Renal Function (CLcr)
 Dose Adjustment
 
Moderate renal impairment (30  CLcr < 50 ml/min)
 10 mg once daily*
 
Severe renal impairment (CLcr < 30 ml/min, not requiring dialysis)
 15 mg every other day**
 
End Stage Renal Disease (ESRD) (CLcr < 30 ml/min, requiring dialysis)
 5 mg once daily. On dialysis days, the dose should be administered following dialysis.
 
* The dose may be escalated to 15 mg once daily after 2 cycles if patient is not responding to treatment and is tolerating the treatment.

** The dose may be escalated to 10 mg once daily if the patient is tolerating the treatment

After initiation of lenalidomide therapy, subsequent lenalidomide dose modification in renally impaired patients should be based on individual patient treatment tolerance, as described above.

Use in patients with impaired hepatic function

Lenalidomide has not formally been studied in patients with impaired hepatic function and there are no specific dose recommendations.

4.3 Contraindications

 • Women who are pregnant.

• Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met (see sections 4.4 and 4.6).

• Hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings and precautions for use

 Pregnancy warning

Lenalidomide is structurally related to thalidomide. Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects. Lenalidomide induced in monkeys malformations similar to those described with thalidomide (see sections 4.6 and 5.3). If lenalidomide is taken during pregnancy, a teratogenic effect of lenalidomide in humans is expected.

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 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

• Sh