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ACT 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: ACT 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 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 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 ACT BORTEZOMIB Page 6 of 91 redness.
Treatment must be administered under the supervision of a physician qualified and experienced in the use of antineoplastic agents. 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 ACT 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 ACT BORTEZOMIB.
For ACT 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 • ACT BORTEZOMIB is contraindicated in patients with hypersensitivity to bortezomib, boron or any of the excipients. • ACT BORTEZOMIB is contraindicated for intrathecal administration.
Fatal events have occurred with intrathecal administration of bortezomib. ACT BORTEZOMIB Page 5 of 91 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • ACT 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 ACT BORTEZOMIB Page 6 of 91 redness.
Treatment must be administered under the supervision of a physician qualified and experienced in the use of antineoplastic agents. 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).
, Neurologic 04/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics .................................................................................................................
2 Geriatrics ................................................................................................................. 4 2 CONTRAINDICATIONS ...................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .............................................................. 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .............................................................................................
2 Recommended Dose and Dosage Adjustment ......................................................... 3 Reconstitution ....................................................................................................... 4 Administration .......................................................................................................
5 Missed Dose........................................................................................................... 12 5 OVERDOSAGE .............................................................................................................
• ACT BORTEZOMIB is contraindicated in patients with hypersensitivity to bortezomib, boron or any of the excipients. • ACT BORTEZOMIB is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of bortezomib.
ACT BORTEZOMIB Page 5 of 91
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 ACT BORTEZOMIB, please see corresponding Product Monographs. Patients Not Suitable for Stem Cell Transplantation ACT BORTEZOMIB is administered in combination with oral melphalan and oral prednisone for ACT BORTEZOMIB Page 7 of 91 nine 6-week treatment cycles as shown in Table 1 In Cycles 1-4, ACT BORTEZOMIB is administered twice weekly (Days 1, 4, 8, 11, 22, 25, 29 and 32).
In Cycles 5-9, ACT BORTEZOMIB is administered once weekly (Days 1, 8, 22 and 29). At least 72 hours should elapse between consecutive doses of ACT BORTEZOMIB. 0 x 109 /L • Non-hematological toxicities should have resolved to Grade 1 or baseline ACT BORTEZOMIB Page 8 of 91 Table 2: Dose Modifications During Subsequent Cycles of Combination ACT 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 ACT BORTEZOMIB therapy should be withheld until symptoms of the toxicity have resolved to Grade 1 or baseline. Then, ACT BORTEZOMIB may be […]
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 ACT 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 ACT BORTEZOMIB.
For ACT 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 ACT BORTEZOMIB, please see corresponding Product Monographs. Patients Not Suitable for Stem Cell Transplantation ACT BORTEZOMIB is administered in combination with oral melphalan and oral prednisone for ACT BORTEZOMIB Page 7 of 91 nine 6-week treatment cycles as shown in Table 1 In Cycles 1-4, ACT BORTEZOMIB is administered twice weekly (Days 1, 4, 8, 11, 22, 25, 29 and 32).
In Cycles 5-9, ACT BORTEZOMIB is administered once weekly (Days 1, 8, 22 and 29). At least 72 hours should elapse between consecutive doses of ACT 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 ACT BORTEZOMIB, Melphalan and Prednisone Dose modification and re-initiation of therapy when ACT BORTEZOMIB is administered in combination with melphalan and prednisone: Prior to initiating a new […]
12 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 12 7 WARNINGS AND PRECAUTIONS.................................................................................. 1 Special Populations ................................................................................................
1 Pregnant Women ............................................................................................... 2 Breast-feeding .................................................................................................... 3 Pediatrics............................................................................................................
20 8 ADVERSE REACTIONS .................................................................................................. 1 Adverse Reaction Overview ...................................................................................
2 Clinical Trial Adverse Reactions .............................................................................. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................................
5 Post-Market Adverse Drug Reactions .................................................................... 39 9 DRUG INTERACTIONS ................................................................................................. 4 Drug-Drug Interactions ..........................................................................................
5 Drug-Food Interactions .......................................................................................... 6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Test Interactions .........................................................................
41 ACT BORTEZOMIB Page 3 of 91 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action..........................................................................................
2 Pharmacodynamics ............................................................................................ 3 Pharmacokinetics ............................................................................................... 44 11 STORAGE, STABILITY AND STABILITY ..........................................................................
48 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 48 PART II: SCIENTIFIC INFORMATION ........................................................................................
49 13 PHARMACEUTICAL INFORMATION ............................................................................. 49 14 CLINICAL TRIALS .........................................................................................................
1 Clinical Trials by Indication ................................................................................. 49 Multiple Myeloma ...........................................................................................................
49 Mantle Cell Lymphoma .................................................................................................... 71 15 MICROBIOLOGY ..........................................................................................................
75 16 NON-CLINICAL TOXICOLOGY ....................................................................................... 75 17 SUPPORTING PRODUCT MONOGRAPH ....................................................................... 79 PATIENT MEDICATION INFORMATION ...................................................................................
80 ACT BORTEZOMIB Page 4 of 91 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS ACT BORTEZOMIB (bortezomib for injection) is […]