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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Deferasirox Oral
Generic Name
Deferasirox Oral
Active Ingredient
DeferasiroxCategory
Iron Chelator [EPC]
Variants
3
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Deferasirox Oral, you must consult a qualified healthcare professional.
Detailed information about Deferasirox Oral
Deferasirox is an oral iron chelator used to treat chronic iron overload caused by blood transfusions or non-transfusion-dependent thalassemia syndromes. It belongs to the iron chelator class of medications.
The dosage of deferasirox is highly individualized and is based on the patient's body weight (mg/kg), the specific formulation used, and the goal of therapy (maintenance vs. reduction of iron stores).
Healthcare providers will typically monitor serum ferritin levels every month to determine if the dose needs to be increased or decreased.
Deferasirox is approved for use in children as young as 2 years old for transfusional iron overload and 10 years and older for NTDT.
Deferasirox is potentially toxic to the kidneys. If a patient's serum creatinine (a marker of kidney function) increases significantly, the dose must be reduced or therapy interrupted. It is contraindicated (should not be used) in patients with a creatinine clearance of less than 40 mL/min.
For patients with moderate hepatic (liver) impairment (Child-Pugh Class B), the starting dose should be reduced by approximately 50%. Deferasirox should not be used in patients with severe hepatic impairment (Child-Pugh Class C).
Patients over the age of 65 are at a higher risk of adverse reactions, particularly kidney and liver toxicity. Doctors often start at the lower end of the dosing range and monitor these patients more frequently.
If you miss a dose, take it as soon as you remember on that same day. If it is almost time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at once to make up for a missed one.
Signs of overdose may include nausea, vomiting, diarrhea, and abdominal pain. In severe cases, it can lead to acute kidney failure or liver toxicity. If an overdose is suspected, contact a poison control center or seek emergency medical attention immediately. Treatment is generally supportive, as there is no specific antidote for deferasirox overdose.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or switch between different brands of deferasirox without medical guidance, as the doses are not the same.
Most patients taking deferasirox will experience some form of mild to moderate side effects, particularly during the first few weeks of treatment as the body adjusts to the medication.
Deferasirox is a potent medication that requires strict adherence to monitoring protocols. It is not a 'simple' supplement; it is a complex chemical agent that interacts with vital organ systems. Patients must be committed to monthly blood tests and regular specialist visits (nephrology, hepatology, audiology, and ophthalmology) to ensure the drug is removing iron without damaging healthy tissue.
According to the FDA-approved labeling, Deferasirox carries the following boxed warnings:
There are several conditions where the risks of deferasirox clearly outweigh any potential benefits. In these cases, the drug must NEVER be used:
Deferasirox is classified as a medication that should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown some evidence of skeletal variations at high doses. Because chronic iron overload itself can complicate pregnancy and harm both the mother and the fetus, the decision to continue chelation must be made by a high-risk obstetrician and a hematologist. If you become pregnant while taking deferasirox, notify your doctor immediately.
It is not known whether deferasirox is excreted in human milk. However, animal studies show that the drug is present in the milk of lactating rats. Because of the potential for serious adverse reactions in nursing infants (including kidney and liver toxicity), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Deferasirox is approved for children 2 years and older for transfusional iron overload. It is vital to monitor the growth and development of children on long-term chelation. If a child’s iron levels become too low (over-chelation), it can interfere with their growth. Weight-based dosing must be adjusted frequently as the child grows to ensure they are receiving the correct amount of medication.
Deferasirox is an orally active chelator that is selective for iron (as Fe3+). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio (two molecules of deferasirox bind one atom of iron). By binding to the iron, it creates a stable complex that prevents the iron from participating in the Fenton reaction—a chemical process that generates toxic hydroxyl radicals. These radicals are responsible for the oxidative stress that damages the heart, liver, and endocrine organs in patients with iron overload.
