Jadenu

Jadenu is a prescription medication used to remove the extra iron that builds up in people who receive repeated blood transfusions and in people with an inherited blood disorder called non-transfusion-dependent thalassemia (NTDT). Jadenu belongs to a group of drugs called iron chelators. It works by attaching to iron in the body so that it can be removed from the body in feces.

This medication comes in a tablet form. It is taken by mouth on an empty stomach or with a light meal (contains less than 7% fat content and approximately 250 calories), once daily.

Common side effects of Jadenu include nausea, rash, and diarrhea. Jadenu can cause dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Jadenu is a prescription medication used for the treatment of chronically (long-lasting) elevated iron blood levels caused by:

• repeated blood transfusions in patients 2 years of age and older
• a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT) in patients 10 years of age and older

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novartis Pharmaceutical Corporation

Serious side effects have been reported. See "Drug Precautions" section.

Common side effects include:

• nausea
• vomiting
• diarrhea
• stomach pain
• increases in kidney laboratory values
• skin rash

​This is not a complete list of Jadenu side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other iron chelating agents
• birth control pills and other hormonal contraceptive medications
• diabetes medications
• seizure medications such as phenytoin (Dilantin) and phenobarbital (Luminal)
• cholesterol-lowering drugs such as simvastatin (Zocor, in Simcor, in Vytorin)
• cholestyramine (Questran, Prevalite)
• colesevelam (Welchol)
• colestipol (Colestid)
• aluminum-containing antacids such as Amphogel, Alternagel, Gaviscon, Maalox, or Mylanta
• cyclosporine (Gengraf, Neoral, Sandimmune)
• repaglinide (Prandin, in Prandimet)
• ritonavir (Norvir)
• anticoagulants ("blood thinners") such as warfarin (Coumadin, Jantoven)
• bisphosphonates such as alendronate (Fosamax), ibandronate (Boniva), risedronate (Actonel, Atelvia), and others
• rifampin (Rimactane, Rifadin)

This is not a complete list of Jadenu drug interactions. Ask your doctor or pharmacist for more information.

Jadenu may cause serious kidney problems, liver problems, and bleeding in the stomach or intestines. In some cases, these problems were fatal. Kidney problems occurred particularly in patients with multiple medical conditions and those who were very ill because of their disease. Bleeding in the stomach or intestines occurred more often in elderly patients. Liver problems were more likely to happen in patients older than 55 years.

• Your doctor should check your kidneys with a blood test called serum creatinine and/or creatinine clearance:
• If you already have a history of kidney problems or are at risk for kidney problems, your doctor will probably check your kidneys more frequently.
• Your doctor should check your liver with blood tests called serum transaminases and bilirubin:

Other serious side effects can occur including:

Blood Disorders. Some patients developed severe blood disorders, in some cases fatal, while on Jadenu therapy. Having a pre-existing blood disorder may increase the risk. Your doctor will give you a blood test to check your blood counts.

Increased Risks When Used in Elderly Patients. Since Jadenu has been on the market, there have been reports of serious reactions, sometimes leading to death. These serious reactions and deaths have happened most often when Jadenu was taken by elderly patients.

Allergic Reactions. Serious allergic reactions (which include swelling of the throat) have been reported in patients taking Jadenu, usually within the first month of treatment. If you develop swelling of the throat, a severe rash, hearing problems, or vision disturbances, stop taking Jadenu and contact your doctor immediately.

Serious Rash. A skin disorder that results in Stevens-Johnson syndrome (SJS) and erythema multiforme, has been reported during treatment with Jadenu. If you develop a severe rash, stop taking Jadenu and contact your doctor immediately.

Hearing and Vision Changes. Changes to hearing and vision have been reported in patients taking Jadenu. If you notice changes in your hearing or eyesight, contact your doctor immediately. You may also receive a hearing or vision test prior to receiving Jadenu and yearly thereafter. Your doctor may change your dose based on the results of these tests.

Do not take Jadenu if you have:

• Certain kinds of kidney problems
• Pre-existing severe liver problems
• High-risk myelodysplastic syndromes (MDS)
• Advanced cancer
• Low blood counts (low platelets)
• An allergy to any ingredient in this medication

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Jadenu, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Jadenu, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Jadenu or any ingredient of Jadenu
• have kidney problems
• have severe liver problems
• have high-risk myelodysplastic syndromes (MDS)
• have advanced cancer
• have low blood platelet counts
• are pregnant or plan on becoming pregnant
• are breastfeeding or plan on breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animals studies, pregnant animals were given this medication and had some babies born with problems. There are no adequate and well-controlled studies that have been done in humans with Jadenu. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Jadenu crosses into human milk, although Jadenu is passed through breast milk in animals. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Jadenu.

Take Jadenu exactly as prescribed.

Jadenu comes as a tablet form to take by mouth.

Take Jadenu by mouth on an empty stomach or with a light meal (contains less than 7% fat content and approximately 250 calories), once daily.

Take Jadenu with water or other liquids.

Take Jadenu at the same time every day.

Do not take more or less of it or take it more often than prescribed by your doctor.

Take Jadenu exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Jadenu dose your doctor recommends will be based on:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your kidney function
• your liver function
• your weight

Transfusional Iron Overload

If you take too much Jadenu call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at room temperature between 25°C (77°F).
• Keep this and all medications out of the reach of children.

WARNING: RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL HEMORRHAGE

Renal Failure

• Jadenu can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders.
• Measure serum creatinine and determine creatinine clearance in duplicate prior to initiation of therapy and monitor renal function at least monthly thereafter. For patients with baseline renal impairment or increased risk of acute renal failure, monitor creatinine weekly for the first month, then at least monthly. Consider dose reduction, interruption, or discontinuation based on increases in serum creatinine.

Hepatic Failure

• Jadenu can cause hepatic injury including hepatic failure and death.
• Measure serum transaminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter.
• Avoid use of Jadenu in patients with severe (Child-Pugh C) hepatic impairment and reduce the dose in patients with moderate (Child Pugh B) hepatic impairment. 

Gastrointestinal Hemorrhage

• Jadenu can cause gastrointestinal (GI) hemorrhages, which may be fatal, especially in elderly patients who have advanced hematologic malignancies and/or low platelet counts.
• Monitor patients and discontinue Jadenu for suspected GI ulceration or hemorrhage.