Jadenu 360mg Tablets

Manufacturer NOVARTIS Active Ingredient Deferasirox Tablets(de FER a sir ox) Pronunciation JAH-deh-noo (De-FER-a-sir-ox)
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.
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Drug Class
Iron chelator
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Pharmacologic Class
Tridentate iron chelator
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Pregnancy Category
Not available
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FDA Approved
Mar 2015
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DEA Schedule
Not Controlled

Overview

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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 extra iron, mainly through your stool.
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How to Use This Medicine

Taking Your Medication

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.

Missing 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.
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Lifestyle & Tips

  • Take Jadenu once daily, preferably at the same time each day.
  • Swallow tablets whole with water. Do not chew, crush, or cut the tablets.
  • Jadenu can be taken with or without a light meal. Avoid taking with high-fat meals.
  • Do not take with aluminum-containing antacids (e.g., Maalox, Mylanta); separate by at least 3 hours.
  • Stay well-hydrated while taking this medication.
  • Attend all scheduled blood tests and doctor appointments to monitor your iron levels and check for side effects.
  • Use effective non-hormonal birth control if you are taking oral contraceptives, as Jadenu may make them less effective.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose for transfusion-dependent iron overload: 7 mg/kg orally once daily. Initial dose for non-transfusion-dependent thalassemia syndromes with chronic iron overload: 3.5 mg/kg orally once daily.
Dose Range: 3.5 - 14 mg

Condition-Specific Dosing:

transfusionDependentIronOverload: Initial: 7 mg/kg orally once daily. May increase to 10.5 mg/kg/day after 3-6 months based on serum ferritin trends. Max: 14 mg/kg/day.
nonTransfusionDependentThalassemia: Initial: 3.5 mg/kg orally once daily. May increase to 7 mg/kg/day after 3-6 months based on serum ferritin trends. Max: 7 mg/kg/day.
chronicIronOverload: Dose adjusted based on serum ferritin levels and patient response. Target serum ferritin < 1000 mcg/L.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (Safety and efficacy not established in pediatric patients less than 2 years of age).
Child: â‰Ĩ2 years: Same as adult dosing based on indication (7 mg/kg/day or 3.5 mg/kg/day initial dose).
Adolescent: Same as adult dosing based on indication (7 mg/kg/day or 3.5 mg/kg/day initial dose).
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Dose Adjustments

Renal Impairment:

Mild: CrCl 60-90 mL/min: No initial dose adjustment, but monitor renal function closely.
Moderate: CrCl 30-59 mL/min: Consider reducing initial dose by 3.5 mg/kg. Monitor renal function closely.
Severe: CrCl < 30 mL/min: Contraindicated.
Dialysis: Contraindicated (not dialyzable to a significant extent).

Hepatic Impairment:

Mild: Child-Pugh A: No initial dose adjustment.
Moderate: Child-Pugh B: Reduce initial dose by 3.5 mg/kg. Monitor liver function closely.
Severe: Child-Pugh C: Contraindicated.

Pharmacology

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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 (2 molecules of deferasirox to 1 atom of iron). It promotes the excretion of iron, primarily via the feces, thereby reducing iron overload in patients.
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Pharmacokinetics

Absorption:

Bioavailability: Jadenu film-coated tablets have approximately 36% higher bioavailability compared to Exjade dispersible tablets. Absolute bioavailability is not precisely quantified but is considered moderate.
Tmax: 2-4 hours
FoodEffect: Jadenu film-coated tablets can be taken with or without a light meal. High-fat meals increase AUC and Cmax, while low-fat meals have minimal effect. Taking with food may reduce GI side effects.

Distribution:

Vd: Not available (Extensively distributed)
ProteinBinding: >99% (primarily to serum albumin)
CnssPenetration: Limited

Elimination:

HalfLife: 8-16 hours (mean ~10 hours)
Clearance: Not available
ExcretionRoute: Biliary/fecal (84%), Renal (8%)
Unchanged: Not available (majority excreted as metabolites)
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Pharmacodynamics

OnsetOfAction: Within days to weeks (reduction in iron stores)
PeakEffect: Months (for significant reduction in serum ferritin)
DurationOfAction: Daily dosing required to maintain iron chelation
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

