Bezom

Bezom

bortezomib

Manufacturer:

Hetero Labs

Distributor:

Camber
Concise Prescribing Info
Contents
Bortezomib
Indications/Uses
Progressive multiple myeloma w/ at least 1 prior therapy that has undergone or unsuitable for haematopoietic stem cell transplantation as monotherapy or w/ pegylated liposomal doxorubicin or dexamethasone. Previously untreated multiple myeloma not eligible for high-dose chemotherapy w/ haematopoietic stem cell transplantation w/ melphalan & prednisone. Induction treatment w/ previously untreated multiple myeloma eligible for high-dose chemotherapy w/ haematopoietic stem cell transplantation w/ dexamethasone or w/ dexamethasone & thalidomide.
Dosage/Direction for Use
Monotherapy: 1.3 mg/m2/dose IV inj twice wkly for 2 wk on days 1, 4, 8 & 11 for 21 days. Re-initiate treatment from 1.3 mg/m2 to 1 mg/m2 to 0.7 mg/m2. Neuropathic pain &/or peripheral neuropathy Grade 1 w/ pain or grade 2, grade 2 w/ pain or grade 3: Reduce dose to 1 mg/m2 or change treatment schedule to 1.3 mg/m2 once wkly. Re-initiate treatment & reduce dose to 0.7 mg/m2 once wkly. Combination therapy w/ pegylated liposomal doxorubicin: 1.3 mg/m2 twice wkly for 2 wk on days 1, 4, 8 & 11 for 21-days + pegylated liposomal doxorubicin at 30 mg/m2 on day 4 of treatment cycle as 1 hr IV infusion. Max: 8 cycles. Combination w/ dexamethasone: 1.3 mg/m2 twice wkly for 2 wk on days 1, 4, 8 & 11 for 21-days + dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 & 12. Max: 4 cycles. Dose adjustments for combination therapy for patient w/ progressive multiple myeloma 1.3 mg/m2/dose IV inj twice wkly for 2 wk on days 1, 4, 8 & 11 for 21-days. Combination therapy w/ melphalan & prednisone: Administer Bortezomib for 6 wk. Cycles 1-4 bortezomib is administered twice wkly on days 1, 4, 8, 11, 22, 25, 29 & 32. Cycles 5-9 bortezomib is administered once wkly on days 1, 8, 22 & 29. Melphalan & prednisone should both be given orally on days 1, 2, 3 & 4 of the 1st wk of each cycle. Combination therapy w/ dexamethasone: 40 mg administered orally on days 1, 2, 3, 4, 8, 9, 10 & 11. Combination therapy w/ dexamethasone & thalidomide: 50 mg of thalidomide administered orally on days 1-14 & if tolerated the dose is increased to 100 mg on days 15-28 & 200 mg daily from cycle 2 thereafter. 40 mg of dexamethasone administered orally on days 1, 2, 3, 4, 8, 9, 10 & 11.
Contraindications
Hypersensitivity. Intrathecal administration. Acute diffuse infiltrative pulmonary & pericardial disease.
Special Precautions
Intrathecal administration. GI & haematological toxicity. Herpes zoster virus reactivation. Discontinue use if progressive multifocal leukoencephalopathy & posterior reversible encephalopathy syndrome are diagnosed. Peripheral neuropathy. Orthostatic/postural hypotension. CHF. Renal & hepatic impairment. Tumour lysis syndrome. Concomitant use w/ CYP3A4 or CYP2C19 substrates. Serum sickness-type reaction, polyarthritis w/ rash & proliferative glomerulonephritis. May impair ability to drive or operate machinery. Pregnancy & lactation.
Adverse Reactions
Nausea, diarrhea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia, peripheral neuropathy (including sensory), headache, paraesthesia, decreased appetite, dyspnoea, rash, herpes zoster, myalgia.
Drug Interactions
Ketoconazole, ritonavir. May reduced efficacy w/ rifampicin, carbamazepine, phenytoin, phenobarb & St. John's wort. Oral antidiabetics.
ATC Classification
L01XG01 - bortezomib ; Belongs to the class of proteasome inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Bezom powd for soln for inj 3.5 mg
Packing/Price
1's
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