Deferasirox 360mg Tablets
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
Iron chelator
Pregnancy Category
C
FDA Approved
Nov 2005
DEA Schedule
Not Controlled
Overview
What is this medicine?
Deferasirox is a medication used to remove excess iron from the body. This excess iron can build up in people who receive frequent blood transfusions or have certain blood disorders like thalassemia. Too much iron can damage organs like the liver and heart. Deferasirox works by binding to the iron, forming a complex that the body can then remove, mostly through stool.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication on an empty stomach or with a light meal.
Swallow your medication whole with water or another liquid.
If you have trouble swallowing tablets, you can crush them and mix with a small amount of soft food. Take the mixture immediately and do not save it for later use.
Note: If you need to crush the 90 mg tablet, consult with your doctor or pharmacist first, as certain types of tablet crushers should not be used.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
To ensure your medication remains effective and safe:
Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure location, 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 by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take the missed dose as soon as you remember.
If it's 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 a missed dose.
To get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication on an empty stomach or with a light meal.
Swallow your medication whole with water or another liquid.
If you have trouble swallowing tablets, you can crush them and mix with a small amount of soft food. Take the mixture immediately and do not save it for later use.
Note: If you need to crush the 90 mg tablet, consult with your doctor or pharmacist first, as certain types of tablet crushers should not be used.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
To ensure your medication remains effective and safe:
Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure location, 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 by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take the missed dose as soon as you remember.
If it's 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 a missed dose.
Lifestyle & Tips
- Take the tablet once daily at approximately the same time each day, preferably on an empty stomach or with a light meal to ensure consistent absorption.
- Swallow tablets whole. Do not chew, crush, or cut them.
- Maintain good hydration, especially if experiencing diarrhea or vomiting.
- Avoid taking aluminum-containing antacids (e.g., Maalox, Mylanta) with deferasirox. If needed, take them at least 3 hours apart.
- Report any new or worsening side effects to your doctor immediately.
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-transfusional thalassemia syndromes: 7 mg/kg orally once daily. Adjust in increments of 3.5-7 mg/kg based on serum ferritin trends.
Dose Range:
3.5 - 28 mg
Condition-Specific Dosing:
transfusionalIronOverload:
Initial: 14 mg/kg/day. Max: 28 mg/kg/day. Adjust based on serum ferritin every 3-6 months.
nonTransfusionalThalassemiaSyndromes:
Initial: 7 mg/kg/day. Max: 14 mg/kg/day. Adjust based on serum ferritin every 3-6 months.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (safety and efficacy not established in pediatric patients younger than 2 years of age)
Child:
Initial dose for transfusional iron overload (>=2 years): 14 mg/kg orally once daily. Initial dose for non-transfusional thalassemia syndromes (>=10 years): 7 mg/kg orally once daily. Adjust in increments of 3.5-7 mg/kg based on serum ferritin trends.
Adolescent:
Same as adult dosing for respective indications.
Dose Adjustments
Renal Impairment:
Mild:
Initial dose reduction to 7 mg/kg/day for transfusional iron overload if eGFR < 90 mL/min/1.73 m2. Monitor serum creatinine closely.
Moderate:
Initial dose reduction to 7 mg/kg/day for transfusional iron overload if eGFR < 90 mL/min/1.73 m2. Avoid use if eGFR < 40 mL/min/1.73 m2.
Severe:
Contraindicated if eGFR < 40 mL/min/1.73 m2 or in patients with advanced renal impairment or high-risk renal dysfunction.
Dialysis:
Contraindicated in patients requiring dialysis.
Hepatic Impairment:
Mild:
No initial dose adjustment required (Child-Pugh A). Monitor liver function tests closely.
Moderate:
Reduce initial dose by 50% (Child-Pugh B). Monitor liver function tests closely. Avoid use 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 zinc and copper, and does not cause pathological excretion of these essential trace metals.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 70% (for film-coated tablets compared to oral suspension)
Tmax:
1.5 to 4 hours
FoodEffect:
High-fat meal increases AUC by 16% and Cmax by 29%. Low-fat meal increases AUC by 18% and Cmax by 16%. Take on an empty stomach or with a light meal to minimize variability.
