Deferasirox 250mg Tablets For Susp
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
Chelating Agents
Pharmacologic Class
Iron Chelator
Pregnancy Category
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 helps your body get rid of that extra iron.
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, 30 minutes before a meal.
To take your medication, mix the tablet with fruit juice (such as orange or apple) or water until it is fully dissolved, then drink the mixture right away. Do not chew or swallow the tablet whole.
After drinking the mixture, rinse the glass with more juice or water to ensure you get all of the medication, and then drink the rinse.
Take your medication at the same time every day.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel 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 safe location, out of the 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.
If you have questions about disposing of your medication, ask your pharmacist. You may also have access to drug take-back programs in your area.
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 is close to the time for your next 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, 30 minutes before a meal.
To take your medication, mix the tablet with fruit juice (such as orange or apple) or water until it is fully dissolved, then drink the mixture right away. Do not chew or swallow the tablet whole.
After drinking the mixture, rinse the glass with more juice or water to ensure you get all of the medication, and then drink the rinse.
Take your medication at the same time every day.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel 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 safe location, out of the 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.
If you have questions about disposing of your medication, ask your pharmacist. You may also have access to drug take-back programs in your area.
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 is close to the time for your next 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 medicine once daily, preferably at the same time each day.
- For tablets for oral suspension (Exjade), disperse the tablet completely by stirring in water, orange juice, or apple juice until a fine suspension is formed. Drink immediately. Do not chew tablets or swallow them whole.
- Take on an empty stomach or with a light meal to ensure consistent absorption.
- Avoid taking with aluminum-containing antacids (e.g., Maalox, Mylanta).
- Stay well-hydrated.
- Attend all scheduled blood tests and doctor appointments to monitor your iron levels and check for side effects.
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: 20 mg/kg orally once daily. Initial dose for non-transfusional thalassemia syndromes: 10 mg/kg orally once daily. Adjust dose in 5-10 mg/kg increments/decrements every 3-6 months based on serum ferritin trends and patient response. Max dose: 40 mg/kg/day.
Dose Range:
10 - 40 mg
Condition-Specific Dosing:
transfusionalIronOverload:
Initial: 20 mg/kg/day. Target serum ferritin < 1000 mcg/L. Max: 40 mg/kg/day.
nonTransfusionalThalassemiaSyndromes:
Initial: 10 mg/kg/day. Target serum ferritin < 300 mcg/L. Max: 20 mg/kg/day (or 40 mg/kg/day if needed for severe overload).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants < 2 years of age. For children 2 to < 6 years, consider starting at 10 mg/kg/day due to lower exposure.
Child:
Initial dose for transfusional iron overload (âĨ2 years): 20 mg/kg orally once daily. Initial dose for non-transfusional thalassemia syndromes (âĨ10 years): 10 mg/kg orally once daily. Adjust dose as per adult guidelines.
Adolescent:
Initial dose for transfusional iron overload: 20 mg/kg orally once daily. Initial dose for non-transfusional thalassemia syndromes: 10 mg/kg orally once daily. Adjust dose as per adult guidelines.
Dose Adjustments
Renal Impairment:
Mild:
CrCl 60-90 mL/min: No initial dose adjustment. Monitor serum creatinine closely.
Moderate:
CrCl 30-59 mL/min: Reduce initial dose by 50%. Monitor serum creatinine closely. Avoid if CrCl < 40 mL/min for non-transfusional iron overload.
Severe:
CrCl < 30 mL/min: Contraindicated.
Dialysis:
Contraindicated.
Hepatic Impairment:
Mild:
Child-Pugh A: No initial dose adjustment. Monitor LFTs closely.
Moderate:
Child-Pugh B: Reduce initial dose by 50%. Monitor LFTs closely. Avoid if Child-Pugh B and high-risk myelodysplastic syndromes or other non-transfusion-dependent anemias.
Severe:
Child-Pugh C: Contraindicated.
Pharmacology
Mechanism of Action
Deferasirox is an orally active chelator that is highly selective for iron. It binds to iron with high affinity in a 2:1 ratio (deferasirox:iron), forming a stable, soluble complex that is then excreted primarily via the feces. This process reduces iron overload in patients with chronic iron accumulation.
Pharmacokinetics
Absorption:
Bioavailability:
70% (oral suspension)
Tmax:
1.5-4 hours
FoodEffect:
High-fat meal increases AUC by 16% and Cmax by 15%. Low-fat meal increases AUC by 18% and Cmax by 16%. Administer on an empty stomach or with a light meal to ensure consistent absorption.
Distribution:
Vd:
14 L
ProteinBinding:
>99% (primarily to serum albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
8-16 hours
Clearance:
Not available (systemic clearance is approximately 10.5 L/h in adults)
ExcretionRoute:
Fecal (84%), Renal (8%)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within days to weeks (reduction in serum ferritin)
PeakEffect:
Months (for significant reduction in iron burden)
DurationOfAction:
Dependent on continued administration and iron intake
Safety & Warnings
BLACK BOX WARNING
RENAL IMPAIRMENT, HEPATIC IMPAIRMENT, 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. Avoid use in patients with severe renal impairment (CrCl < 30 mL/min) or severe hepatic impairment (Child-Pugh C).
