Deferasirox 90mg Oral Granules
WARNING: This drug may cause kidney problems. Some people have needed dialysis. Sometimes, these kidney problems have been deadly. The risk of kidney problems may be higher if you already have kidney problems or other health problems. You will need to have your kidney function checked as you have been told by your doctor. If you have questions, talk with your doctor.If you are dehydrated or are taking any drugs that can raise the chance of kidney problems, talk with your doctor. There are many drugs that can raise the chance of kidney problems. Ask your doctor or pharmacist if you are not sure.This drug may cause liver problems. Sometimes, this has been deadly. The risk of liver problems may be higher if you are older than 55 years or if you already have liver problems or other health problems. You will need to have your liver function checked as you have been told by your doctor. If you have questions, talk with your doctor.If you have kidney or liver problems, talk with your doctor. This drug may need to be avoided or the dose may need to be changed with certain types of kidney or liver problems.This drug may raise the chance of severe and sometimes deadly stomach or bowel problems like ulcers or bleeding. The risk is greater in older people, and in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. @ COMMON USES: It is used to get rid of iron when too much is in the body.
Drug Class
Iron Chelator
Pharmacologic Class
Tridentate Iron Chelating Agent
Pregnancy Category
C
FDA Approved
Nov 2005
DEA Schedule
Not Controlled
Overview
What is this medicine?
Deferasirox is a medicine used to remove extra iron from your body. Too much iron can build up in your organs, especially if you receive many blood transfusions, and can cause serious health problems. This medicine works by binding to the iron, allowing your body to get rid of it, mostly through your stool.
How to Use This Medicine
Taking Your Medication
To take this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication on an empty stomach or with a light meal. To administer, sprinkle the granules onto a small amount of soft food, such as yogurt or applesauce. Swallow the mixture immediately, and do not store it for later use. Establish a routine by taking the medication at the same time every day. Continue taking the medication as directed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry location, avoiding bathrooms. Keep all medications in a secure place, out of reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To take this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication on an empty stomach or with a light meal. To administer, sprinkle the granules onto a small amount of soft food, such as yogurt or applesauce. Swallow the mixture immediately, and do not store it for later use. Establish a routine by taking the medication at the same time every day. Continue taking the medication as directed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry location, avoiding bathrooms. Keep all medications in a secure place, out of reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take deferasirox granules by sprinkling the entire dose on a small amount of soft food (e.g., yogurt, applesauce) or mixing with a small amount of liquid (e.g., orange juice, apple juice, milk). Stir until dispersed and consume immediately. Do not chew the granules.
- Take the medicine at approximately the same time each day, preferably on an empty stomach or with a light meal to ensure consistent absorption.
- Do not take with aluminum-containing antacids (e.g., Maalox, Mylanta).
- Stay well-hydrated while taking this medication.
- Attend all scheduled doctor appointments and laboratory tests, as regular monitoring of blood, kidney, and liver function, as well as vision and hearing, is crucial.
- Report any new or worsening side effects immediately to your doctor.
Available Forms & Alternatives
Available Strengths:
- Deferasirox 90mg Tablets
- Deferasirox 360mg Tablets
- Deferasirox 125mg Tablets For Susp
- Deferasirox 500mg Tablets For Susp
- Deferasirox 250mg Tablets For Susp
- Deferasirox 180mg Tablets
- Deferasirox 90mg Oral Granules
- Deferasirox 180mg Granules
- Deferasirox 360mg Granules
- Deferasirox 180mg Granules
- Deferasirox 360mg Granules
- Deferasirox 90mg Oral Granules
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose for transfusional iron overload: 14 mg/kg orally once daily. Initial dose for non-transfusion-dependent thalassemia (NTDT) syndromes: 7 mg/kg orally once daily.
Dose Range:
7 - 28 mg
Condition-Specific Dosing:
Transfusional Iron Overload:
Initial: 14 mg/kg/day. Adjust in 3-7 mg/kg increments every 3-6 months based on serum ferritin (target <1000 mcg/L). Max: 28 mg/kg/day.
