Ramucirumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Metastatic colorectal cancer As adjuvant therapy with FOLFIRI (irinotecan, folinic acid, fluorouracil): 8 mg/kg every 2 weeks prior to FOLFIRI administration. Advanced gastric carcinoma; Gastro-oesophageal junction adenocarcinoma As monotherapy: 8 mg/kg every 2 weeks. As adjuvant therapy with paclitaxel: 8 mg/kg on days 1 and 15 of a 28-day cycle, prior to paclitaxel administration. Locally advanced non-small cell lung carcinoma; Metastatic non-small cell lung carcinoma As adjuvant therapy with docetaxel: 10 mg/kg on day 1 of a 21-day cycle, prior to docetaxel administration. All doses are continued until disease progression or unacceptable toxicity occurs. In case of toxicity, omit dose/s or modify according to product literature.
Dosage Details
Intravenous
Metastatic colorectal cancer
Adult: As adjuvant therapy with FOLFIRI (irinotecan, folinic acid, fluorouracil) in patients with disease progression on, or after, or prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine: 8 mg/kg via infusion over 1 hour every 2 weeks prior to FOLFIRI administration. Continue until disease progression or unacceptable toxicity occurs. In case of toxicity, omit dose/s or modify according to product literature.

Intravenous
Advanced gastric carcinoma, Gastro-oesophageal junction adenocarcinoma
Adult: As monotherapy in patients with disease progression on or after fluoropyrimidine or platinum-based chemotherapy: 8 mg/kg via infusion over 1 hour every 2 weeks. As adjuvant therapy with paclitaxel in patients with disease progression on, or after fluoropyrimidine or platinum-based chemotherapy: 8 mg/kg via infusion over 1 hour on days 1 and 15 of a 28-day cycle, prior to paclitaxel administration. Continue until disease progression or unacceptable toxicity occurs. In case of toxicity, omit dose/s or modify according to product literature.

Intravenous
Locally advanced non-small cell lung carcinoma, Metastatic non-small cell lung carcinoma
Adult: As adjuvant therapy with docetaxel in patients with disease progression on, or after platinum-based chemotherapy: 10 mg/kg via infusion over 1 hour on day 1 of a 21-day cycle, prior to docetaxel administration. Continue until disease progression or unacceptable toxicity occurs. In case of toxicity, omit dose/s or modify according to product literature.
Reconstitution
Withdraw appropriate volume and dilute with NaCl 0.9% to a final volume of 250 mL. Mix by gentle inversion. Do not shake.
Incompatibility
Dextrose solutions.
Contraindications
Tumour cavitation or tumour involvement of major vessels (when used for treatment of non-small cell lung carcinoma).
Special Precautions
Patient with known or at risk of coronary artery disease, or those undergoing elective surgery. Hepatic impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Hypertension, infusion-related reaction, proteinuria, reversible posterior leukoencephalopathy syndrome, hypothyroidism, impaired wound healing.
Blood and lymphatic system disorders: Anaemia, leucopenia, neutropenia, thrombocytopenia.
Gastrointestinal disorders: Diarrhoea, abdominal pain, intestinal obstruction, stomatitis.
General disorders and administration site conditions: Fatigue, asthenia, peripheral oedema, mucosal inflammation.
Nervous system disorders: Headache.
Metabolism and nutrition disorders: Hypoalbuminaemia, hypokalaemia, hyponatraemia.
Respiratory, thoracic and mediastinal disorders: Epistaxis.
Skin and subcutaneous tissue disorders: Rash.
Potentially Fatal: Haemorrhage (including gastrointestinal haemorrhage), gastrointestinal perforation, MI, cardiac arrest, CVA, ischaemia.
Patient Counseling Information
Do not drive or operate machinery if any symptoms which may affect the ability to concentrate is experienced.
MonitoringParameters
Monitor LFT, urine protein, thyroid function, CBC with differential (when used as an adjuvant therapy) and blood pressure. Monitor signs and symptoms of haemorrhage, MI, CVA, ischaemia, gastrointestinal perforation, wound healing impairment and reversible posterior leukoencephalopathy syndrome.
Action
Description: Ramucirumab is a recombinant human IgG1 monoclonal antibody that specifically binds to vascular endothelial growth factor receptor 2 (VEGFR2), inhibiting the proliferation and migration of endothelial cells by VEGFR ligands.
Pharmacokinetics:
Excretion: Elimination half-life: 14 days.
Storage
Store between 2-8°C. Protect from light. Do not freeze.
Any unused portions should be disposed of in accordance with local requirements.
ATC Classification
L01XC21 - ramucirumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
References
Anon. Ramucirumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/02/2018.

Buckingham R (ed). Ramucirumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/02/2018.

Cyramza Solution (Eli Lilly Company). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/02/2018.

Joint Formulary Committee. Ramucirumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/02/2018.

McEvoy GK, Snow EK, Miller J et al (eds). Ramucirumab. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 02/02/2018.

Ramucirumab. Drugs and Lactation Database (LactMed) [Internet]. Bethesda, MD. U.S. National Library of Medicine. https://www.ncbi.nlm.nih.gov/books/NBK501922/. Accessed 02/02/2018.

Disclaimer: This information is independently developed by MIMS based on Ramucirumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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