IntravenousLocally advanced non-small cell lung carcinoma, Metastatic non-small cell lung carcinomaAdult: In patients with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations that progressed on or after platinum-based chemotherapy weighing <80 kg: 1,050 mg once weekly for 4 weeks, then once every 2 weeks starting Week 5; ≥80 kg: 1,400 mg once weekly for 4 weeks, then once every 2 weeks starting Week 5. All doses are given via infusion. Week 1 doses are given as split infusion for 2 consecutive days: 350 mg on Day 1, then the remaining dose is given on Day 2. Infusion rates may vary with each dose (refer to detailed product guidelines). Premedicate with antihistamines and antipyretics before every infusion, and with corticosteroids before the first 2 doses (Days 1 and 2 of Week 1) and as needed for subsequent doses. Dose reduction, dose interruption, or discontinuation may be required according to individual safety and tolerability.
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Dilute the required dose with dextrose 5% in water or NaCl 0.9% solution to make a final volume of 250 mL in infusion bags. Gently invert to mix. Do not shake.
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Patient with ILD or pneumonitis. Pregnancy and lactation.
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Significant: Photosensitivity, infusion-related reactions (e.g. nausea, vomiting, dyspnoea, flushing, chills, chest discomfort, hypotension); toxic epidermal necrolysis (TEN), ILD/pneumonitis, keratitis.
Blood and lymphatic system disorders: Lymphocytopenia.
Eye disorders: Blurred vision, visual impairment, ocular itching, dry eye symptoms, conjunctival redness, growth of eyelashes, uveitis.
Gastrointestinal disorders: Constipation, diarrhoea, abdominal pain, stomatitis.
General disorders and administration site conditions: Fatigue, oedema.
Investigations: Increased serum creatinine, glucose, GGT, ALT, AST, alkaline phosphatase; decreased serum albumin, phosphate, K, Mg, Ca, Na.
Metabolism and nutrition disorders: Decreased appetite.
Musculoskeletal and connective tissue disorders: Myalgia, myasthenia.
Nervous system disorders: Peripheral neuropathy, headache.
Respiratory, thoracic and mediastinal disorders: Cough, pleural effusion.
Skin and subcutaneous tissue disorders: Rash, acneiform dermatitis, dry skin, pruritus, paronychia.
Vascular disorders: Pulmonary embolism, haemorrhage.
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IV: Z (Not recommended in pregnancy unless benefits outweigh risks.)
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This drug may cause dizziness, fatigue, and visual impairment, if affected, do not drive or operate machinery. Women of childbearing potential must use proven birth control methods during therapy and for 3 months after stopping the treatment. Do not breastfeed during therapy and for 3 months after the last dose. Avoid excessive exposure to sunlight or UV light during and for 2 months after stopping the treatment; use sunscreen or protective clothing when going outdoors.
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Evaluate pregnancy status in females of childbearing potential prior to treatment initiation. Perform validated tests to determine EGFR Exon 20 insertion mutation status. Conduct HBV screening including HBsAg, HBV core antibody, total Ig or IgG, and antibody to HBV surface antigen before (or at the beginning of) systemic anticancer therapy. Monitor for signs and symptoms of ILD/pneumonitis, infusion-related reactions, severe rashes with atypical distribution or appearance, and eye problems.
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Description:
Mechanism of Action: Amivantamab is a human IgG1-based bispecific antibody which targets both EGFR and mesenchymal-epithelial transition (MET). It binds to the extracellular domains of EGFR and MET and disrupts their signalling functions by blocking ligand binding and enhancing EGFR and MET degradation in exon 20 insertion mutation models, hence impeding tumour growth and progression. The presence of EGFR and MET on the surface of tumour cells also allows for targeted cell destruction by immune effector cells such as natural killer cells through antibody-dependent cellular cytotoxicity (ADCC), and by macrophages via trogocytosis mechanisms.
Pharmacokinetics:
Distribution: Volume of distribution: 5.13 L.
Excretion: Elimination half-life: 11.3 days.
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Intact vials: Store between 2-8°C. Protect from light. Do not freeze. Diluted solutions: Store between 15-25°C; administer within 10 hours.
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L01FX18 - amivantamab ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.
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Anon. Amivantamab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 01/12/2023. Anon. Amivantamab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/12/2023. Buckingham R (ed). Amivantamab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/12/2023. Joint Formulary Committee. Amivantamab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/12/2023. Rybrevant 350 mg/7 mL Concentrate for Solution for Infusion (Johnson & Johnson Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 01/12/2023. Rybrevant 50 mg/mL Concentrate for Solution for Infusion (Janssen-Cilag Ltd). MHRA. https://products.mhra.gov.uk. Accessed 01/12/2023. Rybrevant Concentrate for Solution for Infusion 350 mg/7 mL (Johnson & Johnson [HK] Ltd.). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 01/12/2023. Rybrevant Injection (Janssen Biotech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/12/2023.
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