Velcade

Velcade

bortezomib

Manufacturer:

Johnson & Johnson
Concise Prescribing Info
Contents
Bortezomib
Indications/Uses
In combination w/ melphalan & prednisone for the treatment of patients w/ previously untreated multiple myeloma who are not eligible for high dose chemotherapy w/ bone marrow transplant. Multiple myeloma in patients who have received at least 1 prior therapy & have demonstrated disease progression on the last therapy. Mantle cell lymphoma in patients who have received at least 1 prior therapy.
Dosage/Direction for Use
IV/SC Relapsed multiple myeloma & mantle cell lymphoma Recommended dose: 1.3 mg/m2/dose as a 3- to 5-sec IV bolus inj twice wkly for 2 wk (days 1, 4, 8 & 11) followed by a 10-day rest period (days 12-21). At least 72 hr should elapse between consecutive doses. Patient w/ a confirmed complete response may receive additional 2 cycles beyond a confirmation. Patient who do not achieve a complete remission may receive a total of 8 cycles of therapy. Previously untreated multiple myeloma 1.3 mg/m2/dose as a 3-5 sec bolus IV inj in combination w/ oral melphalan & oral prednisone for nine 6-wk treatment cycles. In cycles 1-4, Velcade is administered twice wkly (days 1, 4, 8, 11, 22, 25, 29 & 32). In cycles 5-9, Velcade is administered once wkly (days 1, 8, 22 & 29). At least 72 hr should elapse between consecutive doses of Velcade.
Contraindications
Hypersensitivity to bortezomib, boron or mannitol.
Special Precautions
Not for intrathecal administration. Peripheral neuropathy; history of syncope, patients receiving medications associated w/ hypotension, dehydration; heart disease; acute liver failure. Conduct comprehensive diagnostic evaluation in the event of new or worsening cardiopulmonary symptoms. Frequently monitor CBC. Hold therapy when platelet count is <25,000/microL. Advise patients regarding appropriate measures to avoid dehydration. High tumor burden prior to treatment. Discontinue in patients developing posterior reversible encephalopathy syndrome (PRES). May impair ability to drive or operate machinery. Hepatic & renal impairment. Pregnancy & lactation.
Adverse Reactions
Thrombocytopenia, anemia, neutropenia, leucopenia, lymphopenia, pancytopenia, febrile neutropenia; cardiac, eye, GI, hepatobiliary, musculoskeletal & connective tissue, nervous system, psychiatric, renal & urinary, resp, thoracic & mediastinal, skin & SC, vascular disorders; hearing impairment; asthenic conditions; hypersensitivity; infections & infestations; catheter related complication; increased ALT, AST, alkaline phosphatase, GGT; decreased appetite & anorexia, dehydration, hyperglycemia, hypoglycemia, hyponatremia; tumor lysis syndrome.
Drug Interactions
Increased mean AUC w/ potent CYP3A4 inhibitors (eg, ketoconazole, ritonavir). Reduced mean AUC w/ CYP3A4 inducers (eg, rifampicin, carbamazepine, phenytoin, phenobarb, St. John's wort). Oral antidiabetics; amiodarone, antivirals, INH, nitrofurantoin or statins.
ATC Classification
L01XX32 - bortezomib ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Velcade powd for inj 3.5 mg
Packing/Price
1's (Rp10,971,000/boks)
Form
Velcade powd for inj 1 mg
Packing/Price
1's
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