Exjade

Generic Name: deferasirox (de FER a sir ox)

What is Exjade?

Exjade is an iron-chelating agent. It binds to the extra iron in the blood and removes it from the body.

Exjade is used to treat high levels of iron in the blood caused by blood transfusions in adults and children at least 2 years old.

Exjade may also be used for purposes other than those listed in this medication guide.

Important information about Exjade

Before taking Exjade, tell your doctor if you have kidney or liver disease, a history of stomach or intestinal bleeding, or problems with your hearing or vision.

Take Exjade on an empty stomach, at least 30 minutes before you eat.

Do not chew, crush, or swallow the Exjade tablet whole. Place it into a glass of water, orange juice, or apple juice and allow the tablet to disperse in the liquid. The Exjade tablet will not dissolve completely. Drink this mixture right away. To make sure you get the entire dose, add a little more liquid to the same glass, swirl gently and drink right away.

Stop using Exjade and call your doctor if you have a severe skin rash, weakness or fainting, bloody or tarry stools, coughing up blood, severe stomach pain spreading to your back, vision or hearing loss, easy bruising or bleeding, fever, chills, flu symptoms, urinating less than usual or not at all, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

While you are taking Exjade, do not take antacids that contain aluminum, such as Amphojel, Gaviscon, Maalox, Mi-Acid, Mylanta, Rulox, and others.

Before using Exjade

Do not use Exjade if you are allergic to deferasirox.

Before taking Exjade, tell your doctor if you are allergic to any drugs, or if you have:

heart disease;

a history of stomach or intestinal bleeding;

vision or hearing problems; or

a weak immune system caused by disease (such as cancer, HIV, or AIDS), or by receiving steroids, chemotherapy, or radiation.

If you have any of the conditions listed above, you may not be able to use Exjade or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category B. Exjade is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether deferasirox passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Exjade?

Take Exjade exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take Exjade on an empty stomach at least 30 minutes before food. Take the medication at the same time every day.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. Drink plenty of fluids while taking Exjade to keep from getting dehydrated.

Do not chew, crush, or swallow the Exjade tablet whole. Place it into a glass of water, orange juice, or apple juice and allow the tablet to disperse in the liquid. The tablet will not dissolve completely. Drink this mixture right away. To make sure you get the entire dose, add a little more liquid to the same glass, swirl gently and drink right away.

Use 3.5 ounces, or just under 1/2 cup of liquid if your Exjade dose is less than 1000 milligrams (1 gram). Use 7 ounces, or just under 1 cup of liquid if your Exjade dose is more than 1000 milligrams.

To be sure Exjade is helping your condition, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.

Store Exjade tablets at room temperature, away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a Exjade overdose may include nausea and diarrhea.

What should I avoid while taking Exjade?

Exjade can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Exjade side effects

Stop using Exjade and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

weakness or fainting, bloody or tarry stools;

coughing up blood or vomit that looks like coffee grounds;

severe stomach pain that may spread to your back;

increased thirst and urination, loss of appetite, weakness, constipation;

problems with vision or hearing;

severe skin rash;

easy bruising or bleeding, unusual weakness;

fever, chills, sore throat, body aches, flu symptoms;

urinating less than usual or not at all;

swelling or numbness in your hands or feet; or

nausea, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious Exjade side effects may include:

mild stomach pain, diarrhea, nausea or vomiting;

fever;

dizziness, anxiety, tired feeling;

sleep problems (insomnia);

mild skin rash, discolored skin; or

headache, cough, sinus pain, runny or stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Exjade?

While you are taking Exjade, do not take antacids that contain aluminum, such as Amphojel, Gaviscon, Maalox, Mi-Acid, Mylanta, Rulox, and others.

Do not use other iron chelating medicines such as deferoxamine (Desferal) with Exjade unless your doctor has told you to.

Many drugs can interact with Exjade. Below is just a partial list. Tell your doctor if you are using:

alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel), tiludronate (Skelid), or zoledronic acid (Reclast, Zometa);

an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., Erythrocin, Ery-Tab), telithromycin (Ketek), and others;

birth control pills;

a blood thinner such as warfarin (Coumadin);

cholesterol-lowering drugs such as atorvastatin (Lipitor), lovastatin (Mevacor), simvastatin (Zocor);

heart or blood pressure medications such as amlodipine (Norvasc, Lotrel), diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Adalat), nisoldipine (Sular), or verapamil (Calan, Covera, Isoptin).

heart rhythm medication such as quinidine (Quinaglute, Quinidex, Quin-Release);

HIV medicines such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, Kaletra), saquinavir (Invirase), and others;

medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune) or tacrolimus (Prograf);

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others;

a sedative such as alprazolam (Xanax), diazepam (Valium), midazolam (Versed), or triazolam (Halcion); or

steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others.

This list is not complete and there are many other medicines that can interact with Exjade. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.