deferasirox

dee-FER-a-sir-ox

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. These reactions were more frequently observed in patients with advanced age, high risk myelodysplastic syndromes (MDS), underlying renal or hepatic impairment or low platelet counts (less than 50 x 10(9)/L). Therapy requires close patient monitoring, including laboratory tests of renal and hepatic function .

Commonly used brand name(s)

In the U.S.

• Exjade

Available Dosage Forms:

• Tablet for Suspension

Therapeutic Class: Heavy Metal Chelator

Uses For deferasirox

Deferasirox is used to remove excess iron from the body after a person has had too many blood transfusions.

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.

deferasirox is available only with your doctor's prescription.

Before Using deferasirox

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 deferasirox, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to deferasirox 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of deferasirox in children up to 2 years of age. Safety and efficacy have not been established.

Geriatric

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 age-related liver, kidney, or heart problems, which may require caution in patients receiving deferasirox.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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.

Interactions with 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 deferasirox, 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 deferasirox 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.

• Paclitaxel


• Theophylline

Using deferasirox 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

Interactions with Food/Tobacco/Alcohol

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 deferasirox. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow disorders (e.g., agranulocytosis, neutropenia) or


• Eye problems (e.g., cataracts, glaucoma) or


• Hearing problems or


• Kidney disease or


• Stomach ulcers or bleeding problems—Use with caution. May make these conditions worse.

• Bone marrow problems (e.g., myelodysplastic syndrome) or


• Cancer 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 deferasirox.

Proper Use of deferasirox

It is best to take deferasirox 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 deferasirox 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 deferasirox. 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:
    
    • Adults and children over 2 years of age—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 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.
    
    
  
  

Missed Dose

If you miss a dose of deferasirox, 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 deferasirox

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.

deferasirox 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 deferasirox.

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.

Stop using deferasirox and check with your doctor right away if you or your child have the following symptoms: 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.

Liver problems may occur while you are using deferasirox. Stop using deferasirox and check with your doctor right away if you or your child are having more than one of these symptoms: abdominal or stomach pain or tenderness; clay-colored stools; dark urine; fever; nausea and vomiting; skin rash; or yellow eyes or skin.

Check with your doctor right away if you or your child have these symptoms: 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 deferasirox. Stop using deferasirox 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 deferasirox.

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

deferasirox may cause some people to become dizzy. Do not drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

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 deferasirox with aluminum-containing antacids (Mylanta®, Maalox®).

deferasirox Side Effects

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

• Body aches or pain


• chills


• congestion


• cough or cough producing mucus


• diarrhea


• difficulty with breathing


• difficulty with moving


• dryness or soreness of the throat


• earache or pain in the ear


• ear drainage


• fever with or without chills


• general feeling of discomfort or illness


• headache


• hoarseness


• joint pain


• loss of appetite


• muscle aches and pains


• nausea


• shivering


• shortness of breath


• stuffy or runny nose


• tender, swollen glands in the neck


• tightness in the chest


• trouble with sleeping


• trouble with swallowing


• unusual tiredness or weakness


• voice changes


• vomiting


• wheezing

Rare

• Blindness


• blurred vision


• change in hearing


• change in vision


• decreased hearing


• decreased vision


• high-frequency hearing loss


• loss of vision


• pain or discomfort in the eye


• white area over the eye

Incidence not known

• Agitation


• black, tarry stools


• bleeding gums


• blood in the urine or stools


• confusion


• decrease in urine amount


• depression


• difficulty with swallowing


• dizziness


• fast heartbeat


• hives or welts


• hostility


• irritability


• itching


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• lethargy


• lower back or side pain


• muscle twitching


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rapid weight gain


• redness, soreness or itching of the skin


• seizures


• skin rash


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• sores, welting, or blisters


• stupor


• swelling of face, ankles, or hands


• unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain


• back pain


• muscle stiffness

Incidence not known

• Hair loss or thinning of the hair

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.

See also: deferasirox side effects (in more detail)

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More deferasirox resources

• Deferasirox Side Effects (in more detail)
• Deferasirox Use in Pregnancy & Breastfeeding
• Deferasirox Drug Interactions
• Deferasirox Support Group
• 0 Reviews for Deferasirox - Add your own review/rating

• Deferasirox Professional Patient Advice (Wolters Kluwer)


• Deferasirox Monograph (AHFS DI)


• Deferasirox MedFacts Consumer Leaflet (Wolters Kluwer)


• Exjade Prescribing Information (FDA)


• Exjade Consumer Overview

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