Jedoxred

Jedoxred

deferasirox

Manufacturer:

Dr. Reddy's Lab

Distributor:

DKSH
Concise Prescribing Info
Contents
Deferasirox
Indications/Uses
Chronic Fe overload due to blood transfusions in adults & ped patients ≥2 yr & nontransfusion-dependent thalassemia syndromes in patients ≥10 yr.
Dosage/Direction for Use
Transfusion-related chronic Fe overload Initially 20 mg/kg daily, may be adjusted in steps of 5-10 mg/kg every 3-6 mth. Patient receiving packed RBC >14 mL/kg/mth Initially 30 mg/kg. Maintenance of body Fe level Patient receiving packed RBC <7 mL/kg/mth Initially 10 mg/kg. Max: 40 mg/kg daily. Non-transfusion dependent thalassaemia syndrome Initially 10 mg/kg daily, may be adjusted in 5-10 mg/kg every 3-6 mth. Max: 20 mg/kg daily. Patient whom liver Fe conc was not assessed & serum ferritin ≤2,000 mcg/L Not to exceed 10 mg/kg daily.
Administration
Should be taken on an empty stomach: Take at least 30 min before meals, preferably at the same time each day. Disperse tab completely by stirring in 100-210 mL of water/apple juice/orange juice until a fine susp is obtained, then consume. Rinse the glass w/ a small volume of water/juice to re-suspend any residue & drink remainder. Do not disperse in carbonated drinks/milk. Do not chew/swallow tab whole. Do not take w/ Al-containing antacids.
Contraindications
Hypersensitivity. High-risk myelodysplastic syndrome (MDS), other hematological & non-hematological malignancies not expected to benefit from chelation therapy due to rapid disease progression. CrCl <40 mL/min or serum creatinine >2 x age-appropriate ULN.
Special Precautions
Discontinue use if any severe cutaneous ARs eg, SJS, TEN or DRESS is suspected, hypersensitivity reactions occur. Interrupt therapy if metabolic acidosis develops; proteinuria, glycosuria, renal tubulopathy or Fanconi syndrome & unexplained cytopenia occurs. Not recommended in patients w/ short life expectancy eg, high-risk MDS. Patients w/ platelet counts <50,000/mm3 (50 x 109/L); signs & symptoms of GI ulceration & haemorrhage; blood disorders; cardiac dysfunction. Monitor serum creatinine, CrCl, plasma cystatin C prior to initiation, wkly during 1st mth & mthly thereafter; serum transaminases, bilirubin & alkaline phosphatase prior to initiation, every 2 wk during 1st mth & mthly thereafter; serum ferritin mthly. Perform auditory & ophth testing prior to initiation & annually thereafter. Ensure adequate hydration & acid-base balance. Long-term use. Concomitant use w/ medicinal products depressing renal function; substances w/ known ulcerogenic potential eg, NSAIDs, corticosteroids or oral bisphosphonates; anticoagulants. May affect ability to drive & use machines. Not recommended in severe hepatic impairment (Child-Pugh class C). Pre-existing renal conditions; renal impairment. Women of childbearing potential should use effective contraception. Not to be used during pregnancy. Not recommended during lactation. Monitor body wt, height & sexual development prior to initiation & annually thereafter in childn. Elderly.
Adverse Reactions
Increased blood creatinine. Headache; diarrhoea, constipation, vomiting, nausea, abdominal pain & distension, dyspepsia; increased transaminases; rash, pruritus; proteinuria.
Drug Interactions
Decreased exposure & efficacy w/ potent UGT inducers eg, rifampicin, carbamazepine, phenytoin, phenobarb, ritonavir. Reduced exposure w/ cholestyramine. Decreased exposure & efficacy of midazolam, ciclosporin, simvastatin, hormonal contraceptives, bepridil, ergotamine. Increase AUC & Cmax of repaglinide, theophylline, CYP1A2-metabolised substances w/ narrow therapeutic index eg, clozapine, tizanidine. Low affinity for Al & Al-containing antacids. Increased GI toxicity w/ NSAIDs including ASA, corticosteroids, oral bisphosphonates. Increased GI haemorrhage w/ anticoagulants. Not to be combined w/ other Fe chelator therapies. Increased bioavailability w/ food.
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
Jedoxred dispersible tab 125 mg
Packing/Price
1 × 7's;12 × 7's;4 × 7's
Form
Jedoxred dispersible tab 250 mg
Packing/Price
1 × 7's;12 × 7's;4 × 7's
Form
Jedoxred dispersible tab 500 mg
Packing/Price
1 × 7's;12 × 7's;4 × 7's
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