ce or to any of the excipients.
Special Precautions
Pregnancy warning Lenalidomide is structurally related to thalidomide. Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
If lenalidomide is taken during pregnancy, a teratogenic effect of lenalidomide cannot be ruled out.
The conditions of the Pregnancy Prevention Programme must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential.
Criteria for women of non-childbearing potential A female patient or a female partner of a male patient is considered to have childbearing potential unless she meets at least one of the following criteria:
• Age = 50 years and naturally amenorrhoeic for = 1 year*
• Premature ovarian failure confirmed by a specialist gynaecologist
• Previous bilateral salpingo-oophorectomy, or hysterectomy• XY genotype, Turner syndrome, uterine agenesis.
*Amenorrhoea following cancer therapy does not rule out childbearing potential. Counselling For women of childbearing potential, lenalidomide is contraindicated unless all of the following are met:
• She understands the potential teratogenic risk to the unborn child
• She understands the need for effective contraception, without interruption, 4 weeks before starting treatment, throughout the entire duration of treatment, and 4 weeks after the end of treatment
• Even if a woman of childbearing potential has amenorrhea she must follow all 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 to commence the treatment as soon as lenalidomide is dispensed following a negative pregnancy test
• She understands the need and accepts to undergo pregnancy testing every 4 weeks except in case of confirmed tubal sterilisation
• She acknowledges that she understands the hazards and necessary precautions associated with the use of lenalidomide. For male patients taking lenalidomide, there is no clinical data available on the presence of lenalidomide in human semen.
Male patients taking lenalidomide must meet the following conditions:
• Understand the potential teratogenic risk if engaged in sexual activity with a woman of childbearing potential
• Understand the need for the use of a condom if engaged in sexual activity with a woman of childbearing potential. The prescriber must ensure that for women of childbearing potential:
• The patient complies with the conditions for Pregnancy Prevention Programme, including confirmation that she has an adequate level of understanding
• The patient has acknowledged the aforementioned conditions. Contraception Women of childbearing potential must use one effective method of contraception for 4 weeks before therapy, during therapy, and until 4 weeks after lenalidomide therapy and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis.
If not established on effective contraception, the patient must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated.
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