Jadenu Sprinkle 90mg Granules

Manufacturer NOVARTIS Active Ingredient Deferasirox Sprinkle Granules(de FER a sir ox) Pronunciation 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
Iron Chelating Agent
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Pregnancy Category
Not available
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FDA Approved
Mar 2016
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Jadenu Sprinkle 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. This medicine helps your body get rid of that extra iron.
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How to Use This Medicine

Taking Your Medication Correctly

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 feeling well.

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 is 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 the missed one.
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Lifestyle & Tips

  • Take Jadenu Sprinkle once a day, preferably at the same time each day.
  • Sprinkle the entire dose on a small amount of soft food (e.g., applesauce, yogurt, pudding, or oatmeal) and mix well. Do not chew the granules.
  • Consume the mixture immediately after sprinkling. Do not store for later use.
  • Do not sprinkle the granules on hot foods.
  • Take on an empty stomach or with a light meal to ensure consistent absorption.
  • Stay well-hydrated while taking this medication.
  • Avoid aluminum-containing antacids (e.g., Maalox, Mylanta) as they can reduce the absorption of Jadenu Sprinkle. If you need an antacid, use one that does not contain aluminum.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose: 14 mg/kg/day orally, once daily. Adjust dose based on serum ferritin levels and patient response, typically in increments of 3.5 to 7 mg/kg/day. Maximum dose: 28 mg/kg/day.
Dose Range: 3.5 - 28 mg

Condition-Specific Dosing:

transfusionalIronOverload: Initial dose: 14 mg/kg/day. For patients receiving <7 mL/kg/month of packed red blood cells (PRBCs), consider starting at 10.5 mg/kg/day. For patients receiving >14 mL/kg/month of PRBCs, consider starting at 21 mg/kg/day.
nonTransfusionDependentThalassemia: Initial dose: 7 mg/kg/day. Adjust dose based on serum ferritin levels and patient response, typically in increments of 3.5 to 7 mg/kg/day. Maximum dose: 14 mg/kg/day.
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Pediatric Dosing

Neonatal: Not established (contraindicated in children <2 years of age).
Infant: Not established (contraindicated in children <2 years of age).
Child: For children â‰Ĩ2 years of age: Initial dose 14 mg/kg/day orally, once daily. Adjust dose based on serum ferritin levels and patient response, typically in increments of 3.5 to 7 mg/kg/day. Maximum dose: 28 mg/kg/day.
Adolescent: Initial dose 14 mg/kg/day orally, once daily. Adjust dose based on serum ferritin levels and patient response, typically in increments of 3.5 to 7 mg/kg/day. Maximum dose: 28 mg/kg/day.
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Dose Adjustments

Renal Impairment:

Mild: No initial dose adjustment required, but monitor renal function closely.
Moderate: Initial dose reduction by 50% (e.g., 7 mg/kg/day for transfusional iron overload). Monitor renal function closely. Contraindicated if CrCl <40 mL/min or rapidly worsening renal function.
Severe: Contraindicated (CrCl <40 mL/min or rapidly worsening renal function).
Dialysis: Not recommended for patients on dialysis due to lack of data and potential for increased toxicity.

Hepatic Impairment:

Mild: No initial dose adjustment required.
Moderate: Reduce initial dose by 50% (e.g., 7 mg/kg/day for transfusional iron overload). Monitor liver function closely. (Child-Pugh B).
Severe: Contraindicated (Child-Pugh C).
Confidence: Medium

Pharmacology

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Mechanism of Action

Deferasirox is an orally active chelator that is highly selective for iron. It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio (two molecules of deferasirox to one atom of iron), forming a stable iron complex that is then excreted primarily via the feces.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 133% relative to Exjade (dispersible tablets) when administered as granules. Absolute bioavailability is not precisely known but is low (estimated 10-20% for dispersible tablets).
Tmax: 2-4 hours (granules).
FoodEffect: Administration with a high-fat meal increases AUC by 100% and Cmax by 84%. Administration with a low-fat meal increases AUC by 18% and Cmax by 29%. It is recommended to administer on an empty stomach or with a light meal to minimize variability.

