Alymsys (bevacizumab-maly) for Cancer

Alymsys is a vascular endothelial growth factor inhibitor indicated for the treatment of:

• Metastatic colorectal cancer, in combination with intravenous (into the veins) fluorouracil-based chemotherapy for first- or second-line treatment.

• Metastatic colorectal cancer, in combination with fluoropyrimidine-oxaliplatin or fluoropyrimidine-irinotecan-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.

• Locally advanced, unresectable, recurrent, or metastatic non-squamous non-small cell lung cancer, in combination with paclitaxel and carboplatin for first-line treatment.

• Recurrent glioblastoma in adults.

• Metastatic renal cell carcinoma in combination with interferon alfa.

• Recurrent, persistent, or metastatic cervical cancer, in combination with cisplatin and paclitaxel, or topotecan and paclitaxel.

• Fallopian tube, epithelial ovarian, or primary peritoneal cancer in combination with pegylated liposomal doxorubicin, paclitaxel, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens.

Limitation of use: Alymsys should not be used for adjuvant treatment of colon cancer

Tell your doctor if you:

• are pregnant or planning to become pregnant. Make sure to use effective contraception during treatment with Alymsys and for 6 months after the last dose.

• are breastfeeding or planning to breastfeed. It is not known if Alymsys can pass into breast milk. Do not breastfeed during treatment with Alymsys and for 6 months after the last dose.

Your doctor will withhold for at least 28 days prior to elective surgery. You should not administer Alymsys for 28 days following major surgery and until adequate wound healing.

• 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-oxaliplatin or fluoropyrimidine-irinotecan-based chemotherapy after progression on a first-line bevacizumab product-containing regimen

• 15 mg/kg every 3 weeks with carboplatin and paclitaxel

• 10 mg/kg every 2 weeks

• 10 mg/kg every 2 weeks with interferon alfa

• 15 mg/kg every 3 weeks with paclitaxel and cisplatin, or paclitaxel and topotecan

• 10 mg/kg every 2 weeks with paclitaxel, pegylated liposomal doxorubicin, or topotecan is given every week

• 15 mg/kg every 3 weeks with topotecan given every 3 weeks

The most common side effects are taste alteration, dry skin, lacrimation disorder, back pain, hemorrhage, epistaxis, headache, exfoliative dermatitis, hypertension, rhinitis, and proteinuria.

• Gastrointestinal Perforations and Fistulae: Bevacizumab products including Alymsys may increase the risk of developing gastrointestinal perforations and fistulae. Contact your doctor if you have a high fever, rigors, severe constipation, persistent or severe abdominal pain, or vomiting.

• Surgery and Wound Healing Complications: Bevacizumab products including Alymsys can increase the risk of wound healing complications. Instruct patients not to undergo surgery without first discussing this potential risk with their doctor.

• Hemorrhage: Bevacizumab products including Alymsys can increase the risk of hemorrhage. Contact your doctor for signs and symptoms of serious or unusual bleeding including spitting or coughing blood.

• Arterial and Venous Thromboembolic Events: Bevacizumab products including Alymsys can increase the risk of arterial and venous thromboembolic events. Contact your doctor for signs and symptoms of arterial or venous thromboembolism.

• Hypertension: Bevacizumab products including Alymsys can increase blood pressure. You should make sure to undergo routine blood pressure monitoring and to contact your doctor if you experience changes in blood pressure.

• Posterior Reversible Leukoencephalopathy Syndrome: Posterior reversible encephalopathy syndrome (PRES) has been associated with bevacizumab products treatment. Contact your doctor for new onset or worsening neurological function.

• Renal Injury and Proteinuria: Bevacizumab products including Alymsys can increase the risk of proteinuria and renal injury, including nephrotic syndrome. Treatment with Alymsys will require regular monitoring of renal function and contact your doctor for proteinuria or signs and symptoms of nephrotic syndrome.

• Infusion-Related Reactions: Bevacizumab products including Alymsys can cause infusion-related reactions. Contact your doctor immediately for signs or symptoms of infusion-related reactions.

• Congestive Heart Failure: Bevacizumab products including Alymsys can increase the risk of developing congestive heart failure. Contact your doctor immediately for signs and symptoms of CHF.

• Ovarian Failure: Bevacizumab products including Alymsys may lead to ovarian failure. Advise patients of potential options for preservation of ova prior to starting treatment.

Store refrigerated at 2°C to 8°C in the original carton. Protect from light. Do not freeze or shake the vial or carton.