Distribution:
Vd:
14.3 L (apparent volume of distribution)
ProteinBinding:
>99% (primarily to serum albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
8 to 16 hours
Clearance:
Not available (primarily hepatic metabolism and biliary excretion)
ExcretionRoute:
Biliary/fecal (84%), renal (8%)
Unchanged:
Not available (minimal unchanged drug excreted)
Pharmacodynamics
OnsetOfAction:
Within days to weeks (reduction in serum ferritin)
PeakEffect:
Months (for significant reduction in iron burden)
DurationOfAction:
24 hours (due to once-daily dosing)
Safety & Warnings
BLACK BOX WARNING
Renal Failure, Hepatic Failure, and Gastrointestinal Hemorrhage. Deferasirox can cause acute renal failure, hepatic failure, and gastrointestinal hemorrhage, some of which have been fatal. Monitor renal function, hepatic function, and gastrointestinal bleeding.
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 immediately or seek emergency 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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ 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 vision
Chest pain or pressure, rapid heartbeat, or fainting
Flu-like symptoms
Rashes, which may require stopping the medication; if you develop a rash, contact your doctor promptly to determine the best course of action
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which can affect internal organs and be life-threatening; seek medical help immediately if you experience:
- 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
- Swollen glands
Bone marrow suppression, which can lead to severe bleeding problems or infections; contact your doctor right away if you experience:
+ Signs of infection, such as fever, chills, severe sore throat, ear or sinus pain, cough, increased sputum production, or changes in sputum color
+ Unusual bruising or bleeding
+ Fatigue or weakness
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. If you encounter any of the following side effects or any other symptoms that concern you or do not resolve, contact your doctor:
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 immediately or seek emergency 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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ 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 vision
Chest pain or pressure, rapid heartbeat, or fainting
Flu-like symptoms
Rashes, which may require stopping the medication; if you develop a rash, contact your doctor promptly to determine the best course of action
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which can affect internal organs and be life-threatening; seek medical help immediately if you experience:
- 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
- Swollen glands
Bone marrow suppression, which can lead to severe bleeding problems or infections; contact your doctor right away if you experience:
+ Signs of infection, such as fever, chills, severe sore throat, ear or sinus pain, cough, increased sputum production, or changes in sputum color
+ Unusual bruising or bleeding
+ Fatigue or weakness
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. If you encounter any of the following side effects or any other symptoms that concern you or do not resolve, contact your doctor:
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 bleeding)
- Decreased urination, swelling in legs/feet, unusual tiredness (signs of kidney problems)
- Yellowing of skin or eyes, dark urine, pale stools, severe nausea/vomiting, pain in upper right stomach area (signs of liver problems)
- Blurred vision, changes in vision, difficulty seeing at night
- Hearing loss, ringing in ears
- Severe skin rash, blistering, peeling skin, fever (signs of severe skin reactions)
- Unexplained weight loss
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, such as:
+ Inability to eat or drink normally
+ Diarrhea
+ Vomiting
+ Other illnesses that may cause dehydration
Use of another medication similar to this one. If you are unsure, consult your doctor or pharmacist.
Concurrent use of the following medications:
+ Cholestyramine
+ Colesevelam
+ Colestipol
+ Phenobarbital
+ Phenytoin
+ Rifampicin
+ Ritonavir
+ Theophylline
+ Tizanidine
If you are breast-feeding. Note: 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 drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Do not initiate, terminate, or modify the dosage of any medication without first 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, such as:
+ Inability to eat or drink normally
+ Diarrhea
+ Vomiting
+ Other illnesses that may cause dehydration
Use of another medication similar to this one. If you are unsure, consult your doctor or pharmacist.
Concurrent use of the following medications:
+ Cholestyramine
+ Colesevelam
+ Colestipol
+ Phenobarbital
+ Phenytoin
+ Rifampicin
+ Ritonavir
+ Theophylline
+ Tizanidine
If you are breast-feeding. Note: 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 drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Do not initiate, terminate, or modify the dosage of any medication without first 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 and engaging in other activities that require alertness.
To monitor your health, follow your doctor's instructions for regular blood work, lab tests, eye exams, and hearing tests. When taking this medication, do not use antacids containing aluminum.
