Jadenu Sprinkle 180mg Granules

Deferasirox is an orally active tridentate chelator with a high affinity for iron. It forms a stable 2:1 complex with iron, promoting its excretion, primarily via the feces. It is designed to remove excess iron from the body, which accumulates in patients receiving frequent blood transfusions or those with non-transfusion-dependent thalassemia syndromes.

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 or seek immediate 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 immediately for guidance.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can 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; or swollen glands.
Decreased bone marrow function, 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, increased or discolored sputum, painful urination, mouth sores, or unhealing wounds; bruising or bleeding; or excessive 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 bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

* Diarrhea, stomach pain, upset stomach, or vomiting.

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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.

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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, such as:
+ Cancer
+ Blood or bone marrow disorders (e.g., low platelet count, 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, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions. Verify that it is safe to take this medication with your existing medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without consulting your doctor.

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. As directed by your doctor, regularly undergo blood tests, other laboratory tests, eye exams, and hearing tests to monitor your condition.

When taking this medication, do not consume antacids containing aluminum, as they may interact with the drug. If you are 55 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. Similarly, if the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in pediatric populations.

If you are administering this medication to a child and notice any changes in their weight, consult with your doctor, as the dosage may need to be adjusted. Additionally, be aware that birth control pills and other hormone-based contraceptives may be less effective when taken with this medication. To prevent pregnancy, consider using an alternative form of birth control, such as a condom, in conjunction with your regular contraceptive method.

If you are pregnant or planning to become pregnant, inform your doctor, as it is crucial to discuss the potential benefits and risks associated with using this medication during pregnancy.

• Other iron chelator therapies (e.g., deferoxamine, deferiprone) due to increased toxicity
• Severe renal impairment (CrCl <30 mL/min)
• Severe hepatic impairment (Child-Pugh C)
• Myelodysplastic syndrome (MDS) patients with advanced or rapidly progressing disease

• Aluminum-containing antacids (e.g., aluminum hydroxide): Avoid concomitant use due to potential for increased deferasirox exposure.
• CYP3A4 inducers (e.g., rifampin, phenytoin, phenobarbital, carbamazepine, St. John's Wort): May decrease deferasirox exposure; consider increasing deferasirox dose.
• UGT inducers (e.g., rifampin, phenobarbital, phenytoin): May decrease deferasirox exposure; consider increasing deferasirox dose.
• CYP2C8 inhibitors (e.g., gemfibrozil, repaglinide): May increase deferasirox exposure; consider reducing deferasirox dose.
• Drugs metabolized by CYP1A2 (e.g., theophylline, clozapine, tizanidine): Deferasirox may decrease their exposure; monitor and adjust dose.
• Drugs metabolized by CYP2D6 (e.g., metoprolol, dextromethorphan): Deferasirox may decrease their exposure; monitor and adjust dose.
• Drugs metabolized by CYP2C19 (e.g., omeprazole, citalopram): Deferasirox may decrease their exposure; monitor and adjust dose.
• Oral contraceptives: Deferasirox may decrease efficacy; consider alternative or additional birth control methods.
• Vitamin C: Concomitant use with high doses (>500 mg) may increase iron toxicity, especially in patients with severe iron overload. Avoid high doses.

• NSAIDs (e.g., ibuprofen, naproxen): Increased risk of GI irritation/hemorrhage.
• Corticosteroids: Increased risk of GI irritation/hemorrhage.
• Oral anticoagulants (e.g., warfarin): Increased risk of GI hemorrhage; monitor INR closely.
• Proton pump inhibitors (PPIs) and H2-receptor antagonists: May reduce deferasirox absorption (less significant with sprinkle formulation).

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

• Signs of renal impairment (e.g., decreased urine output, edema)
• Signs of hepatic impairment (e.g., jaundice, dark urine, abdominal pain, fatigue)
• Gastrointestinal symptoms (e.g., abdominal pain, nausea, vomiting, diarrhea, GI bleeding)
• Skin rash
• Hearing changes (e.g., ringing in ears, decreased hearing)
• Vision changes (e.g., blurred vision, decreased vision)
• Fever, sore throat, signs of infection (due to potential for agranulocytosis/neutropenia)

Category C. There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies showed adverse effects on development at doses higher than human therapeutic doses.

It is not known whether deferasirox is excreted in human milk. Due to the potential for serious adverse reactions in the breastfed infant, 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.

Approved for transfusional iron overload in patients ≥2 years of age and for NTDT in patients ≥10 years of age. Dosing is weight-based. Close monitoring of renal and hepatic function is crucial, especially in younger children. Growth and development should be monitored.

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

• Jadenu Sprinkle granules should be mixed with soft food (e.g., yogurt, applesauce) or non-carbonated liquid (e.g., water, orange juice) and taken immediately. Do NOT chew the granules.
• Take on an empty stomach or with a light meal to optimize absorption and minimize food effects.
• Strict adherence to monitoring protocols (renal, hepatic, ferritin, vision, hearing) is critical due to potential for serious adverse effects.
• Black Box Warnings for renal, hepatic, and GI hemorrhage are significant; educate patients on warning signs.
• Patients should be well-hydrated to minimize renal toxicity.
• Consider dose adjustments for concomitant medications that are strong CYP3A4/UGT inducers or CYP2C8 inhibitors.
• Deferasirox is generally preferred over deferoxamine for long-term oral therapy due to convenience, but deferoxamine may be used in severe cases or when deferasirox is contraindicated/not tolerated.

• Deferoxamine (Desferal) - parenteral iron chelator
• Deferiprone (Ferriprox) - oral iron chelator (often used in combination with deferoxamine or as monotherapy for specific indications)

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 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 quantity, and the time it occurred.