Exjade

Exjade

deferasirox

Manufacturer:

Novartis Healthcare

Distributor:

Zuellig
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 w/ non-transfusion-dependent thalassemia (NTDT) syndromes ≥10 yr.
Dosage/Direction for Use
Transfusional Fe overload Initially 20 mg/kg daily. Adjust dose if necessary in steps of 5-10 mg/kg every 3-6 mth. Patient receiving >14 mL/kg/mth of packed RBC (approx >4 u/mth for adult) & for whom objective is reduction of Fe overload May consider initial daily dose of 30 mg/kg. Patient receiving <7 mL/kg/mth of packed RBC (approx <2 u/mth for adult) & for whom the objective is maintenance of body Fe level May consider initial daily dose of 10 mg/kg. Patient already well-managed on treatment w/ deferoxamine May consider starting dose that is numerically ½ that of the deferoxamine dose. Patient not adequately controlled w/ 30 mg/kg (eg, serum ferritin level persistently >2,500 mcg/L & not showing a decreasing trend over time) May consider dose up to 40 mg/kg. Patient whose serum ferritin level has reached the target (usually between 500 & 1,000 mcg/L) Reduce dose in steps of 5-10 mg/kg. NTDT syndrome Initially 10 mg/kg daily. Consider increasing in increments of 5-10 mg/kg if LIC ≥7 mg Fe/g dw, or serum ferritin is consistently >2,000 mcg/L & not showing a downward trend, & drug is tolerated well. Patient in whom LIC was not assessed & serum ferritin is ≤2,000 mcg/L Not to exceed 10 mg/kg. Patient in whom dose was increased to >10 mg/kg Reduce dose to 10 mg/kg or less when LIC is <7 mg Fe/g dw or serum ferritin is ≤2,000 mcg/L. Moderate hepatic impairment (Child-Pugh B) Reduce starting dose by approx 50%.
Administration
Should be taken on an empty stomach: Preferably taken at the same time each day. Do not chew/swallow whole tab. Disperse tab in water or apple/orange juice (100-200 mL) until fine suspension & drink. Rinse glass w/ small amt of water/juice & drink. Do not disperse in carbonated drinks/milk.
Contraindications
Hypersensitivity. High risk myelodysplastic syndrome patients & patients w/ other hematological & non-hematological malignancies who are not expected to benefit from chelation therapy due to rapid progression of disease. CrCl <40 mL/min or serum creatinine >2 x the age-appropriate ULN.
Special Precautions
Discontinue use in case of severe hypersensitivity reactions; suspected severe cutaneous adverse reactions including SJS, TEN & DRESS. Non-progressive rises in serum creatinine; acute renal failure; renal tubulopathy. Hepatic failure. Cytopenias. GI irritation; upper GI ulceration & hemorrhage; multiple ulcers; ulcers complicated w/ GI perforation. Skin rashes. Auditory (decreased hearing) & ocular (lens opacities) disturbances. Risk of toxicity may be increased in inappropriate high doses in patients w/ low Fe burden or w/ serum ferritin levels that are only slightly elevated. Patients w/ CrCl between 40 & <60 mL/min; platelet counts <50 x 109/L. Perform tests for proteinuria mthly. Maintain adequate hydration in patients who develop diarrhea or vomiting. Concomitant use w/ drugs that have ulcerogenic potential (eg, NSAIDs, corticosteroids or oral bisphosphonates & anticoagulants); hormonal contraceptive agents. Not recommended in patients w/ galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption. Caution when driving or operating machines in patients experiencing dizziness. Not recommended in severe hepatic impairment (Child-Pugh C). Pregnancy. Not recommended to be used during lactation. Monitor ped patients for body wt & longitudinal growth every 12 mth. Elderly.
Adverse Reactions
Increased blood creatinine. Headache; diarrhea, constipation, vomiting, nausea, abdominal pain & distension, dyspepsia; increased transaminases; rash, pruritus; proteinuria.
Drug Interactions
Efficacy may be decreased w/ potent UGT inducers (eg, rifampicin, phenytoin, phenobarb, ritonavir). Increased bioavailability w/ food. Decreased exposure of midazolam. Possibly decreased efficacy of substances metabolized through CYP3A4 (eg, ciclosporin, simvastatin, hormonal contraceptive agents). Increased AUC & Cmax of repaglinide; theophylline. Concomitant use w/ other substrates of CYP2C8 (eg, paclitaxel) & CYP1A2. Increased exposure of busulfan. Not to be taken w/ Al-containing antacid prep. May increase risk of GI irritation w/ drugs that have ulcerogenic potential (eg, NSAIDs, corticosteroids or oral bisphosphonates).
MIMS Class
Antidotes & Detoxifying Agents
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
Exjade dispersible tab 125 mg
Packing/Price
28's (P10,120.9/pack)
Form
Exjade dispersible tab 250 mg
Packing/Price
28's (P20,241.85/pack)
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