Neotigason Warnings

Neotigason is contraindicated in every woman of childbearing potential unless each of the following conditions is met: 1. The patient is suffering from a severe disorder of keratinization which is resistant to standard therapies.
2. She can be relied on to understand and follow the physician's instructions.
3. She is capable of taking the stipulated contraceptive measures reliably and without fail.
4. It is absolutely essential that every woman of childbearing potential who is to undergo treatment with Neotigason uses an effective contraceptive without interruption for 4 weeks before, during and for 3 years after the discontinuation of treatment with Neotigason.
Even female patients who normally do not practice contraception because of a history of infertility should be advised to do so, while taking Neotigason.
5. Therapy should not begin until the second or third day of the next normal menstrual period.
6. At the start of therapy, a negative pregnancy test result (minimum sensitivity of 25mIU/mL) must be obtained up to three days before the first dose is given. During therapy, pregnancy tests should be arranged at 28-day intervals. A negative pregnancy test not older than 3 days is mandatory before prescription is made at these visits. After stopping therapy, pregnancy tests should be performed at 1-3 monthly intervals for a period of 3 years after the last dose is given.
7. Before therapy with Neotigason is instituted, the physician must give patients of childbearing potential detailed verbal and written information about the precautions to be taken, the risk of very severe fetal malformation, and the possible consequences if pregnancy occurs during the course of treatment with Neotigason or within 3 years of discontinuing therapy.
8. The same effective and uninterrupted contraceptive measures must be taken every time therapy is repeated, however long the intervening period may have been, and must be continued for 3 years afterwards.
9. Should pregnancy occur, in spite of these precautions, there is a high risk of severe malformation of the fetus (e.g. craniofacial defects, cardiac and vascular or CNS malformations, skeletal and thymic defects) and the incidence of spontaneous abortion is increased. The risk applies especially during treatment with Neotigason and 2 months after treatment. For up to 3 years after Neotigason discontinuation, the risk is lower (particularly in woman who have not consumed alcohol) but cannot be entirely excluded due to possible formation of etretinate.
10. Women of childbearing age must not consume alcohol (in drinks, food or medicines) during treatment with Neotigason and for 2 months after Neotigason cessation of therapy (see Precautions, Interactions and Pharmacology: Pharmacokinetics under Actions).