IntravenousdMMR advanced endometrial cancer, dMMR recurrent endometrial cancerAdult: 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).
IntravenousdMMR advanced solid tumour, dMMR recurrent solid tumourAdult: 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).
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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).
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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.
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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).
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Women of childbearing potential should use effective contraception during treatment and up to 4 months after the last dose.
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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).
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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.
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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.
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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.
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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.
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