Lenangio 10/Lenangio 15 Patient Counseling Information

For women of childbearing potential, lenalidomide is contraindicated unless all of the following are met: She understands the expected 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 sterilization.
She acknowledges that she understands the hazards and necessary precautions associated with the use of lenalidomide.
For male patients taking lenalidomide, pharmacokinetic data has demonstrated that lenalidomide is present in human semen at extremely low levels during treatment and is undetectable in human semen 3 days after stopping the substance in the healthy subject. As a precaution and taking into account special populations with prolonged elimination time such as renal impairment, all male patients taking lenalidomide must meet the following conditions: Understand the expected teratogenic risk if engaged in sexual activity with a pregnant woman or a woman of childbearing potential.
Understand the need for the use of a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential not using effective contraception (even if the man has had a vasectomy), during treatment and for 1 week after dose interruptions and/or cessation of treatment.
Understand that if his female partner becomes pregnant whilst he is taking lenalidomide or shortly after he has stopped taking lenalidomide, he should inform his treating physician immediately and that it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
The prescriber must ensure that for women of childbearing potential: The patient complies with the conditions of the Pregnancy Prevention Programme, including confirmation that she has an adequate level of understanding.
The patient has acknowledged the aforementioned conditions.