Abevmy vial

 Abevmy (bevacizumab) is a biosimilar monoclonal antibody that binds and neutralizes vascular endothelial growth factor (VEGF), thereby inhibiting tumor angiogenesis and growth, and is indicated across a spectrum of metastatic and recurrent solid tumors including colorectal, breast, non‑squamous non‑small cell lung, renal cell carcinoma, Grade IV glioma, ovarian, fallopian tube, primary peritoneal, and cervical cancers . Supplied as a preservative‑free 25 mg/mL solution for dilution in single‑dose vials of 100 mg/4 mL or 400 mg/16 mL, Abevmy is administered via intravenous infusion following standard bevacizumab dosing regimens—with initial infusions over 90 minutes and subsequent infusions shortened—and requires refrigerated storage at 2–8 °C . Adverse effects of clinical significance include hypertension, hemorrhage, proteinuria, gastrointestinal perforation, impaired wound healing, and infusion reactions; fertility impairment and contraindication during pregnancy warrant additional caution . Pricing varies by region, e.g., CAD $347.85 per 100 mg vial in Canada and PHP ₱38,062.50 per 400 mg vial in the Philippines .

Product & Manufacturer

Abevmy® is marketed by BGP Pharma ULC under license to Viatris and is approved in multiple jurisdictions including Canada (DINs 02522179 & 02522160), Australia (AUST R 334816 & 334814), the European Union, Rwanda, and the Philippines . It is available as clear glass single‑use vials with a latex‑free, butyl rubber stopper and contains no preservatives .

Composition & Formulation

Active Ingredient: Bevacizumab 25 mg/mL, supplied as either 100 mg in 4 mL or 400 mg in 16 mL .

Nonmedicinal Ingredients: Sodium dihydrogen phosphate dihydrate, sodium phosphate dibasic anhydrous, α,α‑trehalose dihydrate, polysorbate 20, sodium hydroxide, ortho phosphoric acid, and water for injection .

Appearance: Clear to slightly opalescent, colourless to pale brown solution .

Sodium Content: 4.196 mg of sodium per 4 mL vial (0.21% of WHO daily intake) and 16.784 mg per 16 mL vial (0.84%) .

Mechanism of Action

Bevacizumab is a recombinant humanized IgG1 monoclonal antibody that selectively binds to and neutralizes all biologically active isoforms of VEGF‑A, preventing its interaction with VEGF receptors on endothelial cells and thereby inhibiting angiogenesis and tumor vascularization .

Indications

Abevmy is indicated—always in combination with specified chemotherapy regimens—in the following settings:

Metastatic Colorectal Cancer (mCRC)

Locally Recurrent or Metastatic Breast Cancer

Advanced, Metastatic or Recurrent Non‑Squamous NSCLC

Advanced and/or Metastatic Renal Cell Carcinoma

Grade IV Glioma (post‑relapse)

Front‑line and Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Persistent, Recurrent or Metastatic Carcinoma of the Cervix .

Dosage & Administration

1. Reconstitution & Dilution

Reconstitute each vial with sterile water for injection and dilute further in 0.9% sodium chloride to a final concentration of 1.4–10 mg/mL. 

2. Infusion Sequence

1st infusion: administer over 90 minutes;

2nd infusion (if 1st tolerated): over 60 minutes;

Subsequent infusions: over 30 minutes .

3. Standard Adult Dosing

mCRC: 5 mg/kg IV Q2W (bolus‑IFL) or 10 mg/kg IV Q2W (FOLFOX4) until progression/toxicity .

NSCLC: 15 mg/kg IV Q3W with carboplatin + paclitaxel .

Renal Cell Carcinoma: 10 mg/kg IV Q2W with interferon α‑2a .

Grade IV Glioma: 10 mg/kg IV Q2W .

Ovarian/Fallopian/Peritoneal Cancer: 15 mg/kg IV Q3W (front‑line and recurrent settings) .

Cervical Cancer: 15 mg/kg IV Q3W with paclitaxel + cisplatin/topotecan .

Adverse Effects & Precautions

Common: Hypertension, proteinuria, epistaxis, headache, abdominal pain, dysphonia, infusion‑related reactions .

Serious: Gastrointestinal perforation, wound healing complications, arterial thromboembolic events, hemorrhage, reversible posterior leukoencephalopathy syndrome .

Special Warnings: Do not use until 28 days post‑surgery and wound fully healed; discuss fertility preservation with women of childbearing potential; contraindicated in pregnancy .

Storage & Handling

Store vials refrigerated at 2–8 °C in the original carton to protect from light; do not freeze or shake. In‑use stability demonstrated for 48 hours at 2–30 °C in 0.9% sodium chloride infusion bags without PVC/PO incompatibilities .

Availability & Pricing

Canada: CAD $347.85/vial (100 mg) and CAD $1,391.40/vial (400 mg) .

Philippines: PHP ₱38,062.50 per 400 mg vial via Garrod Specialty Pharmacy .

Other Regions: Available through hosp

ital pharmacies and oncology infusion centers, subject to local approvals and reimbursement.