Chelova 250 Tablet

Generic Name: Deferasirox

Strength: 250mg

Indications:

Chelova 250 is indicated for the treatment of chronic iron overload due to:

• Repeated blood transfusions in adult and pediatric patients aged 2 years and over with thalassemia, sickle cell disease, and myelodysplastic syndrome.

• Non-transfusion-dependent thalassemia syndromes in patients aged 10 years and older.

Pharmacology:

Deferasirox is an orally active iron chelator. It binds to iron with a high affinity in a 2:1 ratio, promoting iron excretion, primarily in the feces. Deferasirox has a low affinity for zinc and copper.

Dosage and Administration:

• The drug should be started after the transfusion of approximately 20 units (about 100 ml/kg) of packed red blood cells or when there is evidence of chronic iron overload (e.g., serum ferritin >1,000 microgram/L).

• The recommended initial daily dose of deferasirox is 20-40 mg/kg body weight per day.

• It should be taken on an empty stomach, preferably half an hour before breakfast.

• The tablets are dispersed by stirring in a glass of water, apple, or orange juice (100 to 200 ml) until a fine suspension is obtained.

• After the suspension is swallowed, any residue should be re-suspended in a small volume of water or juice and swallowed.

• The tablets must not be chewed or swallowed whole.

• Dispersion in carbonated drinks or milk is not recommended.

• Serum ferritin should be monitored monthly, and the dose adjusted every 3 to 6 months based on serum ferritin trends.

• Doses of up to 40 mg/kg may be considered if iron overload is inadequately controlled.

• Dose reductions in steps of 5 to 10 mg/kg should be considered to maintain serum ferritin at 500 microgram/l if the serum ferritin level is controlled.

• Dose interruption can be done if sustained control is achieved.

Contraindications:

Deferasirox is contraindicated in patients with:

• Hypersensitivity to the active substance or any of the excipients.

• Creatinine clearance <40 ml/min or serum creatinine >2 times the upper limit of normal.

Warnings and Precautions

• Renal Impairment: Deferasirox is contraindicated in patients with severe renal impairment. Use with caution in patients with mild or moderate renal impairment and monitor renal function.

• Hepatic Impairment: Use with caution in patients with hepatic impairment.

• Gastrointestinal Disorders: Caution should be taken when deferasirox is used in combination with drugs with ulcerogenic potential (e.g., NSAIDs, corticosteroids, oral bisphosphonates) or with anticoagulants.

• Pregnancy: Deferasirox may cause fetal harm when administered to a pregnant woman.

• Lactation: It is not known whether deferasirox is excreted in human milk.

• Drug Interactions: Deferasirox should not be taken with aluminum-containing antacids. It should be used with caution when combined with drugs metabolized through CYP3A4 (e.g., cyclosporine, simvastatin, hormonal contraceptives, midazolam) or CYP2C8 substrates (e.g., paclitaxel). Dose increase should be considered when concomitantly used with rifampicin, phenytoin, phenobarbital, ritonavir, etc.

Side Effects:

Common side effects may include:

• Nausea

• Vomiting

• Diarrhea

• Abdominal pain

• Skin rash

• Increased serum creatinine

Remember:

• This information provides a general overview. Always consult your healthcare provider for specific instructions and advice regarding Chelova 250 Tablet.

• Do not stop taking this medication without consulting your doctor.

• Report any unusual or severe side effects to your doctor immediately.