Jadenu 90mg 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
Chelating Agent
Pregnancy Category
Category C
FDA Approved
Aug 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
Jadenu is a medicine used to remove extra iron from your body. Too much iron can build up from frequent blood transfusions or certain blood disorders, and it can harm your organs. Jadenu helps your body get rid of this excess iron, mainly 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. Swallow the tablet whole with water or another liquid. If you have difficulty swallowing tablets, you can crush the tablet and mix it with a small amount of soft food. However, be sure to consume the mixture immediately and do not store it for later use.
Important 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. 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 your medication at room temperature in a dry place, avoiding 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 with 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 is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
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. Swallow the tablet whole with water or another liquid. If you have difficulty swallowing tablets, you can crush the tablet and mix it with a small amount of soft food. However, be sure to consume the mixture immediately and do not store it for later use.
Important 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. 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 your medication at room temperature in a dry place, avoiding 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 with 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 is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take Jadenu film-coated tablets whole with water, on an empty stomach or with a light meal. Do not chew, crush, or cut the tablets.
- If using Jadenu Sprinkle granules, sprinkle the entire dose on a small amount of soft food (e.g., yogurt, applesauce) and consume immediately. Do not chew the granules.
- Take at the same time each day.
- Maintain adequate hydration, especially during hot weather or exercise.
- Avoid aluminum-containing antacids within 2 hours of taking Jadenu.
- Regular blood tests and doctor visits are crucial to monitor iron levels, kidney function, liver function, and for potential side effects.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose: 14 mg/kg orally once daily. Adjust in 3-6 month increments of 3.5-7 mg/kg based on serum ferritin trends and patient response. 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 with serum ferritin <2000 mcg/L, consider initial dose of 10.5 mg/kg/day. Adjust in 3-6 month increments of 3.5-7 mg/kg based on serum ferritin trends and patient response. Max dose: 28 mg/kg/day.
nonTransfusionDependentThalassemia:
Initial dose: 7 mg/kg orally once daily. Adjust in 3-6 month increments of 3.5-7 mg/kg based on serum ferritin trends and patient response. Max dose: 14 mg/kg/day.
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 (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.
Adolescent:
Initial dose for transfusional iron overload: 14 mg/kg orally once daily. Initial dose for non-transfusion-dependent thalassemia: 7 mg/kg orally once daily. Dosing adjustments similar to adults.
Dose Adjustments
Renal Impairment:
Mild:
Initial dose reduction to 7 mg/kg/day for patients with baseline creatinine clearance (CrCl) 40-60 mL/min. Monitor renal function closely. Avoid if CrCl <40 mL/min.
Moderate:
Avoid use 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. Deferasirox is not dialyzable.
Hepatic Impairment:
Mild:
Child-Pugh A: No initial dose adjustment required. Monitor liver function closely.
Moderate:
Child-Pugh B: Reduce initial dose by 50%. Monitor liver function closely. Avoid if Child-Pugh C.
Severe:
Child-Pugh C: Contraindicated.
Pharmacology
Mechanism of Action
Deferasirox is an orally active chelator that is highly selective for iron (Fe3+). It forms a stable 2:1 complex with iron, which is then excreted primarily via the feces. It promotes the excretion of iron from the body, thereby reducing iron overload in patients with chronic transfusional hemosiderosis or non-transfusion-dependent thalassemia.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 70% (relative to oral suspension)
Tmax:
2-4 hours
FoodEffect:
High-fat meal increases AUC by 16% and Cmax by 15%. Low-fat meal increases AUC by 18% and Cmax by 16%. Jadenu film-coated tablets can be taken with a light meal or on an empty stomach. Jadenu Sprinkle granules should be taken on an empty stomach or with a light meal.
Distribution:
Vd:
Not available (reported as low)
ProteinBinding:
>99% (primarily to serum albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
8-16 hours
Clearance:
Not available
ExcretionRoute:
Fecal (84%), Renal (8%)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Not precisely defined, but iron chelation begins shortly after administration.
