"The US Food and Drug Administration (FDA) has approved Bayer AG's unmodified, full-length recombinant antihemophilic factor VIII product, Kovaltry, for the treatment of hemophilia A in children and adults, the company said.
(deferasirox) Tablets for Oral Suspension
RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL HEMORRHAGE
- 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].
- 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].
- 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].
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:
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...
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.
Last reviewed on RxList: 8/21/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Exjade Information
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