JOBEVNE 25 mg/mL
bevacizumab-nwgd · INJECTION · Biocon Biologics Inc.
JOBEVNE is a injection containing bevacizumab-nwgd at 25 mg/mL, taken intravascular. Manufactured by Biocon Biologics Inc..
Key Facts
- Brand Name
- JOBEVNE
- Generic Name
- bevacizumab-nwgd
- NDC Code (Product)
83257-010- Manufacturer
- Biocon Biologics Inc.
- Strength
- 25 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVASCULAR
- Marketing Status
- Application #
- BLA761175
- Drug Class
- Vascular Endothelial Growth Factor Inhibitor [EPC]
- Marketing Start
- 04/10/2025
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Jobevne 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 : Jobevne 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: o in combination with carboplatin and paclitaxel, followed by Jobevne as a single agent, …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Withhold for at least 28 days prior to elective surgery. Do not administer Jobevne 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 cycle…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Effects of Jobevne 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 Biocon Biologics at 1-833-986-1468 or FDA at 1…
Frequently Asked Questions
What is JOBEVNE used for?
JOBEVNE contains bevacizumab-nwgd. It is a injection taken intravascular. Consult your doctor for specific uses.
Is JOBEVNE a controlled substance?
JOBEVNE is not classified as a controlled substance by the DEA.
What is the generic name for JOBEVNE?
The generic name for JOBEVNE is bevacizumab-nwgd. There are no other listed brand versions of bevacizumab-nwgd.
What is the NDC code for JOBEVNE 25 mg/mL?
The NDC (National Drug Code) for JOBEVNE 25 mg/mL is 83257-010, listed by Biocon Biologics Inc..
Other JOBEVNE Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)