Pomarza

Pomalidomide

In combination w/ bortezomib & dexamethasone for adults w/ relapsed or refractory multiple myeloma who have received at least 1 prior treatment regimen including lenalidomide. In combination w/ dexamethasone for adults w/ relapsed & refractory multiple myeloma who have received at least 2 prior treatment regimens including both lenalidomide & bortezomib w/ demonstrated disease progression on the last therapy.

In combination w/ bortezomib & dexamethasone 4 mg once daily on days 1-14 of repeated 21-day cycles. Bortezomib: 1.3 mg/m² IV or SC once daily on days 1, 4, 8 & 11 of each 21-day cycle for cycle 1-8 & on days 1 & 8 of each 21-day cycle for cycle 9 onwards. Dexamethasone: 20 mg once daily on days 1, 2, 4, 5, 8, 9, 11 & 12 of each 21-day cycle for cycle 1-8 & on days 1, 2, 8 & 9 of each 21-day cycle for cycle 9 onwards. Elderly >75 yr Dexamethasone: 10 mg once daily on days 1, 2, 4, 5, 8, 9, 11 & 12 of each 21-day cycle for cycle 1-8 & on days 1, 2, 8 & 9 of each 21-day cycle for cycle 9 onwards. In combination w/ dexamethasone 4 mg once daily on days 1-21 of repeated 28-day cycles. Dexamethasone: 40 mg once daily on days 1, 8, 15 & 22 of each 28-day cycle. Elderly >75 yr Dexamethasone: 20 mg once daily on days 1, 8, 15 & 22 of each 28-day cycle.

May be taken with or without food: Take at the same time each day. Swallow whole, do not open/break/chew.

Hypersensitivity. Male patients unable to follow or comply w/ required contraceptive measures. Women of childbearing potential unless all conditions set by the pregnancy prevention programme are met. Pregnancy.

Discontinue use if exfoliative or bullous rash, SJS, TEN or DRESS is suspected. Permanently discontinue if angioedema & anaphylactic reaction occur; progressive multifocal leukoencephalopathy is confirmed. Interrupt treatment if ILD is confirmed. Ongoing ≥grade 2 peripheral neuropathy; significant cardiac dysfunction (CHF NYHA III/IV, MI w/in 12 mth of starting study, unstable or poorly controlled angina pectoris), pre-existing cardiac disease or risk factors; tumour lysis syndrome; 2nd primary malignancies eg, non-melanoma skin cancer; dizziness, confusion. Monitor CBC at baseline, wkly for 1st 8 wk & mthly thereafter. Closely monitor patients w/ known risk factors for thromboembolism. Perform baseline & ongoing monitoring of thyroid function. Regularly monitor hepatic function for 1st 6 mth & clinically thereafter. Closely monitor for signs & symptoms of active HBV infection in patients previously infected w/ HBV including patients who are anti-HBc +ve but HBsAg -ve. Concomitant use w/ erythropoietic agents. May affect ability to drive & use machines. Women of childbearing potential must use 2 effective contraception for at least 4 wk before, during, until at least 4 wk after therapy & even in case of dose interruption. Perform pregnancy testing prior to & repeated at least every 4 wk including 4 wk after treatment. Male patients should use contraception & avoid blood, semen or sperm donations during treatment, dose interruption & for 4 wk after treatment. Teratogenic risk during pregnancy. Lactation.

Pneumonia; neutropenia, thrombocytopenia, leucopenia, anaemia; dyspnoea, cough; diarrhoea, nausea, constipation; fatigue, pyrexia, peripheral oedema. Bronchitis, URTI, resp tract infection; febrile neutropenia; hyperkalaemia; peripheral sensory neuropathy, dizziness, tremor; vomiting; bone pain, muscle spasms; atrial fibrillation; DVT; pulmonary embolism; rash; urinary retention; increased ALT. In combination w/ bortezomib & dexamethasone: Viral URTI; hypokalaemia, hyperglycaemia; insomnia; muscular weakness, back pain. Sepsis, septic shock, Clostridium difficile colitis, lung infection, lower resp tract infection, flu, bronchiolitis, UTI; basal cell carcinoma; lymphopenia; hypomagnesaemia, hypocalcaemia, hypophosphataemia, hypercalcaemia; depression; syncope, peripheral sensorimotor neuropathy, paraesthesia, dysgeusia; cataract; hypotension; HTN; abdominal pain & distention, upper abdominal pain, stomatitis, dry mouth; acute & chronic kidney injury; non-cardiac chest pain, eedema; decreased wt; fall. In combination w/ dexamethasone: Decreased appetite. Neutropenic sepsis, bronchopneumonia, nasopharyngitis, herpes zoster; hyponatraemia; confusional state; depressed level of consciousness; vertigo; GI haemorrhage; pruritus; renal failure; pelvic pain; decreased neutrophil, WBC & platelet count, pancytopenia; angioedema, urticaria; hyperuricaemia; intracranial haemorrhage; cardiac failure, MI; epistaxis, ILD; increased blood uric acid.

Increased mean exposure w/ strong CYP1A2 inhibitor eg, ciprofloxacin, enoxacin, fluvoxamine. Close monitoring of warfarin conc.

Cancer Immunotherapy

L04AX06 - pomalidomide ; Belongs to the class of other immunosuppressants.

B