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Pomalyst

Pomalyst

pomalidomide

Manufacturer:

Celgene

Distributor:

DCH Auriga
Concise Prescribing Info
Contents
Pomalidomide
Indications/Uses
In combination w/ bortezomib & dexamethasone for adults w/ 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, & have demonstrated disease progression on the last therapy.
Dosage/Direction for Use
In combination w/ bortezomib & dexamethasone Initially pomalidomide 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 on cycles 1-8, & days 1 & 8 on cycles 9 onwards + dexamethasone 20 mg once daily on days 1, 2, 4, 5, 8, 9, 11, 12 on cycles 1-8, & days 1, 2, 8, 9 on cycle 9 onwards. In combination w/ dexamethasone Initially pomalidomide 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.
Administration
May be taken with or without food: Take at the same time each day. Swallow whole, do not open/break/chew.
Contraindications
Hypersensitivity. Male patients unable to follow or comply w/ the required contraceptive measures. Women of childbearing potential. Pregnancy.
Special Precautions
Teratogenicity during pregnancy. Women of childbearing potential must use 2 effective methods of contraception for at least 4 wk before, during & until at least 4 wk after therapy. Concomitant use w/ combined OC pills & insertion of copper-releasing IUD are not recommended. Perform pregnancy testing prior to starting treatment, to be repeated at least every 4 wk, & 4 wk after treatment. Male patients should use condoms if partner is pregnant or a woman of childbearing potential during treatment, dose interruption & for 4 wk after treatment. Avoid blood, semen or sperm donations during treatment (including during dose interruption) & for 4 wk following discontinuation of treatment. Monitor patients for haematological adverse reactions, 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/ drugs known to increase risk of bleeding. Monitor complete blood counts at baseline, wkly for the first 8 wk & mthly thereafter. Caution in concomitant use w/ erythropoietic agents & other agents that may increase risk of thromboembolic events. Peripheral neuropathy. Patients w/ significant cardiac dysfunction [CHF (NY Heart Association 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 Stevens-Johnson syndrome, toxic epidermal necrosis or DRESS is suspected; Grade 2-3 skin rash & angioedema occur. Dizziness & confusion. Interrupt treatment if interstitial lung disease is confirmed. Regularly monitor liver function for the first 6 mth of treatment. Concomitant use w/ dexamethasone in patients previously infected w/ HBV, including patients who are anti-HBc positive but HBsAg negative. Minor or moderate influence on the ability to drive & use machines. Contraindicated in pregnancy & in women of childbearing potential. Lactation.
Adverse Reactions
Pneumonia (bacterial, viral & fungal infections, including opportunistic infections), bronchitis, upper resp tract infection, viral upper resp tract infection; neutropenia, thrombocytopenia, leucopenia, anaemia; hypokalaemia, hyperglycemia, hyperkalaemia, hyperuricaemia; 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, influenza, bronchitis/bronchiolitis, UTI, lower resp tract infection, nasopharyngitis, herpes zoster; basal cell carcinoma; febrile neutropenia; lymphopenia; hyponatraemia; hypomagnesaemia, hypocalcaemia, hypophosphataemia, hypercalcaemia; confusional state, depression; depressed level of consciousness, peripheral sensory neuropathy, dizziness, tremor, syncope, paraesthesia, dysgeusia; vertigo, cataract; atrial fibrillation; DVT, hypotension, HTN; pulmonary embolism; 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 alanine aminotransferase & blood uric acid, decreased wt; fall. Hepatitis B reactivation, drug reaction w/ eosinophilia & systemic symptoms, toxic epidermal necrolysis, Stevens-Johnson syndrome.
Drug Interactions
Increased mean exposure w/ strong CYP1A2 inhibitor eg, ciprofloxacin, enoxacin & fluvoxamine.
ATC Classification
L04AX06 - pomalidomide ; Belongs to the class of other immunosuppressants.
Presentation/Packing
Form
Pomalyst hard cap 1 mg
Packing/Price
21's
Form
Pomalyst hard cap 2 mg
Packing/Price
21's
Form
Pomalyst hard cap 4 mg
Packing/Price
21's
Form
Pomalyst hard cap 3 mg
Packing/Price
21's
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