Exjade (Deferasirox)

(de fer' a sir ox)

Deferasirox may cause serious or life-threatening damage to the kidneys. The risk that you will develop kidney damage is greater if you have many medical conditions, or are very sick because of a blood disease. Tell your doctor if you have or have ever had kidney disease. Your doctor may tell you not to take deferasirox. If you experience any of the following symptoms, call your doctor immediately: decreased urination, swelling in the ankles, legs, or feet, excessive tiredness, shortness of breath, and confusion. For children taking this medication, there is an increased risk that you will develop kidney problems if you get sick while taking deferasirox and develop diarrhea, vomiting, fever, or stop drinking fluids normally. Call your doctor immediately if you experience any of these symptoms. Deferasirox may also cause serious or life-threatening damage to the liver. The risk that you will develop liver damage is greater if you are older than 55 years of age, or if you have other serious medical conditions. Tell your doctor if you have or have ever had liver disease. If you develop any of the following symptoms, call your doctor immediately: yellowing of the skin or eyes, flu-like symptoms, lack of energy, loss of appetite, pain in the upper right part of the stomach, or unusual bruising or bleeding. Deferasirox may also cause serious or life threatening bleeding in the stomach or intestines. The risk that you will develop severe bleeding in the stomach or intestines may be greater if you are elderly, or are very sick from a blood condition. Tell your doctor if you have or have ever had a low level of platelets (a type of blood cell that is needed to control bleeding), or if you are taking any of the following medications: anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven); aspirin or other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin, others) and naproxen (Aleve, Naprosyn, others); certain medications to strengthen the bones including alendronate (Binosto, Fosamax), etidronate, ibandronate (Boniva), pamidronate, risedronate (Actonel, Atelvia), and zoledronic acid (Reclast, Zometa); or steroids such as dexamethasone, methylprednisolone (A-methapred, Depo-medrol, Medrol, Solu-medrol), or prednisone (Rayos). If you experience any of the following symptoms, call your doctor immediately: burning stomach pain, vomit that is bright red or looks like coffee grounds, bright red blood in stools, or black or tarry stools. Keep all appointments with your doctor and the laboratory. Your doctor will order laboratory tests before and during your treatment to be sure it is safe for you to take deferasirox and to see if you are developing these serious side effects.

Deferasirox is used to treat adults and children 2 years of age and older who have too much iron in their body because they received many blood transfusions. It is also used to treat adults and children 10 years of age and older who have too much iron in their body because of a genetic blood disorder called non–transfusion-dependent thalassemia (NTDT). Deferasirox is in a class of medications called iron chelators. It works by attaching to iron in the body so that it can be excreted (removed from the body) in feces.

Deferasirox comes as a tablet, granules, and a tablet for suspension (a tablet to dissolve in liquid) to take by mouth. It should be taken on an empty stomach once a day, at least 30 minutes before eating, The tablets and granules can also be taken with a light meal such as a whole wheat English muffin with jelly and skim milk, or a small turkey sandwich on whole wheat bread. Take deferasirox at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take deferasirox exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Different deferasirox products are absorbed by the body in different ways and cannot be substituted for one another. If you need to switch from one deferasirox product to another, your doctor may need to adjust your dose. Each time you receive your medication, check to be sure that you have received the deferasirox product that was prescribed for you. Ask your pharmacist if you are not sure that you received the right medication. Swallow deferasirox tablets with water or other liquid. If you have trouble swallowing the tablet, you may crush the tablet and mix with a soft food such as yogurt or applesauce immediately before taking. However, do not crush the 90 mg tablet using a professional crushing device that has jagged edges. To take deferasirox granules, sprinkle the granules on a soft food such a yogurt or applesauce immediately before taking. To take deferasirox tablets for suspension, follow these steps:

• Always dissolve the tablets for suspension in liquid before you take them. Do not chew or swallow the tablets for suspension whole.
• If you are taking less than 1000 mg of deferasirox, fill a cup halfway (about 3.5 oz/100 mL) with water, apple juice, or orange juice. If you are taking more than 1000 mg of deferasirox, fill a cup (about 7 oz/200 mL) with water, apple juice, or orange juice. If you are not sure how much deferasirox you are to take, ask your doctor or pharmacist.
• Place the number of tablets your doctor has told you to take in the cup.
• Stir the liquid for 3 minutes to completely dissolve the tablets.The mixture may become thick as you stir it.
• Drink the liquid immediately.
• Add a small amount of liquid to the empty cup and stir. Swish the cup to dissolve any medication that is still in the glass or on the stirrer.
• Drink the rest of the liquid.

