TM Owner Celltrion
Vegzelma 400mg/16ml Vial
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Indications & Clinical Uses
- Vegzelma 400 mg/16 mL (25 mg/mL) contains bevacizumab-adcd, a biosimilar of the reference medicine Avastin that blocks vascular endothelial growth factor (VEGF).
- It is given only as an intravenous infusion by a healthcare provider in a medical facility.
- In the US it is approved for metastatic colorectal cancer (with fluorouracil-based chemotherapy, and after progression on a bevacizumab-containing regimen), first-line unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (with carboplatin and paclitaxel), recurrent glioblastoma in adults, metastatic renal cell carcinoma (with interferon alfa), persistent, recurrent or metastatic cervical cancer, and epithelial ovarian, fallopian tube or primary peritoneal cancer.
- It is not indicated for adjuvant treatment of colon cancer.
- In the EU, Vegzelma (Celltrion Healthcare Hungary) is authorised for adults with colorectal, metastatic breast, non-squamous lung, kidney, ovarian and cervical cancers, so the approved uses differ by market.
Side Effects
- In the US label, the most common side effects (more than 10% of patients) are nosebleeds (epistaxis), headache, high blood pressure, runny nose (rhinitis), protein in the urine, altered taste, dry skin, bleeding, excessive tearing, back pain and peeling skin inflammation (exfoliative dermatitis).
- Serious reactions include gastrointestinal perforation and fistulae, wound-healing complications after surgery, serious bleeding, arterial and venous blood clots, severe hypertension, posterior reversible encephalopathy syndrome (PRES), kidney injury with proteinuria, infusion-related reactions, heart failure and ovarian failure in women.
- The current US label for Vegzelma carries no boxed warning.
- Tell your care team straight away about severe abdominal pain, coughing up blood, chest pain, sudden severe headache, confusion, vision changes, or swelling and breathlessness.
Precautions & Warnings
- Blood pressure and urine protein are checked during treatment.
- Vegzelma is stopped in serious situations such as gastrointestinal perforation, fistula, serious bleeding or uncontrolled severe hypertension; the EU product information also requires permanent discontinuation for tracheoesophageal or any grade 4 fistula and for grade 3-4 bleeding.
- Bevacizumab can impair wound healing, so tell your surgeon you are being treated; the EU information describes a 28-day interval around major surgery.
- Vegzelma can harm an unborn baby: use effective contraception during treatment and for 6 months after the last dose.
- It can cause ovarian failure and may affect fertility in women.
- Vegzelma comes as 100 mg/4 mL and 400 mg/16 mL single-dose vials (25 mg/mL), so the pharmacy must check the vial strength used.
- Unopened vials are kept refrigerated at 2°C to 8°C in the original carton and are never frozen or shaken.
Avoid Interactions
- Drugs and foods that increase effect or toxicity: the US label sections reviewed do not name specific medicines that raise bevacizumab levels.
- Drugs that reduce efficacy: none are named in the label sections reviewed.
- The US label reports no clinically meaningful effect of bevacizumab on the pharmacokinetics of irinotecan and its active metabolite SN38, interferon alfa, carboplatin or paclitaxel when used together.
- Tell your prescriber about all prescription and non-prescription medicines, vitamins and herbal supplements you use.
- Vegzelma is prepared and diluted by trained staff.
- Because Vegzelma is used with chemotherapy, the side effects of the whole regimen also apply, so ask your oncology team about every medicine in your treatment plan.
References
Frequently Asked Questions
Vegzelma (bevacizumab-adcd) is a biosimilar of Avastin used with chemotherapy for cancers including metastatic colorectal, non-squamous lung, kidney, cervical and ovarian cancer. In the US it is also approved for recurrent glioblastoma. Approved uses differ between the US and EU, so your oncologist confirms which applies to you.
Vegzelma (bevacizumab-adcd) is given as an intravenous infusion by a healthcare provider in a medical facility, never injected by you at home. The infusion runs slowly through a needle in a vein; drug information sources describe 30 to 90 minutes. Your oncology team sets how often you receive it.
Common Vegzelma side effects include nosebleeds, headache, high blood pressure, runny nose, protein in the urine, taste changes, dry skin and back pain. Serious effects include bowel perforation, bleeding, blood clots and slow wound healing. Report severe stomach pain, coughing up blood, chest pain or sudden severe headache immediately. The US label has no boxed warning.
Avoid becoming pregnant while receiving Vegzelma (bevacizumab-adcd); use effective contraception during treatment and for 6 months after the last dose. Tell your surgeon you are on Vegzelma, because it can delay wound healing. The US label reports no clinically meaningful interaction with irinotecan, interferon alfa, carboplatin or paclitaxel.
During a Vegzelma infusion a nurse places a needle in a vein and the bevacizumab-adcd drips in slowly while your team watches for infusion-related reactions. Blood pressure and urine protein are checked during treatment. Tell staff at once about chills, rash, breathlessness or swelling during or after the infusion.
Vegzelma (bevacizumab-adcd) is a biosimilar, meaning it is highly similar to the reference medicine Avastin, with no clinically meaningful differences in safety or effectiveness. Both contain bevacizumab. Vegzelma is made by Celltrion and unopened vials are stored refrigerated at 2°C to 8°C.
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