RENAL IMPAIRMENT, HEPATIC IMPAIRMENT, GASTROINTESTINAL HEMORRHAGE, AND BONE MARROW SUPPRESSION. Deferasirox can cause acute renal failure, hepatic failure, and gastrointestinal hemorrhage, sometimes fatal. Monitor renal function, liver function, and complete blood counts regularly. Discontinue deferasirox for unexplained increases in serum creatinine, transaminases, or cytopenias. Deferasirox is contraindicated in patients with severe renal impairment (CrCl < 30 mL/min), severe hepatic impairment (Child-Pugh C), and in patients with myelodysplastic syndrome (MDS) and advanced malignancies who may not benefit from chelation due to rapid disease progression.
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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 eyesight
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 promptly for guidance
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 increase the risk of:
+ Infections; seek medical help if you experience:
- Fever
- Chills
- Severe sore throat
- Ear or sinus pain
- Cough
- Increased or discolored sputum
- Painful urination
- Mouth sores
- Unhealing wounds
+ Bleeding problems; seek medical help if you experience:
- Bruising or bleeding
+ Fatigue or weakness

Other Possible Side Effects

Most people do not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following symptoms, contact your doctor for guidance:

Diarrhea
Stomach pain
Upset stomach
Vomiting

This is not an exhaustive list of possible side effects. If you have concerns or questions, 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.
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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, pale stools (signs of liver problems)
  • Decreased urination, swelling in legs or feet (signs of kidney problems)
  • Unexplained fever, sore throat, easy bruising or bleeding (signs of bone marrow suppression)
  • Severe skin rash, blistering, peeling skin (signs of severe skin reactions)
  • Sudden changes in vision or hearing
  • Severe diarrhea or vomiting that doesn't stop
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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. 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, terminate, or modify the dosage of any medication without consulting your doctor.
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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 instructed by your doctor to monitor your health. Do not take antacids containing aluminum while using this medication, as it may interfere with its effectiveness.

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 higher in pediatric patients. If your child's weight changes while taking this medication, consult your doctor, as their dose 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 contraceptive method.

If you are pregnant or plan to become pregnant, consult your doctor to discuss the potential benefits and risks of using this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

  • Abdominal pain
  • Diarrhea
  • Nausea
  • Vomiting
  • Headache
  • Dizziness
  • Renal impairment
  • Hepatic impairment

What to Do:

Seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is supportive. There is no specific antidote.

Drug Interactions

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Contraindicated Interactions

  • Patients with severe renal impairment (CrCl < 30 mL/min)
  • Patients with severe hepatic impairment (Child-Pugh C)
  • Patients with myelodysplastic syndrome (MDS) and advanced malignancies who may not benefit from chelation due to rapid disease progression
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Major Interactions

  • Aluminum-containing antacids (e.g., aluminum hydroxide): Decreased deferasirox exposure. Separate administration by at least 3 hours.
  • Midazolam (CYP3A4 substrate): Decreased midazolam exposure. Avoid concomitant use or increase midazolam dose.
  • Repaglinide (CYP2C8 substrate): Increased repaglinide exposure. Avoid concomitant use.
  • Theophylline (CYP1A2 substrate): Decreased theophylline exposure. Monitor theophylline levels.
  • Oral contraceptives (CYP3A4 substrates): Decreased efficacy of oral contraceptives. Advise use of non-hormonal contraception.
  • UGT inducers (e.g., rifampin, phenytoin, phenobarbital, ritonavir): Decreased deferasirox exposure. Consider increasing deferasirox dose.
  • UGT inhibitors (e.g., fluconazole, ketoconazole): Increased deferasirox exposure. Consider reducing deferasirox dose.
  • Drugs that cause nephrotoxicity (e.g., NSAIDs, aminoglycosides, amphotericin B): Increased risk of renal toxicity. Monitor renal function closely.
  • Drugs that cause hepatotoxicity (e.g., acetaminophen, methotrexate): Increased risk of hepatic toxicity. Monitor liver function closely.
  • Vitamin K antagonists (e.g., warfarin): Increased INR/bleeding risk. Monitor INR closely.
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Moderate Interactions

  • Cholestyramine: May decrease deferasirox exposure. Monitor iron levels.
  • Proton pump inhibitors (PPIs): May increase deferasirox exposure. Monitor for adverse effects.
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Minor Interactions

  • Not specifically categorized as minor in clinical guidelines, but general caution with drugs metabolized by CYP enzymes.

