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TARO-BORTEZOMIB is a brand name for Bortezomib, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Taro-Bortezomib (bortezomib) for injection is indicated: as part of combination therapy for the treatment of patients with previously untreated multiple myeloma who are unsuitable for stem cell transplantation. as part of a medically recognized combination therapy for induction treatment of patients with…
Verbatim from this product's HC label. Tap a section to expand.
5 mg/mL) Because each route of administration has a different reconstituted concentration, caution should be used when calculating the volume to be administered. For subcutaneous administration, the reconstituted solution is injected into the thighs (right or left) or abdomen (right or left).
Injection sites should be rotated for successive injections. 5 cm from an old site and never into areas where the site is tender, bruised, erythematous, or indurated. 4 Administration and follow reconstitution instructions for 1 mg/mL).
4 Administration). In clinical trials, local skin irritation was reported in 5% of patients, but extravasation of bortezomib was not associated with tissue damage. In a clinical trial of subcutaneous bortezomib, a local reaction was reported in 6% of patients as an adverse event, mostly redness.
Treatment must be administered under the supervision of a physician qualified and experienced in the use of antineoplastic agents. Taro-Bortezomib (Bortezomib for Injection) Page 6 of 86 Bortezomib for injection has not been formally studied in patients with impaired renal function.
Patients with compromised renal function should be monitored carefully, especially if creatinine clearance is ≤ 30 mL/minute (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS). Bortezomib has been studied in patients with impaired hepatic function.
Patients with mild hepatic impairment do not require a starting dose adjustment and should be treated as per the recommended bortezomib dose. Patients with moderate or severe hepatic impairment should be started on a reduced dose. See Dose Modification in Patients with Hepatic Impairment and 7 WARNINGS AND PRECAUTIONS.
There is no evidence to suggest that dose adjustments are necessary in elderly patients (see 8 ADVERSE REACTIONS). The safety and effectiveness of bortezomib in children and adolescents have not been established. 3 mg/m2 body surface area to be administered intravenously twice weekly on days 1, 4, 8, and 11, followed by a rest period of up to 20 days, which is considered a treatment cycle.
Three to six cycles should be administered. At least 72 hours should elapse between consecutive doses of Taro-Bortezomib. For Taro-Bortezomib dosage adjustments for transplant eligible patients follow dose modification guidelines described under Dosage in Relapsed Multiple Myeloma and Relapsed/Refractory Mantle Cell Lymphoma and Dose Modification in Patients with Hepatic Impairment.
, 10 CLINICAL PHARMACOLOGY, and 14 CLINICAL TRIALS). 2 CONTRAINDICATIONS Taro-Bortezomib for injection is contraindicated in patients with hypersensitivity to bortezomib, boron or any of the excipients. Taro-Bortezomib is contraindicated for intrathecal administration.
Fatal events have occurred with intrathecal administration of bortezomib. Taro-Bortezomib (Bortezomib for Injection) Page 5 of 86 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Taro-Bortezomib must be administered under the supervision of a physician qualified in the use of antineoplastic agents.
5 mg/mL) Because each route of administration has a different reconstituted concentration, caution should be used when calculating the volume to be administered. For subcutaneous administration, the reconstituted solution is injected into the thighs (right or left) or abdomen (right or left).
Injection sites should be rotated for successive injections. 5 cm from an old site and never into areas where the site is tender, bruised, erythematous, or indurated. 4 Administration and follow reconstitution instructions for 1 mg/mL).
4 Administration). In clinical trials, local skin irritation was reported in 5% of patients, but extravasation of bortezomib was not associated with tissue damage. In a clinical trial of subcutaneous bortezomib, a local reaction was reported in 6% of patients as an adverse event, mostly redness.
Treatment must be administered under the supervision of a physician qualified and experienced in the use of antineoplastic agents. Taro-Bortezomib (Bortezomib for Injection) Page 6 of 86 Bortezomib for injection has not been formally studied in patients with impaired renal function.
Patients with compromised renal function should be monitored carefully, especially if creatinine clearance is ≤ 30 mL/minute (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS). Bortezomib has been studied in patients with impaired hepatic function.
, Neurologic 02/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 3 Reconstitution...................................................................................................................
4 Administration................................................................................................................... 5 Missed Dose ......................................................................................................................
12 5 OVERDOSAGE ......................................................................................................................... 12 6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.............................................
13 7 WARNINGS AND PRECAUTIONS............................................................................................... 1 Special Populations............................................................................................................
1 Pregnant Women ....................................................................................................... 2 Breast-feeding ............................................................................................................
3 Pediatrics.................................................................................................................... 19 8 ADVERSE REACTIONS..............................................................................................................
