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Deferasirox
Before initiating treatment with Deferasirox, it is essential for patients to consult their healthcare provider to ensure it is the appropriate choice for their condition. Important precautions to consider include:
- Renal and Hepatic Function: Deferasirox can cause kidney toxicity and liver toxicity. Baseline assessments of renal and liver function are necessary, and these parameters should be monitored regularly throughout treatment. Dose adjustments may be needed for patients with pre-existing kidney or liver impairment.
- Hematologic Monitoring: Regular monitoring of hemoglobin and hematocrit levels is required, as anemia may develop due to the drug's effect on iron metabolism.
- Pregnancy and Breastfeeding: Deferasirox is classified as a Category C drug during pregnancy, meaning its safety during pregnancy has not been well established. It should only be used if the potential benefits outweigh the risks. The drug is excreted into breast milk, so breastfeeding should be avoided during treatment.
- Gastrointestinal Disorders: Deferasirox may cause gastrointestinal discomfort, including nausea, diarrhea, and abdominal pain. These side effects should be reported to a healthcare provider if they persist.
- Hypersensitivity: Deferasirox can cause allergic reactions, including rash, fever, or more severe reactions like Steven-Johnson syndrome. Patients should be monitored for any signs of hypersensitivity.
Deferasirox is primarily prescribed for the treatment of iron overload in conditions where the body accumulates excess iron, typically as a result of blood transfusions:
- Chronic Iron Overload Due to Blood Transfusions: Deferasirox is used to treat chronic iron overload in patients who require regular blood transfusions, such as those with thalassemia, sickle cell anemia, or other hemoglobinopathies. The drug helps remove excess iron from the body and reduce the risk of iron-related organ damage.
- Non-transfusion-dependent Thalassemia: Deferasirox is also used to treat iron overload in non-transfusion-dependent thalassemia syndromes where iron buildup can occur due to increased intestinal iron absorption.
- Iron Overload Due to Hemochromatosis: It is also indicated for treating iron overload in patients with hereditary hemochromatosis who cannot undergo phlebotomy (the removal of blood).
Certain conditions or situations may make it unsafe to use Deferasirox. Contraindications include:
- Hypersensitivity: Deferasirox should not be used in patients with a known hypersensitivity to the drug or any of its components.
- Severe Renal Impairment: Patients with severe renal impairment (e.g., eGFR < 40 mL/min/1.73 m²) should not use Deferasirox due to the increased risk of kidney toxicity. The drug should also be avoided in patients who are undergoing dialysis.
- Active Liver Disease: Deferasirox is contraindicated in patients with severe hepatic impairment, active liver disease, or cirrhosis due to the increased risk of liver toxicity.
- Children under 2 years of age: Deferasirox is contraindicated in children under 2 years of age as it has not been established as safe or effective in this population.
- Pregnancy: Deferasirox should be avoided during pregnancy unless the potential benefits justify the risks.
Deferasirox can cause a range of side effects, some of which may require medical attention:
- Common Side Effects:
- Gastrointestinal Symptoms: Nausea, diarrhea, and abdominal pain are common and may resolve with continued treatment.
- Skin Rash: A rash is commonly seen, which may be mild or moderate in nature.
- Fatigue: Some patients may experience tiredness or lethargy during treatment.
- Elevated Liver Enzymes: ALT and AST levels may rise, indicating potential liver dysfunction.
- Serious Side Effects:
- Renal Toxicity: Deferasirox can cause kidney damage and even renal failure, especially in patients with pre-existing kidney conditions. Patients should be monitored for elevated serum creatinine and urine output.
- Hepatic Toxicity: Severe liver damage and hepatitis are possible, and monitoring of liver function tests is essential during treatment.
- Hematologic Effects: Thrombocytopenia, leukopenia, and anemia can occur due to the drug's impact on the blood.
- Severe Skin Reactions: Rarely, Deferasirox may cause serious skin reactions, including Steven-Johnson syndrome or toxic epidermal necrolysis.
- Gastrointestinal Bleeding: Due to the risk of bleeding, patients on Deferasirox should be monitored for signs of gastrointestinal bleeding.
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Deferasirox is an iron chelator that works by binding to excess iron in the body and facilitating its excretion:
- Chelation of Iron: Deferasirox selectively binds to free iron (Fe²⁺ and Fe³⁺) in the blood and tissues, forming a stable complex that can be excreted in the feces.
- Reduction of Iron Stores: By removing excess iron, Deferasirox helps to reduce the iron burden in organs such as the heart, liver, and endocrine glands, which can otherwise be damaged by iron overload.
- Prevention of Organ Damage: By lowering body iron levels, Deferasirox helps prevent damage to organs from iron-induced oxidative stress, reducing the risk of complications like cardiac failure and liver cirrhosis.
Deferasirox can interact with several medications, which may affect the drug's efficacy or safety:
- Antacids and Proton Pump Inhibitors: Medications like antacids or proton pump inhibitors (PPIs) that reduce stomach acidity may decrease the absorption of Deferasirox. These should be taken at least 2 hours apart from Deferasirox.
- Cyclosporine: Co-administration with cyclosporine may increase the levels of both drugs, leading to a higher risk of kidney toxicity and other adverse effects. Close monitoring of renal function is recommended if these drugs are used together.
- Warfarin: Deferasirox may increase the effects of warfarin, leading to an increased risk of bleeding. Frequent monitoring of INR is necessary when using both drugs together.
- Other Chelating Agents: Combining Deferasirox with other iron chelators (such as deferoxamine) may increase the risk of toxicity. The use of multiple chelating agents should be avoided unless directed by a healthcare provider.
- Aspirin: The combination of aspirin with Deferasirox may increase the risk of gastrointestinal bleeding.
The usual starting dose for adults is based on the severity of iron overload and body weight:
- Chronic Iron Overload Due to Transfusions: The typical starting dose is 20 mg/kg/day, administered orally. This may be adjusted based on serum ferritin levels, clinical response, and adverse effects. Doses up to 30 mg/kg/day may be used for patients with more severe iron overload.
- Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia: The recommended dose is typically 10 mg/kg/day to 20 mg/kg/day, depending on the degree of iron overload.
- Hepatic Monitoring: Dosage adjustments may be required if liver function becomes impaired, and regular liver enzyme monitoring is critical.
For children, the dose is based on body weight, and it may differ based on the condition being treated:
- Children aged 2 years and older: The usual starting dose for iron overload is 20 mg/kg/day. Dose adjustments are made based on the child’s response and monitoring of ferritin levels and organ function. Regular check-ups are crucial to ensure proper dosage and reduce the risk of adverse effects.
As with adults, any changes to dosage or treatment plan should be discussed and managed by a healthcare provider.
For patients with mild to moderate renal impairment (e.g., eGFR > 40 mL/min/1.73 m²), the standard dose can generally be maintained. However, in cases of severe renal impairment (e.g., eGFR < 40 mL/min/1.73 m²), Deferasirox should be avoided, or the dose should be adjusted as advised by the healthcare provider, with frequent monitoring of renal function.