Non-Transfusion-Dependent Thalassemia (NTDT) Syndromes:
Initial: 7 mg/kg/day. Adjust in 3.5-7 mg/kg increments every 3-6 months based on serum ferritin (target <300 mcg/L). Max: 14 mg/kg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for <2 years of age for transfusional iron overload; Not established for <10 years of age for NTDT.
Child:
Transfusional Iron Overload (âĨ2 years): Initial 14 mg/kg orally once daily. NTDT (âĨ10 years): Initial 7 mg/kg orally once daily. Doses adjusted similarly to adults.
Adolescent:
Transfusional Iron Overload (âĨ2 years): Initial 14 mg/kg orally once daily. NTDT (âĨ10 years): Initial 7 mg/kg orally once daily. Doses adjusted similarly to adults.
Dose Adjustments
Renal Impairment:
Mild:
Initial dose reduction may be considered for patients with baseline creatinine clearance (CrCl) 40-60 mL/min. Monitor renal function closely.
Moderate:
Initial dose reduction may be considered for patients with baseline CrCl 40-60 mL/min. Monitor renal function closely. Avoid if CrCl <40 mL/min.
Severe:
Contraindicated if CrCl <40 mL/min or serum creatinine >2 times the age-appropriate upper limit of normal.
Dialysis:
Not recommended in patients with end-stage renal disease (ESRD) on dialysis.
Hepatic Impairment:
Mild:
No initial dose adjustment required (Child-Pugh A). Monitor liver function closely.
Moderate:
Reduce initial dose by 50% (Child-Pugh B). Monitor liver function closely. Avoid if Child-Pugh C.
Severe:
Contraindicated (Child-Pugh C).
Pharmacology
Mechanism of Action
Deferasirox is an orally active chelator that is highly selective for iron. It forms a stable 2:1 complex with iron (Fe3+), thereby promoting the excretion of iron from the body, primarily via the feces. It has a low affinity for other essential metals like zinc and copper.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 70% (oral granules vs. oral suspension).
Tmax:
1.5-4 hours (oral granules).
FoodEffect:
High-fat meals increase AUC by 100% and Cmax by 160%. Low-fat meals increase AUC by 50% and Cmax by 80%. Administer on an empty stomach or with a light meal to ensure consistent absorption.
Distribution:
Vd:
14.3 L (apparent volume of distribution).
ProteinBinding:
>99% (primarily to serum albumin).
CnssPenetration:
Limited
Elimination:
HalfLife:
8-16 hours (mean 11-16 hours).
Clearance:
Approximately 11.6 L/h (apparent oral clearance).
ExcretionRoute:
Predominantly fecal (84%), minor renal (8%).
Unchanged:
Not available (most is metabolized or excreted as complex)
Pharmacodynamics
OnsetOfAction:
Within days to weeks, as evidenced by reduction in serum ferritin.
PeakEffect:
Reduction in iron burden typically observed over months of therapy.
DurationOfAction:
Related to half-life; daily dosing maintains chelation.
