DEFERASIROX

Other

Brand names: Deferasirox

Oral

Mechanism of Action

12.1 Mechanism of Action Deferasirox is an orally active chelator that is selective for iron (as Fe 3+ ). 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.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS Deferasirox is contraindicated in patients with: Estimated GFR less than 40 mL/min/1.73 m 2 [see Dosage and Administration (2.5)
• Warnings and Precautions (5.1) ]
• Poor performance status [see Warnings and Precautions ( 5.1
• 5.3 )]
• High-risk myelodysplastic syndromes (this patient population was not studied and is not expected to benefit from chelation therapy)

FDA Warnings

5 WARNINGS AND PRECAUTIONS Acute Kidney Injury: Measure serum creatinine in duplicate before starting therapy
2 ) Fatal and Nonfatal Gastrointestinal (GI) Bleeding, Ulceration, and Irritation: Risk may be greater in patients who are taking deferasirox in combination with drugs that have known ulcerogenic or hemorrhagic potential
3 ) Bone Marrow Suppression: Neutropenia, agranulocytosis, worsening anemia, and thrombocytopenia, including fatal events; monitor blood counts during deferasirox therapy
4 ) Age-related Risk of Toxicity: Monitor elderly and pediatric patients closely for toxicity

Known Side Effects

7 documented side effects by frequency

Diarrhea

>10%

Fever

1-10%

Nausea

1-10%

General Unwellness

1-10%

Fatigue

1-10%

Vomiting

0.1-1%

Abdominal Pain

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral