Cyramza

Ramucirumab

In combination w/ paclitaxel for advanced gastric cancer or gastro-oesophageal junction (GEJ) adenocarcinoma w/ disease progression after prior platinum & fluoropyrimidine chemotherapy. Monotherapy for advanced gastric cancer or GEJ adenocarcinoma w/ disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination w/ paclitaxel is not appropriate. In combination w/ FOLFIRI (irinotecan, folinic acid & 5-fluorouracil) for metastatic CRC w/ disease progression on or after prior therapy w/ bevacizumab, oxaliplatin & a fluoropyrimidine. In combination w/ erlotinib for the 1st-line treatment of metastatic NSCLC w/ activating epidermal growth factor receptor (EGFR) mutations. In combination w/ docetaxel for locally advanced or metastatic NSCLC w/ disease progression after platinum-based chemotherapy. Monotherapy for advanced or unresectable hepatocellular carcinoma (HCC) who have a serum α-fetoprotein (AFP) of ≥400 ng/mL & who have been previously treated w/ sorafenib.

Adult Administer as IV infusion over approx 60 min. Premedication w/ a histamine H₁ antagonist is recommended prior to ramucirumab infusion. Gastric cancer & GEJ adenocarcinoma in combination w/ paclitaxel Ramucirumab 8 mg/kg on days 1 & 15 of a 28-day cycle, prior to paclitaxel infusion. Paclitaxel: 80 mg/m² IV infusion over approx 60 min on days 1, 8 & 15 of a 28-day cycle. Prior to each paclitaxel infusion, patients should have a CBC & blood chemistry performed to evaluate hepatic function. Monotherapy for gastric cancer & GEJ adenocarcinoma 8 mg/kg every 2 wk. CRC 8 mg/kg IV infusion every 2 wk, prior to FOLFIRI administration. Prior to chemotherapy, patients should have CBC. NSCLC w/ activating EGFR mutations in combination w/ erlotinib Ramucirumab 10 mg/kg every 2 wk. Determine EGFR mutation status prior to treatment initiation. NSCLC in combination w/ docetaxel after platinum-based chemotherapy Ramucirumab 10 mg/kg on day 1 of a 21-day cycle, prior to docetaxel infusion. Docetaxel: 75 mg/m² IV infusion over approx 60 min on day 1 of a 21-day cycle. HCC 8 mg/kg every 2 wk.

Hypersensitivity. NSCLC patients w/ tumour cavitation or tumour involvement of major vessels.

Reports of serious arterial thromboembolic events. May increase risk of severe bleeding & GI perforations. Reports of infusion-related reactions. Pulmonary haemorrhage in NSCLC. Reports of increased incidence of severe HTN; monitor BP. Temporarily discontinue for severe HTN until controlled, or permanently discontinue if medically significant HTN cannot be controlled w/ antihypertensive therapy. Discontinue in patients who experience posterior reversible encephalopathy syndrome. May promote formation of aneurysms &/or artery dissections. Potential to adversely affect wound healing; discontinue if patient develops wound healing complications during therapy. W/hold treatment for at least 4 wk prior to scheduled surgery. Report of higher rate of hepatic encephalopathy in HCC patients. Caution in patients w/ severe liver cirrhosis (Child-Pugh B or C), cirrhosis w/ hepatic encephalopathy, clinically significant ascites due to cirrhosis, or hepatorenal syndrome. Increased risk for development of fistula. Reports of increased incidence of proteinuria & stomatitis. Temporarily discontinue if the urine protein level is ≥2 g/24 hr. Permanently discontinue if the urine protein level is >3 g/24 hr or in the event of nephrotic syndrome. Limited safety data available for patients w/ severe renal impairment (CrCl 15-29 mL/min). Not recommended during pregnancy & in women of childbearing potential not using contraception. Women of childbearing potential should use effective contraception during & up to 3 mth after the last ramucirumab dose. Discontinue breast-feeding during treatment & for at least 3 mth after the last dose. Elderly patients w/ NSCLC.

As monotherapy: Peripheral oedema, HTN, diarrhoea, abdominal pain, headache, proteinuria, thrombocytopenia. In combination w/ chemotherapy: Fatigue/asthenia, neutropenia, diarrhoea, epistaxis, stomatitis. In combination w/ erlotinib: Infections, diarrhoea, HTN, stomatitis, proteinuria, alopecia, epistaxis.

Targeted Cancer Therapy

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

P₁S₁S₃