Deferasirox

What is deferasirox?

Deferasirox binds to iron and removes it from the blood stream.

Deferasirox is used to treat iron overload caused by blood transfusions in adults and children at least 2 years old.

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

What is the most important information I should know about deferasirox?

Before taking deferasirox, 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 deferasirox on an empty stomach, at least 30 minutes before you eat.

Do not chew, crush, or swallow the deferasirox 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.

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

What should I discuss with my healthcare provider before using deferasirox?

Do not use this medication if you are allergic to deferasirox.

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

• kidney disease;
• liver disease;

• 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 deferasirox or you may need a dosage adjustment or special tests during treatment.

How should I take deferasirox?

Take this medication 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.

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

Do not chew, crush, or swallow the deferasirox 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 deferasirox dose is less than 1000 milligrams (1 gram). Use 7 ounces, or just under 1 cup of liquid if your deferasirox dose is more than 1000 milligrams.

To be sure this medication 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.

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 deferasirox overdose may include nausea and diarrhea.

What should I avoid while taking deferasirox?

Deferasirox 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.

Deferasirox side effects

Stop using deferasirox 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 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.

Deferasirox Dosing Information

Usual Adult Dose for Hemosiderosis:

Initial Dose: 20 mg/kg once a day

Deferasirox should be taken on an empty stomach at least 30 minutes before food and preferably at the same time each day.

Tablets should not be chewed or swallowed whole. Tablets should be completely dispersed by stirring in water, orange juice, or apple juice until a fine suspension is obtained. Doses less than 1,000 mg should be dispensed in 3.5 ounces of liquid and doses greater than 1,000 mg should be dispensed in seven ounce of liquid.

After initial therapy, serum ferritin should be monitored every month and the dose of deferasirox should be adjusted if necessary every three to six months based on serum ferritin trends. Dose adjustments should be made in steps of 5 or 10 mg/kg according to the individual patient's response and therapeutic goals (maintenance or reduction of body iron burden). If serum ferritin falls consistently below 500 mcg/L, consideration should be given to temporary interruption of deferasirox therapy.

Because there is limited experience with doses above 30 mg/kg, doses should not exceed 30 mg/kg.

Usual Pediatric Dose for Hemosiderosis:

Greater than or equal to 2 years old

Initial Dose: 20 mg/kg once a day

Deferasirox should be taken on an empty stomach at least 30 minutes before food and preferably at the same time each day.

Tablets should not be chewed or swallowed whole. Tablets should be completely dispersed by stirring in water, orange juice, or apple juice until a fine suspension is obtained. Doses less than 1,000 mg should be dispensed in 3.5 ounces of liquid and doses greater than 1,000 mg should be dispensed in seven ounce of liquid.

After initial therapy, serum ferritin should be monitored every month and the dose of deferasirox should be adjusted if necessary every three to six months based on serum ferritin trends. Dose adjustments should be made in steps of 5 or 10 mg/kg according to the individual patient's response and therapeutic goals (maintenance or reduction of body iron burden). If serum ferritin falls consistently below 500 mcg/L, consideration should be given to temporary interruption of deferasirox therapy.

Because there is limited experience with doses above 30 mg/kg, doses should not exceed 30 mg/kg.

What other drugs will affect deferasirox?

While you are taking deferasirox, 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 deferasirox unless your doctor has told you to.

Many drugs can interact with deferasirox. 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.

Where can I get more information?

• Your pharmacist can provide more information about deferasirox.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.