May 28, 2017
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Exjade

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Exjade

EXJADE®
(deferasirox) Tablets for Oral Suspension




WARNING

RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL HEMORRHAGE

Renal Failure

  • Exjade can caus e acute renal failure and death, particularly in patients with comorbidities and thos e who are in the advanced s tages of their hematologic disorders .
  • Measureserum creatinine and determine creatinine clearance in duplicate prior to initiation of therapy and monitor renal function at leas t monthly thereafter. For patients with bas eline renal impairment or increas ed ris k of acute renal failure, monitor creatinine weekly for the firs t month, then at leas t monthly. Cons ider dos e reduction, interruption, or dis continuation bas ed on increas es in s erum creatinine [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].

Hepatic Failure

  • Exjade can caus e hepatic injury including hepatic failure and death.
  • Measureserum trans aminas es and bilirubin in all patients prior to initiating treatment, every 2 weeks during the firs t month, and at leas t monthly thereafter.
  • Avoid us e of Exjade in patients with s evere (Child-Pugh C) hepatic impairment and reduce the dos e in patients with moderate (Child Pugh B) hepatic impairment [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].

Gastrointestinal Hemorrhage

  • Exjade can caus e gas trointes tinal (GI) hemorrhages , which may be fatal, es pecially in elderly patients who have advanced hematologic malignancies and/or low platelet counts.
  • Monitor patients and dis continue Exjade for s us pected 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-1-yl]-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 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...

Read All Potential Precautions of Exjade »

Last reviewed on RxList: 5/1/2017
This monograph has been modified to include the generic and brand name in many instances.

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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