Cyramza

Cyramza

ramucirumab

Manufacturer:

Eli Lilly

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Ramucirumab
Indications/Uses
Monotherapy or in combination w/ paclitaxel in adult patients w/ advanced gastric cancer or gastro-oesophageal junction adenocarcinoma w/ disease progression after prior platinum- or fluoropyrimidine-containing chemotherapy. In combination w/ irinotecan, folinic acid & 5-fluorouracil (FOLFIRI) for metastatic CRC in adult patients w/ disease progression on or after prior therapy w/ bevacizumab, oxaliplatin & fluoropyrimidine. In combination w/ erlotinib as 1st-line treatment in adult patients w/ metastatic NSCLC w/ activating epidermal growth factor receptor (EGFR) mutations. In combination w/ docetaxel for adult patients w/ locally advanced or metastatic NSCLC w/ disease progression after platinum-based chemotherapy. Monotherapy in adult patients w/ advanced or unresectable hepatocellular carcinoma w/ serum α fetoprotein (AFP) of ≥400 ng/mL & who have been previously treated w/ sorafenib.
Dosage/Direction for Use
Adult Gastric cancer & gastro-oesophageal junction adenocarcinoma 8 mg/kg every 2 wk as single agent or in combination w/ paclitaxel: 8 mg/kg ramucirumab on days 1 & 15 of 28-day cycle, prior to paclitaxel infusion 80 mg/m2 IV infusion over approx 60 min on days 1, 8 & 15 of 28-day cycle. CRC 8 mg/kg IV infusion every 2 wk prior to FOLFIRI administration. NSCLC in combination w/ erlotinib 10 mg/kg every 2 wk. In combination w/ docetaxel 10 mg/kg on day 1 of 21-day cycle, prior to docetaxel 75 mg/m2 IV infusion over approx 60 min on day 1 of 21-day cycle. East Asian patients Reduce docetaxel 60 mg/m2 on day 1 of 21-day cycle. Hepatocellular carcinoma 8 mg/kg every 2 wk. Patients w/ urine protein levels of <2 g/24 hr Initially 8 mg/kg or 10 mg/kg. 1st dose reduction: 6 mg/kg or 8 mg/kg, ≥2 g/24 hr 2nd dose reduction: 5 mg/kg or 6 mg/kg.
Contraindications
Hypersensitivity. Tumour cavitation or involvement of major vessels in patients w/ NSCLC.
Special Precautions
Infusion-related reactions. Permanently discontinue treatment in patients w/ severe arterial thromboembolic events; GI perforation; Grade 3 or 4 bleeding; significant HTN uncontrolled w/ antihypertensive therapy; hepatic encephalopathy or hepatorenal syndrome; urine level >3 g/24 hr or in the event of nephrotic syndrome. Discontinue if posterior reversible encephalopathy syndrome occurs. Withhold treatment 4 wk prior to surgery. Increased incidence of severe HTN, impaired wound healing, fistula development, stomatitis. History of aneurysm. Na-restricted patient. Monitor blood counts & coagulation parameters in patients w/ conditions predisposing to bleeding & on anticoagulant treatment & other drugs increasing risk of bleeding; BP. Perform screening & treatment for oesophageal varices in hepatocellular carcinoma patients before treatment. May affect ability to drive & use machines. Severe liver cirrhosis (Child-Pugh B or C), cirrhosis w/ hepatic encephalopathy, clinically significant ascites due to cirrhosis or hepatorenal syndrome. Severe hepatic & renal (CrCl <30 mL/min) impairment. Women of childbearing potential should use contraception during & up to 3 mth after last dose. Not recommended during pregnancy. Discontinue lactation during treatment & at least 3 mth after last dose. Childn & adolescents <18 yr. Elderly w/ NSCLC.
Adverse Reactions
Haemangioma; hypothyroidism; dysphonia. Monotherapy: Thrombocytopenia; headache; HTN; abdominal pain, diarrhoea; proteinuria; peripheral oedema. Neutropenia; hypokalaemia, hyponatraemia, hypoalbuminaemia; arterial thromboembolic events; epistaxis; intestinal obstruction; rash; infusion-related reactions. In combination w/ chemotherapy or erlotinib: Infections; neutropenia, leukopenia, thrombocytopenia, anaemia; headache; HTN; epistaxis; stomatitis, diarrhoea; alopecia; proteinuria; fatigue, mucosal inflammation, peripheral oedema. Sepsis; febrile neutropenia; hypoalbuminaemia, hyponatraemia; pulmonary haemorrhage; GI haemorrhage & perforation, gingival bleeding; palmar-plantar erythrodysaesthesia syndrome.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FG02 - ramucirumab ; Belongs to the class of VEGF/VEGFR (Vascular Endothelial Growth Factor) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Cyramza infusion conc 10 mg/mL
Packing/Price
10 mL x 1's;50 mL x 1's
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