JADENU

Clinical safety rating: caution

Comprehensive clinical and safety monograph for JADENU (JADENU).

How it works

Deferasirox is an oral iron chelator that binds trivalent iron (Fe3+) with high affinity, forming a stable complex that is excreted primarily in the feces.

What the body does with it

Metabolism	Primarily metabolized via glucuronidation by UGT1A1 and UGT1A3, with minor contributions from CYP1A2, CYP2D6, and CYP3A4. Excreted mainly in the feces (84%) and to a lesser extent in urine (8%).
Excretion	Primarily fecal (hepatobiliary) ~75-90% as unchanged drug and iron complex; renal excretion of deferasirox is minimal (<5% unchanged).
Half-life	Terminal elimination half-life is 8-16 hours (mean ~12 h) in patients with transfusional iron overload, allowing once-daily dosing.
Protein binding	Deferasirox is highly protein bound (>99%) primarily to serum albumin.
Volume of Distribution	Apparent Vd is approximately 14-16 L in adults (<0.2 L/kg); reflects extensive tissue distribution, including liver and heart.
Bioavailability	Oral tablet: Absolute bioavailability ~70% (JADENU); limited data for other formulations.
Onset of Action	Oral: Reductions in serum ferritin and liver iron concentration are detectable after 2-4 weeks of continuous dosing.
Duration of Action	24 hours (once-daily dosing); iron chelation continues throughout the dosing interval. Clinical effects monitored monthly via serum ferritin.

Classification & Brands

Dosing & administration

30 mg/kg once daily orally, up to a maximum of 60 mg/kg/day, for iron chelation in patients with thalassemia or other chronic iron overload; dose should be adjusted based on serum ferritin levels and therapeutic response.

Dosage form	TABLET
Renal impairment	Contraindicated in patients with GFR < 40 mL/min/1.73m². For GFR 40-60 mL/min/1.73m², reduce dose by 50% and monitor renal function weekly. For GFR > 60 mL/min/1.73m², no adjustment needed.
Liver impairment	Child-Pugh Class A: No adjustment. Child-Pugh Class B: Reduce dose by 50%. Child-Pugh Class C: Contraindicated due to risk of hepatic toxicity.
Pediatric use	For pediatric patients aged 2 years and older, weight-based dosing: 20-30 mg/kg once daily, adjusted based on serum ferritin and iron burden. Maximum 60 mg/kg/day. Safety and efficacy not established in children under 2 years.
Geriatric use	No specific dose adjustment recommended, but caution due to age-related renal impairment; monitor renal function and iron levels closely. Start at lower end of dosing range.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for JADENU (JADENU).

Breastfeeding	Deferasirox is excreted into breast milk in animal studies; human data unknown. M/P ratio not established. Due to potential for adverse effects in nursing infants (e.g., iron deficiency, gastrointestinal toxicity), breastfeeding is not recommended during therapy.
Teratogenic Risk	Pregnancy Category D. First trimester: Based on animal studies and limited human data, deferasirox may cause fetal harm. There is a potential for increased risk of spontaneous abortion and major birth defects. Second and third trimesters: Exposure may cause fetal anemia, iron overload, and possible fetal growth restriction due to maternal iron chelation. Use only if benefit outweighs risk.

Warnings & precautions

■ FDA Black Box Warning

JADENU may cause severe and potentially fatal renal toxicity, hepatic toxicity, including hepatic failure, and gastrointestinal hemorrhage. Monitor renal function, hepatic function, and gastrointestinal symptoms closely.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Estimated glomerular filtration rate (eGFR) less than 40 mL/min/1.73 m2","Poor performance status with high-risk myelodysplastic syndromes (MDS) or advanced malignancies","Hypersensitivity to deferasirox or any component of the formulation"]

Clinical Precautions

Precautions

["Renal toxicity: Acute renal failure, proteinuria, Fanconi syndrome; monitor serum creatinine and creatinine clearance","Hepatic toxicity: Increased liver enzymes, hepatic failure; monitor liver function tests","Gastrointestinal hemorrhage: Fatal events reported; monitor for GI bleeding","Cytopenias: Agranulocytosis, neutropenia, anemia; monitor blood counts","Hypersensitivity reactions: Rash, urticaria, severe reactions including anaphylaxis and Stevens-Johnson syndrome","Auditory and ocular disturbances: Hearing loss, visual impairment; perform regular audiometric and ophthalmic exams"]

Clinical Tips & Counseling

Drug interactions

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JADENU

Clinical safety rating: caution

Comprehensive clinical and safety monograph for JADENU (JADENU).

How it works

Deferasirox is an oral iron chelator that binds trivalent iron (Fe3+) with high affinity, forming a stable complex that is excreted primarily in the feces.

What the body does with it

Metabolism	Primarily metabolized via glucuronidation by UGT1A1 and UGT1A3, with minor contributions from CYP1A2, CYP2D6, and CYP3A4. Excreted mainly in the feces (84%) and to a lesser extent in urine (8%).
Excretion	Primarily fecal (hepatobiliary) ~75-90% as unchanged drug and iron complex; renal excretion of deferasirox is minimal (<5% unchanged).
Half-life	Terminal elimination half-life is 8-16 hours (mean ~12 h) in patients with transfusional iron overload, allowing once-daily dosing.
Protein binding	Deferasirox is highly protein bound (>99%) primarily to serum albumin.
Volume of Distribution	Apparent Vd is approximately 14-16 L in adults (<0.2 L/kg); reflects extensive tissue distribution, including liver and heart.
Bioavailability	Oral tablet: Absolute bioavailability ~70% (JADENU); limited data for other formulations.
Onset of Action	Oral: Reductions in serum ferritin and liver iron concentration are detectable after 2-4 weeks of continuous dosing.
Duration of Action	24 hours (once-daily dosing); iron chelation continues throughout the dosing interval. Clinical effects monitored monthly via serum ferritin.

Classification & Brands

Dosing & administration

Dosage form	TABLET
Renal impairment	Contraindicated in patients with GFR < 40 mL/min/1.73m². For GFR 40-60 mL/min/1.73m², reduce dose by 50% and monitor renal function weekly. For GFR > 60 mL/min/1.73m², no adjustment needed.
Liver impairment	Child-Pugh Class A: No adjustment. Child-Pugh Class B: Reduce dose by 50%. Child-Pugh Class C: Contraindicated due to risk of hepatic toxicity.
Pediatric use	For pediatric patients aged 2 years and older, weight-based dosing: 20-30 mg/kg once daily, adjusted based on serum ferritin and iron burden. Maximum 60 mg/kg/day. Safety and efficacy not established in children under 2 years.
Geriatric use	No specific dose adjustment recommended, but caution due to age-related renal impairment; monitor renal function and iron levels closely. Start at lower end of dosing range.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for JADENU (JADENU).

Breastfeeding	Deferasirox is excreted into breast milk in animal studies; human data unknown. M/P ratio not established. Due to potential for adverse effects in nursing infants (e.g., iron deficiency, gastrointestinal toxicity), breastfeeding is not recommended during therapy.
Teratogenic Risk	Pregnancy Category D. First trimester: Based on animal studies and limited human data, deferasirox may cause fetal harm. There is a potential for increased risk of spontaneous abortion and major birth defects. Second and third trimesters: Exposure may cause fetal anemia, iron overload, and possible fetal growth restriction due to maternal iron chelation. Use only if benefit outweighs risk.