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BAMBEVI is a brand name for Bevacizumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indications have been granted on the basis of similarity between BAMBEVI (bevacizumab for injection) and the reference biologic drug AVASTIN. Bambevi (bevacizumab) is indicated for: • Metastatic Colorectal Cancer (mCRC) − Bambevi in combination with fluoropyrimidine-based chemotherapy is indicated for first-line…
Verbatim from this product's HC label. Tap a section to expand.
, 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS). 1 Dosing Considerations It is recommended that Bambevi treatment be continued until progression of the underlying disease. There are no recommended dose reductions. Discontinue Bambevi for: • Gastrointestinal perforations (gastrointestinal perforations, fistula formation in the gastrointestinal tract, intra-abdominal abscess); • Internal fistula not arising in the GI tract, tracheoesophageal (TE) fistula or any Grade 4 fistula; • Wound dehiscence and wound healing complications requiring medical intervention; • Necrotizing fasciitis; • Serious hemorrhage or recent hemoptysis; • Severe arterial thromboembolic events; • Life- threatening (Grade 4) VTEs, including pulmonary embolism; • Severe hypertension not controlled with medical management; • Hypertensive crisis or hypertensive encephalopathy; BAMBEVI (bevacizumab) Product Monograph Page 7 of 107 Unclassified / Non classifié • Posterior Reversible Encephalopathy Syndrome (PRES); • Nephrotic syndrome.
Temporarily suspend Bambevi for: • At least 4 weeks prior to elective surgery; • Moderate to severe proteinuria pending further evaluation; • Severe infusion reactions. 2 Recommended Dose and Dosage Adjustment Health Canada has not authorized an indication for pediatric use (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics).
Metastatic Colorectal Cancer The recommended dose of Bambevi is 5 mg/kg of body weight given once every 14 days as an intravenous infusion. Locally Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC) The recommended dose of Bambevi is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion in addition to carboplatin + paclitaxel chemotherapy regimen.
In clinical trials, bevacizumab was administered in addition to carboplatin/paclitaxel chemotherapy for up to 6 cycles of treatment followed by bevacizumab as a single agent until disease progression. Platinum-Sensitive Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer The recommended dose of Bambevi is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Bambevi is administered in combination with carboplatin and gemcitabine for 6 cycles and up to 10 cycles followed by continued use of Bambevi as single agent until disease progression. 5 CLINICAL TRIALS – REFERENCE BIOLOGIC DRUG section, Study MO22224 (AURELIA) for chemotherapy regimens).
). 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Eye Disorders: Bambevi is not formulated and has not been authorized for intravitreal use. Local and systemic adverse events have been reported in the post-market setting with unauthorized intravitreal use (see 7 WARNINGS AND PRECAUTIONS, General).
BAMBEVI (bevacizumab) Product Monograph Page 6 of 107 Unclassified / Non classifié • Gastrointestinal Perforations: Bambevi administration can result in the development of gastrointestinal perforation in some instances resulting in fatality.
e. was not correlated to duration of exposure). The typical presentation was reported as abdominal pain associated with symptoms such as constipation and vomiting. Gastrointestinal perforation should be included in the differential diagnosis of patients on Bambevi presenting with abdominal pain.
2%. 7% in platinum-resistant ovarian cancer studies. The incidence of gastrointestinal perforation in patients receiving irinotecan/bolus 5- fluorouracil/leucovorin with bevacizumab was 2%. Bambevi therapy should be permanently discontinued in patients with gastrointestinal perforation (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
• Wound Healing Complications: Bambevi administration can result in wound dehiscence, in some instances resulting in fatality. Bambevi therapy should be permanently discontinued in patients with wound dehiscence requiring medical intervention.
Bambevi should be discontinued at least 28 days prior to elective surgery. Bambevi therapy should not be initiated for at least 28 days following major surgery or until the surgical wound is fully healed (see 7 WARNINGS AND PRECAUTIONS, • Hemorrhage: Severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, central nervous systems (CNS) hemorrhage, epistaxis, and vaginal bleeding occurred up to five-fold more frequently in patients receiving bevacizumab.
12/2024 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 ..................................................................................................................... 5 2 CONTRAINDICATIONS ...................................................................................................
5 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 ............................................................................................................... 8 5 OVERDOSAGE ................................................................................................................
Bambevi is contraindicated in patients with known hypersensitivity to: • This drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Chinese hamster ovary cell products or other recombinant human or humanised antibodies. Bambevi is contraindicated in patients with untreated Central Nervous System (CNS) metastases (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 CLINICAL TRIALS – REFERENCE BIOLOGIC DRUG section, Study MO22224 (AURELIA) for chemotherapy regimen). Malignant Glioma (WHO Grade IV) - Glioblastoma The recommended dose of Bambevi is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion in combination with lomustine every 6 weeks until disease progression.
5 CLINICAL TRIALS – REFERENCE BIOLOGIC DRUG section). 3 Reconstitution Parenteral Products: Parenteral drug products should be inspected visually for particulate matter and discolorations prior to administration. Discard the vial if visible particles are observed.
Bambevi should be prepared by a healthcare professional using aseptic technique. Use sterile needle and syringe to prepare Bambevi. 9% sodium chloride solution. 5 mg/mL. Discard any unused portion left in a vial, as the product contains no preservatives (see 11 STORAGE, STABILITY AND DISPOSAL).
