Jadenu Sprinkle 360mg Granules
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
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
Before Using This Medicine
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.
Precautions & Cautions
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.
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
Contraindicated Interactions
- Aluminum-containing antacids (within 2 hours of deferasirox administration)
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)
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)
Minor Interactions
- Not specifically listed as minor, but general caution with drugs affecting renal or hepatic function.
Monitoring
Baseline Monitoring
Rationale: To establish baseline iron burden and guide initial dosing.
Timing: Prior to initiation of therapy.
Rationale: To assess renal function, guide dosing, and identify patients at risk for renal impairment.
Timing: Prior to initiation of therapy.
Rationale: To assess for renal tubular dysfunction.
Timing: Prior to initiation of therapy.
Rationale: To assess hepatic function and guide dosing.
Timing: Prior to initiation of therapy.
Rationale: To assess for myelosuppression.
Timing: Prior to initiation of therapy.
Rationale: To establish baseline hearing function.
Timing: Prior to initiation of therapy.
Rationale: To establish baseline ocular function.
Timing: Prior to initiation of therapy.
Routine Monitoring
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.
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.
Frequency: Monthly
Target: Negative or trace protein.
Action Threshold: If persistent or increasing proteinuria, consider dose reduction or interruption and further renal evaluation.
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.
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.
Frequency: Annually
Target: Stable hearing.
Action Threshold: If hearing impairment develops, consider dose reduction or interruption.
Frequency: Annually
Target: Stable vision.
Action Threshold: If visual disturbances develop, consider dose reduction or interruption.
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
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:
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.
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.
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
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.
Alternative Therapies
- Deferoxamine (Desferal) - parenteral iron chelator
- Deferiprone (Ferriprox) - oral iron chelator (often used in combination with deferoxamine or as monotherapy in specific cases)