Pomalidomide (Specialist drug)

PRESCRIBING: treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma. COMBINATION PARTNERS (as stated in the SPC): with bortezomib and dexamethasone — bortezomib 1.3 mg/m2 intravenous or subcutaneous once daily on the days shown in SPC Table 1 (four dosing days per 21-day cycle in Cycles 1-8 and two dosing days per cycle from Cycle 9 onwards; the specific day numbers were lost when the source table was flattened during fetching and must be read off the SPC) and dexamethasone 20 mg orally once daily (Cycles 1-8: Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle; Cycle 9 onwards: Days 1, 2, 8 and 9). With dexamethasone alone — dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 of each 28-day cycle. STARTING A NEW CYCLE: the neutrophil count must be at least 1 x 10^9/l and the platelet count at least 50 x 10^9/l. DOSE REDUCTION LADDER: starting dose 4 mg, dose level -1 is 3 mg, dose level -2 is 2 mg, dose level -3 is 1 mg; if adverse reactions occur after reduction to 1 mg, treatment should be discontinued. DOSE MODIFICATION: for ANC below 0.5 x 10^9/l or febrile neutropenia (fever at least 38.5 degrees C with ANC below 1 x 10^9/l), interrupt for the remainder of the cycle and follow full blood count weekly, resuming one dose level lower when ANC returns to at least 1 x 10^9/l; for platelets below 25 x 10^9/l, interrupt for the remainder of the cycle and resume one dose level lower when platelets return to at least 50 x 10^9/l; for Grade 2-3 rash consider interruption or discontinuation; for Grade 4 rash or blistering (including angioedema, anaphylactic reaction, exfoliative or bullous rash, or suspected Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS) permanently discontinue; for other Grade 3 or higher pomalidomide-related events interrupt for the remainder of the cycle and resume one dose level lower at the next cycle once resolved or improved to Grade 2 or less. STRONG CYP1A2 INHIBITORS: if co-administered, the pomalidomide dose should be reduced by 50%. ELDERLY: no dose adjustment for pomalidomide; for patients over 75 years the dexamethasone starting dose is 10 mg once daily on the scheduled days of the 21-day regimen, or 20 mg once daily on Days 1, 8, 15 and 22 of the 28-day regimen. HEPATIC IMPAIRMENT: no adjustment of the starting dose is required by Child-Pugh criteria, but patients should be carefully monitored and dose reduction or interruption used as needed; patients with serum total bilirubin above 1.5 x ULN were excluded from clinical studies. PAEDIATRIC: there is no relevant use of pomalidomide in children aged 0-17 years for multiple myeloma; outside its authorised indications it has been studied in children aged 4 to 18 years with recurrent or progressive brain tumours but the results did not allow a conclusion that benefits outweigh risks. MISSED DOSE: if a dose is forgotten on one day, take the normal prescribed dose as scheduled the next day; do not adjust the dose to make up for a missed dose on previous days. PREGNANCY PREVENTION PROGRAMME: 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. US LABELLING DIFFERENCES (from the openFDA provider in the same bundle, for cross-check only): US dosing for multiple myeloma is 4 mg once daily on Days 1 through 21 of each 28-day cycle with dexamethasone, and the US label additionally covers Kaposi sarcoma at 5 mg once daily on Days 1 through 21 of each 28-day cycle — the Kaposi sarcoma indication is not in the fetched UK SPC. SOURCE LIMITS: eMC §4.5 was not fetched and §4.4/§4.8 were truncated.