Jadenu Sprinkle 90mg 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 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.
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.
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: 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.
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).
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 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.
Precautions & Cautions
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.
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
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.
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
Baseline Monitoring
Rationale: To establish baseline iron overload and guide initial dosing.
Timing: Prior to initiation of therapy.
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.
Rationale: To assess baseline hepatic function, as deferasirox can cause hepatic toxicity.
Timing: Prior to initiation of therapy.
Rationale: To screen for renal tubular dysfunction.
Timing: Prior to initiation of therapy.
Rationale: To establish baseline hearing, as deferasirox can cause hearing loss.
Timing: Prior to initiation of therapy.
Rationale: To establish baseline vision, as deferasirox can cause visual disturbances.
Timing: Prior to initiation of therapy.
Routine Monitoring
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.
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.
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.
Frequency: Monthly
Target: Negative or stable baseline.
Action Threshold: If new or worsening proteinuria, investigate and consider dose adjustment.
Frequency: Annually
Target: Stable hearing.
Action Threshold: If new or worsening hearing loss, investigate and consider dose adjustment or discontinuation.
Frequency: Annually
Target: Stable vision.
Action Threshold: If new or worsening visual disturbances, investigate and consider dose adjustment or discontinuation.
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
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:
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
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.
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
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.
Alternative Therapies
- Deferoxamine (Desferal) - parenteral iron chelator
- Deferiprone (Ferriprox) - oral iron chelator