From the medical web re the drug
Pregnancy prevention programme
This medicinal product is TERATOGENIC.
Toctino is contraindicated in women of childbearing potential unless all of the following conditions of the Pregnancy Prevention Program are met:
• She understands the teratogenic risk.
• She understands the need for rigorous follow-up, on a monthly basis.
• She understands and accepts the need for effective contraception, without interruption, 1 month before starting treatment, throughout the duration of treatment and 1 month after the end of treatment. At least one and preferably two complementary forms of contraception including a barrier method should be used.
• Even if she has amenorrhea she must follow all of the advice on effective contraception.
• She should be capable of complying with effective contraceptive measures.
• She is informed and understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy.
• She understands the need and accepts to undergo pregnancy testing before, during and 5 weeks after the end of treatment.
• She has acknowledged that she has understood the hazards and necessary precautions associated with the use of Toctino.
These conditions also concern women who are not currently sexually active unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy.
The prescriber must ensure that:
• The patient complies with the conditions for pregnancy prevention as listed above, including confirmation that she has an adequate level of understanding.
• The patient has acknowledged the aforementioned conditions.
• The patient has used at least one and preferably two methods of effective contraception including a barrier method for at least 1 month prior to starting treatment and is continuing to use effective contraception throughout the treatment period and for at least 1 month after cessation of treatment.
• Negative pregnancy test results have been obtained before, during and 5 weeks after the end of treatment. The dates and results of pregnancy tests should be documented.
Contraception
Female patients must be provided with comprehensive information on pregnancy prevention and should be referred for contraceptive advice if they are not using effective contraception.
As a minimum requirement, female patients at potential risk of pregnancy must use at least one effective method of contraception. Preferably the patient should use two complementary forms of contraception including a barrier method. Contraception should be continued for at least 1 month after stopping treatment with Toctino, even in patients with amenorrhea.
Pregnancy testing
According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/mL are recommended to be performed in the first 3 days of the menstrual cycle, as follows:
One Month prior to starting therapy
In order to exclude the possibility of pregnancy prior to starting contraception, it is recommended that an initial medically supervised pregnancy test should be performed and its date and result recorded. In patients without regular menses, the timing of this pregnancy test should reflect the sexual activity of the patient and should be undertaken approximately 3 weeks after the patient last had unprotected sexual intercourse. The prescriber should educate the patient about contraception.
At the start of therapy
A medically supervised pregnancy test should also be performed during the consultation when Toctino is prescribed or in the 3 days prior to the visit to the prescriber, and should have been delayed until the patient had been using effective contraception for at least 1 month. This test should ensure the patient is not pregnant when she starts treatment with Toctino.
Follow-up visits
Follow-up visits should be arranged at 28 day intervals. The need for repeated medically supervised pregnancy tests every month should be determined in consideration amongst other of the patient's sexual activity and recent menstrual history (abnormal menses, missed periods or amenorrhea). Where indicated, follow-up pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.
End of treatment
Five weeks after stopping treatment, women should undergo a final pregnancy test to exclude pregnancy.
Prescribing and dispensing restrictions
Prescriptions of alitretinoin for women of childbearing potential should be limited to 30 days of treatment and continuation of treatment requires a new prescription. Ideally, pregnancy testing, issuing a prescription and dispensing of alitretinoin should occur on the same day. Dispensing of alitretinoin should be completed within a maximum of 7 days of the prescription.