Ipilimumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Metastatic melanoma 3 mg/kg over 90 minutes every 3 weeks for a total of 4 doses. In case of toxicity, modify dose according to product literature. As adjuvant treatment of cutaneous melanoma 10 mg/kg over 90 minutes every 3 weeks for a total of 4 doses then, 10 mg/kg every 12 weeks for up to 3 years. In case of toxicity, modify dose according to product literature.
Dosage Details
Intravenous
Metastatic melanoma
Adult: 3 mg/kg via infusion over 90 minutes every 3 weeks for a total of 4 doses. In case of toxicity, doses may be delayed, but all treatment must be given within 16 weeks of 1st dose, or modified according to product literature.
Child: ≥12 years Same as adult dose.

Intravenous
Melanoma
Adult: As adjuvant therapy in patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of >1 mm who have undergone complete resection: 10 mg/kg via infusion over 90 minutes every 3 weeks for a total of 4 doses then, 10 mg/kg every 12 weeks for up to 3 years or until documented disease recurrence or unacceptable toxicity. In case of toxicity, omit dose/s or modify according to product literature.
Reconstitution
Allow vials to sit at room temperature for approx 5 minutes. Withdraw appropriate volume and dilute with normal saline or dextrose 5% to a final concentration of 1-2 mg/mL. Mix by gentle inversion. Do not shake.
Special Precautions
Patient with history of autoimmune disease. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Uveitis, iritis, episcleritis, Vogt-Koyanagi-Harada-like syndrome.
Blood and lymphatic system disorders: Anaemia, lymphopaenia.
Eye disorders: Blurred vision, eye pain.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, GERD, abdominal pain, gastrointestinal haemorrhage.
General disorders and administration site conditions: Fatigue, lethargy, asthenia, mucosal inflammation, oedema, pyrexia, chills, influenza-like illness.
Hepatobiliary disorders: Abnormal hepatic function.
Injury, poisoning and procedural complications: Inj site reaction.
Investigations: Weight loss.
Metabolism and nutrition disorders: Decreased appetite, hypokalaemia, dehydration.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia, musculoskeletal pain, muscle spasms.
Neoplasms benign, malignant and unspecified: Tumour pain.
Nervous system disorders: Dizziness, headache.
Psychiatric disorders: Confusion, insomnia.
Respiratory, thoracic and mediastinal disorders: Dyspnoea, cough.
Skin and subcutaneous tissue disorders: Rash, pruritus, erythema, urticaria, eczema, vitiligo, alopecia, night sweats, dry skin.
Vascular disorders: Hypotension, flushing, hot flush.
Potentially Fatal: Immune-mediated reactions [e.g. enterocolitis (including colitis, gastrointestinal perforation), hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, endocrinopathy (including hypopituitarism and hypothyroidism)].
IV/Parenteral: C
Patient Counseling Information
This drug may cause dizziness, blurred vision or eye pain, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor for ACTH level, thyroid function tests and LFTs at baseline and before each dose; signs and symptoms of immune-mediated reactions at baseline and before each dose.
Drug Interactions
May increase hepatotoxicity of vemurafenib.
Action
Description: Ipilimumab, an antineoplastic drug, is a recombinant, fully human monoclonal antibody. It inhibits cytotoxic-T-lymphocyte-associated antigen 4 (CTLA-4), a down-regulator of T-cell activation pathways, thereby prolonging T-cell activation and proliferation and enhancing anti-tumour immune response. It may also decrease T-regulatory cell function and increase T cell responsiveness.
Pharmacokinetics:
Excretion: Terminal elimination half-life: 15.4 days.
Storage
Store between 2-8°C. Protect from light. Do not freeze. Reconstituted solution: Store between 2-25°C, stable for up to 24 hours.
Any unused portions should be disposed of in accordance with local requirements.
ATC Classification
L01XC11 - ipilimumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
References
Anon. Ipilimumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/01/2018.

Buckingham R (ed). Ipilimumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/01/2018.

Joint Formulary Committee. Ipilimumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/01/2018.

McEvoy GK, Snow EK, Miller J et al (eds). Ipilimumab. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 03/01/2018.

Yervoy Injection (E.R. Squibb & Sons, L.L.C.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/01/2018.

Disclaimer: This information is independently developed by MIMS based on Ipilimumab 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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