Ferasirrox Tablet
Deferasirox
500mg
UniMed UniHealth Pharmaceuticals Ltd.
| Pack size | 20's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 120.00 AED |
Available as:
Indications
Ferasirrox Tablet is used for:
Chronic iron overload
Adult Dose
Oral
Transfusional Hemosiderosis/Transfusional Iron Overload:
Indicated for the treatment of chronic iron overload caused by blood transfusion
20 mg/kg once daily; 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 once daily
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 once daily (calculate dose to nearest tablet size);
if LIC >15 mg Fe/g dw after 4 weeks, consider increasing dose to 20 mg/kg/day
Child Dose
Oral
Transfusional Hemosiderosis/Transfusional Iron Overload:
Indicated for the treatment of chronic iron overload caused by blood transfusion
<2 years: Safety and efficacy not established
20 mg/kg once daily; 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 once daily
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 once daily (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
Deferasirox may cause serious and fatal:
acute kidney injury, including acute renal failure requiring dialysis and renal tubular toxicity, including Fanconi syndrome
hepatic toxicity, including failure
gastrointestinal hemorrhage
Deferasirox therapy requires close patient monitoring, including laboratory tests of renal and hepatic function.
Acute Kidney Injury: Measure serum creatinine in duplicate before starting therapy. Monitor renal function during Deferasirox therapy and reduce dose or interrupt therapy for toxicity.
Hepatic Toxicity: Monitor hepatic function. Reduce dose or interrupt therapy for toxicity.
Fatal and Nonfatal Gastrointestinal (GI) Bleeding, Ulceration, and Irritation: Risk may be greater in patients who are taking Deferasirox in combination with drugs that have known ulcerogenic or hemorrhagic potential.
Bone Marrow Suppression: Neutropenia, agranulocytosis, worsening anemia, and thrombocytopenia, including fatal events; monitor blood counts during Deferasirox therapy. Interrupt therapy for toxicity.
Age-related Risk of Toxicity: Monitor elderly and pediatric patients closely for toxicity.
Hypersensitivity Reactions: Discontinue Deferasirox for severe reactions and institute medical intervention.
Severe Skin Reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS): Discontinue Deferasirox.
MONITORING PARAMETERS
Monitor of the following patient parameters: baseline Serum creatinine twice and Creatinine clearance once before initiation of treatment, weekly in the first month after treatment initiation or modification, then monthly thereafter;
Proteinuria before treatment initiation then monthly thereafter, and other markers of renal tubular function as needed;
Liver function before treatment initiation, every 2 weeks during the first month of treatment, then monthly thereafter;
Eye and ear examinations before treatment and annually during treatment;
Serum ferritin concentration monthly.
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
Do not take Deferasirox with aluminum-containing antacid preparations.
Deferasirox increases the exposure of repaglinide. Consider repaglinide dose reduction and monitor blood glucose levels.
Avoid the use of Deferasirox with theophylline as theophylline levels could be increased.
Deferasirox increases exposure of busulfan.
Monitor plasma concentrations of busulfan when coadministered with deferasirox to allow dose adjustment of busulfan, as needed.
Contraindicated (0)
Serious (7)
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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
Ferasirrox 500mg Tablet manufactured by UniMed UniHealth Pharmaceuticals Ltd.. Its generic name is Deferasirox. Ferasirrox is availble in Bangladesh.
Farmaco BD drug index information on Ferasirrox Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.