JADENU FILM-COATED TABLET 180MG

Deferasirox

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

Deferasiroxum | ICL 670 | ICL 670a | Deferasirox |

Description

Deferasirox is an oral iron chelator. Its main use is to reduce chronic iron overload in patients who are receiving long term blood transfusions for conditions such as beta-thalassemia and other chronic anemias. It is the first oral medication approved in the USA for this purpose.

Indication

For the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.

Mechanism of Action

Two molecules of deferasirox are capable of binding to 1 atom of iron. Deferasirox works in treating iron toxicity by binding trivalent (ferric) iron (for which it has a strong affinity), forming a stable complex which is eliminated via the kidneys.

Pharmacodynamics

Deferasirox is an orally active chelator that is selective for iron (as Fe3+). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio. Although deferasirox has very low affinity for zinc and copper there are variable decreases in the serum concentration of these trace metals after the administration of deferasirox. The clinical significance of these decreases is uncertain.

Pharmacokinetics

Absorption:

The absolute bioavailability (AUC) of deferasirox tablets for oral suspension is 70% compared to an intravenous dose.

Distribution:

* 14.37 ± 2.69 L

Metabolism:

Hepatic. CYP450-catalyzed (oxidative) metabolism of deferasirox appears to be minor in humans (about 8%). Glucuronidation is the main metabolic pathway for deferasirox, with subsequent biliary excretion.

Elimination:

Deferasirox and metabolites are primarily (84% of the dose) excreted in the feces. Renal excretion of deferasirox and metabolites is minimal (8% of the administered dose).

Half-life

The mean elimination half-life ranged from 8 to 16 hours following oral administration.

Clearance

Not Available

Toxicity

Not Available

References

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

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Approval Information

JADENU FILM-COATED TABLET 180MG was registered with Health Science Authority of Singapore by NOVARTIS (SINGAPORE) PTE LTD. It is marketed with the registration number of SIN15214P with effective from 2017-04-18.

This product contains 180mg of Deferasirox in the form of TABLET, FILM-COATED.

The medicine was manufactured by Novartis Pharma Stein AG in SWITZERLAND, and Novartis Pharma Produktions GmbH (primary 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: V03AC03

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