Panitumumab


Concise Prescribing Info
Indications/Uses
Wild-type RAS metastatic colorectal cancer.
Dosage/Direction for Use
Adult : IV Combined with fluoropyrimidine-containing chemotherapy or as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy: 6 mg/kg via infusion every 14 days over 60 minutes for dosage ≤1,000 mg and over 90 minutes for >1,000 mg, continued until disease progression or unacceptable toxicity.
Dosage Details
Intravenous
Metastatic colorectal cancer
Adult: In combination with fluoropyrimidine-containing chemotherapy or as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy in patients with wild-type RAS cases: 6 mg/kg via infusion every 14 days over 60 minutes for dosage ≤1,000 mg and over 90 minutes for >1,000 mg, continued until disease progression or unacceptable toxicity. Dose reduction, dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Reconstitution
Dilute vial labelled as containing 20 mg/mL with NaCl 0.9% to a total volume of 100 mL for dosage <1,000 mg and 150 mL for dosage >1,000 mg, to provide a concentration not exceeding 10 mg/mL. Do not shake. Gently invert to mix.
Contraindications
Interstitial pneumonitis or pulmonary fibrosis, RAS mutation-positive metastatic colorectal cancer or unknown RAS mutation status. Lactation. Concomitant use of bevacizumab-containing and IFL (irinotecan, 5-fluorouracil and leucovorin)-containing chemotherapy.
Special Precautions
Patient with history of keratitis, ulcerative keratitis or severe dry eye. Pregnancy.
Adverse Reactions
Significant: Infusion reactions (e.g. fever, chills, hypotension), photosensitivity, dermatologic toxicities (e.g. erythema, pruritus, rash, dry skin, skin fissures, skin exfoliation, acneiform dermatitis, paronychia, local abscesses), electrolyte depletion (e.g. hypomagnesemia, hypokalaemia , keratitis or ulcerative keratitis.
Blood and lymphatic system disorders: Anaemia, leucopenia.
Cardiac disorders: Tachycardia.
Eye disorders: Abnormal eyelashes growth, blepharitis, dry eye, eye pruritus or irritation, conjunctivitis.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, dyspepsia, GERD, abdominal pain, rectal haemorrhage, dry mouth, cheilitis, stomatitis or aphthous ulcer.
General disorders and administration site conditions: Fatigue, weakness, asthenia, pyrexia, chills, mucosal inflammation, peripheral oedema, pain.
Immune system disorders: Hypersensitivity reactions, antibody formation.
Infections and infestations: Folliculitis, cellulitis, localised infection, paronychia.
Investigations: Decreased weight.
Metabolism and nutrition disorders: Decreased appetite, dehydration, hyperglycaemia, hypocalcaemia, hypophosphataemia, hypokalaemia.
Musculoskeletal and connective tissue disorders: Back pain, pain in extremity.
Nervous system disorders: Headache, dizziness.
Psychiatric disorders: Insomnia, anxiety.
Renal and urinary disorders: UTI.
Respiratory, thoracic and mediastinal disorders: Cough, dyspnoea, pulmonary embolism, epistaxis.
Skin and subcutaneous tissue disorders: Alopecia, hypertrichosis, hyperhidrosis, palmar-plantar erythrodysaesthesia syndrome, skin ulcer, nail disorder (e.g. onychoclasis).
Vascular disorders: Flushing, hypertension, deep vein thrombosis.
Potentially Fatal: Severe dermatological toxicities (e.g. necrotising fasciitis, sepsis, Stevens-Johnson syndrome, toxic epidermal necrolysis), severe diarrhoea, dehydration. Rarely, bullous mucocutaneous disease, infusion-related toxicities (e.g. bronchospasm, hypotension, angioedema, anaphylaxis), interstitial lung disease, pulmonary fibrosis.
Patient Counseling Information
This drug may cause dizziness and blurred vision, if affected, do not drive or operate machinery. Patients should wear protective clothing and/or use sunscreen when exposed to sunlight during treatment.
MonitoringParameters
Perform RAS genotyping of tumour tissue before initiation of therapy. Monitor serum electrolytes (e.g. Ca, Mg, K) periodically and for at least 8 weeks after discontinuation of treatment. Monitor for infusion-related events, signs and symptoms of dermatological or pulmonary toxicities, keratitis or ulcerative keratitis.
Drug Interactions
Potentially Fatal: Increased incidence of adverse reactions (e.g. dermatologic toxicities, severe diarrhoea and dehydration) with bevacizumab-containing chemotherapy. Increased incidence of severe diarrhoea with IFL-containing chemotherapy.
Action
Description: Panitumumab is a recombinant, human IgG2 kappa monoclonal antibody that binds to the epidermal growth factor receptor (EGFR), thereby inhibiting phosphorylation and activation of intracellular tyrosine kinases resulting in inhibition of cell growth, proliferation, transformation and overall survival of tumour cells.
Pharmacokinetics:
Excretion: Elimination half-life: Approx 7.5 days.
Storage
Store between 2-8°C. Do not freeze. Protect from light.
ATC Classification
L01XC08 - panitumumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
References
Anon. Panitumumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 10/04/2018.

Anon. Panitumumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 10/04/2018.

Buckingham R (ed). Panitumumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/04/2018.

Joint Formulary Committee. Panitumumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/04/2018.

Vectibix Solution (Amgen Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 10/04/2018.

Disclaimer: This information is independently developed by MIMS based on Panitumumab 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
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in