Jadenu Sprinkle 360mg 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
Tridentate Ligand 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 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, which 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 resume 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 daily, preferably at the same time each day.
  • Sprinkle the entire dose on a small amount (e.g., 1 tablespoon) of soft food like yogurt, applesauce, or pudding. Stir until completely dispersed. Do not chew the granules.
  • Consume the entire mixture immediately. Do not store for later use.
  • Do not sprinkle on hot foods.
  • Do not mix with carbonated beverages or milk.
  • Avoid aluminum-containing antacids (e.g., Maalox, Mylanta) within 2 hours of taking Jadenu Sprinkle.
  • Stay well-hydrated while taking this medication.
  • Attend all scheduled doctor appointments and laboratory tests (blood tests, eye exams, hearing tests) as directed by your doctor. These are very important to monitor your treatment and check for side effects.
  • Report any new or worsening symptoms to your doctor immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose varies by indication and patient weight. Typically 14 mg/kg/day (transfusional iron overload) or 7 mg/kg/day (non-transfusion-dependent thalassemia).
Dose Range: 7 - 28 mg

Condition-Specific Dosing:

Transfusional Iron Overload: Initial: 14 mg/kg/day. Max: 28 mg/kg/day. Adjust in 3.5-7 mg/kg increments based on serum ferritin.
Non-Transfusion-Dependent Thalassemia (NTDT): Initial: 7 mg/kg/day. Max: 14 mg/kg/day. Adjust in 3.5-7 mg/kg increments based on serum ferritin.
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Pediatric Dosing

Neonatal: Not established (contraindicated in patients <2 years old for transfusional iron overload, and <10 years old for NTDT).
Infant: Not established (contraindicated in patients <2 years old for transfusional iron overload, and <10 years old for NTDT).
Child: Transfusional Iron Overload (â‰Ĩ2 years old): Initial 14 mg/kg/day. NTDT (â‰Ĩ10 years old): Initial 7 mg/kg/day. Dosing and adjustments similar to adults based on weight and ferritin.
Adolescent: Dosing similar to adults based on weight and ferritin for both indications.
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Dose Adjustments

Renal Impairment:

Mild: Initial dose reduction by 7 mg/kg/day for transfusional iron overload (e.g., 14 mg/kg/day to 7 mg/kg/day) or 3.5 mg/kg/day for NTDT (e.g., 7 mg/kg/day to 3.5 mg/kg/day) if baseline creatinine is above age-appropriate upper limit of normal or eGFR <90 mL/min/1.73m2. Monitor renal function closely.
Moderate: Initial dose reduction by 7 mg/kg/day for transfusional iron overload (e.g., 14 mg/kg/day to 7 mg/kg/day) or 3.5 mg/kg/day for NTDT (e.g., 7 mg/kg/day to 3.5 mg/kg/day) if baseline creatinine is above age-appropriate upper limit of normal or eGFR <90 mL/min/1.73m2. Monitor renal function closely. Consider lower starting doses or avoid if severe impairment.
Severe: Contraindicated in patients with creatinine clearance <40 mL/min or severe renal impairment.
Dialysis: Not recommended in patients on dialysis due to lack of data and potential for increased systemic exposure.

Hepatic Impairment:

Mild: No initial dose adjustment required for Child-Pugh A. Monitor liver function closely.
Moderate: Reduce initial dose by 50% for Child-Pugh B. Monitor liver function closely. Max dose 14 mg/kg/day.
Severe: Contraindicated in patients with Child-Pugh C hepatic impairment.

Pharmacology

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Mechanism of Action

Deferasirox is an orally active tridentate iron chelator. It binds to iron with high affinity in a 2:1 ratio (two molecules of deferasirox to one atom of iron), forming a stable complex that is then excreted primarily via the bile into the feces. It is designed to remove excess iron from the body, particularly in patients with chronic iron overload due to frequent blood transfusions or non-transfusion-dependent thalassemia.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 70% (relative to an intravenous dose). Jadenu Sprinkle has higher bioavailability than Exjade tablets.
Tmax: 1.5-4 hours (median 2-4 hours)
FoodEffect: High-fat meals increase AUC by 100% and Cmax by 160%. Low-fat meals increase AUC by 18% and Cmax by 29%. Should be taken on an empty stomach or with a light meal to minimize variability and avoid excessive exposure.