Bambevi INFUSIONS SHOULD NOT BE ADMINISTERED OR MIXED WITH DEXTROSE OR GLUCOSE SOLUTIONS. A concentration-dependent degradation profile of Bambevi was observed when diluted with dextrose solutions (5%). No incompatibilities between Bambevi and polyvinyl chloride or polyolefin bags have been observed.
Bambevi is not formulated for intravitreal use (see 7 WARNINGS AND PRECAUTIONS). 4 Administration Do not administer as an intravenous push or bolus. The initial Bambevi dose should be delivered over 90 minutes as an intravenous infusion.
If the first infusion is well tolerated, the second infusion may be administered over 60 minutes. If the 60-minute infusion is well tolerated, all subsequent infusions may be administered over 30 minutes. 5 Missed Dose For a missed dose of Bambevi, the physician will decide when the patient should receive the next dose.
Do not administer Bambevi to patients with serious hemorrhage or recent hemoptysis (see 4 DOSAGE AND ADMINISTRATION, 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS). 1 Dosing Considerations It is recommended that Bambevi treatment be continued until progression of the underlying disease.
There are no recommended dose reductions. Discontinue Bambevi for: • Gastrointestinal perforations (gastrointestinal perforations, fistula formation in the gastrointestinal tract, intra-abdominal abscess); • Internal fistula not arising in the GI tract, tracheoesophageal (TE) fistula or any Grade 4 fistula; • Wound dehiscence and wound healing complications requiring medical intervention; • Necrotizing fasciitis; • Serious hemorrhage or recent hemoptysis; • Severe arterial thromboembolic events; • Life- threatening (Grade 4) VTEs, including pulmonary embolism; • Severe hypertension not controlled with medical management; • Hypertensive crisis or hypertensive encephalopathy; BAMBEVI (bevacizumab) Product Monograph Page 7 of 107 Unclassified / Non classifié • Posterior Reversible Encephalopathy Syndrome (PRES); • Nephrotic syndrome.
Temporarily suspend Bambevi for: • At least 4 weeks prior to elective surgery; • Moderate to severe proteinuria pending further evaluation; • Severe infusion reactions. 2 Recommended Dose and Dosage Adjustment Health Canada has not authorized an indication for pediatric use (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics).
Metastatic Colorectal Cancer The recommended dose of Bambevi is 5 mg/kg of body weight given once every 14 days as an intravenous infusion. Locally Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC) The recommended dose of Bambevi is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion in addition to carboplatin + paclitaxel chemotherapy regimen.
In clinical trials, bevacizumab was administered in addition to carboplatin/paclitaxel chemotherapy for up to 6 cycles of treatment followed by bevacizumab as a single agent until disease progression. Platinum-Sensitive Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer The recommended dose of Bambevi is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Bambevi is administered in combination with carboplatin and gemcitabine for 6 cycles and up to 10 cycles followed by continued use of Bambevi as single agent until disease progression. 5 CLINICAL TRIALS – REFERENCE BIOLOGIC DRUG section, Study MO22224 (AURELIA) for chemotherapy regimens).
5 CLINICAL TRIALS – REFERENCE BIOLOGIC DRUG section, Study MO22224 (AURELIA) for chemotherapy regimen). Malignant Glioma (WHO Grade IV) - Glioblastoma The recommended dose of Bambevi is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion in combination with lomustine every 6 weeks until disease progression.
An oral dose of 90 mg/m2 (maximum dose 160 mg) of lomustine is recommended for the first cycle; in BAMBEVI (bevacizumab) Product Monograph Page 8 of 107 Unclassified / Non […]
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ......................... 8 7 WARNINGS AND PRECAUTIONS .................................................................................. 1 Special Populations ...................................................................................................
1 Pregnant Women ........................................................................................... 2 Breast-feeding ............................................................................................... 3 Pediatrics .......................................................................................................
4 Geriatrics ....................................................................................................... 17 8 ADVERSE REACTIONS .................................................................................................
1 Adverse Reaction Overview ...................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................... 3 Less Common Clinical Trial Adverse Reactions .......................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................................ 5 Post-Market Adverse Reactions ................................................................................
69 9 DRUG INTERACTIONS .................................................................................................. 2 Drug Interactions Overview .......................................................................................
4 Drug-Drug Interactions .............................................................................................. 5 Drug-Food Interactions .............................................................................................
6 Drug-Herb Interactions .............................................................................................. 7 Drug-Laboratory Test Interactions ............................................................................
71 BAMBEVI (bevacizumab) Product Monograph Page 3 of 107 Unclassified / Non classifié 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action ...............................................................................................
2 Pharmacodynamics ................................................................................................. 3 Pharmacokinetics ....................................................................................................
72 11 STORAGE, STABILITY AND DISPOSAL ...................................................................... 74 12 SPECIAL HANDLING INSTRUCTIONS ......................................................................... 75 PART II: SCIENTIFIC INFORMATION .......................................................................................
76 13 PHARMACEUTICAL INFORMATION ............................................................................ 76 14 CLINICAL TRIALS .........................................................................................................
1 Clinical Trials by Indication ...................................................................................... 77 15 MICROBIOLOGY ............................................................................................................
94 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 94 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................. 96 PATIENT MEDICATION INFORMATION […]