenic potential and children exposed in utero to Divalproex sodium/Valproate/Valproic Acid have a high risk for congenital malformations and neurodevelopmental disorders (see Use in Pregnancy & Lactation).
Divalproex sodium/Valproate/Valproic Acid is contraindicated in the following situations: Treatment of epilepsy: in pregnancy unless there is no suitable alternative treatment (see Precautions and Use in Pregnancy & Lactation); in women of childbearing potential, unless the measures for prevention of pregnancy mentioned as follows and in Contraindications and Use in Pregnancy & Lactation are met.
Treatment of mania and prophylaxis of migraine attacks: in pregnancy (see Use in Pregnancy & Lactation); in women of childbearing potential, unless the measures for prevention of pregnancy mentioned as follows and in Contraindications and Use in Pregnancy & Lactation are met.
The treating physician must ensure that: Individual circumstances should be evaluated in each case, involving the patient in the discussion, to guarantee her engagement, discuss therapeutic options and ensure her understanding of the risks and the measures needed to minimize the risks.
The potential for pregnancy is assessed for all female patients.
The patient has understood and acknowledged the risks of congenital malformations and neurodevelopmental disorders including the magnitude of these risks for children exposed to Divalproex sodium/Valproate/Valproic Acid in utero.
The patient understands the need to undergo pregnancy testing prior to initiation of treatment and during treatment, as needed.
The patient is counselled regarding contraception, and that the patient is capable of complying with the need to use effective contraception (for further details refer to Contraception as follows), without interruption during the entire duration of treatment with Divalproex sodium/Valproate/Valproic Acid.
The patient understands the need for regular (at least annual) review of treatment by the treating physician, preferably by a specialist experienced in the management of epilepsy, or mania or prophylaxis of migraine.
The patient understands the need to consult her physician as soon as she is planning pregnancy to ensure timely discussion and switching to alternative treatment options prior to conception, and before contraception is discontinued.
The patient understands the hazards and necessary precautions associated with Divalproex sodium/Valproate/Valproic Acid use and the need to urgently consult her physician in case of pregnancy.
The patient has received the patient guide.
These conditions also concern women who are not currently sexually active unless the treating physician considers that there are compelling reasons to indicate that there is no risk of pregnancy.
Female children: The treating physician must ensure that parents/caregivers of female children understand the need to contact the specialist once the female child using Divalproex sodium/Valproate/Valproic Acid experiences menarche.
The treating physician must ensure that parents/caregivers of female children who have experienced menarche are provided with comprehensive information about the risks of congenital malformations and neurodevelopmental disorders including the magnitude of these risks for children exposed to Divalproex sodium/Valproate/Valproic Acid in utero.
In patients who experienced menarche, the prescribing specialist must reassess the need for Divalproex sodium/Valproate/Valproic Acid therapy annually and consider alternative treatment options. If Divalproex sodium/Valproate/Valproic Acid is the only suitable treatment, the need for using effective contraception and all other measures as described in Contraindications, Precautions and Use in Pregnancy & Lactation should be discussed. Every effort should be made by the specialist to switch the female children to alternative treatment before they reach child bearing potential.
Pregnancy must be excluded before start of treatment with Divalproex sodium/Valproate/Valproic Acid.
Contraception: Women of childbearing potential who are prescribed Divalproex sodium/Valproate/Valproic Acid must use effective contraception, without interruption during the entire duration of treatment with Divalproex sodium/Valproate/Valproic Acid. These patients must be provided with comprehensive information on pregnancy prevention and should be referred for contraceptive advice if they are not using effective contraception. At least one effective method of contraception (preferably a user independent form such as an intra-uterine device or implant) or two complementary forms of contraception including a barrier method should be used. Individual circumstances should be evaluated in each case, when choosing the contraception method involving the patient in the discussion, to guarantee her engagement and compliance with the chosen measures. Even if she has amenorrhea she must follow all the advice on effective contraception.
Annual treatment reviews preferably by a specialist: The treating physician should at least annually review whether Divalproex sodium/Valproate/Valproic Acid is the most suitable treatment for the patient.
The treating physician should ensure the patient has understood and acknowledged the risks of congenital malformations and neurodevelopmental disorders including the magnitude of these risks for children exposed to Divalproex sodium/Valproate/Valproic Acid in utero.
Pregnancy planning: For the indication epilepsy, if a woman is planning to become pregnant, a specialist experienced in the management of epilepsy, must reassess Divalproex sodium/Valproate/Valproic Acid therapy and consider alternative treatment options. Every effort should be made to switch to appropriate alternative treatment prior to conception, and before contraception is discontinued (see Use in Pregnancy & Lactation). If switching is not possible, the woman should receive further counselling regarding the Divalproex sodium/Valproate/Valproic Acid risks for the unborn child to support her informed decision making regarding family planning.
For the indications mania and prophylaxis of migraine, if a woman is planning to become pregnant a specialist experienced in the management of mania and prophylaxis of migraine must be consulted and treatment with Divalproex sodium/Valproate/Valproic Acid should be discontinued and if needed switched to an alternative treatment prior to conception, and before contraception is discontinued.
In case of emergency: In case of pregnancy, the patient should immediately contact a specialist/physician to re-evaluate treatment and consider alternative options.
Pharmacist must ensure that: the patients are advised not to stop Divalproex sodium/Valproate/Valproic Acid medication and to immediately contact a specialist in case of planned or suspected pregnancy.
Educational materials: In order to assist healthcare professionals and patients in avoiding exposure to Divalproex sodium/Valproate/Valproic Acid during pregnancy, the Marketing Authorization Holder has provided educational materials like a physician guide to reinforce the warnings and provide guidance regarding use of Divalproex sodium/Valproate/Valproic Acid in women of childbearing potential and the details of the pregnancy prevention programme. A patient guide should be provided to all women of childbearing potential using Divalproex sodium/Valproate sodium/Valproic Acid.
Visual Reminder on outer packaging: In order to inform and remind patients about avoiding exposure to Divalproex sodium/Valproate/Valproic Acid during pregnancy, the Marketing Authorization Holder has added a pictogram and warning to its outer packaging.
Warning for Women and Girls: This medicine can seriously harm an unborn baby. Always use effective contraception during treatment.
If the patient is thinking about becoming pregnant, or becomes pregnant, talk to a doctor straight away.
Do not stop taking this medicine unless the doctor tells to.