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BORTEZOMIB FOR 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: Bortezomib for Injection SDZ (bortezomib) 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 previously…
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 instructionsfor 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. Bortezomib 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 ADVERSEREACTIONS).
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 for Injection SDZ 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 Bortezomib for Injection SDZ.
For Bortezomib for Injection SDZ 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). Bortezomib For Injection SDZ Page 5 of 103 2 CONTRAINDICATIONS Bortezomib for Injection SDZ is contraindicated in patients with hypersensitivity to bortezomib, boron or any of the excipients.
Bortezomib for Injection SDZ is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of bortezomib. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Bortezomib for Injection SDZ 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 instructionsfor 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. Bortezomib 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 ADVERSEREACTIONS).
, Neurologic 09/2022 TABLE OF CONTENTS Secti ons or subse cti ons that are not appl i cabl e at the ti me of authori zati on are not l i sted. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ............................................................................................................... 1 Pediatrics................................................................................................................
2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS ..................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations.........................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 92 Bortezomib For Injection SDZ Page 4 of 103 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Bortezomib for Injection SDZ (bortezomib) is indicated: as part of combination therapy for the treatment of patients with […]
Bortezomib for Injection SDZ is contraindicated in patients with hypersensitivity to bortezomib, boron or any of the excipients. Bortezomib for Injection SDZ is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of bortezomib.
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 Bortezomib for Injection SDZ, please see corresponding Product Monographs. Bortezomib For Injection SDZ Page 7 of 103 Patients Not Suitable for Stem Cell Transplantation Bortezomib for Injection SDZ 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, Bortezomib for Injection SDZ is administered twice weekly (Days 1, 4, 8, 11, 22, 25, 29 and 32). In Cycles 5-9, Bortezomib for Injection SDZ is administered once weekly (Days 1, 8, 22 and 29). At least 72 hours should elapse between consecutive doses of Bortezomib for Injection SDZ.
0 x 109/L Non-hematological toxicities should have resolved to Grade 1 or baseline Bortezomib For Injection SDZ Page 8 of 103 Table 2: Dose Modifications during Subsequent Cycles of Combination Bortezomib for Injection SDZ, 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.
75 x 109/L on a Bortezomib for Injection SDZ dosing day (other than day 1) Bortezomib for Injection SDZ dose should be withheld If several Bortezomib for Injection SDZ doses in a cycle are withheld (≥3 doses during twice- weekly administration […]
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 for Injection SDZ 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 Bortezomib for Injection SDZ.
For Bortezomib for Injection SDZ 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 Bortezomib for Injection SDZ, please see corresponding Product Monographs. Bortezomib For Injection SDZ Page 7 of 103 Patients Not Suitable for Stem Cell Transplantation Bortezomib for Injection SDZ 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, Bortezomib for Injection SDZ is administered twice weekly (Days 1, 4, 8, 11, 22, 25, 29 and 32). In Cycles 5-9, Bortezomib for Injection SDZ is administered once weekly (Days 1, 8, 22 and 29). At least 72 hours should elapse between consecutive doses of Bortezomib for Injection SDZ.
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 […]