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JADENU FILM COATED TABLET 360MG

Product Information

Registration Status: Active

SIN15215P

JADENU FILM COATED TABLET 360MG is approved to be sold in Singapore with effective from 2017-04-18. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN15215P.

This product contains Deferasirox 360mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.

This product is manufactured by Novartis Pharma Stein AG in SWITZERLAND, andNovartis Pharma Produktions GmbH (primary and secondary packager) in GERMANY.

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

Product Reference
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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.

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

Active Ingredient/Synonyms

Deferasiroxum | ICL 670 | ICL 670a | 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.

References

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

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