Eli Lilly


Agencia Lei Va Hong
Concise Prescribing Info
In combination w/ paclitaxel for advanced gastric cancer or gastro-oesophageal junction adenocarcinoma w/ disease progression after prior platinum & fluoropyrimidine chemotherapy. Monotherapy for advanced gastric cancer or gastro-oesophageal junction 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 colorectal cancer (mCRC) w/ disease progression on or after prior therapy w/ bevacizumab, oxaliplatin & a fluoropyrimidine. In combination w/ docetaxel for locally advanced or metastatic non-small cell lung cancer w/ disease progression after platinum-based chemotherapy.
Dosage/Direction for Use
Gastric cancer & gastro-oesophageal junction 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 complete blood count & blood chemistry performed to evaluate hepatic function. Monotherapy 8 mg/kg every 2 wk. Colorectal cancer 8 mg/kg IV infusion every 2 wk. Non-small cell lung cancer 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.
Hypersensitivity. Patients w/ tumour cavitation or tumour involvement of major vessels.
Special Precautions
Permanently discontinue in patients who experience serious, sometimes fatal, arterial thromboembolic events (ATEs), risk of GI perforations, patients who experience Grade 3 or 4 bleeding, patients who experience a Grade 3 or 4 infusion-related reactions. Pulmonary haemorrhage. Patients w/ uncontrolled HTN, monitor BP. Temporarily discontinue for severe HTN until controlled, or permanently discontinue if medically significant HTN cannot be controlled w/ antihypertensive therapy. Serious or non-healing wounds; discontinue if patient develops wound healing complications during therapy. Severe liver cirrhosis (Child-Pugh B or C), cirrhosis w/ hepatic encephalopathy, clinically significant ascites due to cirrhosis, or hepatorenal syndrome. Discontinue if patients develop fistula. 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. Severe renal impairment (CrCl 15-29 mL/min); patients on Na-restricted diet. May impair ability to drive & operate machinery. Pregnancy & lactation. Elderly.
Adverse Reactions
Neutropenia, leukopenia, thrombocytopenia; hypoalbuminaemia; HTN; epistaxis; GI haemorrhage events, stomatitis, diarrhoea; proteinuria; fatigue/asthenia, peripheral oedema; abdominal pain; palmar-plantar erythrodysaesthesia syndrome; mucosal inflammation.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XC21 - ramucirumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Cyramza conc for soln for infusion 100 mg/10 mL
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