1 Adverse Reaction Overview............................................................................................... 2 Clinical Trial Adverse Reactions .........................................................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ...............................................................................................................................................
Taro-Bortezomib for injection is contraindicated in patients with hypersensitivity to bortezomib, boron or any of the excipients. Taro-Bortezomib is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of bortezomib.
Taro-Bortezomib (Bortezomib for Injection) Page 5 of 86
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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For dosing instructions for other medicinal products combined with Taro-Bortezomib, please see corresponding Product Monographs. Patients Not Suitable for Stem Cell Transplantation Taro-Bortezomib is administered in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles as shown in Table 1.
In Cycles 1-4, Taro-Bortezomib is administered twice weekly (Days 1, 4, 8, 11, 22, 25, 29 and 32). In Cycles 5-9, Taro-Bortezomib is administered once weekly (Days 1, 8, 22 and 29). At least 72 hours should elapse between consecutive doses of Taro-Bortezomib.
0 x 109/L Non-hematological toxicities should have resolved to Grade 1 or baseline Table 2: Dose Modifications During Subsequent Cycles of Combination Taro-Bortezomib, Melphalan and Prednisone Therapy Toxicity Dose modification or delay Hematological toxicity during a cycle: If prolonged (≥ 5 days) Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle Consider reduction of the melphalan dose by 25% in the next cycle.
7 mg/m2) Grade ≥ 3 non-hematological toxicities Taro-Bortezomib therapy should be withheld until symptoms of the toxicity have resolved to Grade […]
Patients with mild hepatic impairment do not require a starting dose adjustment and should be treated as per the recommended bortezomib dose. Patients with moderate or severe hepatic impairment should be started on a reduced dose. See Dose Modification in Patients with Hepatic Impairment and 7 WARNINGS AND PRECAUTIONS.
There is no evidence to suggest that dose adjustments are necessary in elderly patients (see 8 ADVERSE REACTIONS). The safety and effectiveness of bortezomib in children and adolescents have not been established. 3 mg/m2 body surface area to be administered intravenously twice weekly on days 1, 4, 8, and 11, followed by a rest period of up to 20 days, which is considered a treatment cycle.
Three to six cycles should be administered. At least 72 hours should elapse between consecutive doses of Taro-Bortezomib. For Taro-Bortezomib dosage adjustments for transplant eligible patients follow dose modification guidelines described under Dosage in Relapsed Multiple Myeloma and Relapsed/Refractory Mantle Cell Lymphoma and Dose Modification in Patients with Hepatic Impairment.
For dosing instructions for other medicinal products combined with Taro-Bortezomib, please see corresponding Product Monographs. Patients Not Suitable for Stem Cell Transplantation Taro-Bortezomib is administered in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles as shown in Table 1.
In Cycles 1-4, Taro-Bortezomib is administered twice weekly (Days 1, 4, 8, 11, 22, 25, 29 and 32). In Cycles 5-9, Taro-Bortezomib is administered once weekly (Days 1, 8, 22 and 29). At least 72 hours should elapse between consecutive doses of Taro-Bortezomib.
3 mg/m2) Day 1 -- -- -- Day 8 rest period Day 22 Day 29 rest period Melphalan (9 mg/m2) Prednisone (60 mg/m2) Day 1 Day 2 Day 3 Day 4 -- rest period -- -- rest period See 14 CLINICAL TRIALS Dose Modification Guidelines for Combination Therapy with Taro-Bortezomib, Melphalan and Prednisone Dose modification and re-initiation of […]
5 Post-Market Adverse Reactions.......................................................................................... 39 9. DRUG INTERACTIONS .............................................................................................................
4 Drug-Drug Interactions ...................................................................................................... 5 Drug-Food Interactions ......................................................................................................
6 Drug-Herb Interactions ...................................................................................................... 7 Drug- Laboratory Test Interactions .....................................................................................
41 10 CLINICAL PHARMACOLOGY .................................................................................................... 1 Mechanism of Action .......................................................................................................
2 Pharmacodynamics.......................................................................................................... 3 Pharmacokinetics: ...........................................................................................................
44 11 STORAGE, STABILITY AND DISPOSAL...................................................................................... 47 12 SPECIAL HANDLING INSTRUCTIONS .......................................................................................
47 PART II: SCIENTIFIC INFORMATION ............................................................................................ 48 13 PHARMACEUTICAL INFORMATION ........................................................................................
48 14 CLINICAL TRIALS .................................................................................................................... 1 Clinical Trials by Indication ...............................................................................................
48 Multiple Myeloma................................................................................................................... 48 Mantle Cell Lymphoma............................................................................................................
67 15 […]