Cyramza

Cyramza

ramucirumab

Manufacturer:

Eli Lilly

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Ramucirumab
Indications/Uses
Monotherapy for adult patients whom treatment in combination w/ paclitaxel is inappropriate w/ advance gastric cancer or gastro-oesophageal junction (GEJ) adenocarcinoma w/ disease progression after prior platinum & fluoropyrimidine chemotherapy. In combination w/ paclitaxel for adult patients w/ advanced gastric cancer or GEJ adenocarcinoma w/ disease progression after prior platinum & fluoropyrimidine chemotherapy. In combination w/ irinotecan, folinic acid & 5-fluorouracil (FOLFIRI) for adult patients w/ metastatic CRC w/ disease progression on or after prior therapy w/ bevacizumab, oxaliplatin & fluoropyrimidine. In combination w/ erlotinib for 1st-line treatment of adult patients w/ metastatic NSCLC w/ activating epidermal growth factor receptor mutations. In combination w/ docetaxel for adult patients w/ locally advanced or metastatic NSCLC w/ disease progression after platinum-based chemotherapy. Monotherapy for adult patients w/ advanced or unresectable hepatocellular carcinoma (HCC) who have serum α fetoprotein ≥400 ng/mL & have been previously treated w/ sorafenib.
Dosage/Direction for Use
Gastric cancer & GEJ adenocarcinoma Monotherapy: 8 mg/kg every 2 wk. In combination w/ paclitaxel: 8 mg/kg on days 1 & 15 of 28-day cycle prior to paclitaxel 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 patient Reduce docetaxel to 60 mg/m2 on day 1 of 21-day cycle. HCC 8 mg/kg every 2 wk.
Contraindications
Hypersensitivity. Tumour cavitation or tumour involvement of major vessels for NSCLC.
Special Precautions
Not to be inj IV blous or push. Permanently discontinue if patients experience grade 3 or 4 infusion-related reactions (IRR); in the event of severe arterial thromboembolic events (ATE), GI perforations, grade 3 or 4 bleeding, posterior reversible encephalopathy syndrome, fistula development, hepatic encephalopathy or hepatorenal syndrome, nephrotic syndrome; urine protein level >3 g/24 hr. Not to be initiated in patients w/ uncontrolled HTN. NSCLC patients w/ recent pulmonary bleeding, patients w/ evidence of baseline tumour cavitation or invasion, or major blood vessels encasement. Increased incidence of severe HTN, stomatitis; aneurysms &/or artery dissections; impaired wound healing; cardiac failure. Discontinue at least 4 wk prior to elective surgery. Na-restricted diet. May affect ability to drive & use machines. Severe hepatic impairment & 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). May affect fertility. Women of childbearing potential should use effective contraception during & up to 3 mth after last dose. Not recommended during pregnancy. Not to be used during lactation & at least 3 mth after last dose. Childn & adolescents <18 yr. Elderly ≥65 yr; elderly w/ NSCLC.
Adverse Reactions
Thrombocytopenia; headache; HTN; abdominal pain, diarrhoea; proteinuria; peripheral oedema; infections; neutropenia, leukopenia, anaemia; epistaxis; stomatitis; alopecia; fatigue, mucosal inflammation. Hypokalaemia, hyponatraemia, hypoalbuminaemia; hepatic encephalopathy; ATE; intestinal obstruction; rash; IRR; sepsis; febrile neutropenia; pulmonary haemorrhage; GI haemorrhage events & perforation; gingival bleeding; palmar-plantar erthyrodysaesthesia syndrome; haemangioma; hypothyroidism; dysphonia.
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 100 mg/10 mL
Packing/Price
1's
Form
Cyramza infusion conc 500 mg/50 mL
Packing/Price
1's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in