Distribution:

Vd: Approximately 14 L in adults.
ProteinBinding: >99% (primarily to serum albumin).
CnssPenetration: Limited.

Elimination:

HalfLife: 8-16 hours.
Clearance: Not explicitly stated as a single rate, but total plasma clearance is approximately 10.5 L/h in adults.
ExcretionRoute: Fecal (approximately 84%), renal (approximately 8%).
Unchanged: Less than 1% of the dose is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Not acutely defined; chronic iron chelation effect.
PeakEffect: Not acutely defined; chronic iron chelation effect.
DurationOfAction: Not acutely defined; chronic iron chelation effect.

Safety & Warnings

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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. Use with caution in patients with pre-existing renal or hepatic impairment, or those at high risk for GI complications.
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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: 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 promptly to determine the best course of action.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek immediate medical attention 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.
Bone marrow suppression, which can lead to severe bleeding problems or infections. Contact your doctor right away if you experience signs of infection, such as fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal; bruising or bleeding; or extreme 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.

Reporting Side Effects

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.
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Seek Immediate Medical Attention If You Experience:

  • Signs of kidney problems: decreased urination, swelling in legs/feet, unusual tiredness, nausea, confusion.
  • Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, pale stools, severe stomach pain, unusual tiredness.
  • Signs of stomach bleeding: black, tarry stools; vomiting blood or material that looks like coffee grounds; severe stomach pain.
  • Severe skin rash, blistering, or peeling skin.
  • Sudden decrease in hearing or vision changes (blurred vision, loss of vision).
  • Severe diarrhea or vomiting.
  • Unexplained fever, sore throat, or signs of infection (may indicate low white blood cell count).
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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 any symptoms.
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
+ Colesipol
+ 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.

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 interfere with its effectiveness.

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 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, 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.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Headache
  • Increased liver enzymes
  • Increased creatinine

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.

Drug Interactions

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Major Interactions

  • UGT inducers (e.g., rifampin, phenytoin, phenobarbital, ritonavir): May significantly decrease deferasirox exposure, reducing efficacy. Consider increasing deferasirox dose.
  • UGT inhibitors (e.g., fluconazole): May increase deferasirox exposure. Consider decreasing deferasirox dose.
  • Aluminum-containing antacids: May decrease deferasirox absorption. Do not take concurrently.
  • CYP1A2 substrates (e.g., theophylline, clozapine, tizanidine): Deferasirox may increase exposure of these drugs. Monitor and adjust dose of CYP1A2 substrate.
  • CYP3A4 substrates (e.g., midazolam): Deferasirox may decrease exposure of these drugs. Efficacy of CYP3A4 substrate may be reduced.
  • Oral contraceptives (hormonal): Efficacy may be reduced. Advise use of non-hormonal contraception.
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Moderate Interactions

  • Vitamin K antagonists (e.g., warfarin): Increased risk of bleeding. Monitor INR closely.
  • Corticosteroids (e.g., prednisone): Increased risk of GI ulceration, hemorrhage. Use with caution.
  • Other drugs that may cause GI ulceration or hemorrhage (e.g., NSAIDs, oral bisphosphonates): Increased risk of GI ulceration, hemorrhage. Use with caution.
  • Nephrotoxic drugs (e.g., aminoglycosides, NSAIDs): Increased risk of renal toxicity. Monitor renal function closely.
  • Hepatotoxic drugs (e.g., acetaminophen in high doses, methotrexate): Increased risk of hepatic toxicity. Monitor liver function closely.

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 creatinine clearance (CrCl)

Rationale: To assess baseline renal function and guide dosing, as deferasirox is renally eliminated and can cause renal impairment.

Timing: Prior to initiation of therapy.

Liver function tests (ALT, AST, ALP, bilirubin)

Rationale: To assess baseline hepatic function, as deferasirox can cause hepatic toxicity.

Timing: Prior to initiation of therapy.

Urinalysis (for proteinuria)

Rationale: To screen for renal tubular dysfunction.

Timing: Prior to initiation of therapy.

Audiometric testing

Rationale: To establish baseline hearing, as deferasirox can cause hearing loss.

