Pronunciation:

dee-FER-a-sir-ox

Brand Names:

• Exjade
• Jadenu
• Jadenu Sprinkle

Dosage Forms:

• Tablet for Suspension
• Granule
• Tablet

Warnings:

Renal Failure:Deferasirox can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders.Evaluate baseline renal function prior to starting or increasing deferasirox dosing in all patients. Deferasirox is contraindicated in adult and pediatric patients with estimated GFR less than 40 mL/min/1.73 m(2). Measure serum creatinine in duplicate prior to initiation of therapy. Monitor renal function at least monthly. For patients with baseline renal impairment or increased risk of acute renal failure, monitor renal function weekly for the first month, then at least monthly. Reduce the starting dose in patients with pre-existing renal disease. During therapy, increase the frequency of monitoring and modify the dose for patients with an increased risk of renal impairment, including use of concomitant nephrotoxic drugs, and pediatric patients with volume depletion or overchelation.Hepatic Failure:Deferasirox can cause hepatic injury including hepatic failure and death Measure serum transaminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter.Avoid use of deferasirox in patients with severe (Child-Pugh C) hepatic impairment and reduce the dose in patients with moderate (Child Pugh B) hepatic impairment.Gastrointestinal Hemorrhage:Deferasirox can cause gastrointestinal (GI) hemorrhages, which may be fatal, especially in elderly patients who have advanced hematologic malignancies and/or low platelet counts.Monitor patients and discontinue deferasirox for suspected GI ulceration or hemorrhage ..

Classifications:

Therapeutic—

Heavy Metal Chelator

Uses of This Medicine:

Deferasirox is used to remove excess iron from the body in patients who have had too many blood transfusions and in patients with non-transfusion dependent thalassemia syndromes.

Deferasirox is an iron chelator (binder). It 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness 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.

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.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Oxide
• Aluminum Phosphate
• Amiodarone
• Busulfan
• Cholestyramine
• Colesevelam
• Colestipol
• Daprodustat
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Duloxetine
• Enzalutamide
• Exagamglogene Autotemcel
• Fosphenytoin
• Levoketoconazole
• Lovotibeglogene Autotemcel
• Methotrexate
• Pexidartinib
• Phenobarbital
• Phenytoin
• Rifampin
• Ritonavir
• Selexipag
• Theophylline
• Tizanidine
• Tucatinib
• 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.

• Repaglinide

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 (eg, agranulocytosis, anemia, neutropenia) or
• Eye problems (eg, cataracts, glaucoma) or
• Hearing problems or
• Kidney disease (eg, Fanconi's syndrome) or
• Stomach problems (eg, ulcers or bleeding, perforation)—Use with caution. May make these conditions worse.

• Bone marrow problems (eg, 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 (eg, hepatitis), moderate—You may need a lower dose of this medicine.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Swallow tablets whole with water or other liquids.

If you have trouble swallowing the whole tablet, it may be crushed and mixed with soft foods (eg, apple sauce or yogurt) immediately before taking it orally.

Sprinkle the granules on soft food (eg, applesauce or yogurt) immediately before taking it orally.

It is best to take the tablet and granules at the same time each day on an empty stomach or with a light meal.

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

Dissolve the tablet for suspension 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 chronic iron overload after blood transfusions:
  • For oral dosage forms (granules, tablets):
    • 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 14 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 28 mg per kg per day.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (tablet for suspension):
    • 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:
  • For oral dosage forms (granules, tablets):
    • 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 7 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 14 mg per kg per day.
    • Children younger than 10 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (tablet for suspension):
    • 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—

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.

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

Keep the bottle closed tightly and away from moisture.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor right away if you or your child have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, troubled breathing, unusual tiredness or weakness, vomiting, or weight gain. These may be symptoms of a serious kidney problem.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, 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.

Deferasirox will lower the number of some types of blood cells in your body. Because of this, you 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.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require 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.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or red skin rash, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

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

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

This medicine may make you dizzy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Birth control pills may not work while you are using this medicine. To keep from getting pregnant, use another form of birth control such as condoms, diaphragms, or contraceptive foams or jellies.

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

Diarrhea

dizziness

earache or pain in the ear

nausea

stomach pain

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 urine

decrease in the amount of urine

general feeling of tiredness or weakness

hives, welts, skin rash

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

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, itching of the skin

sores, blisters

stomach pain, continuing

unusual bleeding or bruising

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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.