Novatretin Use In Pregnancy & Lactation





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Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: Acitretin is highly teratogenic. Its use is contraindicated not only in pregnant women and women who might become pregnant during or within 2 years of the cessation of treatment, but in all women of childbearing potential. The risk of giving birth to a deformed child is exceptionally high if acitretin is taken before or during pregnancy, no matter for how long or at what dosage. Foetal exposure to acitretin always involves a risk of congenital malformation.
Acitretin is contraindicated in every woman of childbearing potential unless each of the following conditions is met: The patient is suffering from a severe disorder of keratinization which is resistant to standard therapies.
The patient can be relied on to understand and follow the physician's instructions.
The patient is capable of taking the stipulated contraceptive measures reliably and without fail.
It is absolutely essential that every woman of childbearing potential who is to undergo treatment with acitretin uses an effective contraceptive (preferably 2 complementary methods) without interruption for four weeks before, during and for 2 years after the discontinuation of treatment with acitretin. Primary contraceptive method is a combination hormonal contraceptive product or an intrauterine device and it is recommended that a condom or a diaphragm (cap) is also used. Low dose progesterone-only products (minipills) are not recommended due to indications of possible interference with their contraceptive effect.
Therapy should not begin until the second or third day of the next normal menstrual period.
A negative pregnancy test result must be obtained as minimum, one week before commencement of treatment. (It is advisable to perform additional pregnancy tests at monthly intervals during therapy and at 1-3 monthly intervals after stopping therapy.)
Before therapy with acitretin 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 foetal malformation, and the possible consequences if pregnancy occurs during the course of treatment with acitretin or within 2 years of discontinuing therapy.
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 2 years afterwards.
Should pregnancy occur, in spite of these precautions, during treatment with acitretin or up to 2 years after its discontinuation there is a high risk of severe malformation of the fetus (e.g. exencephaly).
The patient must avoid alcohol consumption during treatment and for 2 months after stopping treatment.
Nursing mothers: Acitretin must not be given to nursing mothers.
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