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AVASTIN 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: AVASTIN (bevacizumab for injection) is indicated for: • Metastatic Colorectal Cancer (mCRC) - Avastin in combination with fluoropyrimidine-based chemotherapy is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum. - Consideration should be given to current standard of care…
Verbatim from this product's HC label. Tap a section to expand.
, 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS). 4 DOSAGE AND ADMINISTRATION Substitution by any other biological medicinal product requires the consent of the prescribing physician. 1 Dosing Considerations It is recommended that Avastin treatment be continued until progression of the underlying disease.
There are no recommended dose reductions. Discontinue Avastin 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; • Posterior Reversible Encephalopathy Syndrome (PRES); • Nephrotic syndrome.
Temporarily suspend Avastin 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 Metastatic Colorectal Cancer The recommended dose of Avastin 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 Avastin, 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, Avastin was administered in addition to carboplatin/paclitaxel chemotherapy for up to 6 cycles of treatment followed by Avastin as a single agent until disease progression. AVASTIN (bevacizumab for injection) Page 7 of 95 Platinum-Sensitive Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer The recommended dose of Avastin is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Avastin is administered in combination with carboplatin and gemcitabine for 6 cycles and up to 10 cycles followed by continued use of Avastin as single agent until disease progression. Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer The recommended dose of Avastin is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion when administered in combination with one of the following agents – paclitaxel, topotecan (given weekly) or pegylated liposomal doxorubicin (see Clinical Trials section, Study MO22224 (AURELIA) for chemotherapy regimens).
). 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Eye Disorders: Avastin 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).
• Gastrointestinal Perforations: Avastin 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 Avastin 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 Avastin was 2%.
Avastin therapy should be permanently discontinued in patients with gastrointestinal perforation (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS). • Wound Healing Complications: Avastin administration can result in wound dehiscence, in some instances resulting in fatality.
Avastin therapy should be permanently discontinued in patients with wound dehiscence requiring medical intervention. Avastin should be discontinued at least 28 days prior to elective surgery. Avastin 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 AVASTIN (bevacizumab for injection) Page 6 of 95 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 Avastin.
03/2023 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 .........................................................................................................
8 5 OVERDOSAGE............................................................................................................ 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 8 7 WARNINGS AND PRECAUTIONS .................................................................................
AVASTIN 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.
Avastin is contraindicated in patients with untreated Central Nervous System (CNS) metastases (see 6 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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Alternatively, the recommended dose of Avastin is 15 mg/kg every 3 weeks when administered in combination with topotecan given on days 1-5, every 3 weeks (see Clinical Trials section, Study MO22224 (AURELIA) for chemotherapy regimen).
Malignant Glioma (WHO Grade IV) - Glioblastoma The recommended dose of Avastin 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 the absence of Grade > 1 hematological toxicity during the first cycle, it can be escalated to 110 mg/m2 (maximum dose 200 mg) from the second cycle onwards (see also 14 CLINICAL TRIALS).
3 Reconstitution Parenteral Products: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Discard the vial if visible particles are observed. Avastin should be prepared by a healthcare professional using aseptic technique.
Use sterile needle and syringe to prepare Avastin. 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). AVASTIN INFUSIONS SHOULD NOT BE ADMINISTERED OR MIXED WITH DEXTROSE OR GLUCOSE SOLUTIONS.
A concentration-dependent degradation profile of Avastin was observed when diluted with dextrose solutions (5%). No incompatibilities between Avastin and polyvinyl chloride or polyolefin bags have been observed. Avastin is not formulated for intravitreal use (see 7 WARNINGS AND PRECAUTIONS).
4 Administration Do not administer as an intravenous push or bolus. The initial Avastin 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.
Do not administer Avastin to patients with serious hemorrhage or recent hemoptysis (see 4 DOSAGE AND ADMINISTRATION, 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS). 4 DOSAGE AND ADMINISTRATION Substitution by any other biological medicinal product requires the consent of the prescribing physician.
1 Dosing Considerations It is recommended that Avastin treatment be continued until progression of the underlying disease. There are no recommended dose reductions. Discontinue Avastin 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; • Posterior Reversible Encephalopathy Syndrome (PRES); • Nephrotic syndrome.
Temporarily suspend Avastin 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 Metastatic Colorectal Cancer The recommended dose of Avastin 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 Avastin, 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, Avastin was administered in addition to carboplatin/paclitaxel chemotherapy for up to 6 cycles of treatment followed by Avastin as a single agent until disease progression. AVASTIN (bevacizumab for injection) Page 7 of 95 Platinum-Sensitive Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer The recommended dose of Avastin is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Avastin is administered in combination with carboplatin and gemcitabine for 6 cycles and up to 10 cycles followed by continued use of Avastin as single agent until disease progression. Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer The recommended dose of Avastin is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion when administered in combination with one of the following agents – paclitaxel, topotecan (given weekly) or pegylated liposomal doxorubicin (see Clinical Trials section, Study MO22224 (AURELIA) for chemotherapy regimens).
Alternatively, the recommended dose of Avastin is 15 mg/kg every 3 weeks when administered in combination with topotecan given on days 1-5, every 3 weeks (see Clinical Trials section, Study MO22224 (AURELIA) for chemotherapy regimen).
Malignant Glioma (WHO Grade IV) - Glioblastoma The recommended dose of Avastin 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 the absence of Grade > 1 hematological toxicity during the first cycle, it can be escalated to 110 mg/m2 (maximum dose 200 mg) from the second cycle onwards (see also 14 CLINICAL TRIALS).
3 Reconstitution Parenteral Products: Parenteral drug products […]
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 AVASTIN (bevacizumab for injection) Page 3 of 95 Quantitative Data.............................................................................................................
5 Post-Market Adverse Reactions............................................................................. 60 9 DRUG INTERACTIONS .............................................................................................. 2 Drug Interactions Overview ...................................................................................
4 Drug-Drug Interactions .......................................................................................... 5 Drug-Food Interactions .......................................................................................... 6 Drug-Herb Interactions ..........................................................................................
7 Drug-Laboratory Test Interactions......................................................................... 62 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action .......................................................................................
2 Pharmacodynamics .......................................................................................... 3 Pharmacokinetics ............................................................................................. 63 11 STORAGE, STABILITY AND DISPOSAL ........................................................................
65 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 65 PART II: SCIENTIFIC INFORMATION ..................................................................................... 66 13 PHARMACEUTICAL INFORMATION ..........................................................................
66 14 CLINICAL TRIALS ...................................................................................................... 1 Clinical Trials by Indication ..............................................................................
3 Immunogenicity ............................................................................................... 83 15 MICROBIOLOGY ......................................................................................................
83 16 NON-CLINICAL TOXICOLOGY .................................................................................... 83 PATIENT MEDICATION INFORMATION ................................................................................ 86 AVASTIN (bevacizumab for injection) Page 4 of 95 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS AVASTIN (bevacizumab for injection) is indicated for: • Metastatic Colorectal Cancer (mCRC) - Avastin in […]