IntravenousMetastatic non-small cell lung carcinomaAdult: In combination with erlotinib as 1st-line treatment in patients with activating epidermal growth factor receptor (EGFR) mutations: 10 mg/kg every 2 weeks via infusion over 1 hour, prior to erlotinib administration. Continue until disease progression or unacceptable toxicity occurs. Premedicate with IV antihistamine (e.g. diphenhydramine) prior to infusion. Infusion rate reduction, dosing interruption or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline).
IntravenousMetastatic colorectal cancerAdult: In combination with folinic acid, fluorouracil, and irinotecan (FOLFIRI) in patients with disease progression on or after prior treatment with bevacizumab, oxaliplatin and a fluoropyrimidine: 8 mg/kg every 2 weeks via infusion over 1 hour, prior to FOLFIRI administration. Continue until disease progression or unacceptable toxicity occurs. Premedicate with IV antihistamine (e.g. diphenhydramine) prior to infusion. Infusion rate reduction, dosing interruption or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline).
IntravenousAdvanced gastric carcinoma, Advanced gastrooesophageal junction adenocarcinomaAdult: As monotherapy in patients with disease progression after prior platinum or fluoropyrimidine chemotherapy, and for whom therapy in combination with paclitaxel is not appropriate: 8 mg/kg every 2 weeks via infusion over 1 hour. In combination with paclitaxel in patients with disease progression after prior platinum and fluoropyrimidine chemotherapy: 8 mg/kg on Days 1 and 15 of a 28-day cycle via infusion over 1 hour, prior to paclitaxel administration. Continue until disease progression or unacceptable toxicity occurs. Premedicate with IV antihistamine (e.g. diphenhydramine) prior to infusion. Infusion rate reduction, dosing interruption or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline).
IntravenousAdvanced hepatocellular carcinoma, Unresectable hepatocellular carcinomaAdult: As monotherapy in patients who have ≥400 ng/mL serum alpha-fetoprotein (AFP) and who have been previously treated with sorafenib: 8 mg/kg every 2 weeks via infusion over 1 hour. Continue until disease progression or unacceptable toxicity occurs. Premedicate with IV antihistamine (e.g. diphenhydramine) prior to infusion. Infusion rate reduction, dosing interruption or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline).
IntravenousLocally advanced non-small cell lung carcinoma, Metastatic non-small cell lung carcinomaAdult: In combination with docetaxel in patients with disease progression after platinum-based chemotherapy: 10 mg/kg on Day 1 of a 21-day cycle via infusion over 1 hour, prior to docetaxel administration. Continue until disease progression or unacceptable toxicity occurs. Premedicate with IV antihistamine (e.g. diphenhydramine) prior to infusion. Infusion rate reduction, dosing interruption or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline).
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Withdraw appropriate dose and required volume, then dilute with NaCl 0.9% solution to make a final total volume of 250 mL. Mix by gentle inversion. Do not shake.
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Must not be mixed with dextrose solutions.
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Tumour cavitation or tumour involvement of major vessels (when used for the treatment of non-small cell lung cancer [NSCLC]). Pregnancy and lactation.
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Patient with risk factors for aneurysms and/or artery dissections (e.g. hypertension, history of aneurysm) and those at risk of bleeding. Patient undergoing elective surgery. Hepatic impairment, particularly severe liver cirrhosis (Child-Pugh class B or C), cirrhosis with hepatic encephalopathy, clinically significant ascites due to cirrhosis, or hepatorenal syndrome. Elderly.
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Significant: New onset or worsening hepatic encephalopathy, ascites, hepatorenal syndrome; new or worsening hypertension, cardiac failure, proteinuria, nephrotic syndrome, hypothyroidism, impaired wound healing, infusion-related reactions (e.g. chills, flushing, back pain or spasm, rigors, tremors, paraesthesia, chest pain/tightness, dyspnoea, bronchospasm, supraventricular tachycardia, hypotension); fistula development.
Blood and lymphatic system disorders: Anaemia, leucopenia, neutropenia, thrombocytopenia.
