Vegzelma 400 mg/16mL
bevacizumab-adcd · INJECTION, SOLUTION · CELLTRION USA, Inc.
Vegzelma is a injection, solution containing bevacizumab-adcd at 400 mg/16mL, taken intravenous. Manufactured by CELLTRION USA, Inc..
Key Facts
- Brand Name
- Vegzelma
- Generic Name
- bevacizumab-adcd
- NDC Code (Product)
72606-012- Manufacturer
- CELLTRION USA, Inc.
- Strength
- 400 mg/16mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761268
- Drug Class
- Vascular Endothelial Growth Factor Inhibitor [EPC]
- Marketing Start
- 04/03/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. ( 1.1 ) Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. ( 1.1 ) Limitations of Use : VEGZELMA is not indicated for adjuvant treatment of colon cancer. ( 1.1 ) Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. ( 1.2 ) Recurrent glioblastoma in adults. ( 1.3 ) Metastatic renal cell carcinoma in combination with interferon alfa. ( 1.4 ) Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan. ( 1.5 ) Epithelial ovarian, fallopian tube, or primary peritoneal cancer: in combination with carboplatin and paclitaxel, followed by VEGZELMA as a single agent, for stage I…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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. ( 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-res…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 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.
Adverse Reactions
6 ADVERSE REACTIONS 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) ]. 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 Inc. at 1-833-938-2021 or FDA at 1-800-FDA-1088 or www.fda.…
Frequently Asked Questions
What is Vegzelma used for?
Vegzelma contains bevacizumab-adcd. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Vegzelma a controlled substance?
Vegzelma is not classified as a controlled substance by the DEA.
What is the generic name for Vegzelma?
The generic name for Vegzelma is bevacizumab-adcd. There are no other listed brand versions of bevacizumab-adcd.
What is the NDC code for Vegzelma 400 mg/16mL?
The NDC (National Drug Code) for Vegzelma 400 mg/16mL is 72606-012, listed by CELLTRION USA, Inc..
Other Vegzelma Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)