Safety & Warnings
BLACK BOX WARNING
Renal Impairment: Deferasirox can cause acute renal failure, and fatal outcomes have been reported. Monitor serum creatinine and/or creatinine clearance weekly during the first month after initiation or dose modification and monthly thereafter. Hepatic Impairment: Deferasirox can cause hepatic failure, and fatal outcomes have been reported. Monitor serum transaminases and bilirubin weekly during the first month after initiation or dose modification and monthly thereafter. Gastrointestinal Hemorrhage: Gastrointestinal hemorrhage, including fatal hemorrhage, has been reported, especially in elderly patients with advanced hematologic malignancies and/or low platelet counts. Bone Marrow Suppression: Agranulocytosis, neutropenia, and thrombocytopenia, including fatal cases, have been reported. Monitor blood counts regularly.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of bowel problems, including:
+ Black, tarry, or bloody stools
+ Fever
+ Mucus in the stools
+ Vomiting blood or coffee ground-like material
+ Severe stomach pain, constipation, or diarrhea
Changes in hearing or eyesight
Chest pain or pressure, rapid heartbeat, or fainting
Flu-like symptoms
Rashes (may require discontinuation of the medication; consult your doctor if you develop a rash)
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions (may affect internal organs and can be life-threatening)
+ Symptoms include: red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands
Bone marrow suppression, which can lead to:
+ Severe bleeding problems
+ Infections
+ Symptoms include: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, unhealing wounds, bruising, bleeding, or feeling extremely tired or weak
Other Possible Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If you encounter any of the following side effects or any other unusual symptoms, consult your doctor or seek medical attention if they bother you or persist:
Diarrhea
Stomach pain
Upset stomach
Vomiting
This is not an exhaustive list of potential side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of bowel problems, including:
+ Black, tarry, or bloody stools
+ Fever
+ Mucus in the stools
+ Vomiting blood or coffee ground-like material
+ Severe stomach pain, constipation, or diarrhea
Changes in hearing or eyesight
Chest pain or pressure, rapid heartbeat, or fainting
Flu-like symptoms
Rashes (may require discontinuation of the medication; consult your doctor if you develop a rash)
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions (may affect internal organs and can be life-threatening)
+ Symptoms include: red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands
Bone marrow suppression, which can lead to:
+ Severe bleeding problems
+ Infections
+ Symptoms include: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, unhealing wounds, bruising, bleeding, or feeling extremely tired or weak
Other Possible Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If you encounter any of the following side effects or any other unusual symptoms, consult your doctor or seek medical attention if they bother you or persist:
Diarrhea
Stomach pain
Upset stomach
Vomiting
This is not an exhaustive list of potential side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe stomach pain, black or bloody stools, vomiting blood (signs of GI hemorrhage)
- Yellowing of skin or eyes (jaundice), dark urine, light-colored stools (signs of liver problems)
- Swelling in legs or feet, decreased urination, unusual tiredness (signs of kidney problems)
- Sudden decrease in hearing or vision, blurred vision, changes in color perception
- Unexplained fever, sore throat, mouth sores, unusual bruising or bleeding (signs of bone marrow suppression)
- Severe skin rash, blistering, peeling skin, or swelling of face/lips (signs of severe skin reactions)
- Severe diarrhea or vomiting that does not stop
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Cancer
+ Blood or bone marrow disorders, such as low platelet count or high-risk myelodysplastic syndrome (MDS)
+ Kidney disease
+ Liver disease
Any instances of dehydration, which can be caused by:
+ Inability to eat or drink normally
+ Diarrhea
+ Vomiting
+ Other illnesses that may lead to dehydration
Use of another medication with similar properties. If you are unsure, consult your doctor or pharmacist for clarification.
Concurrent use of certain medications, including:
+ Cholestyramine
+ Colesevelam
+ Colestipol
+ Phenobarbital
+ Phenytoin
+ Rifampicin
+ Ritonavir
+ Theophylline
+ Tizanidine
Breast-feeding. Note that you should not breast-feed while taking this medication.
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
Health problems
Ensure that it is safe to take this medication with all your other medications and health conditions. Do not initiate, stop, or modify the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Cancer
+ Blood or bone marrow disorders, such as low platelet count or high-risk myelodysplastic syndrome (MDS)
+ Kidney disease
+ Liver disease
Any instances of dehydration, which can be caused by:
+ Inability to eat or drink normally
+ Diarrhea
+ Vomiting
+ Other illnesses that may lead to dehydration
Use of another medication with similar properties. If you are unsure, consult your doctor or pharmacist for clarification.
Concurrent use of certain medications, including:
+ Cholestyramine
+ Colesevelam
+ Colestipol
+ Phenobarbital
+ Phenytoin
+ Rifampicin
+ Ritonavir
+ Theophylline
+ Tizanidine
Breast-feeding. Note that you should not breast-feed while taking this medication.
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
Health problems
Ensure that it is safe to take this medication with all your other medications and health conditions. Do not initiate, stop, or modify the dosage of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Until you understand how this drug affects you, avoid operating a vehicle or engaging in activities that require alertness.
Regularly undergo blood tests, other laboratory tests, eye exams, and hearing tests as directed by your doctor to monitor your health while taking this medication. Do not take antacids containing aluminum concurrently with this drug, as it may interfere with its effectiveness.
