IMFINZI CONCENTRATE FOR SOLUTION FOR INFUSION 50 MG/ML

Durvalumab

Source of information: Drugbank (External Link). Last updated on: 3rd July 18
*Trade Name used in the content below may not be the same as the HSA-registered product.

Active Ingredient / Synonyms

Durvalumab | Durvalumab |

Description

Durvalumab is a a human monoclonal antibody that blocks programmed death ligand 1 (PD-L1), or CD 274. In May, 2017 it received FDA approval for previously treated patients with locally advanced or metastatic cancer in the urinary system (as Imfinzi). It is shown to be effective in patients with continued disease progression after the platinum-based chemotherapy. This drug has a relatively tolerable safety profile and its structural modification advantageously prevents the induction of antibody-dependent cytotoxicity (ADCC) or complement-dependent cytotoxicity (CDC) [L749].

Indication

Durvalumab is indicated for patients with urothelial carcinoma, such as urinary bladder, urethra or ureter cancer. Patients with prolonged disease progression due to failed platinum-based chemotherapy such as cisplatin and carboplatin are most likely to benefit from durvalumab treatment. Its clinical effectiveness is especially enhanced in PD-L1-positive patient groups [A19123].

Mechanism of Action

Durvalumab is a human immunoglobulin G1 kappa (IgGIk) monoclonal antibody that blocks PD-L1 binding to PD-1 and CD80. PD1 signalling pathway serves to physiologically limit the activity of T cells and autoimmune or inflammatory responses in the body however can be a mechanism of immunity resistance by tumor cells. Blockage of ligand-mediated PD1 pathway enhances further T cell activation, effector T cell proliferation, NK cell activity and cytokine production to minimize the growth of locally advancing or metastasizing solid tumors.

Pharmacodynamics

PD-L1 (programmed cell death ligand 1) is a ligand of PD-1 receptor on activated T cells. Tumor cells and tumor-associated immune cells express this inhibitory immune checkpoint molecule that interrupts normal signalling of T cell and subsequent immune responses in the tumor microenvironment by binding to PD-1 receptors. As a novel anticancer immunotherapy, durvalumab enhances T cell responses at tumor sites. Durvalumab acts as a selective antibody against this ligand and prevents its interaction to the PD-1 receptor and promotes normal antitumor T-cell mediated immune activity. It is also referred to as an immune checkpoint inhibitor.

Pharmacokinetics

Absorption:

Not Available

Distribution:

Mean Vd approximately 5.6 L with 17% coefficient of variation.

Metabolism:

Most likely to be degraded into peptides and amino acids by circulating phagocytic cellsor by target antigen-containing cells [A19126].

Elimination:

Not Available

Half-life

Mean elimination half-life is approximately 12 days with 23.2% coefficient of variation.

Clearance

Mean steady state clearance is approximately 8.24 mL/h (37.3% coefficient of variation).

Toxicity

Many toxic effects of durvalumab therapy are immune-mediated inflammation in various tissues including pneumonitis, hepatitis and colitis. Disturbances in endocrine system are possible adverse effects such as hypo/hyperthyroidism, type I diabetes mellitus and adrenal insufficiency. Cessation of therapy is recommended in case of any immune-mediated or infusion-related adverse reactions. Animal studies suggest a possibility of embryo-fetal toxicity.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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Approval Information

IMFINZI CONCENTRATE FOR SOLUTION FOR INFUSION 50 MG/ML was registered with Health Science Authority of Singapore by ASTRAZENECA SINGAPORE PTE LTD. It is marketed with the registration number of SIN15569P with effective from 2018-10-29.

This product contains 50 mg/ml of Durvalumab in the form of INFUSION, SOLUTION CONCENTRATE.

The medicine was manufactured by Catalent Indiana-LLC in UNITED STATES, and Vetter Pharma-Fertigung GmbH & Co. KG in GERMANY

It is a Presciption Only Medicine which can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Anatomical Therapeutic Chemical (ATC) Classification

ATC Code: L01XC28

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1 DEXTROMETHORPHAN LINCTUS 15mg/5ml Dextromethorphan P Only DRUG HOUSES OF AUSTRALIA PTE LTD Active
22 ZENMOLIN SYRUP 2mg/5ml Salbutamol P Only DRUG HOUSES OF AUSTRALIA PTE LTD Active
41 APO-PROPRANOLOL TABLET 40mg Propranolol POM PHARMAFORTE SINGAPORE PTE LTD Active
42 APO-DIAZEPAM TABLET 2mg Diazepam POM PHARMAFORTE SINGAPORE PTE LTD Active
44 APO-DIAZEPAM TABLET 5mg Diazepam POM PHARMAFORTE SINGAPORE PTE LTD Active
45 APO-DIAZEPAM TABLET 10mg Diazepam POM PHARMAFORTE SINGAPORE PTE LTD Active
46 APO-PROPRANOLOL TABLET 10mg Propranolol POM PHARMAFORTE SINGAPORE PTE LTD Active
55 APO-ISDN TABLET 10mg Isosorbide Dinitrate POM PHARMAFORTE SINGAPORE PTE LTD Active
63 DIAPO TABLET 10mg Diazepam POM BEACONS PHARMACEUTICALS PTE LTD Active
64 FURMIDE TABLET 40mg Furosemide POM BEACONS PHARMACEUTICALS PTE LTD Active

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5 DIPHENHYDRAMINE EXPECTORANT PAED. Ammonium Chloride|Diphenhydramine|Sodium Citrate P Only DRUG HOUSES OF AUSTRALIA PTE LTD Active
400 FAKTU SUPPOSITORY Cinchocaine|Policresulen P Only TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE LTD Active
407 TRIMAXAZOLE TABLET Sulfamethoxazole|Trimethoprim POM BEACONS PHARMACEUTICALS PTE LTD Active
435 APO-SULFATRIM TABLET Sulfamethoxazole|Trimethoprim POM PHARMAFORTE SINGAPORE PTE LTD Active
508 APO-SULFATRIM PEDIATRIC TABLET Sulfamethoxazole|Trimethoprim POM PHARMAFORTE SINGAPORE PTE LTD Active
526 B.S. SUSPENSION Sulfamethoxazole|Trimethoprim POM APEX PHARMA MARKETING PTE LTD Active
583 CO-TRIMEXAZOLE SUSPENSION Sulfamethoxazole|Trimethoprim POM BEACONS PHARMACEUTICALS PTE LTD Active
676 BANEOCIN OINTMENT Bacitracin|Neomycin POM NOVARTIS (SINGAPORE) PTE LTD Active
678 BANEOCIN POWDER Bacitracin|Neomycin POM NOVARTIS (SINGAPORE) PTE LTD Active
706 TIENAM 500 FOR INJECTION Imipenem|Cilastatin POM MSD PHARMA (SINGAPORE) PTE LTD Active