then 40 mg once daily on days 1-4 every 28 days. Dosing is continued or modified based upon clinical and laboratory findings (see section 4.4). Prescribing physicians should carefully eva luate which dose of dexamethasone to use, taking into account the condition and disease status of the patient.
Lenalidomide treatment must not be started if the Absolute Neutrophil Counts (ANC) < 1.0 x 109/l, and/or platelet counts < 75 x 109/l or, dependent on bone marrow infiltration by plasma cells, platelet counts < 30 x 109/l.
Recommended dose adjustments during treatment and restart of treatment
Dose adjustments, as summarised below, are recommended to manage grade 3 or 4 neutropenia or thrombocytopenia, or other grade 3 or 4 toxicity judged to be related to lenalidomide.
• Dose reduction steps
Starting dose
25 mg
Dose level 1
15 mg
Dose level 2
10 mg
Dose level 3
5 mg
• Platelet counts
Thrombocytopenia
When platelets
Recommended Course
First fall to < 30 x 109/l
Interrupt lenalidomide treatment
Return to 30 x 109/l
Resume lenalidomide at Dose Level 1
For each subsequent drop below 30 x 109/l
Interrupt lenalidomide treatment
Return to 30 x 109/l
Resume lenalidomide at next lower dose level (Dose Level 2 or 3) once daily. Do not dose below 5 mg once daily.
• Absolute Neutrophil counts (ANC)
Neutropenia
When neutrophils
Recommended Course
First fall to < 0.5 x 109/l
Interrupt lenalidomide treatment
Return to 0.5 x 109/l when neutropenia is the only observed toxicity
Resume lenalidomide at Starting Dose once daily
Return to 0.5 x 109/l when dose-dependent haematological toxicities other than neutropenia are observed
Resume lenalidomide at Dose Level 1 once daily
For each subsequent drop below < 0.5 x 109/l
Interrupt lenalidomide treatment
Return to 0.5 x 109/l
Resume 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 patients
There is no experience in children and adolescents. Therefore, lenalidomide should not be used in the paediatric age group (017 years).
Elderly patients
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 (see section 5.1). 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 function
Lenalidomide is substantially excreted by the kidney, therefore care should be taken in dose selection and monitoring of renal function is advised.
No dose ad