If you are 55 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. Similarly, when administering this drug to children, use it with caution, as they may have a higher risk of experiencing certain side effects. If your child's weight changes while taking this medication, consult your doctor, as their dosage may need to be adjusted.
Be aware that birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy while taking this medication. To minimize the risk of unintended pregnancy, use an additional form of birth control, such as condoms, in conjunction with your regular birth control method.
If you are pregnant or planning to become pregnant, consult your doctor to discuss the potential benefits and risks associated with using this medication during pregnancy.
Regularly undergo blood tests, other laboratory tests, eye exams, and hearing tests as directed by your doctor to monitor your health while taking this medication. Do not take antacids containing aluminum concurrently with this drug, as it may interfere with its effectiveness.
If you are 55 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. Similarly, when administering this drug to children, use it with caution, as they may have a higher risk of experiencing certain side effects. If your child's weight changes while taking this medication, consult your doctor, as their dosage may need to be adjusted.
Be aware that birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy while taking this medication. To minimize the risk of unintended pregnancy, use an additional form of birth control, such as condoms, in conjunction with your regular birth control method.
If you are pregnant or planning to become pregnant, consult your doctor to discuss the potential benefits and risks associated with using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Headache
- Increased liver enzymes
- Renal impairment
What to Do:
There is no specific antidote. Treatment is symptomatic and supportive. Induce emesis or perform gastric lavage. Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention.
Drug Interactions
Major Interactions
- Aluminum-containing antacids (e.g., aluminum hydroxide): Concomitant use not recommended due to potential for deferasirox-aluminum complex formation.
- Midazolam (CYP3A4 substrate): Deferasirox may decrease exposure of CYP3A4 substrates. Monitor for decreased efficacy of CYP3A4 substrates.
- Repaglinide (CYP2C8 substrate): Deferasirox is a moderate CYP2C8 inhibitor. Concomitant use may increase repaglinide exposure, increasing risk of hypoglycemia. Avoid or monitor blood glucose closely.
- Theophylline (CYP1A2 substrate): Deferasirox is a moderate CYP1A2 inducer. Concomitant use may decrease theophylline exposure. Monitor theophylline levels.
- Oral Contraceptives (CYP3A4 substrates): Deferasirox may decrease exposure of oral contraceptives, potentially reducing efficacy. Advise alternative non-hormonal contraception.
Moderate Interactions
- UGT inducers (e.g., rifampicin, phenytoin, phenobarbital, ritonavir): May significantly decrease deferasirox exposure, reducing efficacy. Consider increasing deferasirox dose and monitor serum ferritin.
- UGT inhibitors (e.g., fluconazole): May increase deferasirox exposure. Monitor for increased adverse effects.
- Cholestyramine: May significantly decrease deferasirox exposure. Avoid concomitant use.
- Drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone): Deferasirox is a moderate CYP2C8 inhibitor. Monitor for increased exposure of these drugs.
- Vitamin K antagonists (e.g., warfarin): Increased risk of bleeding. Monitor INR closely.
Confidence Interactions
Monitoring
Baseline Monitoring
Serum ferritin
Rationale: To establish baseline iron overload and guide initial dosing.
Timing: Prior to initiation of therapy.
Serum creatinine and estimated GFR
Rationale: To assess renal function and guide initial dosing/contraindications.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST, alkaline phosphatase, bilirubin)
Rationale: To assess hepatic function and guide initial dosing/contraindications.
Timing: Prior to initiation of therapy.
Urinalysis (proteinuria)
Rationale: To assess for renal tubular dysfunction.
Timing: Prior to initiation of therapy.
Audiometric testing
Rationale: To establish baseline hearing function due to potential for auditory toxicity.
Timing: Prior to initiation of therapy.
Ophthalmologic examination (slit lamp, fundoscopy, visual acuity)
Rationale: To establish baseline ocular function due to potential for ocular toxicity.