Distribution:

Vd: 14.3 L (apparent volume of distribution at steady state)
ProteinBinding: >99% (primarily to serum albumin)
CnssPenetration: Limited

Elimination:

HalfLife: 8-16 hours (median 8-16 hours)
Clearance: Not readily available as a single value, but total body clearance is approximately 10.1 L/h.
ExcretionRoute: Predominantly fecal (84% of dose), with minor renal excretion (8% of dose).
Unchanged: Not available (most is metabolized)
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Pharmacodynamics

OnsetOfAction: Not acutely defined; iron chelation is a chronic process. Reduction in serum ferritin levels typically observed within weeks to months.
PeakEffect: Reduction in iron burden is a long-term effect, assessed by serum ferritin trends and liver iron concentration (LIC).
DurationOfAction: Daily dosing required due to half-life.

Safety & Warnings

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BLACK BOX WARNING

RENAL FAILURE, HEPATIC FAILURE, GASTROINTESTINAL HEMORRHAGE, AND BONE MARROW SUPPRESSION. Deferasirox can cause acute renal failure, hepatic failure, and gastrointestinal hemorrhage, sometimes fatal. Deferasirox can also cause bone marrow suppression. Monitor renal function, hepatic function, and complete blood counts regularly. Discontinue deferasirox for unexplained, persistent increases in serum creatinine, or for severe hepatic impairment. Interrupt deferasirox for severe gastrointestinal hemorrhage or severe bone marrow suppression.
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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 or 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 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 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 lead to severe bleeding problems or infections; contact your doctor if you experience:
+ Signs of infection, such as fever, chills, severe sore throat, ear or sinus pain, cough, or changes in sputum
+ Bruising or bleeding
+ 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, contact your doctor:

Diarrhea
Stomach pain
Upset stomach
Vomiting

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain, nausea, vomiting, or diarrhea
  • Black, tarry stools or vomiting blood (signs of stomach bleeding)
  • Yellowing of your skin or eyes (jaundice)
  • Dark urine or pale stools
  • Unusual tiredness or weakness
  • Decreased urine output or swelling in your legs/feet
  • Changes in vision (e.g., blurred vision, difficulty seeing at night)
  • Changes in hearing (e.g., ringing in ears, difficulty hearing)
  • Skin rash or itching
  • Fever, chills, or sore throat (signs of infection)
  • Unusual bruising or bleeding
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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, 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
If you are breast-feeding. Note that you should not breast-feed while taking this medication.

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Do not initiate, stop, or modify the dose of any medication without first 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 directed 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 dosage may need to be adjusted.

Be aware that birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy while taking this medication. To minimize the risk of unplanned pregnancy, use an additional form of birth control, such as a condom, in conjunction with your regular 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. This will enable you to make an informed decision about your treatment.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Headache
  • Dizziness
  • Elevated liver enzymes
  • Renal impairment

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive. Hemodialysis is not effective for deferasirox removal.

Drug Interactions

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Contraindicated Interactions

  • Aluminum-containing antacids (within 2 hours of deferasirox administration)
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Major Interactions

  • Midazolam (CYP3A4 substrate, deferasirox is a weak inducer)
  • Repaglinide (UGT1A1 substrate, deferasirox is an inhibitor)
  • Oral contraceptives (hormonal, deferasirox may decrease efficacy)
  • Vitamin K antagonists (e.g., Warfarin, increased risk of bleeding)
  • Drugs metabolized by CYP2C8 (e.g., Paclitaxel, deferasirox is an inhibitor)
  • Bile acid sequestrants (e.g., Cholestyramine, Colesevelam - may decrease deferasirox exposure)
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Moderate Interactions

  • Proton pump inhibitors (e.g., Omeprazole, may increase deferasirox exposure)
  • Corticosteroids (may increase risk of GI hemorrhage)
  • NSAIDs (may increase risk of GI hemorrhage)
  • Other myelosuppressive agents (additive risk of bone marrow suppression)
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Minor Interactions

  • Not specifically listed as minor, but general caution with drugs affecting renal or hepatic function.

