Indications & Uses
Deferasirox is used to treat chronic iron overload caused by repeated blood transfusions in adults and children aged 2 years and older who have thalassaemia, sickle cell disease or myelodysplastic syndrome. It is also used to treat chronic iron overload in patients aged 10 years and older with non-transfusion-dependent thalassaemia syndromes.
Pharmacology
Deferasirox is taken by mouth and works as an iron chelator with high selectivity for iron. It is a tridentate ligand, meaning it binds iron in a 2:1 ratio with strong affinity. The medicine helps the body get rid of excess iron mainly through the stool. Deferasirox has only a weak affinity for zinc and copper, so it does not lead to persistently low levels of these metals in the blood. In a metabolic study looking at iron balance in adult thalassaemia patients with iron overload, daily doses of 10, 20, and 40 mg/kg led to a mean net iron excretion of 0.119, 0.329, and 0.445 mg per kg of body weight per day, respectively.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Dosage
Deferasirox should be started after the patient has received approximately 20 units (about 100 ml/kg) of packed red blood cells, or when there is evidence of chronic iron overload (for example, a serum ferritin level above 1,000 microgram/L).
The recommended starting dose is 20-40 mg/kg body weight once daily, taken on an empty stomach, preferably half an hour before breakfast.
How to take the tablets: Disperse the tablets by stirring them in a glass (100 to 200 ml) of water, apple juice or orange juice until a fine suspension forms. After swallowing the suspension, re-suspend any residue in a small amount of water or juice and swallow that as well. The tablets must not be chewed or swallowed whole. Dispersing them in carbonated drinks or milk is not recommended, because carbonated drinks cause foaming and milk disperses the tablets slowly.
Monitoring and dose adjustment: Serum ferritin should be checked every month, and the dose adjusted every 3 to 6 months according to the trend in serum ferritin. If iron overload is not adequately controlled, doses of up to 40 mg/kg may be considered. Once serum ferritin is under control, dose reductions in steps of 5 to 10 mg/kg should be considered in order to keep serum ferritin at around 500 microgram/L. Treatment may be interrupted if sustained control has been achieved.
Side Effects
Deferasirox may lower blood cell counts (cytopenias). Digestive problems such as diarrhoea, constipation, vomiting, nausea, abdominal pain, abdominal bloating and indigestion have been reported, as have ulcers and bleeding in the upper digestive tract. Headache and dizziness, along with other effects on the central nervous system, may occur. Liver enzyme (transaminase) levels may rise. Stevens-Johnson syndrome (SJS) and skin rash have been reported rarely. Hearing and vision disturbances may also occur.
Cautions & Contraindications
Warnings & Precautions
Fatal and non-fatal gastrointestinal bleeding, ulceration, and irritation may occur during Ferasirrox treatment. Use caution in patients who are taking Ferasirrox together with drugs that have known ulcerogenic or hemorrhagic potential, such as NSAIDs, corticosteroids, oral bisphosphonates, and anticoagulants. Cytopenias, including agranulocytosis, neutropenia, and thrombocytopenia, have been reported. Monitor blood counts during Ferasirrox therapy. Serious hypersensitivity reactions have been reported. If reactions are severe, discontinue Ferasirrox and institute appropriate medical intervention.
Contraindications
Deferasirox must not be used by anyone who is allergic (hypersensitive) to deferasirox itself or to any of the inactive ingredients in the product. It also cannot be given to people with significantly reduced kidney function, meaning a creatinine clearance below 40 ml/min or a serum creatinine level more than 2 times the upper limit of normal.
Pregnancy & Breastfeeding
Pregnancy Category C. Deferasirox has not been studied in adequate, well-controlled trials involving pregnant women. In animal studies, giving Deferasirox during pregnancy and breastfeeding reduced offspring survival and increased kidney abnormalities in male offspring, at doses lower than those typically used in humans. For this reason, Deferasirox should be used in pregnancy only if the expected benefit to the mother outweighs the possible risk to the unborn baby. Whether Deferasirox passes into human breast milk is not currently known.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric use: Deferasirox was found to be as safe and effective in children as in adults, and younger children responded in the same way as older children. The recommended starting dose and the dose changes are the same for children and adults.
Geriatric use: Elderly patients have a higher risk of Deferasirox toxicity. This is because decreased liver, kidney or heart function is more common in this age group, and so are other diseases and treatment with other medicines.
Renal impairment: Deferasirox has not been studied in patients with renal impairment.
Hepatic impairment: Deferasirox has not been studied in patients with hepatic impairment.
Overdose
The most Deferasirox you should take is 40 mg/kg of body weight. There's no information available on what happens in an overdose of Deferasirox.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Deferasirox in a dry place, below 25°C, and away from light. Make sure children can't reach it.
Drug Interactions
Common questions about Clearon 100 100 mg
What is Clearon 100 100 mg Tablet?
Clearon 100 100 mg Tablet is a medicine that contains Deferasirox. It is made by Incepta Pharmaceuticals Ltd. It belongs to the Antidote preparations group of medicines.
What is Clearon 100 used for?
Deferasirox is used to treat chronic iron overload caused by repeated blood transfusions in adults and children aged 2 years and older who have thalassaemia, sickle cell disease or myelodysplastic syndrome. It is also used to treat chronic iron overload in patients aged 10 years and older with non-transfusion-dependent thalassaemia syndromes.
What are the side effects of Clearon 100?
Deferasirox may lower blood cell counts (cytopenias). Digestive problems such as diarrhoea, constipation, vomiting, nausea, abdominal pain, abdominal bloating and indigestion have been reported, as have ulcers and bleeding in the upper digestive tract.
Can I take Clearon 100 during pregnancy or while breastfeeding?
Pregnancy Category C. Deferasirox has not been studied in adequate, well-controlled trials involving pregnant women. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Clearon 100?
The most Deferasirox you should take is 40 mg/kg of body weight. There's no information available on what happens in an overdose of Deferasirox. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Clearon 100?
Keep Deferasirox in a dry place, below 25°C, and away from light. Make sure children can't reach it.
Can I take other medicines with Clearon 100?
Some medicines can interact with Deferasirox, for example: Cyclosporine, Rifampicin, Paclitaxel, Midazolam, Simvastatin, Ritonavir. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Clearon 100?
Clearon 100 is a prescription (Rx) medicine. Take it as your doctor advises.