If you are 55 years or older, exercise caution when using this drug, as you may be more susceptible to side effects. Similarly, if the patient is a child, use this medication with caution, as children may have a higher risk of experiencing certain side effects. If your child is taking this medication and their weight changes, consult with your doctor, as their dosage may need to be adjusted.
When taking this medication, be aware that birth control pills and other hormone-based birth control methods may be less effective in preventing pregnancy. To minimize the risk of unplanned pregnancy, use an additional form of birth control, such as a condom, in conjunction with your regular birth control method.
If you are pregnant or planning to become pregnant, inform your doctor, as they will need to discuss the potential benefits and risks of using this medication during pregnancy with you.
To monitor your health, follow your doctor's instructions for regular blood work, lab tests, eye exams, and hearing tests. When taking this medication, do not use antacids containing aluminum.
If you are 55 years or older, exercise caution when using this drug, as you may be more susceptible to side effects. Similarly, if the patient is a child, use this medication with caution, as children may have a higher risk of experiencing certain side effects. If your child is taking this medication and their weight changes, consult with your doctor, as their dosage may need to be adjusted.
When taking this medication, be aware that birth control pills and other hormone-based birth control methods may be less effective in preventing pregnancy. To minimize the risk of unplanned pregnancy, use an additional form of birth control, such as a condom, in conjunction with your regular birth control method.
If you are pregnant or planning to become pregnant, inform your doctor, as they will need to discuss the potential benefits and risks of using this medication during pregnancy with you.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Headache
- Dizziness
- Renal or hepatic impairment (in severe cases)
What to Do:
Seek immediate medical attention. There is no specific antidote. Treatment is supportive. Contact a poison control center (e.g., 1-800-222-1222) for guidance.
Drug Interactions
Contraindicated Interactions
- Aluminum-containing antacids (due to binding and potential for increased deferasirox exposure)
- Patients with eGFR < 40 mL/min/1.73 m2 or advanced renal impairment
- Patients with Child-Pugh C hepatic impairment
- Patients with high-risk myelodysplastic syndromes (MDS) or advanced malignancies who may not benefit from chelation
Major Interactions
- CYP3A4 inducers (e.g., rifampin, phenytoin, phenobarbital, carbamazepine): May decrease deferasirox exposure, consider dose increase.
- UGT inducers (e.g., rifampin, phenobarbital, phenytoin): May decrease deferasirox exposure, consider dose increase.
- Midazolam (CYP3A4 substrate): Deferasirox may decrease midazolam exposure.
- Repaglinide (CYP2C8 substrate): Deferasirox may increase repaglinide exposure, increasing risk of hypoglycemia.
- Theophylline (CYP1A2 substrate): Deferasirox may decrease theophylline exposure.
- Oral contraceptives (hormonal): Deferasirox may decrease efficacy, advise alternative contraception.
Moderate Interactions
- Drugs causing GI irritation/ulceration/hemorrhage (e.g., NSAIDs, corticosteroids, oral bisphosphonates, anticoagulants): Increased risk of GI adverse events.
- Nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, NSAIDs): Increased risk of renal toxicity.
- Drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone): Deferasirox may increase exposure of these drugs.
- Drugs metabolized by CYP1A2 (e.g., clozapine, tizanidine): Deferasirox may decrease exposure of these drugs.
Minor Interactions
- Not specifically categorized as minor, but general caution with drugs that may affect renal or hepatic function.
Monitoring
Baseline Monitoring
Serum ferritin
Rationale: To establish baseline iron burden and guide initial dosing.
Timing: Prior to initiation of therapy.
Serum creatinine and estimated Glomerular Filtration Rate (eGFR)
Rationale: To assess renal function and guide dosing; deferasirox is renally eliminated and can cause renal impairment.
Timing: Prior to initiation of therapy (at least two measurements).
Liver function tests (ALT, AST, alkaline phosphatase, bilirubin)
Rationale: To assess hepatic function; deferasirox is hepatically metabolized and can cause hepatic toxicity.
Timing: Prior to initiation of therapy.
Urinalysis (proteinuria)
Rationale: To screen for renal tubular dysfunction.
