Generic Name: deferasirox (dee-FER-a-sir-ox)
Brand Name: Jadenu
Jadenu may cause severe and sometimes fatal kidney problems or liver problems. The risk may be greater in patients who already have kidney or liver problems. Lab tests, including kidney and liver function, will be performed while you use Jadenu to check for these problems. Be sure to keep all doctor and lab appointments.
Jadenu may also cause severe and sometimes fatal stomach or bowel bleeding. The risk may be greater in elderly patients who have advanced blood or bone marrow cancer and/or low blood platelet counts.
Tell your doctor if you develop symptoms of kidney problems (eg, decreased urination) or liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, stomach pain, or loss of appetite). Tell your doctor if you develop symptoms of stomach or bowel bleeding (eg, stomach pain; black, tarry stools; vomit that looks like coffee grounds).
Jadenu is used for:
Treating high levels of iron in the blood.
Jadenu is an iron-chelating agent. It works by binding to the extra iron in the blood and removing it from the body.
Do NOT use Jadenu if:
- you are allergic to any ingredient in Jadenu
- you have severe kidney or liver problems or very low blood platelet levels
- you have certain blood or bone marrow problems (high-risk MDS) or advanced cancer
Contact your doctor or health care provider right away if any of these apply to you.
Before using Jadenu:
Some medical conditions may interact with Jadenu. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of kidney problems (eg, kidney failure), liver problems (eg, cirrhosis), or stomach or bowel problems (eg, bleeding, ulcers)
- if you have cancer, blood or bone marrow problems, low blood platelets, vision or eye problems, hearing problems, or an infection
- if you have trouble swallowing tablets
- if you are dehydrated
- if you are 65 years old or older and have MDS
Some MEDICINES MAY INTERACT with Jadenu. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin), oral bisphosphonates (eg, alendronate), corticosteroids (eg, prednisone), or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of stomach or bowel ulcers or bleeding may be increased
- Other iron-chelating medicines (eg, deferoxamine) because they may increase the risk of Jadenu's side effects
- Cholestyramine, colesevelam, colestipol, fosphenytoin, phenobarbital, phenytoin, rifampin, or ritonavir because they may decrease Jadenu's effectiveness
- Alosetron, caffeine, duloxetine, melatonin, paclitaxel, ramelteon, repaglinide, tacrine, theophyllines (eg, aminophylline), or tizanidine because the risk of their side effects may be increased by Jadenu
- Alfentanil, aprepitant, budesonide, buspirone, conivaptan, cyclosporine, darifenacin, darunavir, dasatinib, dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine, everolimus, felodipine, fentanyl, fluticasone, hormonal contraceptives (eg, birth control), indinavir, lopinavir, lovastatin, lurasidone, maraviroc, midazolam, nisoldipine, pimozide, quetiapine, quinidine, saquinavir, sildenafil, simvastatin, sirolimus, tacrolimus, tolvaptan, tipranavir, triazolam, ticagrelor, or vardenafil because their effectiveness may be decreased by Jadenu
- Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, NSAIDs [eg, ibuprofen], tacrolimus, vancomycin) or the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of kidney or liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney or liver
This may not be a complete list of all interactions that may occur. Ask your health care provider if Jadenu may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Jadenu:
Use Jadenu as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Jadenu by mouth with water or other liquids. Take it at the same time of day.
- Take Jadenu on an empty stomach or with a light meal.
- Do not take an antacid that has aluminum in it at the same time you take Jadenu. If you take antacids that contain aluminum, ask your doctor or pharmacist how to take them with Jadenu.
- Take as you have been told, even if you feel well.
- To gain the most benefit, do not miss doses.
- If you miss a dose of Jadenu, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Jadenu.
Important safety information:
- Tell your doctor or dentist that you take Jadenu before you receive any medical or dental care, emergency care, or surgery.
- Jadenu may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Jadenu with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
- Serious and sometimes fatal bone marrow problems have been reported in patients taking Jadenu. Contact your doctor or get medical help right away if you develop symptoms of infection (eg, fever, chills, persistent sore throat or cough), unusual bruising or bleeding, or unusual tiredness or weakness.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Do not switch between different forms of Jadenu without first talking with the doctor.
- Hormonal birth control (eg, birth control pills) may not work as well while you are using Jadenu. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- Have your vision and hearing checked as you have been told by your doctor.
- Lab tests may be performed while you take Jadenu. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Jadenu with caution in the ELDERLY; they may be more sensitive to its effects, especially kidney problems, liver problems, and stomach or bowel bleeding.
- If your CHILD is taking Jadenu, the dose may need to be changed as your child's weight changes. Have your child's weight checked often. Talk with the doctor before changing your child's dose.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Jadenu while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Jadenu.
Possible side effects of Jadenu:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; nausea; stomach pain; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); decreased hearing, hearing loss, or other hearing problems; symptoms of kidney problems (eg, decreased urination); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, stomach pain, or loss of appetite); symptoms of stomach or bowel bleeding or ulcers (eg, stomach pain; black, tarry stools; vomit that looks like coffee ground); vision changes (eg, blurred or cloudy vision, decreased vision).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Jadenu:
Store Jadenu at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Jadenu out of the reach of children and away from pets.
- If you have any questions about Jadenu, please talk with your doctor, pharmacist, or other health care provider.
- Jadenu is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Jadenu or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Jadenu. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Jadenu. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Jadenu.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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