Generic Name: Deferasirox Brand Name(s): Deferasirox.

Uses

What is Deferasirox used for?

Deferasirox is commonly used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. It is also used to treat high levels of iron in people with a certain blood disorder who do not require blood transfusions (non-transfusion-dependent thalassemia). It works by binding to iron, allowing the body to pass extra iron out in the stool. Deferasirox belongs to a class of drugs known as iron-chelating agents.

Frequent blood transfusions are often needed in certain types of blood diseases (such as sickle cell disease, anemia). Blood transfusions have very helpful benefits, but they can cause the body to hold on to too much iron. The extra iron can build up in the body and cause problems such as heart failure, liver disease, and diabetes. Getting rid of extra iron can decrease the risk of these diseases.

How should I take Deferasirox?

Take this medication by mouth on an empty stomach or with a light meal (such as a whole-wheat english muffin with jelly and nonfat milk) as directed by your doctor, usually once daily. Avoid taking this medication with a meal high in calories (greater than 250 calories) and fat since it may increase your risk of side effects. Ask your doctor or pharmacist for more details.

Take the tablets with water or other beverages. If you have trouble swallowing the tablets, you may crush the tablets and mix it with soft foods (such as applesauce, yogurt). Swallow all of the drug/food mixture right away. Do not prepare a supply in advance.

If you are using the sprinkle granules, sprinkle the dose on soft food (such as applesauce, yogurt) and take all of it right away.

Antacids that contain aluminum can bind with deferasirox which may affect how deferasirox works. Avoid taking this medication with antacids that contain aluminum.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

The dosage is based on your medical condition, weight, laboratory tests, and response to treatment. Your dosage may need to be lowered or your treatment may need to be stopped if you get certain side effects. Follow your doctor’s instructions carefully.

How do I store Deferasirox?

Deferasirox is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Deferasirox in the bathroom or the freezer. There may be different brands of Deferasirox that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Deferasirox down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Deferasirox?

Before taking deferasirox, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, low platelet counts, advanced cancer, certain bone marrow disorders involving damaged blood-forming cells (high-risk myelodysplastic syndromes).

This drug may make you dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially liver problems, stomach/intestinal bleeding, and ulcers.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Deferasirox during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this Deferasirox. This Deferasirox is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Deferasirox?

Nausea, vomiting, diarrhea, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: hearing loss, vision changes (such as blurred vision).

This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can worsen anemia, decrease your body’s ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following unlikely symptoms: unusual tiredness, pale skin, signs of infection (such as fever, chills, persistent sore throat), easy bruising/bleeding.

This drug may rarely cause serious stomach/intestinal problems (such as stomach/intestinal bleeding and ulcers). If you notice any of the following unlikely but serious side effects, stop taking deferasirox and consult your doctor or pharmacist right away: black/bloody stools, vomit that looks like coffee grounds, persistent stomach/abdominal pain.

Deferasirox may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing of eyes/skin, dark urine.

Deferasirox has rarely caused very serious (possibly fatal) kidney problems. Tell your doctor right away if you develop signs of kidney problems, such as: change in the amount of urine, frothy urine.

Deferasirox can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Deferasirox?

Some products that may interact with this drug include: other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, “blood thinners” such as dabigatran/warfarin).

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Deferasirox may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Deferasirox?

Deferasirox may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Deferasirox?

Deferasirox may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Deferasirox.

What is the dose of Deferasirox for an adult?

Usual Adult Dose for Iron Overload

Exjade(R):

Initial dose: 20 mg/kg, orally, once a day – calculate dose to the nearest whole tablet

Monitor serum ferritin monthly: Adjust dose every 3 to 6 months, by 5 to 10 mg/kg, based on serum ferritin trends

Maximum dose: 40 mg/kg

Jadenu(R):

Initial dose: 14 mg/kg, orally, once a day – calculate dose to the nearest whole tablet

Monitor serum ferritin monthly: Adjust dose every 3 to 6 months, by 3.5 to 7 mg/kg, based on serum ferritin trends

Maximum dose: 28 mg/kg

Comments:

-Only consider therapy when evidence of chronic transfusional overload exists (e.g. transfusion of at least 100 mL/kg packed red blood cells and a serum ferritin consistently greater than 1000 mcg/L).

-Prior to treatment, obtain serum ferritin level, baseline serum creatinine in duplicate and determine creatinine clearance, serum transaminases, bilirubin, and baseline auditory and ophthalmic examinations.

-Tailor dose to patient response and therapeutic goals.