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. Avoid use in patients with severe renal impairment (CrCl < 30 mL/min) or severe hepatic impairment (Child-Pugh C).
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: 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, or swelling of the mouth, face, lips, tongue, or throat.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellow skin and eyes.
Signs of bowel problems: black, tarry, or bloody stools, fever, mucus in the stool, 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 discontinuation of the medication. If you develop a rash, contact your doctor immediately for guidance.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions, which can be life-threatening. Seek medical help immediately if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.
Blood cell disorders, which can increase the risk of severe bleeding or infections. Contact your doctor if you experience signs of infection, such as fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal; bruising or bleeding; or excessive 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 persist, contact your doctor:
* Diarrhea, stomach pain, upset stomach, or 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: 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, or swelling of the mouth, face, lips, tongue, or throat.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellow skin and eyes.
Signs of bowel problems: black, tarry, or bloody stools, fever, mucus in the stool, 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 discontinuation of the medication. If you develop a rash, contact your doctor immediately for guidance.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions, which can be life-threatening. Seek medical help immediately if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.
Blood cell disorders, which can increase the risk of severe bleeding or infections. Contact your doctor if you experience signs of infection, such as fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal; bruising or bleeding; or excessive 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 persist, contact your doctor:
* Diarrhea, stomach pain, upset stomach, or 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)
- Yellowing of skin or eyes (jaundice), dark urine, unusual tiredness (signs of liver problems)
- Swelling in legs or feet, decreased urination (signs of kidney problems)
- Blurred vision, changes in vision, or hearing loss
- Severe skin rash, blistering, or peeling skin
- Unexplained fever, sore throat, or easy bruising/bleeding (signs of blood problems)
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 similar medications. If you are unsure, consult your doctor or pharmacist.
Concurrent use of the following medications:
+ Cholestyramine
+ Colesevelam
+ Colestipol
+ Phenobarbital
+ Phenytoin
+ Rifampicin
+ Ritonavir
+ Theophylline
+ Tizanidine
Breast-feeding. Note: You should not breast-feed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. Ensure that it is safe to take this medication with your existing 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, such as:
+ Inability to eat or drink normally
+ Diarrhea
+ Vomiting
+ Other illnesses that may cause dehydration
Use of similar medications. If you are unsure, consult your doctor or pharmacist.
Concurrent use of the following medications:
+ Cholestyramine
+ Colesevelam
+ Colestipol
+ Phenobarbital
+ Phenytoin
+ Rifampicin
+ Ritonavir
+ Theophylline
+ Tizanidine
Breast-feeding. Note: You should not breast-feed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. Ensure that it is safe to take this medication with your existing 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. As directed by your doctor, regularly undergo blood tests, other laboratory tests, eye exams, and hearing tests to monitor your health.
When taking this medication, do not consume antacids containing aluminum, as they may interact with the drug. If you are 55 years or older, exercise caution when using this medication, 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.
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 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, consult with your doctor to discuss the potential benefits and risks of using this medication during pregnancy.
When taking this medication, do not consume antacids containing aluminum, as they may interact with the drug. If you are 55 years or older, exercise caution when using this medication, 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.
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 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, consult with your doctor to discuss the potential benefits and risks of 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 for advice.
Drug Interactions
Contraindicated Interactions
- Not specified as contraindicated with specific drugs, but caution with drugs that increase risk of renal/hepatic/GI toxicity.
Major Interactions
- Aluminum-containing antacids (e.g., aluminum hydroxide): Avoid concomitant use due to potential for increased deferasirox absorption.
- CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital): May significantly decrease deferasirox exposure, requiring dose increase of deferasirox.
- UGT inducers (e.g., rifampin, phenytoin, phenobarbital, ritonavir): May significantly decrease deferasirox exposure, requiring dose increase of deferasirox.
- Midazolam (CYP3A4 substrate): Deferasirox may decrease midazolam exposure. Consider dose adjustment of midazolam.
- Repaglinide (CYP2C8 substrate): Deferasirox may increase repaglinide exposure. Avoid concomitant use if possible, or monitor blood glucose closely and consider dose reduction of repaglinide.
- Oral contraceptives (hormonal): Deferasirox may decrease efficacy of hormonal contraceptives. Advise use of non-hormonal birth control methods.
Moderate Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): May increase deferasirox exposure. Monitor for adverse effects and consider dose reduction of deferasirox.
- Vitamin K antagonists (e.g., warfarin): Increased risk of bleeding. Monitor INR closely.
- Drugs metabolized by CYP2C8 (e.g., paclitaxel): Deferasirox may inhibit CYP2C8, increasing exposure of these drugs. Monitor for toxicity.
