IntravenousUnresectable hepatocellular carcinomaAdult: In combination with durvalumab: Patients weighing <30 kg: 4 mg/kg as a single dose via infusion over 60 minutes, followed by durvalumab on Day 1 of Cycle 1; ≥30 kg: 300 mg as a single dose via infusion over 60 minutes, followed by durvalumab on Day 1 of Cycle 1. After Cycle 1 of combination therapy, continue durvalumab as monotherapy every 4 weeks until disease progression or unacceptable toxicity (refer to specific product information of durvalumab for dosage recommendations). Dosing interruption or discontinuation may be required according to individual safety or tolerability. Treatment recommendations may vary between countries (refer to detailed local guidelines).
IntravenousMetastatic non-small cell lung carcinomaAdult: In patients with squamous or non-squamous tumour histology without sensitising epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumour aberrations: Cycles 1-4: In combination with durvalumab and platinum-based chemotherapy: 1 mg/kg (for patients weighing <30 kg) or 75 mg (for patients weighing ≥30 kg) on Day 1, repeated every 3 weeks for 4 cycles. Platinum-based chemotherapy regimen for up to 4 cycles consists of carboplatin plus nab-paclitaxel or carboplatin/cisplatin plus pemetrexed in patients with non-squamous tumour histology; carboplatin plus nab-paclitaxel or carboplatin/cisplatin plus gemcitabine may be used in patients with squamous tumour histology. Cycle 5: Administer durvalumab (without tremelimumab dose). Revise the dosing interval from every 3 weeks to every 4 weeks starting at Cycle 5 (Week 12). Cycle 6: In combination with durvalumab: 1 mg/kg (for patients weighing <30 kg) or 75 mg (for patients weighing ≥30 kg) on Day 1. After Cycle 6, continue durvalumab until disease progression or unacceptable toxicity. All tremelimumab doses are given via infusion over 60 minutes. If patients receive <4 cycles of platinum-based chemotherapy, administer the remaining tremelimumab doses (up to a total of 5 doses) in combination with durvalumab every 4 weeks after the platinum-based chemotherapy phase. Patients with non-squamous disease who received pemetrexed plus carboplatin/cisplatin may be given an optional pemetrexed therapy starting from Cycle 5 or Week 12 (in combination with durvalumab) until disease progression or unacceptable toxicity. Refer to the specific product information of durvalumab, platinum-based chemotherapy regimens, and pemetrexed for dosage recommendations. Dosing interruption or discontinuation may be required according to individual safety or tolerability. Treatment recommendations may vary between countries (refer to detailed local guidelines).
|
|
|
IV infusion: Dilute the required volume in an IV bag containing NaCl 0.9% solution for inj or dextrose 5% in water to make a final concentration between 0.1-10 mg/mL. Max concentration: 10 mg/mL. Mix by gentle inversion; do not shake. When given in combination with durvalumab, infuse the tremelimumab dose 1st, followed by the durvalumab dose on the same day. When administered in combination with durvalumab and platinum-based chemotherapy or pemetrexed therapy, infuse the tremelimumab dose 1st, followed by the durvalumab dose, and then the platinum-based chemotherapy or pemetrexed dose all on the same day. Use separate infusion bags and filters for each infusion.
|
|
|
Patient with myasthenia gravis. Pregnancy.
|
Significant: Immune-mediated reactions, including colitis (which is frequently associated with diarrhoea), pancreatitis, intestinal perforation, large intestine perforation, endocrinopathies (e.g. hyperthyroidism, hypothyroidism, thyroiditis, primary and secondary adrenal insufficiency, hypophysitis, hypopituitarism), nephritis with renal dysfunction, exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, and rash or dermatitis (including pemphigoid). Rarely, immune-mediated gastritis, duodenitis, and hypoparathyroidism; immune-mediated iritis, uveitis, or other ocular toxicity (e.g. Vogt-Koyanagi-Harada-like syndrome, visual impairment, retinal detachment, blindness).
Blood and lymphatic system disorders: Leucopenia, lymphocytopenia.
Gastrointestinal disorders: Abdominal pain, nausea.
General disorders and administration site conditions: Pyrexia, peripheral oedema, fatigue.
Infections and infestations: Dental and oral soft tissue infections.
Investigations: Increased serum ALT, AST, alkaline phosphatase, bilirubin, and creatinine; increased serum glucose, K, lipase, and amylase; decreased Hb, serum Ca, Na, and albumin.
Metabolism and nutrition disorders: Decreased appetite.
