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 should I discuss with my healthcare provider before taking 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:
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kidney disease;
-
liver disease;
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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.
FDA pregnancy category B. This medication 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 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.
Take deferasirox 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 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.
Store deferasirox tablets at room temperature, away from moisture and heat.
What happens if I miss a dose of deferasirox?
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.
Where can I get more information about deferasirox?
Your pharmacist has information about deferasirox written for health professionals that you may read.
What are the possible side effects of deferasirox?
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:
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weakness or fainting, bloody or tarry stools;
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coughing up blood or vomit that looks like coffee grounds;
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severe stomach pain that may spread to your back;
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increased thirst and urination, loss of appetite, weakness,
constipation;
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problems with vision or hearing;
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severe skin rash;
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easy bruising or bleeding, unusual weakness;
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fever, chills, sore throat, body aches, flu symptoms;
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urinating less than usual or not at all;
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swelling or numbness in your hands or feet; or
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nausea, loss of appetite, itching, dark urine, clay-colored
stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
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mild stomach pain, diarrhea, nausea or vomiting;
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fever;
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dizziness, anxiety, tired feeling;
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sleep problems (insomnia);
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mild skin rash, discolored skin; or
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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. You may report side effects to FDA at 1-800-FDA-1088.
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.
Stop using this medication 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 deferasirox, do not take antacids that contain aluminum, such as
Amphojel, Gaviscon, Maalox, Mi-Acid, Mylanta, Rulox, and others.
There are many other medicines that can interact with deferasirox.
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.
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.
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);
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an antibiotic such as clarithromycin (Biaxin), erythromycin
(E.E.S., Erythrocin, Ery-Tab), telithromycin (Ketek), and others;
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birth control pills;
-
a blood thinner such as warfarin (Coumadin);
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cholesterol-lowering drugs such as atorvastatin (Lipitor),
lovastatin (Mevacor), simvastatin (Zocor);
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heart or blood pressure medications such as amlodipine
(Norvasc, Lotrel), diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Adalat),
nisoldipine (Sular), or verapamil (Calan, Covera, Isoptin).
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heart rhythm medication such as quinidine (Quinaglute,
Quinidex, Quin-Release);
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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);
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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;
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a sedative such as alprazolam (Xanax), diazepam (Valium),
midazolam (Versed), or triazolam (Halcion); or
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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 deferasirox.
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.
What happens if I have an overdose of deferasirox?
