Durvalumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Locally advanced, unresectable non-small cell lung carcinoma In patient whose tumours express PD-L1 and have no disease progression following platinum-based chemoradiation therapy: 10 mg/kg once every 2 weeks. Continue until disease progression, unacceptable toxicity or 12 months maximum therapy. Locally advanced or metastatic urothelial carcinoma In patient who have disease progression during or following platinum-based chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy: 10 mg/kg once every 2 weeks. Continue until disease progression or occurrence of unacceptable toxicity. Dose may be withheld or discontinued based on patient safety and tolerability.
Dosage Details
Intravenous
Locally advanced non-small cell lung carcinoma
Adult: In patients with locally-advanced, unresectable NSCLC whose tumours express PD-L1 and have no disease progression following platinum-based chemoradiation therapy: 10 mg/kg via infusion over 60 minutes once every 2 weeks. Continue until disease progression or unacceptable toxicity or 12 months maximum therapy. Dose may be withheld or discontinued based on patient safety and tolerability.

Intravenous
Locally advanced urothelial carcinoma, Metastatic urothelial carcinoma
Adult: In patients who have disease progression during or following platinum-based chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy: 10 mg/kg via infusion over 60 minutes once every 2 weeks. Continue until disease progression or occurrence of unacceptable toxicity. Dose may be withheld or discontinued based on patient safety and tolerability.
Reconstitution
Withdraw appropriate volume from the vial then transfer to 0.9% NaCl or 5% dextrose in water IV bag to produce final concentration of the diluted solution between 1 mg/mL and 15 mg/mL. Gently invert the bag to mix. Do not shake.
Special Precautions
Pregnancy and lactation.
Adverse Reactions
Significant: Immune-mediated reactions (e.g. rash, type 1 diabetes mellitus, UTI, thyroid disorders (e.g. thyroiditis, hypothyroidism), keratitis, uveitis, increased serum creatinine, elevation of ALT/AST levels, serum bilirubin increased. Rarely, immune-mediated aseptic meningitis, haemolytic anaemia, thrombocytopenia, myocarditis, myositis, hypophysitis, hypopituitarism leading to adrenal insufficiency and diabetes insipidus.
Blood and lymphatic system disorders: Anaemia, neutropenia, lymphocytopenia.
Gastrointestinal disorders: Diarrhoea, constipation, abdominal pain, nausea, pancreatitis, oral candidiasis.
General disorders and admin site conditions: Pyrexia, fatigue, night sweats.
Hepatobiliary disorders: Hypoalbuminaemia.
Immune system disorders: Urticaria.
Infections and infestations: Influenza.
Investigations: Increased gamma-glutamyl transferase.
Metabolism and nutrition disorders: Peripheral oedema, decreased appetite, hypocalcaemia, hyponatraemia, hyperkalaemia, hypermagnesaemia.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia. Rarely, polymyositis.
Psychiatric disorders: Insomnia, dysphonia.
Renal and urinary disorders: Dysuria.
Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection, dyspnoea, productive cough.
Skin and subcutaneous tissue disorders: Rash, dermatitis, pruritus. Rarely, vitiligo.
Potentially Fatal: Immune-mediated reactions including nephritis or acute kidney injury, hepatitis or hepatic injury, colitis, pneumonitis or interstitial lung disease; sepsis, severe infusion-related reactions.
MonitoringParameters
Monitor hepatic, renal, and thyroid function at baseline prior therapy initiation, during each cycle and as clinically indicated thereafter; serum glucose. Monitor for signs and symptoms of thyroid disorders, diabetes, colitis/diarrhoea, hepatitis, hypophysitis or hypopituitarism, adrenal insufficiency, thrombocytopenia, dermatological toxicity (e.g. dermatitis, rash), ocular toxicity (e.g. uveitis, keratitis), and infusion-related reactions. Perform radiographic imaging to evaluate suspected pneumonitis.
Drug Interactions
Use of systemic corticosteroids or immunosuppressants prior to treatment initiation may interfere with the activity and efficacy of durvalumab.
Action
Description: Durvalumab is a human immunoglobulin G1 kappa (IgG1k) monoclonal antibody that selectively inhibits the binding of programmed cell death ligand-1 (PD-L1) to PD-1 and CD80 (B7.1). The blockade of PD-L1/PD-1 and PD-L1/CD80 interactions leads to enhanced antitumour immune response and increased T-cell activation, allowing the T-cells to eliminate tumour cells.
Pharmacokinetics:
Distribution: Crosses placenta.
Excretion: Undergoes protein catabolism via reticuloendothelial system or targeted mediated disposition. Terminal elimination half-life: Approx 18 days.
Storage
Store between 2-8°C. Do not freeze. Protect from light.
ATC Classification
L01XC28 - durvalumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Disclaimer: This information is independently developed by MIMS based on Durvalumab 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