Exjade Tablets / Dispersible
Deferasirox
250mg
Novartis Pharma AG
| Pack size | 28's (7's Blister x 4) |
|---|---|
| Dispensing mode | POM |
| Source | SWITZERLAND |
| Agent | CITY MEDICAL STORE |
| Retail Price | 1831.00 AED |
Available as:
Indications
Exjade Tablets / Dispersible is used for:
Chronic iron overload.
Adult Dose
Transfusional Hemosiderosis
Indicated for treatment of chronic iron overload caused by blood transfusion
20 mg/kg PO qDay; may increase by 5-10 mg increments based on serum ferritin; if not controlled on 30 mg/kg/day (ie, serum ferritin persistently >2500 mcg/L), may increase up to 40 mg/kg qDay
Nontransfusion-Dependent Thalassemia
Indicated for treatment of chronic iron overload caused by nontransfusion-dependent thalassemia syndromes and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (dw) and a serum ferritin >300 mcg/L
10 mg/kg PO qDay (calculate dose to nearest tablet size); if LIC >15 mg Fe/g dw after 4 weeks, consider increasing dose to 20 mg/kg/day
Hepatic Impairment
Mild (Child-Pugh A): No dose adjustment required
Moderate (Child-Pugh B): Decrease initial dose by 50%
Severe (Child-Pugh C): Avoid use
Child Dose
Transfusional Hemosiderosis
Indicated for treatment of chronic iron overload caused by blood transfusion
<2 years: Safety and efficacy not established
20 mg/kg PO qDay; may increase by 5-10 mg increments based on serum ferritin; if not controlled on 30 mg/kg/day (ie, serum ferritin persistently >2500 mcg/L), may increase up to 40 mg/kg qDay
Nontransfusion-Dependent Thalassemia
Indicated for treatment of chronic iron overload caused by nontransfusion-dependent thalassemia syndromes and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (dw) and a serum ferritin >300 mcg/L
<10 years: Safety and efficacy not established
10 mg/kg PO qDay (calculate dose to nearest tablet size); if LIC >15 mg Fe/g dw after 4 weeks, consider increasing dose to 20 mg/kg/day
Renal Dose
Renal Impairment
Baseline renal impairment
CrCl 40-60 mL/min: Reduce starting dose by 50%
Serum Cr >2 xULN or CrCl <40 mL/min: Do not use
Administration
Should be taken on an empty stomach. Take on an empty stomach at least 30 min before meals preferably at the same time daily. Disperse tab completely by stirring in 100-200 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.
Do not chew/ break/crush tab or swallow whole. Do not take w/ Al-containing antacids.
Contra Indications
Hypersensitivity.
Precautions
Monitor renal function and CBC before starting treatment and regularly during treatment; may need to reduce dose or stop treatment if serum creatinine levels are persistently elevated. May increase LFTs. Perform audiological and ophthamological tests before starting treatment and yrly thereafter. Pregnancy.
Lactation: not known whether excreted in breast milk, use caution
Pregnancy-Lactation
Pregnancy
There are no studies with use in pregnant women to inform drug-associated risks; administration of deferasirox to rats during pregnancy resulted in decreased offspring viability and an increase in renal anomalies in male offspring at doses that were about or less than recommended human dose on a mg/ m² basis; no fetal effects were noted in pregnant rabbits at doses equivalent to human recommended dose on a mg/ m² basis; drug should be used during pregnancy only if potential benefit justifies potential risk to fetus
Contraception
Counsel patients to use non-hormonal method(s) of contraception since drug can render hormonal contraceptives ineffective
Lactation
No data are available regarding presence of drug or its metabolites in human milk, effects on breastfed infant, or on milk production; drug and its metabolites is excreted in rat milk; because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue breastfeeding or to discontinue drug, taking into account importance of drug to mother
Interactions
Not to be used with aluminium-containing antacids as it may chelate aluminium.
Adverse Effects
Side effects of Deferasirox :
>10%
Serum creatinine increase (dose related; 7-38%), Abdominal pain (21-28%), Nausea (11-23%), Vomiting (10-21%), Diarrhea (12-20%), Proteinuria (19%), Pyrexia (19%), Headache (16%), Cough (14%), Nasopharyngitis (13%), Pharyngolaryngeal pain (11%), Influenza (11%), Rash (8-11%)
1-10%
Respiratory tract infection (10%), Bronchitis (9%), ALT increased (2-8%), Arthralgia, back pain (6-7%), Acute tonsillitis (6%), Rhinitis (6%), Fatigue (6%), Ear infection (5%), Transaminitis (4%), Urticaria (4%)
<1%
Anaphylaxis, Angioedema, Cytopenias, including agranulocytosis, neutropenia and thrombocytopenia; leukocytoclastic vasculitis
Potentially Fatal: Acute renal failure, serious hypersensitivity reactions such as angioedema and anaphylaxis.
Mechanism of Action
Deferasirox is an orally active chelator that is selective for iron (as Fe3+ ion). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio. It is used in the management of chronic iron overload.
Note
Exjade 250mg Tablets / Dispersible manufactured by Novartis Pharma AG. Its generic name is Deferasirox. Exjade is availble in United Arab Emirates.
Farmaco UAE drug index information on Exjade Tablets / Dispersible is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.