The main effect of deferasirox is the promotion of iron excretion. Unlike deferoxamine, which promotes both urinary and fecal excretion, deferasirox promotes iron excretion almost exclusively through the feces. Clinical studies have shown that a daily dose of 20-30 mg/kg (of the dispersible tablets) can lead to a net negative iron balance in most patients with transfusional iron overload, meaning the body is losing more iron than it is receiving through blood transfusions.
| Parameter | Value |
|---|---|
Common questions about Deferasirox Oral
Deferasirox is primarily used to treat chronic iron overload, a condition where the body accumulates too much iron, usually due to frequent blood transfusions for diseases like sickle cell anemia or thalassemia. It is also used for patients with non-transfusion-dependent thalassemia who absorb too much iron from their diet. By binding to the excess iron, the medication allows it to be excreted through the stool, preventing damage to the heart and liver. It is approved for adults and children as young as two years old. Your doctor will determine the need for this drug based on your serum ferritin levels and liver iron concentration.
The most common side effects of deferasirox include gastrointestinal issues such as nausea, vomiting, diarrhea, and abdominal pain, which affect a large percentage of patients. Many people also experience a mild skin rash or a slight increase in serum creatinine, which is a marker of kidney function. These symptoms are often most noticeable when starting the medication and may improve over time. However, because some side effects can be serious, regular blood and urine tests are required. Always report persistent or worsening stomach pain or changes in urination to your healthcare provider.
There is no known direct chemical interaction between deferasirox and alcohol; however, caution is strongly advised. Both alcohol and deferasirox are processed by the liver, and alcohol consumption can increase the risk of liver stress or dehydration, which may worsen the drug's potential for kidney toxicity. Since deferasirox carries a warning for severe liver and kidney problems, it is best to limit or avoid alcohol to keep these organs as healthy as possible. Discuss your alcohol intake with your doctor to ensure it does not interfere with your treatment safety. Consistency in your metabolic health is vital for successful chelation.
The safety of deferasirox during pregnancy has not been well-established in humans, and it is generally only used if the benefits to the mother clearly outweigh the risks to the fetus. Animal studies have suggested that high doses might cause minor skeletal variations in the developing fetus. However, untreated iron overload also poses significant risks to both the mother and the baby. If you are planning a pregnancy or become pregnant, you must have a detailed discussion with your hematologist and a high-risk obstetrician. Effective contraception is usually recommended for women of childbearing age while taking this medication.
Deferasirox begins binding iron shortly after the first dose, but it takes several months of consistent daily use to see a significant drop in the body's total iron stores. Doctors typically monitor progress by checking serum ferritin levels every month. You may not 'feel' the drug working, as the goal is to prevent long-term organ damage rather than treat immediate symptoms. Most clinical trials show significant reductions in liver iron concentration after 12 months of therapy. It is a long-term maintenance medication that must be taken exactly as prescribed to be effective.
While deferasirox does not cause a physical withdrawal syndrome, you should never stop taking it suddenly without your doctor's approval. Stopping the medication will allow iron to begin building up in your vital organs again, which can eventually lead to heart or liver failure. If you are experiencing side effects that make it difficult to take the drug, your doctor may suggest a dose reduction or a switch to a different formulation rather than stopping entirely. If treatment must be paused for a medical procedure or due to toxicity, your doctor will provide a specific plan for when to restart. Consistency is the most important factor in managing iron overload.
If you miss a dose of deferasirox, you should take it as soon as you remember on the same day. However, if you do not remember until the following day, skip the missed dose and simply take your next scheduled dose at the regular time. Do not take a double dose to make up for the one you missed, as this can increase the risk of kidney or liver toxicity. To help you remember, try taking the medication at the same time every day, such as 30 minutes before breakfast. If you find yourself missing doses frequently, talk to your pharmacist about using a pill organizer or a reminder app.
Weight gain is not a commonly reported side effect of deferasirox in clinical trials. In fact, some patients may experience slight weight loss due to gastrointestinal side effects like nausea or a decreased appetite. If you notice significant or rapid weight gain while taking this medication, it could be a sign of fluid retention, which might indicate a problem with your kidneys or heart. This would require immediate medical evaluation. Always track any significant changes in your weight and report them to your healthcare team during your monthly check-ups.
Deferasirox has several significant drug interactions that your doctor must monitor. It should not be taken with theophylline, as it can cause theophylline levels to become dangerously high. It also interacts with certain diabetes medications like repaglinide and can increase the risk of stomach ulcers if taken with NSAIDs like ibuprofen or aspirin. Additionally, aluminum-containing antacids should be avoided as they can interfere with the drug's absorption. Always provide your doctor and pharmacist with a complete list of all prescription drugs, over-the-counter medicines, and herbal supplements you are taking.