Use: Transfusional iron overload

Usual Adult Dose for Thalassemia

Exjade(R):

Initial dose: 10 mg/kg, orally, once a day – calculate dose to the nearest whole tablet

-If baseline liver iron concentration (LIC) is over 15 Fe/g dw, consider increasing dose to 20 mg/kg/day after 4 weeks

Maximum dose: 20 mg/kg/day

After 6 months therapy:

-If LIC remains above 7 mg Fe/g dw: increase to 20 mg/kg/day

-If LIC is 3 to 7 mg Fe/g dw: Continue at no more than 10 mg/kg/day

Jadenu(R):

Initial dose: 10 mg/kg, orally, once a day – calculate dose to the nearest whole tablet

-If baseline liver iron concentration (LIC) is over 15 Fe/g dw, consider increasing dose to 14 mg/kg/day after 4 weeks

Maximum dose: 14 mg/kg

After 6 months therapy:

-If LIC remains above 7 mg Fe/g dw: increase to 14 mg/kd/day

-If LIC is 3 to 7 mg Fe/g dw: Continue at no more than 7 mg/kg/day

Exjade(R) and Jadenu(R):

Monitor serum ferritin monthly:

-Serum ferritin under 300 mcg/L: Interrupt treatment and determine if LIC has fallen to less than 3 mg Fe/g dw.

If LIC is less than 3 mg Fe/g dw: Interrupt treatment and continue to monitor LIC

-Restart treatment when LIC rises to 5 mg Fe/g dw or higher.

Comments:

-Only consider therapy for liver iron concentration (LIC) of at least 5 mg Fe/g dw and a serum ferritin over 300 mcg/L.

-Prior to treatment, obtain LIC by liver biopsy or other approved method, serum ferritin level, baseline serum creatinine in duplicate and determine creatinine clearance, serum transaminases, bilirubin, and baseline auditory and ophthalmic examinations.

-Monitor LIC every 6 months.

-Monitor blood counts, hepatic function, and renal function.

Use: Chronic iron overload in non-transfusion dependent thalassemia syndromes

Renal Dose Adjustments

Creatinine clearance 40 to 60 mL/min:

-Reduce starting dose by 50%, closely monitor serum creatinine and creatinine clearance.

-Reduce, interrupt, or discontinue based on increases in serum creatinine.

Creatinine clearance under 40 mL/min or serum creatinine more than twice the upper limit of normal: Contraindicated

Comments:

Closely monitor for efficacy and adverse reactions that may require dose titration.

Liver Dose Adjustments

Mild hepatic impairment (Child-Pugh A): No adjustment necessary.

Moderate hepatic impairment (Child-Pugh B): Reduce starting dose by 50%.

Severe hepatic impairment (Child-Pugh C): Avoid use

Comments:

Closely monitor for efficacy and adverse reactions that may require dose titration.

Dose Adjustments

Transfusional Iron Overload Dose Adjustments:

-Patients not adequately controlled at 30 mg/kg (e.g. serum ferritin persistently above 2500 mcg/L with no decreasing trend):

–Exjade(R): Doses up to 40 mg/kg may be considered.

–Jadenu(R): Doses up to 28 mg/kg may be considered.

-Serum ferritin falling consistently below 500 mcg/L: Consider temporary interruption of therapy

Transfusional Iron Overload – Serum Creatinine Increases:

-Reduce Exjade(R) dose by 10 mg/kg or Jadenu(R) dose by 7 mg/kg if:

–16 years and older: If serum creatinine increases 33% or more over baseline, repeat serum creatinine within 1 week; if still elevated 33% or more, reduce dose.

–2 to 15 years: Reduce dose if serum creatinine increases 33% or more over baseline, or is greater than the upper limit of normal.

-Discontinue therapy if serum creatinine is twice the upper limit of normal, or for creatinine clearance under 40 mL/min (all ages).

Thalassemia – Serum Creatinine Increases:

–16 years and older: If serum creatinine increases 33% or more over baseline, repeat serum creatinine within 1 week; if still elevated 33% or more, reduce dose by half if patient is on 10 to 20 mg/kg for Exjade(R) or 7 to 14 mg/kg for Jadenu(R); interrupt therapy if dose is 5 mg/kg for Exjade(R) or 3.5 mg/kg for Jadenu(R).

–10 to 15 years: Serum creatinine increases 33% or more over baseline, or is greater than the upper limit of normal: Reduce dose by 5 mg/kg for Exjade(R) or 3.5 mg/kg for Jadenu(R).

-Discontinue therapy if serum creatinine is twice the upper limit of normal, or for creatinine clearance under 40 mL/min (all ages).

