ALYMSYS

Generic Name/API: bevacizumab-maly

Manufacturer: Amneal Pharmaceuticals

Dosage Forms & Strength & Pack Size:
Injection: 100 mg/4 mL (25 mg/mL) or 400 mg/16 mL (25 mg/mL) in a single-dose vial

Storage:
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton until time of use to protect from light. Do
not freeze or shake the vial or carton.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

Indications and Usage
ALYMSYS® (bevacizumab maly) in the U.S. 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
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
First Line non squamous non small cell lung cancer, in combination with carboplatin and paclitaxel
Recurrent glioblastoma in adults
Metastatic renal cell carcinoma in combination with interferon alfa
Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan
Epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel
Limitations of Use: ALYMSYS® is not indicated for adjuvant treatment of colon cancer.

IMPORTANT SAFETY INFORMATION
ALYMSYS® IMPORTANT SAFETY INFORMATION includes warnings and precautions on severe and fatal hemorrhage; arterial and venous thromboembolic events; hypertension, hypertensive crisis, and hypertensive encephalopathy; renal injury, proteinuria, and nephrotic syndrome; posterior reversible encephalopathy syndrome; embryo fetal toxicity; ovarian failure; congestive heart failure; gastrointestinal perforations and fistula; surgery and wound healing complications, and infusion related reactions.

ADVERSE REACTIONS Reported adverse drug reactions in patients include epistaxis, hemorrhage, hypertension, exfoliative dermatitis, proteinuria, back pain, headache, rhinitis, taste alteration, dry skin, and lacrimation disorder.

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