Cyramza

Ramucirumab

Monotherapy or in combination w/ paclitaxel for adults w/ advanced gastric cancer or gastroesophageal junction adenocarcinoma (GEJ) w/ disease progression after prior platinum & fluoropyrimidine chemotherapy. In combination w/ FOLFIRI (irinotecan, folinic acid, & 5-fluorouracil) for adults w/ metastatic CRC (mCRC) w/ disease progression on or after prior therapy w/ bevacizumab, oxaliplatin, & a fluoropyrimidine. In combination w/ erlotinib for the 1st-line treatment of adults w/ metastatic NSCLC w/ activating epidermal growth factor receptor (EGFR) mutations. In combination w/ docetaxel for adults w/ locally advanced or metastatic NSCLC w/ disease progression after platinum-based chemotherapy. Adults w/ advanced or unresectable hepatocellular carcinoma (HCC) w/ serum α-fetoprotein (AFP) of ≥400 ng/mL in adults & those previously treated w/ sorafenib.

IV Max infusion rate: 25 mg/min. Gastric cancer & GEJ adenocarcinoma Monotherapy: 8 mg/kg every 2 wk. Combination therapy w/ paclitaxel: 8 mg/kg on days 1 & 15 of a 28-day cycle, prior to paclitaxel 80 mg/m² IV infusion over approx 60 min on days 1, 8, & 15 of a 28-day cycle. CRC 8 mg/kg IV infusion every 2 wk prior to FOLFIRI administration. In combination w/ erlotinib for NSCLC w/ activating EGFR mutations 10 mg/kg every 2 wk. In combination w/ docetaxel for NSCLC after platinum-based chemotherapy 10 mg/kg on day 1 of a 21-day cycle, prior to docetaxel 75 mg/m² IV infusion over approx 60 min on day 1 of a 21-day cycle. May reduce docetaxel starting dose to 60 mg/m² on day 1 of a 21-day cycle for East Asian patient. HCC 8 mg/kg as single agent every 2 wk. AFP testing in HCC Select patient based on a serum AFP conc of ≥400 ng/mL w/ a validated AFP test prior to treatment. Premed Premed w/ H₁ antagonists (eg, diphenhydramine) is recommended prior to infusion. If a patient experiences grade 1 or 2 infusion-related reaction (IRR), premed must be given for all subsequent infusions. If a patient experiences 2nd grade 1 or 2 IRR, administer dexamethasone (or equiv); then, for subsequent infusions, premed w/ IV H₁ antagonist (eg, diphenhydramine HCl), paracetamol & dexamethasone. Proteinuria Initially 8 mg/kg or 10 mg/kg. 1st dose reduction: 6 mg/kg or 8 mg/kg; 2nd dose reduction: 5 mg/kg or 6 mg/kg.

Hypersensitivity. Tumor cavitation or tumor involvement of major vessels in patients w/ NSCLC.

IRR. Permanently discontinue in the event of severe arterial thromboembolic events including MI, cardiac arrest, CVA, & cerebral ischemia; GI perforations; severe bleeding (NCI CTCAE grade 3 or 4 bleeding); grade 3 or 4 IRR; if medically significant HTN cannot be controlled w/ antihypertensive therapy; patients who experience posterior reversible encephalopathy syndrome; cardiac failure mostly in combination w/ paclitaxel; hepatic encephalopathy or hepatorenal syndrome; development of fistula. Higher risk of developing serious pulmonary bleeding in patients w/ squamous histology. Risk factors for HTN or history of aneurysm. Temporarily withheld treatment for at least 4 wk prior to scheduled surgery; discontinue use until the wound is fully healed if a patient develops wound healing complications during therapy. Stomatitis. Na-restricted diet. Monitor blood counts & coagulation parameters in patients w/ conditions predisposing to bleeding, & in those treated w/ anticoagulants or other concomitant medicinal products that increase the risk of bleeding. Perform screening for & treatment of esophageal varices in HCC patients w/ evidence of portal HTN or prior history of esophageal variceal bleeding before starting treatment. Monitor for the development or worsening of proteinuria during therapy; temporarily discontinue if the urine protein level is ≥2 g/24 hr or permanently discontinue if the urine protein level is >3 g/24 hr or in the event of nephrotic syndrome. Severe liver cirrhosis (Child-Pugh B or C), cirrhosis w/ hepatic encephalopathy, clinically significant ascites due to cirrhosis, or hepatorenal syndrome. Severe renal impairment (CrCl 15-29 mL/min). Use effective contraception during & up to 3 mth after the last dose of treatment in women of childbearing potential. Not recommended during pregnancy & in women of childbearing potential not using contraception. Discontinue breastfeeding during treatment & for at least 3 mth after the last dose. Elderly patients w/ NSCLC.

GI perforation, severe GI hemorrhage, arterial thromboembolic events, posterior reversible encephalopathy syndrome. Monotherapy: Peripheral edema, HTN; diarrhea, abdominal pain; headache; proteinuria; thrombocytopenia, In combination w/ chemotherapy: Fatigue/asthenia, neutropenia, epistaxis, stomatitis. In combination w/ erlotinib: Infections; anemia; alopecia; mucosal inflammation.

Targeted Cancer Therapy

L01FG02 - ramucirumab ; Belongs to the class of VEGF/VEGFR (Vascular Endothelial Growth Factor) inhibitors. Used in the treatment of cancer.

Rx