Exjade®
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HIGHLIGHTS OF PRESCRIBING INFORMATION |
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These highlights do not include all the information needed to use EXJADE safely and effectively. See full prescribing information for EXJADE. |
EXJADE (deferasirox) tablet, orally disintegrating for oral use
Initial U.S. Approval: 2005
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RECENT MAJOR CHANGES
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Warnings and Precautions, Hepatic Dysfunction and Failure (5.3) 12/2007
Warnings and Precautions, Gastrointestinal (5.6) 10/2008
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INDICATIONS AND USAGE
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Exjade is an iron chelating agent indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1)
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DOSAGE AND ADMINISTRATION
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Recommended initial daily dose is 20 mg/kg body weight, taken on an empty stomach at least 30 minutes before food. (2.1)
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Calculate dose to the nearest whole tablet. (2.1)
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Do not chew or swallow the tablets whole. (2.1)
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Disperse the tablets by stirring in an appropriate amount of water, orange juice, or apple juice. (2.1)
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DOSAGE FORMS AND STRENGTHS
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Tablets for oral suspension: 125 mg, 250 mg, 500 mg. (3)
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CONTRAINDICATIONS
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None. (4)
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WARNINGS AND PRECAUTIONS
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Cases of acute renal failure, some with a fatal outcome, have been reported in the postmarketing use of Exjade. Assess serum creatinine at baseline. Monitor serum creatinine and urine protein monthly. (5.1)
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There have been postmarketing reports of cytopenias in patients treated with Exjade. Some of these patients died. Monitor blood counts regularly. (5.2)
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There have been postmarketing reports of hepatic failure, some with a fatal outcome, in patients treated with Exjade. Monitor liver function tests monthly. (5.3)
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Serious hypersensitivity reactions have been reported. If reactions are severe, discontinue Exjade and institute appropriate medical intervention. (5.4)
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Conduct auditory testing and ophthalmic testing before starting treatment with Exjade and thereafter every 12 months. (5.5)
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Gastrointestinal irritation (ulcer, bleeding) may occur during Exjade treatment. Use caution in patients who are taking Exjade in combination with drugs that have known ulcerogenic or hemorrhagic potential, such as NSAIDs, corticosteroids, oral bisphosphonates, or anticoagulants. (5.6)
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ADVERSE REACTIONS
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The most frequently occurring adverse reactions are diarrhea, vomiting, nausea, abdominal pain, skin rashes, and increases in serum creatinine. (6.1)
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To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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DRUG INTERACTIONS
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Do not take Exjade with aluminum-containing antacid preparations. (7)
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Use caution when Exjade is administered with drugs metabolized by CYP3A4. (7)
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USE IN SPECIFIC POPULATIONS
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Use Exjade with caution in elderly patients due to the greater frequency of decreased hepatic, renal, or cardiac function. (8.5)
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See 17 for PATIENT COUNSELING INFORMATION |
Revised: 11/2008 |
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FULL PRESCRIBING INFORMATION: CONTENTS* |
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Exjade (deferasirox) is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
The recommended initial daily dose of Exjade is 20 mg/kg body weight.
Take Exjade once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day. Do not chew tablets or swallow them whole. Do not take Exjade with aluminum-containing antacid products. Calculate doses (mg/kg per day) to the nearest whole tablet. Completely disperse tablets by stirring in water, orange juice, or apple juice until a fine suspension is obtained. Disperse doses of <1 g in 3.5 ounces of liquid and doses of ≥1 g in 7.0 ounces of liquid. After swallowing the suspension, resuspend any residue in a small volume of liquid and swallow.
Individualize the decision to remove accumulated iron based on anticipated clinical benefit and risks of Exjade therapy. In patients who are in need of iron chelation therapy, it is recommended that therapy with Exjade (deferasirox) be started when a patient has evidence of chronic iron overload, such as the transfusion of approximately 100 mL/kg of packed red blood cells (approximately 20 units for a 40-kg patient) and a serum ferritin consistently >1000 mcg/L.
2.2 Dose Modifications
After commencing initial therapy, monitor serum ferritin every month and adjust the dose of Exjade if necessary every 3-6 months based on serum ferritin trends. Make dose adjustments in steps of 5 or 10 mg/kg and tailor adjustments to the individual patient’s response and therapeutic goals (maintenance or reduction of body iron burden). If the serum ferritin falls consistently below 500 mcg/L, consider temporarily interrupting therapy with Exjade. Do not exceed Exjade doses of 30 mg/kg per day since there is limited experience with doses above this level.
The risk of toxicity of Exjade may be increased when inappropriately high doses are given in patients with low iron burden or with serum ferritin levels that are only slightly elevated. The safety and efficacy of Exjade when administered with other iron chelation therapy have not been established.
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