Bortezomib Alvogen

Monotherapy or in combination w/ pegylated lipos doxorubicin or dexamethasone for the treatment of multiple myeloma in patients >18 yr whose disease is progressive after receiving at least 1 prior treatment & for whom blood stem cell transplantation was not successful or is unsuitable. In combination w/ melphalan & prednisone for the treatment of multiple myeloma in patients >18 yr whose disease has not been previously treated & who are unsuitable for high-dose chemotherapy w/ blood stem cell transplantation. In combination w/ dexamethasone or dexamethasone & thalidomide for the treatment of multiple myeloma in patients >18 yr whose disease has not been previously treated & before receiving high-dose chemotherapy w/ blood stem cell transplantation. In combination w/ rituximab, cyclophosphamide, doxorubicin & prednisone for the treatment of mantle cell lymphoma in patients ≥18 yr whose disease has not been previously treated & for whom blood stem cell transplantation is unsuitable.

Reconstituted soln: Administer 1 mg/mL as 3-5 sec bolus IV inj through peripheral or central IV catheter, or 2.5 mg/mL as SC inj into thighs or abdomen. Starting dose: 1.3 mg/m² twice wkly. Progressive multiple myeloma Monotherapy Administer 4 doses IV or SC on days 1, 4, 8, & 11, followed by 10-day rest period w/o treatment. 21-day period (3 wk) corresponds to 1 treatment cycle. Patient may receive up to 8 cycles (24 wk). In combination w/ pegylated lipos doxorubicin Administer bortezomib IV or SC as 21-day treatment cycle. Administer pegylated lipos doxorubicin 30 mg/m² IV infusion after bortezomib inj on day 4 of each cycle. Patient may receive up to 8 cycles (24 wk). In combination w/ dexamethasone Administer bortezomib IV or SC as 21-day treatment cycle. Administer oral dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11, & 12 of each cycle. Patient may receive up to 8 cycles (24 wk). Previously untreated multiple myeloma Not suitable for blood stem cell transplantation 42-day period (6 wk) corresponds to 1 treatment cycle. Patient will receive 9 cycles (54 wk). Administer bortezomib twice wkly on days 1, 4, 8, 11, 22, 25, 29, & 32 of cycles 1-4, then once wkly on days 1, 8, 22, & 29 of cycles 5-9. Administer oral melphalan 9 mg/m² & oral prednisone 60 mg/m² on days 1, 2, 3, & 4 of the 1st wk of each cycle. Suitable for blood stem cell transplantation (in combination w/ dexamethasone) Administer bortezomib IV or SC as 21-day treatment cycle (3 wk). Administer oral dexamethasone 40 mg on days 1, 2, 3, 4, 8, 9, 10, & 11 of each cycle. Patient will receive 4 cycles (12 wk). Suitable for blood stem cell transplantation (in combination w/ dexamethasone & thalidomide) Administer bortezomib IV or SC as 28-day treatment cycle (4 wk). Administer oral dexamethasone 40 mg on days 1, 2, 3, 4, 8, 9, 10, & 11 of each cycle. Administer oral thalidomide 50 mg on days 1-14 of the 1st cycle, then, if tolerated, increase to 100 mg on days 15-28 of the 1st cycle & may further increase to 200 mg daily from the 2nd cycle onwards. Patient may receive up to 6 cycles (24 wk). Previously untreated mantle cell lymphoma Administer bortezomib IV or SC on days 1, 4, 8, & 11, followed by rest period w/o treatment. 21-day period (3 wk) corresponds to 1 treatment cycle. Patient may receive up to 8 cycles (24 wk). Administer rituximab 375 mg/m² IV infusion, cyclophosphamide 750 mg/m² IV infusion, & doxorubicin 50 mg/m² IV infusion on day 1 of each cycle. Administer oral prednisone 100 mg/m² on days 1, 2, 3, 4, & 5 of each cycle.

Hypersensitivity to bortezomib or boron. Patients w/ severe lung or heart problems.

Do not administer by routes other than IV or SC. Intrathecal administration has resulted in death. Rotate SC inj sites for successive inj. If local inj site reactions occur following SC inj, administer less concentrated soln or switch to IV inj. Caution in patients w/ low numbers of RBC or WBC; bleeding problems &/or low number of platelets; diarrhoea, constipation, nausea or vomiting; history of fainting, dizziness or lightheadedness; kidney problems; moderate to severe liver problems; history of numbness, tingling, or pain in the hands or feet; heart or BP problems; shortness of breath or cough; seizures; shingles (localised including around eyes or spread across body); symptoms of tumor lysis syndrome; memory loss, trouble thinking, walking difficulty or vision loss; present, or history of, hepatitis infection (mantle cell lymphoma patients given rituximab). Regularly perform blood tests before & during treatment. Carefully check for signs of active hepatitis B in patients w/ history of hepatitis B infection. Do not drive or operate tools or machines in case of tiredness, dizziness, fainting, or blurred vision. Women of childbearing potential must use effective contraception during treatment & for 8 mth following completion of treatment. Men should not father a child during treatment & should use effective contraception during treatment & for up to 5 mth after treatment. Do not use during pregnancy, unless clearly necessary. Follow pregnancy prevention programme when given in combination w/ thalidomide. Do not breastfeed while on treatment. Do not use in childn & adolescents.

Multiple myeloma: Sensitivity, numbness, tingling or burning sensation of skin, or pain in hands or feet (due to nerve damage); reduction in number of RBC &/or WBC; fever; nausea or vomiting, loss of appetite; constipation w/ or w/o bloating (can be severe); diarrhoea; fatigue, feeling weak; muscle pain, bone pain. Mantle cell lymphoma: Pneumonia; loss of appetite; sensitivity, numbness, tingling or burning sensation of skin, or pain in hands or feet (due to nerve damage); nausea & vomiting; diarrhoea; mouth ulcers; constipation; muscle pain, bone pain; hair loss & abnormal hair texture; tiredness, feeling weak; fever.

Potential interaction w/ ketoconazole, ritonavir, rifampicin, carbamazepine, phenytoin, phenobarb, St. John's wort, oral antidiabetics.

Targeted Cancer Therapy

L01XG01 - bortezomib ; Belongs to the class of proteasome inhibitors. Used in the treatment of cancer.

P₁S₁S₃