Gastrointestinal disorders: Diarrhoea, abdominal pain, nausea, vomiting, stomatitis, intestinal obstruction, gingival bleeding.
General disorders and administration site conditions: Fatigue, asthenia, peripheral oedema, fever, mucosal inflammation.
Infections and infestations: Infections, sepsis.
Nervous system disorders: Headache.
Neoplasms benign, malignant and unspecified: Haemangioma.
Metabolism and nutrition disorders: Hypoalbuminaemia, hypocalcaemia, hypokalaemia, hyponatraemia, decreased appetite.
Psychiatric disorders: Insomnia.
Respiratory, thoracic and mediastinal disorders: Epistaxis, dysphonia.
Skin and subcutaneous tissue disorders: Rash, alopecia, palmar-plantar erythrodysaesthesia syndrome.
Potentially Fatal: Serious arterial thrombotic events, including MI, cerebral ischaemia, cerebrovascular accident, and cardiac arrest; aortic aneurysm, aortic dissection, severe bleeding, pulmonary haemorrhage (particularly in NSCLC patients with squamous histology), gastrointestinal perforation or haemorrhage. Rarely, posterior reversible encephalopathy syndrome.
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Women of childbearing potential should use proven birth control methods during therapy and up to 3 months after stopping the treatment. Discontinue breastfeeding during treatment and for at least 3 months after the last dose.
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Evaluate EGFR mutation status prior to starting treatment of metastatic NSCLC in combination with erlotinib. Perform AFP testing before starting therapy for hepatocellular carcinoma. Confirm pregnancy status before therapy initiation in females of reproductive potential. Monitor LFTs, urine protein by urine dipstick or urinary protein creatinine ratio, thyroid function, CBC with differential (when used in combination with other chemotherapy agents), and blood pressure (at baseline and every 2 weeks or more frequently if necessary) during treatment. Monitor for signs and symptoms of infusion-related reactions, arterial thromboembolic events, bleeding or haemorrhage, wound healing impairment, gastrointestinal perforation, hepatic encephalopathy, and posterior reversible encephalopathy syndrome.
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Description:
Mechanism of Action: Ramucirumab is a recombinant human IgG1 monoclonal antibody that specifically binds to vascular endothelial growth factor (VEGF) receptor 2. It blocks the binding of VEGF-A, VEGF-C, and VEGF-D, thereby inhibiting ligand-stimulated VEGF receptor 2 activation and its downstream signalling components. This action causes the inhibition of ligand-induced proliferation and migration of human endothelial cells, resulting in reduced tumour vascularity and growth.
Pharmacokinetics:
Excretion: Elimination half-life: 14 days.
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Store between 2-8°C. Do not freeze. Protect from light. Solutions diluted in NaCl 0.9% solution for infusion may be stored between 2-8°C for up to 24 hours or at 25°C for 4 hours. Follow applicable procedures for receiving, handling, administration, and disposal.
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L01FG02 - ramucirumab ; Belongs to the class of VEGF/VEGFR (Vascular Endothelial Growth Factor) inhibitors. Used in the treatment of cancer.
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Annotation of EMA Label for Ramucirumab and EGFR. Pharmacogenomics Knowledgebase (PharmGKB). https://www.pharmgkb.org. Accessed 02/11/2022. Annotation of FDA Label for Ramucirumab and ALK, EGFR. Pharmacogenomics Knowledgebase (PharmGKB). https://www.pharmgkb.org. Accessed 02/11/2022. Anon. Ramucirumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 02/11/2022. Anon. Ramucirumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 31/01/2023. Buckingham R (ed). Ramucirumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 31/01/2023. Cyramza 10 mg/mL Concentrate for Solution for Infusion (Eli Lilly Nederland B.V.). MHRA. https://products.mhra.gov.uk. Accessed 31/01/2023. Cyramza 100 mg/10 mL and 500 mg/50 mL Concentrate for Solution for Infusion (Zuellig Pharma Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 31/01/2023. Cyramza Solution (Eli Lilly and Company). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 31/01/2023. Joint Formulary Committee. Ramucirumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/11/2022.
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