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Deferasirox (Oral route)

Pronunciation:

dee-FER-a-sir-ox

Brand Names:

  • Exjade

Dosage Forms:

  • Tablet for Suspension

Warnings:

Oral route(Tablet for Suspension)

May cause renal impairment (including failure), hepatic impairment (including failure), and gastrointestinal hemorrhage. In some reported cases, these reactions were fatal. Therapy requires close patient monitoring, including laboratory tests of renal and hepatic function .

Classifications:

Therapeutic—

Heavy Metal Chelator

Uses of This Medicine:

Deferasirox is used to remove excess iron from the body after a person has had too many blood transfusions. It is also used to remove excess iron from the body in patients with non-transfusion dependent thalassemia syndromes.

Deferasirox combines with iron in the blood. The combination of iron and deferasirox is then removed from the body by the kidneys. If you have too much iron in the body, it can damage various organs and tissues.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of deferasirox in children. Safety and efficacy have not been established in children with transfusional iron overload who are younger than 2 years of age, or in children with chronic iron overload and non-transfusional-dependent thalassemia who are younger than 10 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of deferasirox in the elderly. However, elderly patients are more likely to have unwanted effects and age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving deferasirox.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amiodarone
  • Chloroquine
  • Clozapine
  • Duloxetine
  • Enzalutamide
  • Ondansetron
  • Paclitaxel
  • Pimozide
  • Propafenone
  • Theophylline
  • Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cholestyramine
  • Midazolam
  • Repaglinide
  • Rifampin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood or bone marrow disorders (e.g., agranulocytosis, anemia, neutropenia) or
  • Eye problems (e.g., cataracts, glaucoma) or
  • Hearing problems or
  • Kidney disease (e.g., Fanconi's syndrome) or
  • Stomach ulcers or bleeding problems—Use with caution. May make these conditions worse.
  • Bone marrow problems (e.g., myelodysplastic syndrome) or
  • Cancer, advanced or
  • Kidney disease, severe or
  • Liver disease, severe or
  • Thrombocytopenia (low platelet count in the blood)—Should not be used in patients with these conditions.
  • Liver disease (e.g., hepatitis)—You may need a lower dose of this medicine.

Proper Use of This Medicine:

It is best to take this medicine at the same time each day on an empty stomach, at least 30 minutes before you eat.

Dissolve the tablet in water, orange juice, or apple juice, mix well, then drink the mixture right away. To make sure you get all of the medicine, add some more liquid to the drinking glass, then drink all of this liquid too. Do not chew or swallow the tablet whole, and do not use it without mixing it in a liquid first.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablet for suspension):
    • For chronic iron overload after blood transfusions:
      • Adults and children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 20 milligrams (mg) per kilogram (kg) of body weight per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per kg per day.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    • For chronic iron overload in non-transfusion dependent thalassemia syndrome:
      • Adults and children 10 years of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 10 milligrams (mg) per kilogram (kg) of body weight per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 20 mg per kg per day.
      • Children younger than 10 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Deferasirox may cause some people to have hearing and vision problems within a few weeks after they start taking it. If you or your child notice any problems with your hearing or vision, such as blurred vision, difficulty with night vision, or difficulty with seeing colors, check with your doctor as soon as possible.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Deferasirox will lower the number of some types of blood cells in your body. Because of this, you or your child may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Check with your doctor right away if you or your child have agitation, confusion, decreased urine output, lethargy, muscle twitching, rapid weight gain, seizures, or swelling of the face, ankles, or hands. These may be symptoms of a serious kidney problem.

Check with your doctor right away if you have upper stomach pain, pale stools, dark urine, loss of appetite, nausea, unusual tiredness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor right away if you or your child have abdominal or stomach pain, cramping, or burning, black, tarry stools, constipation, diarrhea, heartburn, indigestion, nausea, or vomiting of blood or material that looks like coffee grounds. These may be symptoms of a serious stomach or bowel problem.

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, sores or ulcers on the skin, or fever or chills while you or your child are using this medicine.

If you or your child have diarrhea or vomiting, drink plenty of water or fluids to keep your body hydrated.

This medicine may cause some people to become dizzy. Do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Do not take this medicine with aluminum-containing antacids (Maalox®, Mylanta®).

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Abdominal pain
diarrhea
dizziness
earache or pain in the ear
nausea
voice changes
vomiting
Rare
Blindness
blurred vision
change in hearing
change in vision
pain or discomfort in the eye
Incidence not known
Black, tarry stools
bleeding gums
blood in the urine or stools
dark-colored urine
decrease in urine amount
general feeling of tiredness or weakness
hives or welts
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
lethargy
light-colored stools
lower back or side pain
pale skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
redness, soreness or itching of the skin
skin rash
sores, welting, or blisters
stomach pain, continuing
unusual bleeding or bruising
vomiting of blood or material that looks like coffee grounds
yellow eyes or skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 11/4/2014

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