Timing: Prior to initiation of therapy.
Audiometric testing
Rationale: To establish baseline hearing, as deferasirox can cause hearing loss.
Timing: Prior to initiation of therapy.
Ophthalmologic examination (slit lamp, fundoscopy)
Rationale: To establish baseline vision, as deferasirox can cause ocular disturbances.
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum ferritin
Frequency: Monthly for the first year, then every 3-6 months
Target: Goal is to maintain serum ferritin between 500 and 1000 ng/mL, or below 1000 ng/mL for non-transfusional iron overload.
Action Threshold: If serum ferritin consistently < 500 ng/mL, consider dose reduction or interruption. If consistently > 2500 ng/mL, consider dose increase (up to max).
Serum creatinine and eGFR
Frequency: Weekly for the first month, then monthly
Target: Maintain within normal limits or baseline.
Action Threshold: If serum creatinine increases by >33% above baseline on two consecutive measurements, or if eGFR falls below 40 mL/min/1.73 m2, interrupt therapy. Re-initiate at lower dose if renal function recovers.
Liver function tests (ALT, AST)
Frequency: Every 2 weeks for the first month, then monthly
Target: Maintain within normal limits or baseline.
Action Threshold: If ALT/AST increases to >5 times ULN, or >3 times ULN and >2 times baseline, interrupt therapy. Re-initiate at lower dose if LFTs recover.
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 loss detected, consider dose reduction or interruption.
Ophthalmologic examination
Frequency: Annually
Target: Stable vision.
Action Threshold: If visual disturbances detected, consider dose reduction or interruption.
Symptom Monitoring
- Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain, GI hemorrhage)
- Renal symptoms (decreased urine output, edema, fatigue, signs of renal impairment)
- Hepatic symptoms (jaundice, dark urine, pale stools, right upper quadrant pain)
- Visual disturbances (blurred vision, decreased acuity, cataracts)
- Hearing loss (tinnitus, difficulty hearing)
- Skin rash
- Hypersensitivity reactions
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on fetal development.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity observed in animal studies.
Second Trimester:
Potential for developmental toxicity observed in animal studies.
Third Trimester:
Potential for developmental toxicity observed in animal studies.
Lactation
L3 (Moderately Safe). It is not known whether deferasirox is excreted in human milk. Deferasirox and its metabolites were excreted in the milk of lactating rats. 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 in the breastfed infant. Monitor for gastrointestinal upset, rash, or other signs of toxicity.
Pediatric Use
Safety and efficacy have not been established in pediatric patients younger than 2 years of age. In older children, dosing is weight-based and requires careful monitoring of iron burden, renal, and hepatic function. Growth retardation has been reported.
Geriatric Use
Use with caution in elderly patients (âĨ65 years) due to a higher incidence of adverse reactions, particularly renal, hepatic, and gastrointestinal adverse events. Start with a lower initial dose and monitor closely.
Clinical Information
Clinical Pearls
- Deferasirox film-coated tablets (Jadenu) are not bioequivalent to the original dispersible tablets (Exjade) on a mg-to-mg basis. The film-coated tablets have higher bioavailability, so a lower dose is used (e.g., 14 mg/kg of film-coated is equivalent to 20 mg/kg of dispersible).
- Ensure patients understand the importance of consistent daily dosing and the need for regular monitoring tests (blood and urine).
- Educate patients on symptoms of serious adverse events (renal, hepatic, GI) and when to seek immediate medical attention.
- Hydration is important, especially if GI side effects like diarrhea occur, to prevent renal complications.
- Consider dose adjustments for concomitant medications that are strong CYP3A4 or UGT inducers, or CYP2C8 substrates.
- For patients with difficulty swallowing, the film-coated tablets can be crushed and mixed with soft food (e.g., applesauce, yogurt) and consumed immediately.
Alternative Therapies
- Deferoxamine (parenteral iron chelator)
- Deferiprone (oral iron chelator)
Cost & Coverage
Average Cost:
Varies widely, typically $1,000 - $5,000+ per 30 tablets (360mg)
Generic Available:
Yes
Insurance Coverage:
Tier 3 or 4 (Specialty Drug)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, it's crucial to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, it's crucial to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.