Deferasirox GPO

Deferasirox GPO

deferasirox

Manufacturer:

GPO

Distributor:

GPO
Concise Prescribing Info
Contents
Deferasirox
Indications/Uses
Chronic Fe overload due to blood transfusions (transfusional hemosiderosis) in adult & ped patients ≥2 yr. Chronic Fe overload in patients ≥10 yr w/ non-transfusion-dependent thalassemia syndromes.
Dosage/Direction for Use
Chronic Fe overload in nontransfusion-dependent thalassemia syndromes Adult & childn ≥10 yr Initially 10 mg/kg daily. Max dose: 20 mg/kg daily. Adult & adolescent ≥16 yr w/ renal impairment May interrupt therapy if the dose is 5 mg/kg or reduce by 50% if the dose is 10 or 20 mg/kg if serum creatinine increases. Childn 10-15 yr w/ renal impairment Reduce the dose by 5 mg/kg if serum creatinine increases. Moderate hepatic impairment (Child-Pugh class B) Reduce starting dose by 50%. Chronic Fe overload (transfusional) Adult & childn ≥2 yr Initially 20 mg/kg daily. Max dose: 40 mg/kg daily. May be adjusted in increments of 5 or 10 mg/kg, every 3-6 mth if necessary. Adult & adolescents ≥16 yr w/ renal impairment Reduce the dose by 10 mg/kg if serum creatinine increases. Childn 2-15 yr w/ renal impairment Reduce the dose by 10 mg/kg if serum creatinine increases. Moderate hepatic impairment (Child-Pugh class B) Reduce starting dose by 50%.
Administration
Should be taken on an empty stomach: Take at least 30 min before meals preferably at the same each day. Disperse tab completely by stirring in 100-210 mL of water/apple juice/orange juice until a fine susp is obtained; consume entire content. Rinse the glass w/ a little water/juice to resuspend any residue & drink remainder. Do not disperse tab in fizzy drinks/milk. Swallow whole, do not chew/break/crush tab. Do not take w/ Al-containing antacids.
Contraindications
Hypersensitivity. Patients w/ CrCl <40 mL/min or serum creatinine >2 x the age-appropriate ULN, poor performance status, high-risk myelodysplastic syndromes, advanced malignancies, platelet count <50 x 109/L.
Special Precautions
Discontinue treatment if serious hypersensitivity reactions occur. Measure serum creatinine & determine CrCl in duplicate prior to initiation of therapy & monitor renal function at least mthly thereafter. Creatinine should be monitored wkly for the 1st mth, then at least mthly thereafter in patients w/ baseline renal impairment or at increased risk of acute renal failure. Measure serum transaminases & bilirubin prior to initiating treatment, every 2 wk during the 1st mth, & at least mthly thereafter. Avoid use in patients w/ severe (Child-Pugh class C) hepatic impairment; moderate hepatic impairment. Monitor patients & discontinue use for suspected GI ulceration or hemorrhage. Concomitant use w/ drugs that have ulcerogenic or hemorrhagic potential eg, NSAIDs, corticosteroids, oral bisphosphonates or anticoagulants. Preexisting hemotologic disorders; monitor blood cell counts. Interrupt treatment in patients who develop cytopenias. Discontinue treatment if severe skin reactions, including Stevens-Johnson syndrome & erythema multiforme. Perform auditory & ophth testing before starting treatment & thereafter at regular intervals (every 12 mth). Pregnancy & lactation. Ped patients <2 yr w/ chronic Fe overload due to blood transfusions or ped patients <10 yr w/ chronic Fe overload & nontransfusion-dependent thalassemia. Elderly w/ advanced hematologic malignancies &/or low platelet counts.
Adverse Reactions
Abdominal pain, diarrhea, nausea, vomiting, increase in serum creatinine, rash.
Drug Interactions
May increase serum conc of agomelatine, CYP1A2 & CYP2C8 substrates, pirfenidone, repaglinide & theophylline. Effect may be diminished by Al hydroxide. Enhanced adverse reactions of anticoagulants. May decrease serum conc of aripiprazole, axitinib, CYP3A4 substrates, ibrutinib, saxagliptin & simeprevir. Decreased serum conc w/ bile acid sequestrants, fosphenytoin, phenobarb, phenytoin, rifampin & ritonavir. Enhanced adverse reactions w/ bisphosphonate derivatives, corticosteroids (systemic) & NSAIDs.
ATC Classification
V03AC03 - deferasirox ; Belongs to the class of iron chelating agents. Used in the management of chronic iron overload associated with blood transfusion.
Presentation/Packing
Form
Deferasirox GPO orodispersible tab 250 mg
Packing/Price
3 × 10's
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