Jadenu

Deferasirox

Chronic Fe overload due to blood transfusions (transfusional hemosiderosis) in adult & ped patients ≥2 yr & w/ non-transfusion-dependent thalassemia syndromes in patients ≥10 yr.

Transfusional Fe overload Initially 14 mg/kg/day. Patients receiving >14 mL/kg/mth of packed RBC 21 mg/kg/day. Patients receiving <7 mL/kg/mth of packed RBC 7 mg/kg/day. Dose adjustments may be in steps 3.5-7 mg/kg based on individual patient's response. Max: 28 mg/kg/day. Non-transfusion-dependent thalassemia syndromes Initially 7 mg/kg/day. Dose increase in increments of 3.5-7 mg/kg if the patient's LIC is ≥7 mg Fe/g dw or serum ferritin is consistently >2,000 mcg/L & is well tolerated. Max: 14 mg/kg/day.

Hypersensitivity. CrCl <40 mL/min or serum creatinine >2 times the age-appropriate ULN. High risk myelodysplastic syndrome (MDS) patients & those w/ other hematological & non-hematological malignancies who are not expected to benefit from chelation therapy due to the rapid progression of their disease.

Acute renal failure. Severe hepatic impairment. Assess serum creatinine &/or CrCl prior to initiating therapy & monitor, mthly thereafter. Patients w/ CrCl between 40 mL/min & <60 mL/min. Perform tests for proteinuria mthly. Maintain adequate hydration in patients who develop diarrhea or vomiting. Interrupt treatment if there is a progressive increase in serum creatinine beyond ULN. Monitor serum transaminases, bilirubin & alkaline phosphatase prior to initiating therapy, every 2 wk during the 1st mth & mthly thereafter. Regularly monitor blood counts. Consider dose interruption of treatment in patients who develop unexplained cytopenia. Monitor for signs & symptoms of GI ulceration & hemorrhage during therapy & promptly initiate additional evaluation & treatment. Concomitant use w/ drugs w/ ulcerogenic potential eg, NSAIDs, corticosteroids, oral bisphosphonates, anticoagulants & patients w/ platelets counts <50 x 10⁹ L. Discontinue treatment if severe reactions occur. Severe skin rashes. Auditory & ophth (including fundoscopy) testing should be performed prior to treatment & at regular intervals (every 12 mth) thereafter. Monitor body wt & longitudinal growth in ped patients every 12 mth. Do not combine w/ other Fe chelator therapies. Exercise caution when driving & operating machinery. Pregnancy & lactation. Elderly.

Increased blood creatinine. Diarrhea, constipation, vomiting, nausea, abdominal pain & distention, dyspepsia; headache; increased transaminases; rash, pruritus; proteinuria.

Decreased efficacy w/ potent UDP-glucuronosyltranferase (UGT) inducers eg, rifampicin, phenytoin, phenobarb, ritonavir & CYP3A4 metabolites eg, ciclosporin, simvastatin, hormonal contraceptive agents. Increased AUC & C_max of repaglinide & theophylline. Increased AUC of busulfan. May increase risk of GI irritation w/ drugs that have known ulcerogenic potential eg, NSAIDs, corticosteroids, or oral bisphosphonates, & anticoagulants.

Antidotes & Detoxifying Agents

V03AC03 - deferasirox ; Belongs to the class of iron chelating agents. Used in the management of chronic iron overload associated with blood transfusion.

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