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Exjade

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Exjade

EXJADE®
(deferasirox) Tablets for Oral Suspension

Exjade

WARNING

RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL HEMORRHAGE

Renal Failure

  • Exjade can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders.
  • Measure serum creatinine and determine creatinine clearance in duplicate prior to initiation of therapy and monitor renal function at least monthly thereafter. For patients with baseline renal impairment or increased risk of acute renal failure, monitor creatinine weekly for the first month, then at least monthly. Consider dose reduction, interruption, or discontinuation based on increases in serum creatinine [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].

Hepatic Failure

  • Exjade 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 Exjade in patients with severe (Child-Pugh C) hepatic impairment and reduce the dose in patients with moderate (Child Pugh B) hepatic impairment [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].

Gastrointestinal Hemorrhage

  • Exjade 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 Exjade for suspected GI ulceration or hemorrhage [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

Exjade (deferasirox) is an iron chelating agent. Exjade tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1yl]-benzoic acid and its structural formula is:

EXJADE® (deferasirox)  Structural Formula Illustration

Deferasirox is a white to slightly yellow powder. Its molecular formula is C21H15N3O4 and its molecular weight is 373.4.

Inactive Ingredients: Lactose monohydrate (NF), crospovidone (NF), povidone (K30) (NF), sodium lauryl sulphate (NF), microcrystalline cellulose (NF), silicon dioxide (NF), and magnesium stearate (NF).

What are the possible side effects of deferasirox (Exjade)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using deferasirox and call your doctor at once if you have a serious side effect such as:

  • kidney problems - drowsiness, confusion, mood changes, swelling, rapid weight gain, feeling short of breath, urinating less than usual or not at all;
  • liver problems - nausea, upper stomach pain, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • stomach bleeding - bloody...

Read All Potential Side Effects and See Pictures of Exjade »

What are the precautions when taking deferasirox (Exjade)?

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 problems, liver problems, low platelet counts.

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

If you have diarrhea or vomiting, drink plenty of fluids to replace lost body water and minerals. Ask your doctor or pharmacist for more details.

Kidney function...

Read All Potential Precautions of Exjade »

Last reviewed on RxList: 10/31/2013
This monograph has been modified to include the generic and brand name in many instances.

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Exjade - User Reviews

Exjade User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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