Deferasirox

DEFERASIROX

Manufacturer: Amneal Pharmaceuticals NY LLC

Score: 148.0

Quick Summary

Deferasirox is an iron chelator used to treat chronic iron overload due to blood transfusions in patients 2 years of age and older, and for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia syndromes. The recommended initial dose for patients with estimated glomerular filtration rate (eGFR) greater than 60 mL/min/1.73 m^2 is 14 mg per kg body weight orally, once daily for transfusional iron overload, and 7 mg per kg body weight orally, once daily for non-transfusion-dependent thalassemia syndromes. Deferasirox can cause serious adverse reactions, including renal failure, hepatic failure, and gastrointestinal hemorrhage, and is contraindicated in patients with eGFR less than 40 mL/min/1.73 m^2, poor performance status, high-risk myelodysplastic syndromes, advanced malignancies, platelet counts less than 50 x 10^9/L, and known hypersensitivity to deferasirox or any component of deferasirox tablets.

Key Clinical Findings and Indications

Treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older
Treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia syndromes
Reduction of liver iron concentration and serum ferritin levels

Important Safety Information

Warning

Deferasirox can cause serious adverse reactions, including renal failure, hepatic failure, and gastrointestinal hemorrhage

Contraindications

eGFR less than 40 mL/min/1.73 m^2
Poor performance status
High-risk myelodysplastic syndromes
Advanced malignancies
Platelet counts less than 50 x 10^9/L
Known hypersensitivity to deferasirox or any component of deferasirox tablets

Adverse Reactions

Renal failure
Hepatic failure
Gastrointestinal hemorrhage
Diarrhea
Vomiting
Nausea
Abdominal pain
Skin rash

Dosing Recommendations

General Guidance

Dose adjustments should be made based on serum ferritin levels and renal function

Transfusional iron overload

Adult Dose

14 mg per kg body weight orally, once daily

Pediatric Dose

14 mg per kg body weight orally, once daily for patients 2 years of age and older

Non-transfusion-dependent thalassemia syndromes

Adult Dose

7 mg per kg body weight orally, once daily

Pediatric Dose

7 mg per kg body weight orally, once daily for patients 10 years of age and older

Special Population Considerations

Pregnancy

Deferasirox should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
There are no studies with the use of deferasirox in pregnant women to inform drug-associated risks

Nursing Mothers

It is not known whether deferasirox is excreted in human milk
Caution should be exercised when deferasirox is administered to a nursing woman

Pediatric Use

Deferasirox is approved for use in pediatric patients 2 years of age and older for the treatment of transfusional iron overload
Deferasirox is approved for use in pediatric patients 10 years of age and older for the treatment of non-transfusion-dependent thalassemia syndromes

Geriatric Use

Elderly patients experienced a higher frequency of adverse reactions than younger patients
Monitor elderly patients for early signs or symptoms of adverse reactions that may require a dose adjustment