Chelova Dispersible Tablet

Introduction

Chelova Dispersible Tablet 250 mg is an oral iron chelator used to reduce chronic iron overload in patients receiving long-term blood transfusions, such as those with thalassemia, sickle cell anemia, or other chronic anemias. It works by binding to excess iron, facilitating its excretion from the body.

Uses

Chelova Dispersible Tablet 250 mg is primarily used to treat chronic iron overload in patients undergoing repeated blood transfusions. It is indicated for:

Transfusional iron overload due to thalassemia, sickle cell disease, or other anemias.
Non-transfusion-dependent thalassemia (NTDT) with iron overload.

Brand Name	Chelova
Type	Dispersible Tablet
Weight	250 mg
Generic	Deferasirox
Manufacturer	Jenphar Bangladesh Ltd.
Available in	English বাংলা

Mechanism of Action

Chelova Dispersible Tablet 250 mg binds to excess iron in the bloodstream, forming a complex that is excreted through the bile and urine. It selectively binds to ferric iron (Fe3+), preventing the accumulation of toxic levels of free iron, which can damage organs through oxidative stress.

How Long Does It Take to Work?

The effects of Chelova Dispersible Tablet 250 mg on reducing iron levels can be seen within several weeks, though optimal results often require several months of treatment. Regular monitoring of iron levels is necessary to assess efficacy and adjust dosage.

Absorption

Chelova Dispersible Tablet 250 mg is rapidly absorbed after oral administration, with peak plasma concentrations achieved within 1.5 to 4 hours. Absorption may be affected by food, particularly high-fat meals, which can increase its bioavailability.

Route of Elimination

Chelova Dispersible Tablet 250 mg and its iron complexes are primarily eliminated via the feces (approximately 84%), with a smaller percentage excreted through urine (around 8%).

Dosage

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

The recommended initial daily dose of Deferasirox is 20-40 mg/kg body weight per day in empty stomach preferably half an hour before breakfast. The tablets are dispersed by stirring in a glass of water or apple or orange juice (100 to 200 ml) until a fine suspension is obtained. After the suspension has been swallowed, any residue must 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 due to foaming and slow dispersion, respectively.

Serum ferritin to be monitored every month and the dose is adjusted accordingly every 3 to 6 months based on the trends in serum ferritin. If iron overload is inadequately controlled, doses of up to 40 mg/kg may be considered. If serum ferritin level is controlled, dose reductions in steps of 5 to 10 mg/kg should be considered to maintain serum ferritin at 500 microgram/l. Dose interruption can be done if sustained control is achieved,

The recommended starting dose of Chelova Dispersible Tablet 250 mg depends on the patient’s body weight and the degree of iron overload. The following dosage guidelines apply:

Transfusional Iron Overload: 20 mg/kg once daily, taken on an empty stomach. The dose may be adjusted based on serum ferritin levels and tolerability.
Non-transfusion-dependent thalassemia: 10 mg/kg daily. This can be increased up to 20 mg/kg if necessary, based on serum ferritin levels.

Administration

Chelova Dispersible Tablet 250 mg is administered orally once daily, preferably on an empty stomach at least 30 minutes before food. It can be dissolved in water, apple juice, or orange juice for easier administration.

Side Effects

Common side effects include:

Abdominal pain
Nausea
Diarrhea
Skin rash

Serious side effects may include:

Renal toxicity (elevated creatinine)
Hepatic toxicity
Hearing loss
Vision disturbances

Toxicity

In cases of overdose, the most common toxic effects are gastrointestinal disturbances such as nausea, vomiting, and diarrhea. Severe cases may result in renal or hepatic impairment. Treatment of overdose may require symptomatic and supportive measures.

Precautions

Patients with renal or hepatic impairment should use Chelova Dispersible Tablet 250 mg with caution, as the drug may exacerbate these conditions. Regular monitoring of kidney and liver function is essential during treatment.

Interaction

Chelova Dispersible Tablet 250 mg interacts with:

Antacids containing aluminum, as these may reduce its efficacy.
Nonsteroidal anti-inflammatory drugs (NSAIDs), as they can increase the risk of kidney damage.
Warfarin, as it may increase the risk of bleeding.

Disease Interaction

Chelova Dispersible Tablet 250 mg should be used cautiously in patients with renal or hepatic impairment, as well as in those with severe anemia not related to iron overload.

Drug Interaction

Potential interactions include:

CYP3A4 inhibitors (e.g., ketoconazole), which may increase Chelova Dispersible Tablet 250 mg levels.
Rifampin, which may reduce Chelova Dispersible Tablet 250 mg efficacy by inducing its metabolism.
Diuretics, which may exacerbate renal toxicity when used with Chelova Dispersible Tablet 250 mg.

Food Interactions

Food, especially high-fat meals, can increase the absorption of Chelova Dispersible Tablet 250 mg. It is generally recommended to take the drug on an empty stomach to ensure consistent absorption.

Pregnancy Use

There are no adequate and well-controlled studies of Chelova Dispersible Tablet 250 mg in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation Use

It is unknown whether Chelova Dispersible Tablet 250 mg is excreted in human milk. Breastfeeding should be discontinued during treatment to avoid potential harm to the infant.

Acute Overdose

Acute overdose of Chelova Dispersible Tablet 250 mg may cause gastrointestinal disturbances (nausea, vomiting, diarrhea) and renal or hepatic toxicity. In case of overdose, symptomatic treatment and monitoring of kidney and liver function are recommended.

Contraindication

Chelova Dispersible Tablet 250 mg is contraindicated in patients with:

Severe renal impairment (creatinine clearance < 40 mL/min).
Severe hepatic impairment.
Known hypersensitivity to Chelova Dispersible Tablet 250 mg or any of its components.

Use Direction

Chelova Dispersible Tablet 250 mg should be taken once daily on an empty stomach or with a light meal. The tablets should be dispersed in water, apple juice, or orange juice before administration, and the dose should be adjusted based on iron levels and kidney/liver function.

Storage Conditions

Store Chelova Dispersible Tablet 250 mg tablets at room temperature (20-25°C) in a dry place, away from moisture and heat.

Volume of Distribution

The volume of distribution of Chelova Dispersible Tablet 250 mg is approximately 14 L, indicating moderate distribution into body tissues.

Half-Life

The half-life of Chelova Dispersible Tablet 250 mg is approximately 8 to 16 hours, depending on the dose and patient’s metabolic status.

Clearance

Chelova Dispersible Tablet 250 mg is primarily cleared via the hepatobiliary system, with elimination through feces. Its clearance is reduced in patients with hepatic impairment.

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