Musculoskeletal and connective tissue disorders: Myalgia.
Psychiatric disorders: Insomnia.
Renal and urinary disorders: Dysuria.
Respiratory, thoracic and mediastinal disorders: Cough, productive cough, URTI, pneumonia, influenza.
Skin and subcutaneous tissue disorders: Pruritus, night sweats.
Potentially Fatal: Severe immune-mediated reactions, including pneumonitis, interstitial lung disease, hepatitis, type 1 diabetes mellitus (which may be presented with diabetic ketoacidosis), and infusion-related reactions. Rarely, immune-mediated autoimmune neuropathy, meningitis, encephalitis, Guillain-Barre syndrome, nerve paresis, myelitis and demyelination, myasthenic syndrome or myasthenia gravis, pericarditis, myocarditis, vasculitis, rhabdomyolysis, arthritis, myositis, polymyalgia rheumatica, polymyositis, aplastic anaemia, haemolytic anaemia, haemophagocytic lymphohistiocytosis, histiocytic necrotising lymphadenitis (Kikuchi lymphadenitis), immune thrombocytopenia, sarcoidosis, and systemic inflammatory response syndrome.
|
IV: Z (Animal studies showed embryo-foetal harm and death. Generally not recommended. Consult product literature for specific recommendations.)
|
Women of childbearing potential must use proven birth control methods during therapy and for 3 months after stopping the treatment. Do not breastfeed during therapy and for 3 months after the last dose.
|
Evaluate pregnancy status in women of childbearing potential before treatment initiation. Obtain LFTs, serum creatinine, ACTH and thyroid function tests at baseline and before each dose. HBV screening, including HBsAg, hepatitis B core antibody, total Ig or IgG, and antibody to HBsAg is recommended before or at the beginning of systemic anticancer therapy. Monitor patient's weight before each dose (when given in combination with durvalumab and platinum-based chemotherapy); blood glucose. Perform radiographic imaging to evaluate suspected pneumonitis. Closely assess for signs and symptoms of underlying immune-mediated adverse reactions, including adrenal insufficiency, hypophysitis or hypopituitarism, thyroid disorders, myocarditis, pneumonitis, diabetes or hyperglycaemia, colitis, intestinal perforation, hepatitis or hepatotoxicity, dermatologic toxicity, ocular toxicity, and infusion-related reactions.
|
May diminish the therapeutic effect with systemic corticosteroids (except for physiological dose of ≤10 mg/day prednisone or equivalent) or immunosuppressants; after starting tremelimumab therapy, systemic corticosteroids or other immunosuppressants may be used to treat immune-related adverse reactions.
|
Description:
Mechanism of Action: Tremelimumab is a human immunoglobulin (IgG2) monoclonal antibody that is directed against cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), a cell surface receptor expressed on T lymphocytes involved in the downregulation of T-cell activation. Tremelimumab binds to CTLA-4 and inhibits its interaction with the CD80 and CD86 ligands, resulting in enhanced T-cell activation and proliferation. This activity consequently increases T-cell diversity and enhances the anti-tumour effect.
Pharmacokinetics:
Distribution: Volume of distribution: 3.45 L (central); 2.66 L (peripheral).
Excretion: Elimination half-life: Approx 17 days (single dose).
|
Intact vial: Store between 2-8°C. Protect from light. Diluted solution for IV infusion: Stable for up to 24 hours when stored between 2-8°C or at room temperature (up to 30°C). Do not freeze or shake the intact vial and diluted infusion solution. Stability recommendations for diluted infusion solution may vary between countries (refer to specific local guidelines).
|
|
|
L01FX20 - tremelimumab ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.
|
Anon. Tremelimumab-actl. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 20/01/2025. Brayfield A, Cadart C (eds). Tremelimumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 20/01/2025. Imjudo 20 mg/mL Concentrate for Solution for Infusion (AstraZeneca UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 20/01/2025. Imjudo Concentrate for Solution for Infusion 20 mg/mL (AstraZeneca Singapore Pte Ltd). MIMS Singapore. http://www.mims.com/singapore. Accessed 20/01/2025. Imjudo Concentrate for Solution for Intravenous Infusion 20 mg/mL (AstraZeneca Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 20/01/2025. Imjudo Injection, Solution (AstraZeneca Pharmaceuticals LP). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 20/01/2025. Joint Formulary Committee. Tremelimumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 20/01/2025. Tremelimumab. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 20/01/2025.
|
Sign Out
Continue with Google