Yes, deferasirox is available as a generic medication in several forms, including film-coated tablets and tablets for oral suspension. Generic versions are required by the FDA to have the same active ingredient, strength, and effectiveness as the brand-name versions (Exjade or Jadenu). However, even when using a generic, you must ensure you are using the correct formulation, as the film-coated tablets and the dispersible tablets are not interchangeable at the same dose. Switching between different generic manufacturers or formulations should only be done under the direct supervision of your healthcare provider.
Other drugs with the same active ingredient (Deferasirox)
> Warning: Stop taking Deferasirox and call your doctor immediately if you experience any of these serious symptoms.
Prolonged use of deferasirox requires vigilant monitoring. Over years, the primary concerns are chronic kidney disease (CKD) and potential effects on bone mineral density, although data on the latter is still being gathered. In children, there is a theoretical risk that excessive iron chelation (reducing iron levels too much) could interfere with normal growth and development. Therefore, doctors will stop or reduce the dose if ferritin levels drop below a certain threshold (usually 500 ng/mL).
The FDA has issued a Black Box Warning for deferasirox due to the risk of three major complications:
Report any unusual symptoms, especially changes in urine, skin color, or stool appearance, to your healthcare provider immediately.
To safely take deferasirox, your healthcare provider will order the following tests:
Deferasirox is generally not expected to impair your ability to drive or operate machinery. However, if you experience dizziness or visual disturbances as a side effect, you should avoid these activities until the symptoms resolve.
While there is no direct chemical interaction between deferasirox and alcohol, alcohol can stress the liver and dehydrate the body, which may increase the risk of hepatic and renal side effects. It is generally advised to limit alcohol consumption while on this medication.
Do not stop taking deferasirox without consulting your doctor. Stopping the medication will cause iron to begin accumulating in your organs again. There is no 'withdrawal syndrome' associated with deferasirox, but the underlying iron overload will worsen if treatment is interrupted for long periods.
> Important: Discuss all your medical conditions, especially any history of kidney or liver disease, with your healthcare provider before starting Deferasirox.
Deferasirox does not typically interfere with standard laboratory tests, but its effect on reducing iron will naturally change your ferritin, iron, and TIBC (Total Iron Binding Capacity) results. It may also cause a false elevation in serum creatinine that does not always reflect a true drop in GFR, though doctors must treat all creatinine rises as potentially serious.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking. A complete list is necessary to prevent dangerous drug-drug interactions.
In these scenarios, a doctor must perform a careful risk-benefit analysis:
There is no known cross-sensitivity between deferasirox and other iron chelators like deferoxamine or deferiprone, as their chemical structures are entirely different. However, if a patient has a history of severe skin reactions (like SJS) to other medications, they should be monitored with extreme care when starting any new drug like deferasirox.
> Important: Your healthcare provider will evaluate your complete medical history, including your kidney function and blood counts, before prescribing Deferasirox.
Clinical trials of deferasirox did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, post-marketing data shows that elderly patients have a much higher incidence of acute renal failure, hepatic failure, and fatal GI bleeding. Doctors are advised to monitor elderly patients more frequently—sometimes weekly—during the start of therapy.
For patients with mild to moderate renal impairment (Creatinine Clearance 40-60 mL/min), the starting dose should be conservative. For those with a Clearance < 40 mL/min, the drug is strictly contraindicated. If the serum creatinine rises by more than 33% above the baseline during treatment, the dose should be reduced or held until levels return to normal.
Deferasirox is metabolized by the liver. In patients with moderate (Child-Pugh Class B) hepatic impairment, the dose should be reduced by half. It has not been studied in patients with severe (Child-Pugh Class C) impairment, and its use in such patients is not recommended.
> Important: Special populations require individualized medical assessment and more frequent laboratory monitoring to ensure safety.
| Protein Binding | >99% (primarily albumin) |
| Half-life | 8 to 16 hours |
| Tmax | 1.5 to 4 hours |
| Metabolism | Glucuronidation (UGT1A1, UGT1A3) |
| Excretion | Fecal 84%, Renal 8% |
Deferasirox is classified as an iron chelating agent. It is often grouped with other chelators like Deferoxamine (Desferal) and Deferiprone (Ferriprox). Among these, Deferasirox is unique for its long half-life and high oral bioavailability, making it the most commonly prescribed oral chelator for chronic use.