Cyramza

CYRAMZA^® is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated:

• as a single agent or in combination with paclitaxel, for treatment of adults with advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
• in combination with erlotinib, for first-line treatment of adults with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
• in combination with docetaxel, for treatment of adults with metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA.
• in combination with FOLFIRI, for the treatment of adults with metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
• as a single agent, for the treatment of adults with hepatocellular carcinoma in patients who have an alpha fetoprotein of ≥400 ng/mL and have been treated with sorafenib.

• For intravenous infusion only. Do not administer as an intravenous push or bolus.
• Premedicate before each infusion.
• Gastric Cancer
  : Administer CYRAMZA 8 mg/kg every 2 weeks as a single agent or in combination with weekly paclitaxel.
• Non-Small Cell Lung Cancer
  :
  • Administer CYRAMZA 10 mg/kg every 2 weeks with daily erlotinib.
  • Administer CYRAMZA 10 mg/kg on Day 1 of a 21-day cycle prior to docetaxel.
• Colorectal Cancer
  : Administer CYRAMZA 8 mg/kg every 2 weeks prior to FOLFIRI.
• Hepatocellular Carcinoma
  : Administer CYRAMZA 8 mg/kg every 2 weeks.

Injection: 100 mg/10 mL (10 mg/mL) or 500 mg/50 mL (10 mg/mL) clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial

• Lactation
  : Advise not to breastfeed.

• Hemorrhage
  : CYRAMZA increases the risk of hemorrhage and gastrointestinal hemorrhage, including severe and fatal events. Permanently discontinue CYRAMZA in patients who experience severe bleeding.
• Gastrointestinal Perforations
  : CYRAMZA increases the risk of gastrointestinal perforation, which can be fatal. Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation.
• Impaired Wound Healing
  : Withhold CYRAMZA for 28 days prior to elective surgery. Do not administer CYRAMZA for at least 2 weeks following a major surgical procedure and until adequate wound healing. The safety of resumption of CYRAMZA after resolution of wound healing complications has not been established.
• Arterial Thromboembolic Events (ATEs)
  : Serious and sometimes fatal ATEs can occur with CYRAMZA. Permanently discontinue CYRAMZA in patients who experience an ATE.
• Hypertension
  : Monitor blood pressure and treat hypertension. Withhold CYRAMZA for severe hypertension. Permanently discontinue CYRAMZA for hypertension that cannot be controlled with antihypertensive therapy and for hypertensive crisis or hypertensive encephalopathy.
• Infusion-Related Reactions (IRR)
  : Monitor for signs and symptoms during infusion. Reduce the infusion rate for Grade 1 or 2 IRR and permanently discontinue for Grade 3 or 4 IRR.
• Worsening of Pre-existing Hepatic Impairment
  : New onset or worsening encephalopathy, ascites or hepatorenal syndrome can occur in patients with Child-Pugh B or C cirrhosis.
• Posterior Reversible Encephalopathy Syndrome
  : Permanently discontinue CYRAMZA.
• Proteinuria Including Nephrotic Syndrome
  : Monitor for proteinuria. Withhold CYRAMZA for urine protein levels greater than or equal to 2 g per 24 hours. Permanently discontinue CYRAMZA for urine protein levels greater than 3 g per 24 hours or nephrotic syndrome.
• Thyroid Dysfunction
  : Monitor thyroid function during treatment.
• Embryo-Fetal Toxicity
  : Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.