Use with Concomitant Medications (Exjade(R) and Jadenu(R)):

UDP-glucuronosyltransferases (UGT) Inducers e.g. rifampin, phenytoin, phenobarbital, ritonavir)

OR

Bile Acid Sequestrants (e.g. cholestyramine, colesevelam, colestipol):

-Avoid concomitant use; these medications decrease exposure to deferasirox.

-If co-administration cannot be avoided, consider increasing the initial dose of deferasirox by 50%; monitor serum ferritin and clinical response for further dose modification.

Other Comments

Administration advice:

-Do not chew tablets or swallow them whole.

-Take once daily on an empty stomach (30 minutes before food), preferably at the same time each day.

-Completely disperse tablets by stirring in water, or orange or apple juice, until a fine suspension is obtained.

-Mix doses less than 1 gram in 3.5 ounces fluid.

-Mix doses 1 gram or greater in 7 ounces fluid.

-After swallowing the suspension, rinse any residue with a small amount of fluid and swallow.

-Do not take with aluminum containing antacids.

What is the dose of Deferasirox for a child?

Usual Pediatric Dose for Iron Overload

Exjade(R) – 2 years and older:

Initial dose: 20 mg/kg, orally, once a day – calculate dose to the nearest whole tablet

Monitor serum ferritin monthly: Adjust dose every 3 to 6 months, by 5 to 10 mg/kg, based on serum ferritin trends

Maximum dose: 40 mg/kg

Jadenu(R) – 2 years and older:

Initial dose: 14 mg/kg, orally, once a day – calculate dose to the nearest whole tablet

Monitor serum ferritin monthly: Adjust dose every 3 to 6 months, by 3.5 to 7 mg/kg, based on serum ferritin trends

Maximum dose: 28 mg/kg

Comments:

-Only consider therapy when evidence of chronic transfusional overload exists (e.g. transfusion of at least 100 mL/kg packed red blood cells and a serum ferritin consistently greater than 1000 mcg/L).

-Prior to treatment, obtain serum ferritin level, baseline serum creatinine in duplicate and determine creatinine clearance, serum transaminases, bilirubin, and baseline auditory and ophthalmic examinations.

-Tailor dose to patient response and therapeutic goals.

Use: Transfusional iron overload

Usual Pediatric Dose for Thalassemia

Exjade(R):

10 years and older:

Initial dose: 10 mg/kg, orally, once a day – calculate dose to the nearest whole tablet

-If baseline liver iron concentration (LIC) is over 15 Fe/g dw, consider increasing dose to 20 mg/kg/day after 4 weeks

Maximum dose: 20 mg/kg/day

After 6 months therapy:

-If LIC remains above 7 mg Fe/g dw: increase to 20 mg/kg/day

-If LIC is 3 to 7 mg Fe/g dw: Continue at no more than 10 mg/kg/day

Jadenu(R):

10 years and older:

Initial dose: 10 mg/kg, orally, once a day – calculate dose to the nearest whole tablet

-If baseline liver iron concentration (LIC) is over 15 Fe/g dw, consider increasing dose to 14 mg/kg/day after 4 weeks

Maximum dose: 14 mg/kg

After 6 months therapy:

-If LIC remains above 7 mg Fe/g dw: increase to 14 mg/kg/day

-If LIC is 3 to 7 mg Fe/g dw: Continue at no more than 7 mg/kg/day

Exjade(R) and Jadenu(R):

Monitor serum ferritin monthly:

-Serum ferritin under 300 mcg/L: Interrupt treatment and determine if LIC has fallen to less than 3 mg Fe/g dw.

If LIC is less than 3 mg Fe/g dw: Interrupt treatment and continue to monitor LIC

-Restart treatment when LIC rises to 5 mg Fe/g dw or higher.

Comments:

-Only consider therapy for liver iron concentration (LIC) of at least 5 mg Fe/g dw and a serum ferritin over 300 mcg/L.

-Prior to treatment, obtain LIC by liver biopsy or other approved method, serum ferritin level, baseline serum creatinine in duplicate and determine creatinine clearance, serum transaminases, bilirubin, and baseline auditory and ophthalmic examinations.

-Monitor LIC every 6 months.

-Monitor blood counts, hepatic function, and renal function.

Use: Chronic iron overload in non-transfusion dependent thalassemia syndromes

How is Deferasirox available?

Deferasirox is available in the following dosage forms and strengths:

  • Tablet

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a 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 take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: January 19, 2018 | Last Modified: January 19, 2018

Want to live your best life?
Get the Hello Doktor Daily newsletter for health tips, wellness updates and more.