PeakEffect:
Reduction in serum ferritin levels typically observed within weeks to months of consistent therapy.
DurationOfAction:
Once daily dosing maintains therapeutic levels.
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, liver function, and gastrointestinal bleeding. Discontinue for unexplained progressive increases in serum creatinine, hepatic failure, or gastrointestinal hemorrhage.
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 medical help right away:
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 stools, vomiting blood or coffee ground-like vomit, 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 production problems, which can increase the risk of severe bleeding 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 or discolored sputum, painful urination, mouth sores, or unhealing wounds; bruising or bleeding; or extreme 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 bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:
* Diarrhea, stomach pain, upset stomach, or vomiting.
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 medical help right away:
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 stools, vomiting blood or coffee ground-like vomit, 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 production problems, which can increase the risk of severe bleeding 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 or discolored sputum, painful urination, mouth sores, or unhealing wounds; bruising or bleeding; or extreme 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 bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:
* Diarrhea, stomach pain, upset stomach, or vomiting.
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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, dark urine, unusual tiredness (signs of liver problems)
- Decreased urination, swelling in legs or feet (signs of kidney problems)
- Severe skin rash, blistering, or peeling skin (severe skin reactions)
- Sudden decrease in hearing or vision changes (e.g., blurred vision, cataracts)
- Persistent nausea, vomiting, diarrhea, or abdominal pain
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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Cancer
+ Blood or bone marrow disorders (e.g., low platelet count, high-risk myelodysplastic syndrome/MDS)
+ Kidney disease
+ Liver disease
Any instances of dehydration, including:
+ 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.
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. Do not initiate, discontinue, 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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Cancer
+ Blood or bone marrow disorders (e.g., low platelet count, high-risk myelodysplastic syndrome/MDS)
+ Kidney disease
+ Liver disease
Any instances of dehydration, including:
+ 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.
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. Do not initiate, discontinue, 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.
To monitor your health, follow your doctor's instructions for regular blood tests, laboratory evaluations, eye exams, and hearing tests. When taking this medication, do not use 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, 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.
When taking 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 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 your doctor to discuss the potential benefits and risks of using this medication during pregnancy.
To monitor your health, follow your doctor's instructions for regular blood tests, laboratory evaluations, eye exams, and hearing tests. When taking this medication, do not use 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, 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.
When taking 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 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 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
- Dizziness
- Elevated liver enzymes
- Renal dysfunction
What to Do:
Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Treatment is supportive.
Drug Interactions
Major Interactions
- Midazolam (CYP3A4 substrate, deferasirox is a weak CYP3A4 inducer)
- Repaglinide (CYP2C8 substrate, deferasirox is a CYP2C8 inhibitor)
- Theophylline (CYP1A2 substrate, deferasirox is a CYP1A2 inducer)
- Oral contraceptives (hormonal, reduced efficacy due to UGT induction)
- Aluminum-containing antacids (within 2 hours of deferasirox)
Moderate Interactions
- UGT inducers (e.g., Rifampicin, Phenytoin, Phenobarbital, Ritonavir - may decrease deferasirox exposure)
- UGT inhibitors (e.g., Fluconazole - may increase deferasirox exposure)
- Drugs that cause GI irritation/ulceration (e.g., NSAIDs, corticosteroids, oral bisphosphonates - increased risk of GI hemorrhage)
- Warfarin (increased INR reported in some cases)
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 Glomerular Filtration Rate (eGFR)
Rationale: To assess renal function and guide initial dosing/contraindications.
Timing: Prior to initiation of therapy
Liver function tests (ALT, AST, ALP, bilirubin)
Rationale: To assess hepatic function and guide initial dosing/contraindications.
Timing: Prior to initiation of therapy
Urinalysis (proteinuria)
Rationale: To screen for renal tubular dysfunction.
Timing: Prior to initiation of therapy
Audiometry
Rationale: To establish baseline hearing function.
Timing: Prior to initiation of therapy
Ophthalmologic examination (slit lamp, fundoscopy)
Rationale: To establish baseline ocular function.
