lowing can be considered to be examples of suitable methods of contraception:
• Implant
• Levonorgestrel-releasing intrauterine system (IUS) • Medroxyprogesterone acetate depot
• Tubal sterilisation
• Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
• Ovulation inhibitory progesterone-only pills (i.e., desogestrel) Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking lenalidomide and dexamethasone, combined oral contraceptive pills are not recommended (See Interactions).
If a patient is currently using combined oral contraception the patient should switch to one of the effective method listed above. The risk of venous thromboembolism continues for 4-6 weeks after discontinuing combined oral contraception.
The efficacy of contraceptive steroids may be reduced during co-treatment with dexamethasone (See Interactions).
Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding.
Prophylactic antibiotics should be considered particularly in patients with neutropenia.
Copper-releasing intrauterine devices are generally not recommended due to the potential risks of infection at the time of insertion and menstrual blood loss which may compromise patients with neutropenia or thrombocytopenia. Pregnancy testing According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/ml must be performed for women of childbearing potential as outlined below.
This requirement includes women of childbearing potential who practice absolute and continuous abstinence.
Ideally, pregnancy testing, issuing a prescription and dispensing should occur on the same day.
Dispensing of lenalidomide to women of childbearing potential should occur within 7 days of the prescription.
Prior to starting treatment A medically supervised pregnancy test should be performed during the consultation, when lenalidomide is prescribed, or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks.
The test should ensure the patient is not pregnant when she starts treatment with lenalidomide.
Follow-up and end of treatment A medically supervised pregnancy test should be repeated every 4 weeks, including 4 weeks after the end of treatment, except in the case of confirmed tubal sterilisation.
These pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.
Men It is not known whether lenalidomide is present in semen.
Therefore all male patients should use condoms throughout treatment duration, during dose interruption and for 1 week after cessation of treatment if their partner is of childbearing potential and has no contraception.
Additional precautions Patients should be instructed never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of treatment.
Patients should not donate blood or semen during therapy or for 1 week following discontinuation of lenalidomide. Educational materials In order to assist patients in avoiding foetal exposure to lenalidomide, the Marketing Authorisation Holder will provide educational material to health |