Timing: Prior to initiation of therapy.

Ophthalmological examination (slit lamp and fundoscopy)

Rationale: To establish baseline vision, as deferasirox can cause visual disturbances.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum ferritin

Frequency: Monthly

Target: Goal is typically <1000 mcg/L, but individualized based on clinical response.

Action Threshold: If ferritin consistently <500 mcg/L, consider dose reduction or interruption. If ferritin consistently >2500 mcg/L, consider dose increase.

Serum creatinine and estimated CrCl

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

Target: Within normal limits or stable baseline.

Action Threshold: If serum creatinine increases by >33% above baseline on two consecutive measurements, or if CrCl falls below 40 mL/min, consider dose reduction or interruption. If rapidly progressive, discontinue.

Liver function tests (ALT, AST, ALP, bilirubin)

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

Target: Within normal limits or stable baseline.

Action Threshold: If ALT/AST increases to >5 times the upper limit of normal (ULN) or >3 times ULN with concurrent bilirubin increase, consider dose reduction or interruption. If severe, discontinue.

Urinalysis (for proteinuria)

Frequency: Monthly

Target: Negative or stable baseline.

Action Threshold: If new or worsening proteinuria, investigate and consider dose adjustment.

Audiometric testing

Frequency: Annually

Target: Stable hearing.

Action Threshold: If new or worsening hearing loss, investigate and consider dose adjustment or discontinuation.

Ophthalmological examination (slit lamp and fundoscopy)

Frequency: Annually

Target: Stable vision.

Action Threshold: If new or worsening visual disturbances, investigate and consider dose adjustment or discontinuation.

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Symptom Monitoring

  • Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain, GI bleeding)
  • Skin rash
  • Renal dysfunction (decreased urine output, edema, fatigue)
  • Hepatic dysfunction (jaundice, dark urine, pale stools, right upper quadrant pain)
  • Visual disturbances (blurred vision, decreased acuity, cataracts)
  • Hearing loss (decreased hearing, tinnitus)
  • Fever, sore throat, signs of infection (due to potential neutropenia/agranulocytosis)

Special Patient Groups

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Pregnancy

Based on animal data, deferasirox may cause fetal harm. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Animal studies showed skeletal malformations and reduced fetal weight at doses higher than human therapeutic exposure.
Second Trimester: Risk of skeletal malformations and reduced fetal weight observed in animal studies.
Third Trimester: Risk of skeletal malformations and reduced fetal weight observed in animal studies.
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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: Unknown. Potential for serious adverse effects.
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Pediatric Use

Approved for children 2 years of age and older. Safety and efficacy have not been established in children younger than 2 years of age. Increased risk of adverse events (e.g., renal impairment, GI disturbances) in younger children. Close monitoring is essential.

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Geriatric Use

Increased incidence of adverse reactions, particularly renal, hepatic, and gastrointestinal adverse events, including fatal outcomes, have been reported in elderly patients. Use with caution, generally starting at the lower end of the dosing range and monitoring closely.

Clinical Information

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Clinical Pearls

  • Jadenu Sprinkle granules must be mixed with soft food and consumed immediately; they cannot be chewed or taken dry.
  • Consistent administration (empty stomach or light meal) is crucial for predictable absorption.
  • Regular and rigorous monitoring of renal function, liver function, and serum ferritin is paramount due to the risk of serious organ toxicity.
  • Patients should be educated on the signs and symptoms of serious adverse events (renal, hepatic, GI, vision, hearing) and instructed to seek immediate medical attention if they occur.
  • Hydration is important to minimize the risk of renal adverse events.
  • Consider dose adjustments for concomitant medications that are UGT inducers/inhibitors or CYP1A2/3A4 substrates.
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Alternative Therapies

  • Deferoxamine (Desferal) - parenteral iron chelator
  • Deferiprone (Ferriprox) - oral iron chelator
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Cost & Coverage

Average Cost: Highly variable, typically several thousand USD per 30 days supply
Generic Available: Yes
Insurance Coverage: Specialty Tier (requires prior authorization, often subject to step therapy)
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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 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, 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.