Jadenu 180mg Tablets

Deferasirox is an orally active chelator that is highly selective for iron. It forms a stable 2:1 chelate complex with iron, which is then excreted primarily via the feces. This chelation helps to remove excess iron from the body, reducing iron-mediated organ damage.

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 sudden weight gain.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellowing of the skin or 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 conditions, which can be life-threatening. Seek immediate medical attention 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.
Bone marrow suppression, which can increase the risk of severe bleeding 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.

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.

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. Never start, stop, or change the dose of any medication without first 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.

Regularly undergo blood tests, other laboratory tests, eye exams, and hearing tests as instructed 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 while taking this medication. To prevent 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, inform your doctor, as they will need to discuss the potential benefits and risks of using this medication during pregnancy with you.

• Aluminum-containing antacids (e.g., aluminum hydroxide) - due to potential for increased deferasirox exposure and aluminum toxicity.

• CYP3A4 inducers (e.g., rifampin, phenytoin, phenobarbital, carbamazepine) - may significantly decrease deferasirox exposure, reducing efficacy. Consider increasing deferasirox dose.
• UGT inducers (e.g., rifampin, phenobarbital) - may significantly decrease deferasirox exposure, reducing efficacy. Consider increasing deferasirox dose.
• Oral bisphosphonates (e.g., alendronate), NSAIDs (e.g., ibuprofen, naproxen), Corticosteroids (e.g., prednisone) - increased risk of serious gastrointestinal irritation/hemorrhage.
• Vitamin C (high doses, >80 mg/day) - may increase iron toxicity, especially in patients with severe iron overload and cardiac dysfunction. Avoid concomitant use.

• CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) - may increase deferasirox exposure. Consider deferasirox dose reduction.
• UGT inhibitors (e.g., fluconazole, gemfibrozil) - may increase deferasirox exposure. Consider deferasirox dose reduction.
• Drugs metabolized by CYP1A2 (e.g., theophylline, clozapine, tizanidine) - deferasirox may increase their systemic exposure. Monitor and adjust dose of co-administered drug.
• Oral contraceptives (estrogen/progestin) - deferasirox may decrease their efficacy. Advise alternative or additional birth control methods.

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

• Signs of renal dysfunction (e.g., decreased urine output, swelling, fatigue)
• Signs of hepatic dysfunction (e.g., jaundice, dark urine, pale stools, abdominal pain, nausea, vomiting)
• Signs of gastrointestinal bleeding (e.g., black/tarry stools, blood in vomit, severe abdominal pain)
• Signs of bone marrow suppression (e.g., fever, unusual bruising/bleeding, persistent fatigue)
• New or worsening hearing loss or tinnitus
• New or worsening vision changes (e.g., blurred vision, decreased acuity, visual field defects)
• Severe skin rash or hypersensitivity reactions

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

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.

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, and growth parameters is essential. Renal toxicity and growth retardation have been observed in pediatric patients.

Use with caution in elderly patients (≥65 years of age) due to a higher incidence of adverse reactions, particularly gastrointestinal hemorrhage, renal impairment, and hepatic impairment. Initiate at a lower dose and monitor closely.

• Jadenu film-coated tablets have higher bioavailability than Exjade dispersible tablets, so doses are not interchangeable mg-for-mg. Patients switching from Exjade to Jadenu should have their dose adjusted (e.g., 21 mg/kg Exjade ~ 14 mg/kg Jadenu).
• Administer Jadenu with a light meal or on an empty stomach. Avoid high-fat meals as they significantly increase absorption.
• Consistent daily administration time is important for maintaining steady drug levels.
• Strict adherence to monitoring protocols (renal, hepatic, hematologic, ferritin, vision, hearing) is crucial due to the potential for serious adverse effects.
• Educate patients on the signs and symptoms of serious adverse events, especially GI bleeding, and emphasize the importance of seeking immediate medical attention if they occur.
• Consider dose reduction or interruption if serum creatinine increases significantly or if liver enzymes are persistently elevated.

• Deferoxamine (Desferal) - parenteral iron chelator, often used for severe iron overload or when oral options are not tolerated/effective.
• Deferiprone (Ferriprox) - oral iron chelator, approved for transfusional iron overload in specific patient populations, often used in combination with deferasirox or deferoxamine.

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. 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.