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum ferritin
Frequency: Monthly
Target: <1000 mcg/L (transfusional), <300 mcg/L (NTDT)
Action Threshold: Increase dose if ferritin not decreasing or increasing; decrease dose if ferritin <500 mcg/L (transfusional) or <300 mcg/L (NTDT) or if iron-deficient.
Serum creatinine and estimated GFR
Frequency: Weekly for the first month, then monthly thereafter.
Target: Within normal limits for age.
Action Threshold: If serum creatinine increases by >33% above baseline on two consecutive measurements, or if it exceeds the age-appropriate upper limit of normal, consider dose reduction or interruption. Discontinue if CrCl <40 mL/min.
Liver function tests (ALT, AST, alkaline phosphatase, bilirubin)
Frequency: Weekly for the first month, then monthly thereafter.
Target: Within normal limits.
Action Threshold: If ALT/AST increases to >5 times the upper limit of normal (ULN) or >3 times ULN with concurrent bilirubin increase, consider dose reduction or interruption. Discontinue if persistent or severe.
Urinalysis (proteinuria)
Frequency: Monthly
Target: Negative or trace protein.
Action Threshold: If persistent or increasing proteinuria, consider dose reduction or interruption.
Audiometric testing
Frequency: Annually
Target: Stable hearing.
Action Threshold: If hearing impairment develops, consider dose reduction or interruption.
Ophthalmologic examination (slit lamp, fundoscopy, visual acuity)
Frequency: Annually
Target: Stable vision.
Action Threshold: If visual disturbances develop, consider dose reduction or interruption.
Symptom Monitoring
- Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain)
- Skin rash
- Headache
- Fever
- Changes in urine output or color
- Yellowing of skin or eyes (jaundice)
- Unexplained bleeding or bruising
- Signs of bone marrow suppression (fatigue, fever, easy bruising/bleeding)
- Hearing changes (e.g., ringing in ears, decreased hearing)
- Vision changes (e.g., blurred vision, decreased vision, cataracts)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown adverse effects on fetal development. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity based on animal data (skeletal abnormalities, reduced fetal weight).
Second Trimester:
Potential for developmental toxicity based on animal data.
Third Trimester:
Potential for developmental toxicity based on animal data.
Lactation
L3 (Moderately Safe). It is not known whether deferasirox is excreted in human milk. Animal studies show excretion into milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Potential for serious adverse reactions (e.g., renal, hepatic, hematologic toxicity) based on drug's mechanism and animal data. Monitor infant for adverse effects.
Pediatric Use
Approved for transfusional iron overload in patients âĨ2 years of age and for NTDT in patients âĨ10 years of age. Dosing is weight-based. Close monitoring of renal and hepatic function, as well as growth and development, is crucial. Pediatric patients may be more susceptible to certain adverse effects.
Geriatric Use
Increased risk of adverse reactions, particularly gastrointestinal hemorrhage, in elderly patients (âĨ65 years), especially those with advanced hematologic malignancies and/or low platelet counts. Use with caution and monitor closely.
Clinical Information
Clinical Pearls
- Deferasirox granules must be fully dispersed in a liquid or soft food and consumed immediately. Do not chew the granules.
- Consistent administration (empty stomach or light meal) is important for predictable absorption.
- Patients should be educated on the importance of strict adherence to monitoring schedules for renal, hepatic, and hematologic parameters, as well as vision and hearing.
- The Black Box Warning highlights serious and potentially fatal adverse effects; patient education on warning signs is critical.
- Dose adjustments are primarily based on serum ferritin trends, but also on safety parameters (renal/hepatic function).
- Avoid concomitant use with aluminum-containing antacids due to potential for complex formation and reduced deferasirox efficacy.
- Consider alternative contraception for women of childbearing potential due to potential for reduced efficacy of oral contraceptives.
Alternative Therapies
- Deferoxamine (parenteral iron chelator)
- Deferiprone (oral iron chelator, often used in combination or for specific indications)
Cost & Coverage
Average Cost:
Varies widely, typically several thousand dollars per 30 doses
Generic Available:
Yes
Insurance Coverage:
Tier 4 (Specialty Drug) or higher, often requiring prior authorization and step therapy.
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.