Timing: Prior to initiation of therapy
Routine Monitoring
Serum ferritin
Frequency: Monthly
Target: Goal is to maintain serum ferritin levels between 500 and 1000 mcg/L, or as clinically indicated to prevent further iron accumulation.
Action Threshold: Dose adjustment (increase/decrease) based on trends; consider discontinuation if ferritin <500 mcg/L.
Serum creatinine and eGFR
Frequency: Weekly for the first month, then monthly thereafter. More frequently if renal impairment develops.
Target: Maintain within age-appropriate normal limits.
Action Threshold: Increase in serum creatinine >33% above baseline on 2 consecutive measurements, or above age-appropriate upper limit of normal: consider dose reduction or interruption. If CrCl <40 mL/min, discontinue.
Liver function tests (ALT, AST, ALP, bilirubin)
Frequency: Every 2 weeks for the first month, then monthly thereafter.
Target: Maintain within normal limits.
Action Threshold: Persistent, progressive increase in LFTs or levels >5 times ULN: consider dose reduction or interruption. If levels >10 times ULN or progressive increase with bilirubin >3 times ULN: discontinue.
Urinalysis (proteinuria)
Frequency: Monthly
Target: Negative or trace protein.
Action Threshold: Persistent proteinuria: further investigation and dose adjustment/interruption.
Audiometry
Frequency: Annually
Target: Normal hearing.
Action Threshold: Significant hearing loss: consider dose reduction or interruption.
Ophthalmologic examination (slit lamp, fundoscopy)
Frequency: Annually
Target: Normal vision.
Action Threshold: Significant visual disturbances (e.g., cataracts, retinal toxicity): consider dose reduction or interruption.
Symptom Monitoring
- Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain)
- Skin rash
- Hearing changes (decreased hearing)
- Vision changes (blurred vision, cataracts)
- Signs of renal dysfunction (decreased urine output, edema)
- Signs of hepatic dysfunction (jaundice, dark urine, fatigue, right upper quadrant pain)
- Signs of GI hemorrhage (black, tarry stools; blood in vomit)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies show adverse effects on development at clinically relevant exposures.
Trimester-Specific Risks:
First Trimester:
Potential for adverse developmental effects based on animal data.
Second Trimester:
Potential for adverse developmental effects based on animal data.
Third Trimester:
Potential for adverse developmental effects based on animal data.
Lactation
It is not known whether deferasirox is excreted in human milk. Due to the potential for serious adverse reactions in the breastfed infant, 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 L3 (Moderate concern)
Pediatric Use
Safety and efficacy not established in pediatric patients younger than 2 years of age. Dosing for older children is weight-based and requires careful monitoring of growth and development, in addition to standard monitoring parameters.
Geriatric Use
Increased incidence of adverse reactions, including renal failure, gastrointestinal hemorrhage, and myelosuppression, has been observed in elderly patients (âĨ65 years). Use with caution and monitor closely.
Clinical Information
Clinical Pearls
- Jadenu film-coated tablets offer improved patient convenience compared to Exjade (dispersible tablets) as they can be swallowed whole.
- Ensure patients are adequately hydrated, especially in hot climates or during illness, to minimize the risk of renal adverse events.
- Dose adjustments are crucial and should be based on serum ferritin trends, renal function, and liver function. Do not increase dose if serum ferritin is below 500 mcg/L.
- Patients should be educated on the importance of regular monitoring tests and to report any new or worsening symptoms promptly.
- Consider drug interactions carefully, especially with UGT inducers/inhibitors, CYP substrates, and drugs that increase GI irritation.
Alternative Therapies
- Deferoxamine (Desferal) - parenteral iron chelator
- Deferiprone (Ferriprox) - oral iron chelator
Cost & Coverage
Average Cost:
Varies widely, typically $1,500 - $5,000+ per 30 tablets (90mg)
Generic Available:
Yes
Insurance Coverage:
Tier 4 (Specialty Drug)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other 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.