Bevacizumab-bvzr

What Bevacizumab-bvzr is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

VEGZELMA is a vascular endothelial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. …

— FDA label: Vegzelma, CELLTRION USA, Inc., effective August 21, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (injection, solution, intravenous), Vegzelma, CELLTRION USA, Inc.; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 6 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 6 FDA labels for this medicine have a boxed warning.

Bevacizumab-bvzr side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The following clinically significant adverse reactions are described elsewhere in the labeling: Gastrointestinal Perforations and Fistulae [see Warnings and Precautions (5.1)]. Surgery and Wound Healing Complications [see Warnings and Precautions (5.2)]. Hemorrhage [see Warnings and Precautions (5.3)]. Arterial Thromboembolic Events [see Warnings and Precautions (5.4)]. Venous Thromboembolic Events [see Warnings and Precautions (5.5)].

Read more of this section

Hypertension [see Warnings and Precautions (5.6)]. Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.7)]. Renal Injury and Proteinuria [see Warnings and Precautions (5.8)]. Infusion-Related Reactions [see Warnings and Precautions (5.9)]. Ovarian Failure [see Warnings and Precautions (5.11)]. Congestive Heart Failure [see Warnings and Precautions (5.12)]. Most common adverse reactions incidence (incidence >10%) are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact CELLTRION USA, Inc. at 1-800-560-9414 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The safety data in Warnings and Precautions and described below reflect exposure to bevacizumab in 4463 patients including those with mCRC (AVF2107g, E3200), non-squamous NSCLC (E4599), GBM (EORTC 26101), mRCC (BO17705), cervical cancer (GOG-0240), epithelial ovarian, fallopian tube, or primary peritoneal cancer (MO22224, AVF4095, GOG-0213, and GOG-0218) or another cancer at the recommended dose and schedule for a median of 6 to 23 doses. The most common adverse reactions observed in patients receiving bevacizumab as a single agent or in combination with other anti-cancer therapies at a rate >10% were epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis. Across clinical studies, bevacizumab was discontinued in 8% to 22% of patients because of adverse reactions [see Clinical Studies (14)]. Metastatic Colorectal Cancer In Combination with bolus-IFL The safety of bevacizumab was evaluated in 392 patients who received at least one dose of bevacizumab in a double-blind, active-controlled study (AVF2107g), which compared bevacizumab (5 mg/kg every 2 weeks) with bolus-IFL to placebo with bolus-IFL in patients with mCRC [see Clinical Studies (14.1)]. Patients were randomized (1:1:1) to placebo with bolus-IFL, bevacizumab with bolus-IFL, or bevacizumab with fluorouracil and leucovorin. The demographics of the safety population were similar to the demographics of the efficacy population. All Grades 3-4 adverse reactions and selected Grades 1-2 adverse reactions (i.e., hypertension, proteinuria, thromboembolic events) were collected in the entire study population. Adverse reactions are presented in Table 2.

— FDA label: Vegzelma, CELLTRION USA, Inc., effective August 21, 2026. This is part of the section. Read the full label on DailyMed →

Bevacizumab-bvzr drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Effects of VEGZELMA on Other Drugs No clinically meaningful effect on the pharmacokinetics of irinotecan or its active metabolite SN38, interferon alfa, carboplatin or paclitaxel was observed when bevacizumab was administered in combination with these drugs; however, 3 of the 8 patients receiving bevacizumab with paclitaxel and carboplatin had lower paclitaxel exposure after four cycles of treatment (at Day 63) than those at Day 0, while patients receiving paclitaxel and carboplatin alone had a greater paclitaxel exposure at Day 63 than at Day 0.

— FDA label: Vegzelma, CELLTRION USA, Inc., effective August 21, 2026. Read the full label on DailyMed →

Bevacizumab-bvzr dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

Withhold for at least 28 days prior to elective surgery. Do not administer VEGZELMA for 28 days following major surgery and until adequate wound healing.

