Dostarlimab


Generic Medicine Info
Indications and Dosage
Intravenous
dMMR advanced endometrial cancer, dMMR recurrent endometrial cancer
Adult: For the treatment of cases that have progressed on or after previous treatment with a platinum-containing regimen: 500 mg every 3 weeks for 4 doses; then starting 3 weeks after the 4th dose, give 1,000 mg every 6 weeks until disease progression or unacceptable toxicity occurs. Doses are given via infusion over 30 minutes. Dosing interruption or discontinuation may be required according to individual safety or tolerability (refer to detailed product guidelines).

Intravenous
dMMR advanced solid tumour, dMMR recurrent solid tumour
Adult: For the treatment of cases that have progressed on or after previous treatment and who have no satisfactory alternative treatment options: 500 mg every 3 weeks for 4 doses; then starting 3 weeks after the 4th dose, give 1,000 mg every 6 weeks until disease progression or unacceptable toxicity occurs. Doses are given via infusion over 30 minutes. Dosing interruption or discontinuation may be required according to individual safety or tolerability; treatment recommendations may vary between countries (refer to specific product guidelines).
Reconstitution
Withdraw the appropriate dose and required volume from the vial(s), then dilute with NaCl 0.9% solution or dextrose 5% in water to make a final concentration of 2-10 mg/mL. Mix by gentle inversion. Do not shake. Instructions for reconstitution may vary between countries (refer to specific product guidelines).
Contraindications
Pregnancy and lactation.
Special Precautions
Patient with a history of severe or life-threatening skin adverse reaction associated with other immune-stimulatory anticancer agents; risk of transplant-related complications (e.g. those who receive an allogeneic haematopoietic stem cell transplant); myasthenia gravis.
Adverse Reactions
Significant: Immune-mediated rash or dermatitis; bullous and exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, toxic epidermal necrolysis; immune-mediated endocrinopathies (e.g. primary and secondary adrenal insufficiency, type 1 diabetes mellitus [may present with diabetic ketoacidosis], hypophysitis [may present with acute mass effect symptoms] leading to hypopituitarism, hyperthyroidism, hypothyroidism, thyroiditis); immune-mediated colitis, pancreatitis, gastritis or duodenitis; immune-mediated hepatitis; immune-mediated nephritis with kidney dysfunction; immune-mediated uveitis or iritis (cases may be associated with retinal detachment), differing grades of visual impairment (including blindness), Vogt-Koyanagi-Harada-like syndrome; immune-mediated pneumonitis or arthralgia.
Blood and lymphatic system disorders: Anaemia.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea.
General disorders and administration site conditions: Pyrexia, chills.
Skin and subcutaneous tissue disorders: Pruritus.
Potentially Fatal: Infusion-related reactions; other immune-mediated adverse reactions affecting any organ system (e.g. myocarditis, pericarditis, vasculitis, meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome or myasthenia gravis, Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy, myositis or polymyositis, rhabdomyolysis, arthritis, polymyalgia rheumatica, hypoparathyroidism, autoimmune haemolytic anaemia, aplastic anaemia, haemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotising lymphadenitis, sarcoidosis, immune thrombocytopenia). Solid organ transplant rejection; transplant-related complications (e.g. hyperacute graft-versus-host disease [GVHD], acute or chronic GVHD, hepatic veno-occlusive disease).
IV: Z (Not recommended)
Patient Counseling Information
Women of childbearing potential should use effective contraception during treatment and up to 4 months after the last dose.
Monitoring Parameters
Screen for the presence of mismatch repair deficient (dMMR) in tumour specimens. Confirm pregnancy status before treatment initiation in female of reproductive potential. Monitor LFTs, renal function, and thyroid function (at baseline and periodically during treatment); blood glucose. Assess for signs and symptoms of immune-mediated adverse reactions, infusion-related reactions; transplant-related complications (if recipient of haematopoietic stem cell transplant).
Action
Description:
Mechanism of Action: Dostarlimab is a humanised anti-programmed cell death protein-1 (PD-1) immunoglobulin G4 (IgG4) which binds to PD-1 receptors on T-cells and inhibits interactions of binding with its ligands (PD-L1 and PD-L2). The suppression of PD-1 pathway-mediated immune response leads to the prevention of T-cell functions such as proliferation, cytokine production, and cytotoxic activity.
Pharmacokinetics:
Metabolism: Metabolised via catabolic pathways into small peptides, amino acids, and small carbohydrates by lysosome through fluid-phase or receptor-mediated endocytosis.
Excretion: Elimination half-life: 25.4 days.
Storage
Store intact vials between 2-8°C. Do not freeze. Protect from light. Diluted solutions for infusion are stable for 24 hours when stored between 2-8°C or for 6 hours when stored at room temperature up to 25°C (from the time of preparation until the end of administration). Follow applicable procedures for receiving, handling, administration, and disposal.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FF07 - dostarlimab ; Belongs to the class of PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors. Used in the treatment of cancer.
References
Anon. Dostarlimab-gxly. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 08/02/2023.

Anon. Dostarlimab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/02/2023.

Buckingham R (ed). Dostarlimab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/03/2023.

Jemperli 500 mg Concentrate for Solution for Infusion (GlaxoSmithKline UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 08/02/2023.

Jemperli Concentrate for Solution for Infusion 500 mg/10 mL (GlaxoSmithKline Limited [HK]). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 08/02/2023.

Jemperli Injection (GlaxoSmithKline LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 08/02/2023.

Joint Formulary Committee. Dostarlimab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/02/2023.

Disclaimer: This information is independently developed by MIMS based on Dostarlimab 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 © 2024 MIMS. All rights reserved. Powered by MIMS.com
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