Monitoring

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Baseline Monitoring

Serum Ferritin

Rationale: To establish baseline iron burden and guide initial dosing.

Timing: Prior to initiation of therapy.

Serum Creatinine and eGFR

Rationale: To assess renal function, guide dosing, and identify patients at risk for renal impairment.

Timing: Prior to initiation of therapy.

Urinalysis (proteinuria)

Rationale: To assess for renal tubular dysfunction.

Timing: Prior to initiation of therapy.

Liver Function Tests (ALT, AST, ALP, Bilirubin)

Rationale: To assess hepatic function and guide dosing.

Timing: Prior to initiation of therapy.

Complete Blood Count (CBC) with differential

Rationale: To assess for myelosuppression.

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.

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Routine Monitoring

Serum Ferritin

Frequency: Monthly

Target: Goal is typically <1000 mcg/L, but individualized.

Action Threshold: Increase dose if ferritin >2500 mcg/L and well-tolerated; decrease dose if ferritin <500 mcg/L or rapidly declining.

Serum Creatinine and eGFR

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

Target: Within age-appropriate normal limits.

Action Threshold: If creatinine increases by >33% above baseline on two consecutive measurements, or above age-appropriate upper limit of normal, consider dose reduction or interruption. If eGFR <40 mL/min/1.73m2, discontinue.

Urinalysis (proteinuria)

Frequency: Monthly

Target: Negative or trace protein.

Action Threshold: If persistent or increasing proteinuria, consider dose reduction or interruption and further renal evaluation.

Liver Function Tests (ALT, AST, ALP, Bilirubin)

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

Target: Within normal limits.

Action Threshold: If transaminases increase >5 times the upper limit of normal (ULN) or >3 times ULN with bilirubin >2 times ULN, interrupt therapy. If persistent, discontinue.

Complete Blood Count (CBC) with differential

Frequency: Monthly

Target: Within normal limits.

Action Threshold: If significant cytopenias develop (e.g., severe neutropenia, thrombocytopenia, or worsening anemia), consider dose interruption or reduction.

Audiometry

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

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Skin rash
  • Headache
  • Dizziness
  • Hearing changes (e.g., ringing in ears, decreased hearing)
  • Vision changes (e.g., blurred vision, decreased vision)
  • Signs of renal dysfunction (e.g., decreased urine output, swelling)
  • Signs of hepatic dysfunction (e.g., yellowing of skin/eyes, dark urine, severe fatigue)
  • Signs of GI hemorrhage (e.g., black, tarry stools; vomiting blood)
  • Signs of bone marrow suppression (e.g., fever, unusual bleeding/bruising, persistent fatigue)

Special Patient Groups

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Pregnancy

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

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: Risk unknown; potential for serious adverse reactions.
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Pediatric Use

Contraindicated in patients <2 years old for transfusional iron overload and <10 years old for non-transfusion-dependent thalassemia. Close monitoring of renal function, growth, and development is crucial. Dosing is weight-based.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Jadenu Sprinkle granules must be mixed with soft food (e.g., applesauce, yogurt) and consumed immediately. Do NOT chew the granules.
  • Regular and diligent monitoring of renal function (creatinine, eGFR, proteinuria), liver function (transaminases, bilirubin), and CBC is critical due to Black Box Warnings.
  • Patients should be educated on the signs and symptoms of serious adverse events, especially GI hemorrhage, and instructed to seek immediate medical attention if they occur.
  • Dose adjustments are primarily based on serum ferritin trends, but also on safety parameters (renal/hepatic function, CBC).
  • Ensure patients avoid aluminum-containing antacids within 2 hours of deferasirox administration.
  • Hydration is important to minimize renal adverse effects.
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Alternative Therapies

  • Deferoxamine (Desferal) - parenteral iron chelator
  • Deferiprone (Ferriprox) - oral iron chelator (often used in combination with deferoxamine or as monotherapy in specific cases)
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Cost & Coverage

Average Cost: Not available per 30 days
Generic Available: Yes
Insurance Coverage: Specialty Tier / Tier 4
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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, consult your doctor, pharmacist, or other healthcare provider for guidance. 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.