Pomalid

Pomalidomide

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

In combination w/ bortezomib & dexamethasone Initially 4 mg once daily on days 1-14 of repeated 21-day cycles. Bortezomib: Initially 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. Patients >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 Initially 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 treatment cycle. Patients >75 yr Dexamethasone: 20 mg once daily on days 1, 8, 15 & 22 of each 28-day treatment cycle.

May be taken with or without food: Swallow whole, preferably w/ water. Do not open, break, or chew.

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

Monitor patients for haematological AR, especially neutropenia; w/ known risk factors for thromboembolism, including prior thrombosis; signs & symptoms of cardiac events including congestive cardiac failure, pulmonary oedema, atrial fibrillation & active HBV infection. Observe for signs of bleeding including epistaxes especially in concomitant use w/ medicinal products known to increase risk of bleeding. Monitor CBC at baseline, wkly for the 1st 8 wk & mthly thereafter. Caution in concomitant use w/ erythropoietic agents & other agents that may increase risk of thromboembolic events. Patients w/ ongoing ≥ Grade 2 peripheral neuropathy; significant cardiac dysfunction (CHF NYHA Class III or IV), MI w/in 12 mth of starting study, unstable or poorly controlled angina pectoris. Risk of tumour lysis syndrome in patients w/ high tumour burden prior to treatment. Secondary primary malignancies eg, non-melanoma skin cancer. Discontinue treatment if exfoliative or bullous rash, or if SJS, TEN or DRESS is suspected; Grade 2-3 skin rash, angioedema & anaphylactic reaction occur. Dizziness & confusion. ILD & related events, including cases of pneumonitis; interrupt treatment if ILD is confirmed. Regularly monitor liver function for the 1st 6 mth of treatment. Concomitant use w/ dexamethasone in patients previously infected w/ HBV, including patients who are anti-HBc +ve but HBsAg -ve. Thyroid disorders. Monitor patients at regular intervals & consider progressive multifocal leukoencephalopathy (PML) in the differential diagnosis in patients w/ new or worsening neurological symptoms, cognitive or behavioural signs or symptoms. Interrupt further dosing if PML is suspected & permanently discontinue treatment if PML is confirmed. Minor or moderate influence on the ability to drive & use machines. Teratogenic risk during pregnancy. Women of childbearing potential must use at least 1 effective method of contraception for at least 4 wk before, during, & until at least 4 wk after therapy & even in case of dose interruption. Combined OC pills & insertion of Cu-releasing IUD are not recommended. Perform medically supervised pregnancy test w/ min sensitivity of 25 mIU/mL in women of childbearing potential prior to starting treatment, to be repeated at least every 4 wk, & 4 wk after treatment. Male patients, including those who have had a vasectomy, should use condom throughout treatment duration, during dose interruption & for 7 days after dose interruptions &/or cessation of treatment if their partner is pregnant or of childbearing potential & has no contraception. Patients should not donate blood, semen or sperm during treatment (including during dose interruptions) & for 7 days following discontinuation of treatment. Discontinue breast-feeding during treatment.

Pneumonia (bacterial, viral & fungal infections, including opportunistic infections), bronchitis, URTI, viral URTI; neutropenia, thrombocytopenia, leucopenia, anaemia; hypokalaemia, hyperglycaemia; insomnia; peripheral sensory neuropathy, dizziness, tremor; decreased appetite; dyspnoea, cough; diarrhoea, vomiting, nausea, constipation; bone pain, muscle spasms, muscular weakness, back pain; fatigue, pyrexia, peripheral oedema. Neutropenic sepsis, sepsis, septic shock, Clostridium difficile colitis, bronchopneumonia, lung infection, flu, bronchitis/bronchiolitis, UTI, lower resp tract infection, nasopharyngitis, herpes zoster; basal cell carcinoma; febrile neutropenia, lymphopenia, pancytopenia; hypomagnesaemia, hypocalcaemia, hypophosphataemia, hyperkalaemia, hypercalcaemia, hyponatraemia, hyperuricaemia; confusional state, depression; depressed level of consciousness, tremor, syncope, paraesthesia, dysgeusia, intracranial haemorrhage; vertigo, cataract; atrial fibrillation, cardiac failure, MI; DVT, hypotension, HTN; pulmonary embolism, epistaxis, ILD; GI haemorrhage, abdominal pain & distension, stomatitis, dry mouth; rash, pruritus; renal failure, urinary retention, acute & chronic kidney injury; non-cardiac chest pain, oedema; pelvic pain; decreased neutrophil count, WBC & platelet count & increased ALT & blood uric acid, decreased wt; fall; angioedema, urticaria. Hepatitis B reactivation, drug reaction w/ eosinophilia & systemic symptoms, TEN, SJS.

Increased mean exposure w/ strong CYP1A2 inhibitor eg, ciprofloxacin, enoxacin & fluvoxamine.

Cancer Immunotherapy

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

G