Lenalidomide (Specialist drug)

eMC SPC (Lenalidomide 10 mg capsules) §4.2. Treatment must be supervised by a physician experienced in the use of anti-cancer therapies. INDICATION-SPECIFIC REGIMENS (all oral): (1) Newly diagnosed multiple myeloma (NDMM) + dexamethasone, transplant-ineligible — lenalidomide 25 mg once daily days 1-21 of 28-day cycles; dexamethasone 40 mg once daily on days 1, 8, 15 and 22 of each 28-day cycle (20 mg once daily on those days if aged over 75 years). Do not start if ANC <1.0 x 10^9/L and/or platelets <50 x 10^9/L. Dose levels: 25 mg / -1 20 mg / -2 15 mg / -3 10 mg / -4 5 mg / -5 2.5 mg. (2) NDMM + bortezomib and dexamethasone, transplant-ineligible — lenalidomide 25 mg once daily days 1-14 of each 21-day cycle with bortezomib 1.3 mg/m2 subcutaneously twice weekly on days 1, 4, 8 and 11; up to eight 21-day cycles, then continue lenalidomide 25 mg once daily days 1-21 of 28-day cycles with dexamethasone until progression. Do not start if ANC <1.0 x 10^9/L and/or platelets <50 x 10^9/L. (3) NDMM + melphalan and prednisone, transplant-ineligible — lenalidomide 10 mg once daily days 1-21 of 28-day cycles for up to 9 cycles, with melphalan 0.18 mg/kg orally days 1-4 and prednisone 2 mg/kg orally days 1-4 of each 28-day cycle; then lenalidomide monotherapy 10 mg once daily days 1-21 of 28-day cycles until progression. Do not start if ANC <1.5 x 10^9/L and/or platelets <75 x 10^9/L. (4) Maintenance after autologous stem cell transplantation — 10 mg once daily continuously (days 1-28 of repeated 28-day cycles) until progression or intolerance; after 3 cycles the dose may be increased to 15 mg once daily if tolerated; do not dose below 5 mg on days 1-21 every 28 days. Do not start if ANC <1.0 x 10^9/L and/or platelets <75 x 10^9/L. (5) Multiple myeloma with at least one prior therapy — 25 mg once daily days 1-21 of 28-day cycles, with dexamethasone 40 mg once daily on days 1-4, 9-12 and 17-20 of each 28-day cycle for the first 4 cycles, then 40 mg once daily on days 1-4 every 28 days. Do not start if ANC <1.0 x 10^9/L and/or platelets <75 x 10^9/L (or <30 x 10^9/L if dependent on bone-marrow plasma-cell infiltration). Dose levels: 25 mg / -1 15 mg / -2 10 mg / -3 5 mg; do not dose below 5 mg once daily. (6) Follicular lymphoma — 20 mg once daily days 1-21 of 28-day cycles for up to 12 cycles, with rituximab 375 mg/m2 IV weekly in cycle 1 (days 1, 8, 15, 22) and on day 1 of each 28-day cycle for cycles 2-5. Do not start if ANC <1 x 10^9/L and/or platelets <50 x 10^9/L unless secondary to lymphoma marrow infiltration. Dose levels: 20 mg / -1 15 mg / -2 10 mg / -3 5 mg (each days 1-21 every 28 days). All patients should receive tumour lysis syndrome prophylaxis (allopurinol, rasburicase or equivalent) and be well hydrated during the first week of cycle 1. MISSED DOSE: if less than 12 hours have elapsed the dose may be taken; if more than 12 hours, omit and take the next dose at the normal time the following day. DOSE MODIFICATION: adjust for Grade 3-4 thrombocytopenia, neutropenia or other Grade 3-4 lenalidomide-related toxicity (see the SPC tables for each indication); consider growth factors (G-CSF) for neutropenia. Discontinue permanently for angioedema, anaphylaxis, Grade 4 rash, exfoliative or bullous rash, or suspected SJS, TEN or DRESS, and do not resume. ELDERLY: monitor renal function; patients aged 75 years and older with NDMM should be carefully assessed before treatment. PAEDIATRIC: 'Lenalidomide should not be used in children and adolescents from birth to less than 18 years because of safety concerns.' NOTE: the eMC §4.2 renal-impairment table, §4.4 and §4.8 were truncated at the source-fetch limit in the fetched bundle — clinician to verify against the full current SPC.