mide at Dose Level 1 once dailyFor each subsequent drop below < 0.5 x 109 /lInterrupt lenalidomide treatmentReturn to 0.5 x 109 /lResume lenalidomide at next lower dose level (Dose Level 1, 2 or 3) once daily. Do not dose below 5 mg once daily.In case of neutropenia, the physician should consider the use of growth factors in patient management.Paediatric patientsThere is no experience in children and adolescents. Therefore, lenalidomide should not be used in the paediatric age group (017 years).Elderly patientsThe effects of age on the pharmacokinetics of lenalidomide have not been studied. Lenalidomide has been used in clinical trials in multiple myeloma patients up to 86 years of age. The percentage of patients aged 65 or over was not significantly different between the lenalidomide/dexamethasone and placebo/dexamethasone groups. No overall difference in safety or efficacy was observed between these patients and younger patients, but greater pre-disposition of older individuals cannot be ruled out. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it would be prudent to monitor renal function.Use in patients with impaired renal functionLenalidomide is substantially excreted by the kidney, therefore care should be taken in dose selection and monitoring of renal function is advised.No dose adjustments are required for patients with mild renal impairment. The following dose adjustments are recommended at the start of therapy for patients with moderate or severe impaired renal function or end stage renal disease.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 treatmentUse in patients with impaired hepatic functionLenalidomide has not formally been studied in patients with impaired hepatic function and there are no specific dose recommendations.
Child Dosage
Paediatric patients There is no experience in children and adolescents. Therefore, lenalidomide should not be used in the paediatric age group (0-17 years).
Elderly Dosage
The effects of age on the pharmacokinetics of lenalidomide have not been studied.
Lenalidomide has been used in clinical trials in multiple myeloma patients up to 86 years of age. The percentage of patients aged 65 or over was not significantly different between the lenalidomide/dexamethasone and placebo/dexamethasone groups. No overall difference in safety or efficacy was observed between these patients and younger patients, but greater pre-disposition of older individuals cannot be ruled out. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it would be prudent to monitor renal function.
Contra Indications
Contraindications
• Women who are pregnant.
• Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met (see Special Precautions and Interactions).
• Hypersensitivity to the active substan