Your doctor may adjust your dose of deferasirox not more than once every 3 to 6 months, depending on the results of your laboratory tests. Deferasirox removes extra iron from your body slowly over time. Continue to take deferasirox even if you feel well. Do not stop taking deferasirox without talking to your doctor.

Before taking deferasirox,
• tell your doctor and pharmacist if you are allergic to deferasirox, any other medications, or any of the ingredients in deferasirox tablets, granules, or tablets for suspension. Ask your doctor or pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: alosetron (Lotronex), aprepitant (Cinvanti, Emend), budesonide (Entocort, Pulmicort, Uceris, in Symbicort), buspirone, cholestyramine (Prevalite), colesevelam (Welchol), colestipol (Colestid), conivaptan (Vaprisol), cyclosporine (Gengraf, Neoral, Sandimmune), darifenacin (Enablex), darunavir (Prezista, in Prezcobix), dasatinib (Sprycel), dihydroergotamine (D.H.E. 45, Migranal), dronedarone (Multaq), duloxetine (Cymbalta), eletriptan (Relpax), eplerenone (Inspra), ergotamine (Ergomar, in Cafergot, Migergot), everolimus (Afinitor, Zortress), felodipine, fentanyl (Actiq, Duragesic, Subsys, others), fluticasone (Arnuity Ellipta, Flovent, in Breo Ellipta, Advair), hormonal contraceptives (birth control pills, patches, rings, or injections), indinavir (Crixivan), lopinavir (in Kaletra), lovastatin (Altoprev), lurasidone (Latuda), maraviroc (Selzentry), midazolam, nisoldipine (Sular), paclitaxel (Abraxane, Taxol), phenytoin (Dilantin, Phenytek), phenobarbital, pimozide (Orap), quetiapine (Seroquel), quinidine (in Nuedexta). ramelteon (Rozerem), repaglinide (Prandin, in Prandimet), rifampin (Rimactane, Rifadin, in Rifamate, in Rifater), ritonavir (Norvir, in Kaletra, Technivie, Viekira Pak), saquinavir (Invirase), sildenafil (Revatio, Viagra), simvastatin (Flolopid, Zocor, in Vytorin), siroliumus (Rapamune), tacrolimus (Astagraf, Envarsus, Prograf), theophylline (Theo-24), ticagrelor (Brilinta), tipranavir (Aptivus), tizanidine (Zanaflex), triazolam (Halcion), tolvaptan (Samsca), and vardenafil (Levitra, Staxyn). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking aluminum-containing antacids such as Amphojel, Alternagel, Gaviscon, Maalox, or Mylanta, take them 2 hours before or after deferasirox.
• tell your doctor what over the counter products you are taking, especially melatonin, or caffeine supplements.
• tell your doctor if you have myelodysplastic syndrome (a severe problem with the bone marrow that has a high risk of developing into cancer), or cancer. Your doctor may tell you not to take deferasirox.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking deferasirox, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose later in the day, at least 2 hours after your last meal and 30 minutes before eating. However, if it is almost time for the next dose or if you will not be able to take deferasirox on an empty stomach, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Deferasirox may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• stomach pain
• nausea
• vomiting
• diarrhea

Some side effects can be serious. If you experience any of these symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:

• hearing loss
• vision problems
• rash, hives, peeling or blistering skin, fever, swollen lymph nodes
• difficulty breathing or swallowing; swelling of the face, throat, tongue, lips, or eyes; hoarseness
• unusual bruising or bleeding

Deferasirox may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor. You will need to have hearing and eye exams before starting deferasirox and once a year while taking this medication. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.