- Drugs that cause GI irritation/ulceration (e.g., NSAIDs, corticosteroids, bisphosphonates): Increased risk of GI hemorrhage. Use with caution.
Minor Interactions
- Not specifically listed as minor interactions, but general caution with drugs affecting renal or hepatic function.
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 baseline renal function, as deferasirox can cause renal impairment.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST, serum bilirubin)
Rationale: To assess baseline hepatic function, as deferasirox can cause hepatic impairment.
Timing: Prior to initiation of therapy.
Urinalysis (for proteinuria)
Rationale: To screen for renal tubular dysfunction.
Timing: Prior to initiation of therapy.
Ophthalmologic examination (slit lamp and dilated fundoscopy)
Rationale: To screen for ocular abnormalities (e.g., cataracts, retinal toxicity).
Timing: Prior to initiation of therapy.
Audiometric examination
Rationale: To screen for hearing loss.
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum ferritin
Frequency: Monthly
Target: Goal is to maintain serum ferritin between 500-1000 mcg/L for transfusional iron overload, or < 300 mcg/L for non-transfusional thalassemia syndromes.
Action Threshold: If serum ferritin consistently < 500 mcg/L, consider dose reduction. If > 2500 mcg/L, consider dose increase (up to max). If < 300 mcg/L, consider dose interruption.
Serum creatinine and estimated GFR
Frequency: Weekly for the first month, then monthly thereafter.
Target: Within normal limits for age/sex.
Action Threshold: If serum creatinine increases by > 33% above baseline on two consecutive measurements, or above the upper limit of normal, reduce dose by 10 mg/kg. If increase persists, interrupt therapy. If CrCl < 40 mL/min, discontinue for non-transfusional iron overload.
Liver function tests (ALT, AST, serum bilirubin)
Frequency: Every 2 weeks for the first month, then monthly thereafter.
Target: Within normal limits.
Action Threshold: If ALT/AST > 5 times ULN, or > 3 times ULN and increasing, interrupt therapy. Re-initiate at lower dose when levels normalize.
Urinalysis (for proteinuria)
Frequency: Monthly
Target: Negative or trace protein.
Action Threshold: If persistent proteinuria, consider further renal evaluation.
Ophthalmologic examination
Frequency: Annually
Target: Normal findings.
Action Threshold: If visual disturbances or ocular abnormalities occur, interrupt therapy and refer to ophthalmologist.
Audiometric examination
Frequency: Annually
Target: Normal findings.
Action Threshold: If hearing loss occurs, interrupt therapy and refer to audiologist.
Complete Blood Count (CBC)
Frequency: Periodically
Target: Within normal limits.
Action Threshold: Monitor for cytopenias (e.g., neutropenia, thrombocytopenia).
Symptom Monitoring
- Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain, GI bleeding)
- Skin rash
- Visual disturbances (blurred vision, decreased acuity)
- Hearing loss
- Signs of renal dysfunction (decreased urine output, edema)
- Signs of hepatic dysfunction (jaundice, dark urine, fatigue)
- Fever, sore throat (signs of neutropenia)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies showed adverse effects on development.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity based on animal data.
Second Trimester:
Potential for developmental toxicity based on animal data.
Third Trimester:
Potential for developmental toxicity based on animal data.
Lactation
It is not known whether deferasirox is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing 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:
Risk unknown; potential for serious adverse reactions.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients younger than 2 years of age. For children 2 to < 6 years, consider starting at 10 mg/kg/day due to lower exposure. Growth and development should be monitored in pediatric patients receiving deferasirox.
Geriatric Use
Increased incidence of adverse reactions, particularly GI hemorrhage, renal impairment, and hepatic impairment, has been observed in elderly patients (âĨ65 years). Use with caution and monitor closely.
Clinical Information
Clinical Pearls
- Ensure proper preparation of the oral suspension: fully disperse the tablet in liquid (water, orange juice, apple juice) and drink immediately. Do not chew or swallow whole.
- Consistent administration (empty stomach or light meal) is crucial for consistent absorption and efficacy.
- Strict adherence to monitoring protocols (renal, hepatic, ferritin, ophthalmologic, audiometric) is paramount due to potential serious adverse effects.
- Patients should be educated on signs of serious adverse events (GI bleeding, renal/hepatic dysfunction) and instructed to seek immediate medical attention.
- Dose adjustments are frequently needed based on serum ferritin trends and monitoring parameters.
- Consider alternative formulations (Jadenu film-coated tablets or granules) if patient compliance with oral suspension is an issue.
Alternative Therapies
- Deferoxamine (Desferal) - parenteral iron chelator
- Deferiprone (Ferriprox) - oral iron chelator (often used in combination or for specific conditions)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per 30 tablets
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, contact your doctor immediately. It is essential to use your prescribed medication responsibly: do not share it with others, and never 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 refill your prescription. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, promptly call the poison control center or seek immediate medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.