IntravenousWild-type RAS metastatic colorectal cancerAdult: In combination with FOLFOX (folinic acid, fluorouracil, and oxaliplatin) or FOLFIRI (folinic acid, fluorouracil, and irinotecan) as 1st-line treatment; in combination with FOLFIRI in patients who have received 1st-line fluoropyrimidine-based chemotherapy (except irinotecan); or as monotherapy in patients who failed treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy: 6 mg/kg once every 2 weeks (14 days) via an infusion pump over approx 60 minutes; if the initial infusion is tolerated, subsequent infusions may be given over 30-60 minutes. For doses >1,000 mg, infuse over approx 90 minutes. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety and tolerability (refer to detailed product guidelines).
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Dilute in a total volume of 100 mL (for doses ≤1,000 mg) or 150 mL (for doses >1,000 mg) with 0.9% NaCl to yield a final concentration not exceeding 10 mg/mL. Do not shake; gently invert to mix.
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History of severe or potentially fatal hypersensitivity to panitumumab. Existing interstitial pneumonitis or pulmonary fibrosis. Lactation. Combination therapy with bevacizumab-containing chemotherapy.
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Patient with history of interstitial pneumonitis, pulmonary fibrosis, keratitis, or severe dry eye; history of or risk factors for ulcerative keratitis (e.g. contact lens use). Not indicated for the treatment of patients with unknown RAS mutation status or RAS-mutant metastatic colorectal cancer (mCRC), defined as mutation in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), or exon 4 (codons 117 and 146) of KRAS and NRAS. For the traceability of biological medicinal products, record the name and batch number of the product administered to each patient. Elderly. Pregnancy.
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Significant: Dermatologic toxicities (e.g. dermatitis acneiform, erythema, rash, pruritus, skin exfoliation or fissures, paronychia, dry skin), local abscesses (requiring incisions), diarrhoea (incidence and severity may increase with combination chemotherapy), electrolyte depletion (e.g. severe hypomagnesaemia; hypocalcaemia, hypokalaemia), acute renal failure; keratitis, ulcerative keratitis, corneal perforation. Rarely, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Blood and lymphatic system disorders: Anaemia, leucopenia.
Cardiac disorders: Tachycardia, chest pain.
Eye disorders: Conjunctivitis, eye irritation or pruritus, blepharitis, increased lacrimation, ocular hyperaemia, dry eye, abnormal growth of eyelashes.
Gastrointestinal disorders: Nausea, vomiting, abdominal pain, constipation, stomatitis, dry mouth, dyspepsia, rectal haemorrhage, aphthous ulcer, cheilitis, GERD.
General disorders and administration site conditions: Asthenia, fatigue, pyrexia, mucosal inflammation, peripheral oedema, pain, chills.
Infections and infestations: Localised infection.
Investigations: Decreased weight.
Metabolism and nutrition disorders: Decreased appetite, dehydration, hyperglycaemia.
Musculoskeletal and connective tissue disorders: Back pain, pain in extremity.
Nervous system disorders: Dizziness, headache.
Psychiatric disorders: Insomnia, anxiety.
Renal and urinary disorders: UTI.
Respiratory, thoracic and mediastinal disorders: Cough, epistaxis, pulmonary embolism.
Skin and subcutaneous tissue disorders: Alopecia, hypertrichosis, nail disorder (including onychoclasis), hyperhidrosis, palmar-plantar erythrodysaesthesia syndrome.
Vascular disorders: DVT, flushing, hypertension.
Potentially Fatal: Sepsis, necrotising fasciitis, bullous mucocutaneous disease. Rarely, pulmonary fibrosis, interstitial lung disease; serious infusion-related reactions (e.g. bronchospasm, dyspnoea, hypotension, angioedema, anaphylaxis).
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Avoid prolonged exposure to sunlight, apply sunscreen or wear protective clothing or a hat when going outdoors.
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Establish RAS mutation status and verify RAS wild-type (defined as wild-type in both KRAS and NRAS) before initiation of treatment. Monitor electrolytes, particularly Mg and Ca (periodically during and for at least 8 weeks after treatment), and vital signs and temperature (before, during, and after infusion). Closely monitor for infusion reactions (e.g. dyspnoea, wheezing) during and following administration. Observe for skin toxicity, ocular toxicity, and acute onset or worsening pulmonary symptoms.
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Increased risk of severe diarrhoea when used in combination with irinotecan, fluorouracil (bolus), and folinic acid (IFL) chemotherapy; avoid concomitant therapy. Concomitant use with oxaliplatin-based chemotherapy in patients with RAS-mutant mCRC resulted in shortened progression-free survival and overall survival.
Potentially Fatal: Increased toxicity and mortality with bevacizumab and chemotherapy.
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Description:
Mechanism of Action: Panitumumab, a recombinant fully human IgG2 kappa monoclonal antibody, binds specifically and with high affinity to the human epidermal growth factor receptor (EGFR) on both normal and tumour cells. It inhibits receptor autophosphorylation induced by all known EGFR ligands, thus resulting in inhibition of cell growth, survival, proliferation, and transformation. Signal transduction through EGFR may activate the wild-type Kirsten rat sarcoma (KRAS) 2 viral oncogene homologue and Neuroblastoma RAS (NRAS) viral oncogene homologue proteins; cells with activating RAS mutations appear to be unaffected by EGFR inhibition.
Pharmacokinetics:
Excretion: Elimination half-life: Approx 7.5 days (range: 3.6-10.9 days).
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Store intact vials between 2-8°C. Do not freeze. Protect from light. Diluted solutions in 0.9% NaCl solution for infusion: Use within 6 hours if stored at room temperature or within 24 hours if stored between 2-8°C. Follow applicable procedures for receiving, handling, administration, and disposal.
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L01FE02 - panitumumab ; Belongs to the class of EGFR (Epidermal Growth Factor Receptor) inhibitors. Used in the treatment of cancer.
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Anon. Panitumumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 01/04/2022. Anon. Panitumumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/04/2022. Buckingham R (ed). Panitumumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/04/2022. Joint Formulary Committee. Panitumumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/04/2022. Vectibix 100 mg Concentrate for Solution for Infusion (Amgen Biopharmaceuticals Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 01/04/2022. Vectibix 20 mg/mL Concentrate for Solution for Infusion (Amgen Limited). MHRA. https://products.mhra.gov.uk. Accessed 01/04/2022. Vectibix Solution (Amgen Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/04/2022.
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