Read more of this section

(2.1) Metastatic colorectal cancer (2.2) 5 mg/kg every 2 weeks with bolus-IFL 10 mg/kg every 2 weeks with FOLFOX4 5 mg/ kg every 2 weeks or 7.5 mg/kg every 3 weeks with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy after progression on a first-line bevacizumab product containing regimen First-line non−squamous non−small cell lung cancer (2.3) 15 mg/kg every 3 weeks with carboplatin and paclitaxel Recurrent glioblastoma (2.4) 10 mg/kg every 2 weeks Metastatic renal cell carcinoma (2.5) 10 mg/kg every 2 weeks with interferon alfa Persistent, recurrent, or metastatic cervical cancer (2.6) 15 mg/kg every 3 weeks with paclitaxel and cisplatin, or paclitaxel and topotecan Stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer following initial surgical resection (2.7) 15 mg/kg every 3 weeks with carboplatin and paclitaxel for up to 6 cycles, followed by 15 mg/kg every 3 weeks as a single agent, for a total of up to 22 cycles Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (2.7) 10 mg/kg every 2 weeks with paclitaxel, pegylated liposomal doxorubicin, or topotecan given every week 15 mg/kg every 3 weeks with topotecan given every 3 weeks Platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (2.7) 15 mg/kg every 3 weeks with carboplatin and paclitaxel for 6-8 cycles, followed by 15 mg/kg every 3 weeks as a single agent 15 mg/kg every 3 weeks with carboplatin and gemcitabine for 6-10 cycles, followed by 15 mg/kg every 3 weeks as a single agent Administer as an intravenous infusion after dilution. See full Prescribing Information for preparation and administration instructions and dosage modifications for adverse reactions (2.8 and 2.9) 2.1 Important Administration Information Withhold for at least 28 days prior to elective surgery.

— FDA label: Vegzelma, CELLTRION USA, Inc., effective August 21, 2026. This is part of the section. Read the full label on DailyMed →

Bevacizumab-bvzr in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary Based on findings from animal studies and their mechanism of action [see Clinical Pharmacology (12.1)], bevacizumab products may cause fetal harm in pregnant women. Limited postmarketing reports describe cases of fetal malformations with use of bevacizumab products in pregnancy; however, these reports are insufficient to determine drug-associated risks.

Read more of this section

In animal reproduction studies, intravenous administration of bevacizumab to pregnant rabbits every 3 days during organogenesis at doses approximately 1 to 10 times the clinical dose of 10 mg/kg produced fetal resorptions, decreased maternal and fetal weight gain and multiple congenital malformations including corneal opacities and abnormal ossification of the skull and skeleton including limb and phalangeal defects (see Data). Furthermore, animal models link angiogenesis and VEGF and VEGFR2 to critical aspects of female reproduction, embryofetal development, and postnatal development. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Pregnant rabbits dosed with 10 mg/kg to 100 mg/kg bevacizumab (approximately 1 to 10 times the clinical dose of 10 mg/kg) every three days during the period of organogenesis (gestation day 6–18) exhibited decreases in maternal and fetal body weights and increased number of fetal resorptions. There were dose-related increases in the number of litters containing fetuses with any type of malformation (42% for the 0 mg/kg dose, 76% for the 30 mg/kg dose, and 95% for the 100 mg/kg dose) or fetal alterations (9% for the 0 mg/kg dose, 15% for the 30 mg/kg dose, and 61% for the 100 mg/kg dose). Skeletal deformities were observed at all dose levels, with some abnormalities including meningocele observed only at the 100 mg/kg dose level. Teratogenic effects included: reduced or irregular ossification in the skull, jaw, spine, ribs, tibia and bones of the paws; fontanel, rib and hindlimb deformities; corneal opacity; and absent hindlimb phalanges.

— FDA label: Vegzelma, CELLTRION USA, Inc., effective August 21, 2026. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Pfizer Laboratories Div Pfizer Inc2 products
• Biocon Biologics Inc.2 products
• CELLTRION USA, Inc.2 products
• Genentech, Inc.2 products
• Amneal Pharmaceuticals LLC2 products
• Amgen, Inc2 products
• Outlook Therapeutics, Inc.1 product

FDA approval history

• BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

Next steps

• Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
• Latest FDA drug recallsAll medicines, newest first
• AlymsysBrand page: products, maker and price
• AvastinBrand page: products, maker and price
• JobevneBrand page: products, maker and price
• MvasiBrand page: products, maker and price
• Lung cancerCondition named on the label: hospitals that treat it
• Colorectal cancerCondition named on the label: hospitals that treat it
• Cervical cancerCondition named on the label: hospitals that treat it
• Pfizer Laboratories Div Pfizer IncMaker or distributor
• Biocon Biologics Inc.Maker or distributor
• CELLTRION USA, Inc.Maker or distributor
• All prescription drugs A to ZSearch by generic, brand or Spanish name

Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Vegzelma, CELLTRION USA, Inc., effective August 21, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers