Deferasirox 180mg 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
Iron Chelator
Pregnancy Category
Not available
FDA Approved
Mar 2015
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 body, especially if you receive frequent blood transfusions, and can damage organs like your heart and liver. This medicine helps your body get rid of that extra iron, mainly through your stool.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication on an empty stomach or with a light meal. To make it easier to take, 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. 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 better.
Storing and Disposing of Your Medication
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. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication on an empty stomach or with a light meal. To make it easier to take, 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. 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 better.
Storing and Disposing of Your Medication
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. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take the granules by sprinkling them on a small amount of soft food (e.g., applesauce, yogurt) or mixing in a small amount of liquid (e.g., orange juice, apple juice, milk). Stir until completely dispersed. Do not chew the granules.
- Take on an empty stomach or with a light meal (e.g., toast, skim milk) at the same time each day.
- Do not take with aluminum-containing antacids (e.g., Maalox, Mylanta, Gaviscon) as this can interfere with the medicine's absorption.
- Stay well-hydrated, especially if experiencing diarrhea or vomiting.
- Avoid alcohol or other substances that can harm the liver or kidneys.
- Regular blood tests and eye/ear exams are crucial to monitor for side effects and effectiveness.
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: 14 mg/kg orally once daily. Adjust dose in 3-6 month increments by 3.5-7 mg/kg based on serum ferritin trends. Max dose: 28 mg/kg/day.
Dose Range:
14 - 28 mg
Condition-Specific Dosing:
transfusionalIronOverload:
Initial dose: 14 mg/kg orally once daily. For patients receiving <7 mL/kg/month of packed red blood cells (PRBCs), consider initial dose of 10.5 mg/kg/day. For patients with serum ferritin <2000 mcg/L, consider initial dose of 10.5 mg/kg/day. Adjust dose every 3-6 months based on serum ferritin trends (target <1000 mcg/L). Max dose: 28 mg/kg/day.
nonTransfusionDependentThalassemia:
Initial dose: 7 mg/kg orally once daily. Adjust dose in 3-6 month increments by 3.5-7 mg/kg based on serum ferritin trends. Max dose: 14 mg/kg/day. Discontinue when serum ferritin is <300 mcg/L.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants <2 years of age.
Child:
Initial dose for transfusional iron overload (âĨ2 years): 14 mg/kg orally once daily. Initial dose for non-transfusion-dependent thalassemia (âĨ10 years): 7 mg/kg orally once daily. Dosing adjustments similar to adults based on weight and ferritin.
Adolescent:
Dosing similar to adults based on weight and ferritin.
Dose Adjustments
Renal Impairment:
Mild:
No initial dose adjustment for CrCl 60-90 mL/min. Monitor serum creatinine closely.
Moderate:
Initial dose reduction to 7 mg/kg/day for CrCl 40-60 mL/min. Monitor serum creatinine closely. Avoid if CrCl <40 mL/min.
Severe:
Contraindicated if CrCl <40 mL/min or rapidly worsening renal function.
Dialysis:
Not recommended in patients on dialysis due to lack of data and potential for increased exposure.
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 C.
Severe:
Child-Pugh C: Contraindicated.
Pharmacology
Mechanism of Action
Deferasirox is an orally active chelator with a high affinity for iron. It is a tridentate ligand that binds iron with high selectivity in a 2:1 ratio (two molecules of deferasirox to one atom of iron). It promotes the excretion of iron, primarily via the feces, thereby reducing iron overload in the body.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 70% (granules formulation, relative to oral solution)
Tmax:
1.5-4 hours
FoodEffect:
High-fat meal increases AUC by 100% and Cmax by 160%. Low-fat meal increases AUC by 18% and Cmax by 29%. Granules should be taken on an empty stomach or with a light meal to avoid significant increases in exposure.
Distribution:
Vd:
14.3 L (apparent volume of distribution)
ProteinBinding:
>99% (primarily to serum albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
8-16 hours
Clearance:
Not available (apparent oral clearance 10.1 L/h)
ExcretionRoute:
Fecal (84%), Renal (8%)
Unchanged:
Not available (majority excreted as metabolites)
Pharmacodynamics
OnsetOfAction:
Within days to weeks (reduction in iron stores is gradual)
PeakEffect:
Not applicable (chronic therapy, effect measured by ferritin trends)
DurationOfAction:
Not applicable (daily dosing for continuous effect)
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. Discontinue deferasirox for unexplained increases in serum creatinine, worsening hepatic function, or 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. Discontinue deferasirox for unexplained increases in serum creatinine, worsening hepatic function, or gastrointestinal hemorrhage.
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 yellowing of the skin or eyes.
Signs of bowel problems: black, tarry, or bloody stools, fever, mucus in the stool, vomiting blood or coffee ground-like material, or 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 right away 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; or swollen glands.
Blood cell disorders, which can increase the risk of severe bleeding or infections. Contact your doctor immediately 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 many people may not experience any or may only have mild symptoms. If you are concerned about any of the following side effects or if they persist or worsen, 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 about side effects, 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 yellowing of the skin or eyes.
Signs of bowel problems: black, tarry, or bloody stools, fever, mucus in the stool, vomiting blood or coffee ground-like material, or 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 right away 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; or swollen glands.
Blood cell disorders, which can increase the risk of severe bleeding or infections. Contact your doctor immediately 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 many people may not experience any or may only have mild symptoms. If you are concerned about any of the following side effects or if they persist or worsen, 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 about side effects, 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, nausea, vomiting, or diarrhea
- Black, tarry, or bloody stools (signs of GI bleeding)
- Yellowing of skin or eyes (jaundice), dark urine, unusual tiredness (signs of liver problems)
- Decreased urination, swelling in legs/feet, unusual fatigue (signs of kidney problems)
- Sudden changes in hearing or vision (e.g., blurred vision, difficulty seeing at night, ringing in ears)
- Severe skin rash, itching, hives, swelling of face/lips/tongue, difficulty breathing (signs of allergic reaction)
- Unexplained fever, sore throat, easy bruising or 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. Be sure to describe the allergic reaction you experienced.
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 similar to this one. If you are unsure, consult your doctor or pharmacist.
Concurrent use of any of the following medications:
+ Cholestyramine
+ Colesevelam
+ Colestipol
+ Phenobarbital
+ Phenytoin
+ Rifampicin
+ Ritonavir
+ Theophylline
+ Tizanidine
Breast-feeding status. Note that you should not breast-feed while taking this medication.
Please be aware that this is not an exhaustive list of potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use of this medication. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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. Be sure to describe the allergic reaction you experienced.
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 similar to this one. If you are unsure, consult your doctor or pharmacist.
Concurrent use of any of the following medications:
+ Cholestyramine
+ Colesevelam
+ Colestipol
+ Phenobarbital
+ Phenytoin
+ Rifampicin
+ Ritonavir
+ Theophylline
+ Tizanidine
Breast-feeding status. Note that you should not breast-feed while taking this medication.
Please be aware that this is not an exhaustive list of potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use of this medication. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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 avoid potential interactions, do not take antacids containing aluminum while using this medication. If you are 55 years or older, exercise caution when taking this drug, as you may be more susceptible to side effects. Similarly, when administering this medication to a child, use it with caution, as the risk of certain side effects may be increased in pediatric patients. If your child's weight changes while taking this medication, consult with your doctor, as the dosage may need to be adjusted.
When using this medication, be aware that birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy. To minimize the risk of unintended pregnancy, use an additional form of birth control, such as a condom, while taking this drug. If you are pregnant or plan to become pregnant, inform your doctor to discuss the potential benefits and risks of using this medication during pregnancy.
To avoid potential interactions, do not take antacids containing aluminum while using this medication. If you are 55 years or older, exercise caution when taking this drug, as you may be more susceptible to side effects. Similarly, when administering this medication to a child, use it with caution, as the risk of certain side effects may be increased in pediatric patients. If your child's weight changes while taking this medication, consult with your doctor, as the dosage may need to be adjusted.
When using this medication, be aware that birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy. To minimize the risk of unintended pregnancy, use an additional form of birth control, such as a condom, while taking this drug. If you are pregnant or plan to become pregnant, inform your doctor to discuss the potential benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Abdominal pain
- Diarrhea
- Nausea
- Vomiting
- Headache
- Elevated liver enzymes
- Renal dysfunction
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment is supportive; there is no specific antidote. Hemodialysis is not effective for deferasirox removal.
Drug Interactions
Contraindicated Interactions
- Aluminum-containing antacids (e.g., aluminum hydroxide, sucralfate) - due to potential for increased deferasirox absorption and toxicity
Major Interactions
- CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital) - may decrease deferasirox exposure, requiring dose increase
- UGT inducers (e.g., rifampin, phenobarbital, phenytoin) - may decrease deferasirox exposure, requiring 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
- Vitamin K antagonists (e.g., warfarin) - increased risk of bleeding
- Drugs that cause GI irritation/ulceration (e.g., NSAIDs, corticosteroids, bisphosphonates) - increased risk of GI hemorrhage
Moderate Interactions
- Proton pump inhibitors (PPIs) - may increase deferasirox exposure (less significant with granules than tablets)
- H2-receptor antagonists - may increase deferasirox exposure (less significant with granules than tablets)
- Cholestyramine - may decrease deferasirox exposure
Minor Interactions
- Not specifically categorized as minor, but general caution with drugs metabolized by CYP1A2, CYP2C8, CYP2C9, CYP3A4.
Monitoring
Baseline Monitoring
Serum Creatinine (Cr)
Rationale: To assess baseline renal function and identify pre-existing renal impairment, which is a risk factor for adverse events.
Timing: Prior to initiation of therapy.
Creatinine Clearance (CrCl) or eGFR
Rationale: To assess baseline renal function and guide initial dosing.
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs: AST, ALT, ALP, Bilirubin)
Rationale: To assess baseline hepatic function and identify pre-existing hepatic impairment, which is a risk factor for adverse events.
Timing: Prior to initiation of therapy.
Serum Ferritin
Rationale: To establish baseline iron overload and guide initial dosing.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC) with differential
Rationale: To assess baseline hematologic status, as deferasirox can cause bone marrow suppression.
Timing: Prior to initiation of therapy.
Urinalysis (proteinuria)
Rationale: To assess for baseline renal tubular dysfunction.
Timing: Prior to initiation of therapy.
Audiometry
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 Creatinine (Cr)
Frequency: Weekly for the first month, then monthly thereafter. More frequently if dose increased or renal risk factors present.
Target: Within normal limits or stable baseline.
Action Threshold: Increase of >33% above baseline on 2 consecutive measurements, or above upper limit of normal (ULN) and >33% above baseline. Consider dose reduction or interruption.
Liver Function Tests (LFTs: AST, ALT, ALP, Bilirubin)
Frequency: Every 2 weeks for the first month, then monthly thereafter.
Target: Within normal limits or stable baseline.
Action Threshold: Persistent, progressive increase in LFTs, or LFTs >5 times ULN. Consider dose reduction or interruption. If LFTs >10 times ULN, discontinue therapy.
Serum Ferritin
Frequency: Monthly or every 3-6 months (depending on indication and clinical stability).
Target: Transfusional iron overload: <1000 mcg/L. Non-transfusion-dependent thalassemia: <300 mcg/L.
Action Threshold: Trends indicating inadequate chelation (increasing ferritin) or excessive chelation (ferritin <500 mcg/L for transfusional, <300 mcg/L for non-transfusional). Adjust dose accordingly.
Complete Blood Count (CBC) with differential
Frequency: Monthly.
Target: Within normal limits.
Action Threshold: Significant decrease in cell counts (e.g., neutropenia, thrombocytopenia, agranulocytosis). Consider dose interruption or discontinuation.
Urinalysis (proteinuria)
Frequency: Monthly.
Target: Negative or stable baseline.
Action Threshold: New or worsening proteinuria. Consider dose reduction or interruption.
Audiometry
Frequency: Annually.
Target: Stable hearing.
Action Threshold: New or worsening hearing loss. Consider dose reduction or interruption.
Ophthalmologic examination (slit lamp, fundoscopy)
Frequency: Annually.
Target: Stable vision.
Action Threshold: New or worsening ocular disturbances (e.g., cataracts, retinal toxicity). Consider dose reduction or interruption.
Symptom Monitoring
- Signs of renal dysfunction (e.g., decreased urine output, swelling, fatigue)
- Signs of hepatic dysfunction (e.g., jaundice, dark urine, abdominal pain, nausea, vomiting)
- Gastrointestinal symptoms (e.g., abdominal pain, nausea, vomiting, diarrhea, constipation, GI bleeding - black/tarry stools, blood in vomit)
- Skin rash or hypersensitivity reactions (e.g., itching, hives, swelling, difficulty breathing)
- Hearing changes (e.g., ringing in ears, decreased hearing)
- Vision changes (e.g., blurred vision, decreased vision, cataracts)
- Signs of bone marrow suppression (e.g., fever, sore throat, unusual bleeding/bruising, fatigue)
Special Patient Groups
Pregnancy
Limited human data on deferasirox use in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage. Animal studies have shown adverse developmental effects (skeletal malformations, reduced fetal weight) at doses higher than clinical exposure. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for skeletal malformations observed in animal studies at high doses.
Second Trimester:
No specific data, but continued monitoring of maternal and fetal health is advised.
Third Trimester:
No specific data, but continued monitoring of maternal and fetal health is advised.
Lactation
It is not known whether deferasirox is excreted in human milk. Deferasirox and its metabolites were excreted in the milk of lactating rats. Because of the potential for serious adverse reactions in the breastfed infant, including renal and hepatic toxicity, advise women not to breastfeed during treatment with deferasirox and for 7 days after the last dose.
Infant Risk:
Potential for serious adverse reactions (renal/hepatic toxicity, bone marrow suppression).
Pediatric Use
Safety and effectiveness have been established in pediatric patients 2 years of age and older for transfusional iron overload. For non-transfusion-dependent thalassemia, safety and effectiveness have been established in patients 10 years of age and older. Not recommended for children under 2 years due to lack of data and potential for increased risk of adverse events.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients may be at increased risk for adverse reactions, particularly renal, hepatic, and gastrointestinal adverse events. Use with caution and monitor closely.
Clinical Information
Clinical Pearls
- Deferasirox granules must be taken by sprinkling on soft food or mixing in liquid; they should not be chewed or swallowed whole.
- Consistent administration (empty stomach or light meal) is important due to food effects on absorption.
- Strict adherence to monitoring protocols (renal, hepatic, hematologic, ocular, auditory) is critical due to potential for serious and fatal adverse events.
- Patients should be educated on signs of serious adverse events, especially GI bleeding, renal/hepatic dysfunction, and instructed to seek immediate medical attention.
- Dose adjustments are primarily based on serum ferritin trends and patient tolerance, not just body weight.
- Discontinuation criteria for non-transfusion-dependent thalassemia are based on serum ferritin levels (<300 mcg/L).
Alternative Therapies
- Deferoxamine (Desferal) - parenteral iron chelator
- Deferiprone (Ferriprox) - oral iron chelator (often used in combination or for specific indications like cardiac iron overload)
Cost & Coverage
Average Cost:
Varies widely, typically several thousand USD per 30 days supply
Generic Available:
Yes
Insurance Coverage:
Tier 3 or Specialty Tier (requires prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, contact your doctor promptly. It is essential to keep your medication to yourself and not take anyone else's prescription. This medication is accompanied by a Medication Guide, which provides crucial information. Please read it 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 the poison control center or seek medical attention. Be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.