Monitoring

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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 and rule out severe impairment.

Timing: Prior to initiation of therapy

Liver function tests (ALT, AST, bilirubin)

Rationale: To assess baseline hepatic function and rule out severe impairment.

Timing: Prior to initiation of therapy

Urinalysis (proteinuria)

Rationale: To assess for baseline renal tubular dysfunction.

Timing: Prior to initiation of therapy

Audiometric testing

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

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Routine Monitoring

Serum ferritin

Frequency: Monthly

Target: < 1000 mcg/L (goal for most patients)

Action Threshold: Increase dose if ferritin > 2500 mcg/L and stable; decrease dose if ferritin < 500 mcg/L or rapidly decreasing.

Serum creatinine and estimated GFR

Frequency: Weekly for the first month, then monthly thereafter.

Target: Within normal limits or stable baseline

Action Threshold: If creatinine increases by >33% above baseline on two consecutive measurements, or if it exceeds the age-appropriate upper limit of normal, interrupt therapy or reduce dose. If persistent, discontinue.

Liver function tests (ALT, AST, bilirubin)

Frequency: Every 2 weeks for the first month, then monthly thereafter.

Target: Within normal limits or stable baseline

Action Threshold: If transaminases increase to >5 times the upper limit of normal (ULN) or >2 times ULN with a baseline >ULN, interrupt therapy. If persistent, discontinue. If severe hepatic failure, discontinue permanently.

Urinalysis (proteinuria)

Frequency: Monthly

Target: Negative or trace protein

Action Threshold: If persistent proteinuria (e.g., >100 mg/day), consider dose reduction or interruption.

Audiometric testing

Frequency: Annually

Target: Stable hearing

Action Threshold: If hearing impairment develops, consider dose reduction or interruption.

Ophthalmologic examination (slit lamp, fundoscopy)

Frequency: Annually

Target: Stable vision

Action Threshold: If visual disturbances develop, consider dose reduction or interruption.

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Symptom Monitoring

  • Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain)
  • Skin rash
  • Headache
  • Dizziness
  • Fatigue
  • Changes in urine output or color
  • Yellowing of skin or eyes (jaundice)
  • Dark urine, pale stools
  • Unexplained bleeding or bruising
  • Signs of infection (fever, sore throat)
  • Hearing changes (e.g., tinnitus, hearing loss)
  • Vision changes (e.g., blurred vision, cataracts)

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown 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.
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Lactation

It is not known whether deferasirox is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: L3 - Moderate risk (potential for serious adverse reactions)
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Pediatric Use

Safety and efficacy not established in pediatric patients less than 2 years of age. In patients 2 years and older, dosing is weight-based and similar to adults, with careful monitoring due to potential for growth retardation and other adverse effects.

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Geriatric Use

Increased risk of adverse reactions, particularly renal, hepatic, and gastrointestinal adverse events, including GI hemorrhage. Use with caution and monitor closely. Start at the lower end of the dosing range.

Clinical Information

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Clinical Pearls

  • Jadenu film-coated tablets have higher bioavailability than Exjade dispersible tablets, so doses are not interchangeable mg-for-mg. Always ensure the correct formulation and dose are prescribed.
  • Regular and diligent monitoring of renal function, liver function, and serum ferritin is critical due to the risk of serious adverse events.
  • Patients should be educated on the signs and symptoms of serious adverse events (e.g., GI bleeding, renal/hepatic impairment) and instructed to seek immediate medical attention if they occur.
  • Hydration is important to minimize the risk of renal toxicity.
  • For patients with difficulty swallowing, Jadenu Sprinkle granules are an alternative formulation that can be sprinkled on soft food.
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Alternative Therapies

  • Deferoxamine (Desferal) - parenteral iron chelator
  • Deferiprone (Ferriprox) - oral iron chelator (often used in combination or for specific indications)
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Cost & Coverage

Average Cost: Varies widely, typically several thousand dollars per 30 tablets
Generic Available: Yes
Insurance Coverage: Specialty Tier (requires prior authorization, often subject to high co-pays or co-insurance)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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. 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, we encourage you to discuss them with 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.