Jadenu

(Deferasirox)

The active ingredient in Jadenu is deferasirox. Deferasirox binds to excess iron in the body so the iron can be removed, helping lower long-term iron buildup from blood transfusions or certain thalassemia conditions.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Jadenu. However, the following is a synopsis of the general guidelines for the use of Jadenu:

• Jadenu comes as tablets and Jadenu Sprinkle granules. Take your dose 1 time every day, preferably at the same time each day. You may take Jadenu on an empty stomach or with a light meal.
• If you are taking Jadenu tablets, swallow the whole tablet with water or another liquid. If you have trouble swallowing, your healthcare provider may tell you to crush the tablet and mix it with soft food (such as applesauce or yogurt) right before you take it. Take it right away and do not save the mixture for later.
• If you are taking Jadenu Sprinkle, sprinkle the granules onto soft food (such as applesauce or yogurt) right before your dose and take it by mouth.
• Do not take Jadenu or Jadenu Sprinkle with aluminum-containing antacids. Your provider may also adjust your starting dose or change your dose of Jadenu based on body weight, kidney function (such as creatinine/eGFR checks), liver tests, and how your iron levels respond during treatment.
• If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Some mild or common side effects of Jadenu seen in clinical trials as compared to placebo include:

• Diarrhea
• Nausea
• Skin rash
• Abdominal pain

Some individuals may experience serious side effects while using Jadenu. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Jadenu can cause serious and sometimes fatal kidney problems (including acute kidney injury and renal failure that may require dialysis). Call your provider right away if you or your child is urinating less than usual, or if your child becomes sick with fever, vomiting, or diarrhea and cannot drink fluids normally (dehydration can increase risk). Some people may develop renal tubular toxicity, including Fanconi syndrome.
• Jadenu can cause serious liver problems, including liver failure that can sometimes cause death. Call your provider right away if you notice symptoms such as drowsiness, upper right stomach-area (abdomen) pain, yellowing of the skin or eyes, or dark urine.
• Serious bleeding, ulcers, or tears (perforation) in the stomach or intestine can happen and may be fatal. Get emergency medical help right away if you vomit blood, pass black or bloody stools, or have severe stomach pain. Tell your provider if you get heartburn.
• Effects on the bone marrow can happen. This may lead to low white blood cell counts, low platelet counts (platelets), or worsening anemia (low red blood cells) and can be serious.
• Serious allergic reaction symptoms can include trouble breathing or swallowing, swelling of the face/lips/mouth/tongue/throat, hives, chest pain, fast heartbeat, or feeling faint. Severe skin reactions with blistering, skin peeling, mouth sores, high fever, or flu-like symptoms can be life-threatening. Hearing loss and vision problems have also been reported.

These are not all of the possible side effects of Jadenu. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Jadenu, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Kidney problems or a history of abnormal kidney tests (your provider will monitor kidney function during treatment, which may include checking creatinine and eGFR).
• Liver problems (liver tests are checked before starting and during treatment).
• Advanced cancer or a blood disorder that may increase bleeding risk, including problems with platelet counts or anemia.
• Older age (for example, over 55 years of age), since the risk of toxicity can be higher, and monitoring may need to be closer.

Yes. Jadenu is contraindicated in patients with an estimated GFR less than 40 mL/min/1.73 m2, in patients with poor performance status, in patients with high-risk myelodysplastic syndrome (MDS), and in patients with advanced malignancies.

It is also recommended not to take Jadenu if you have certain kidney problems, high-risk MDS, advanced cancer, a low platelet count, or an allergy to deferasirox or any ingredient in the product.

Jadenu does not “fix” iron overload in a single dose. It is meant for the ongoing treatment of chronic iron overload. Your healthcare provider will monitor how well it is working over time using lab tests such as serum ferritin levels, and in some people (such as certain thalassemia patients) by checking liver iron.

When Jadenu is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Aluminum-containing antacids
• Theophylline
• Cyclosporine
• Hormonal contraceptives (birth control)
• Simvastatin
• Repaglinide
• Paclitaxel
• Rifampicin
• Phenytoin
• Phenobarbital
• Ritonavir
• Bile acid sequestrants (cholesterol medicines) such as cholestyramine, colesevelam, and colestipol
• Busulfan
• NSAIDs
• Corticosteroids
• Oral bisphosphonates
• Anticoagulants (blood thinners).

Jadenu tablets are available in 90 mg, 180 mg, and 360 mg strengths. Jadenu Sprinkle granules are also available in 90 mg, 180 mg, and 360 mg sachets.

Deferasirox is also available in a dispersible tablet formulation under the brand name Exjade.

Store Jadenu tablets and Jadenu Sprinkle at room temperature. Keep the container tightly closed and protect it from moisture. Keep all medicines out of reach of children.

Jadenu and Jadenu Sprinkle are distributed by Novartis Pharmaceuticals Corporation.

There are generics available for Jadenu.

Do not change your dose of Jaden u or stop taking it unless your healthcare provider tells you to. If side effects occur, your provider may change your dose or temporarily or permanently stop Jadenu, and will guide you on the next steps and when to restart (if appropriate).

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.