Exjade 125 mg/1
deferasirox · TABLET, FOR SUSPENSION · Novartis Pharmaceuticals Corporation
Exjade (deferasirox) is an oral iron chelator tablet used to treat chronic iron overload in patients who receive frequent blood transfusions or have certain blood disorders. It works by binding to excess iron in the body so it can be removed through the bowels.
Key Facts
- Brand Name
- Exjade
- Generic Name
- deferasirox
- NDC Code (Product)
0078-0468- Manufacturer
- Novartis Pharmaceuticals Corporation
- Strength
- 125 mg/1
- Dosage Form
- TABLET, FOR SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- NDA021882
- Drug Class
- Iron Chelator [EPC]
- Marketing Start
- 11/30/2005
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Exjade is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. ( 1.1 ) Exjade is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. ( 1.2 ) Limitations of Use: The safety and efficacy of Exjade when administered with other iron chelation therapy have not been established. ( 1.3 ) 1.1 Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) Exjade is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. 1.2 Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes Exjade is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Transfusional Iron Overload: Initial dose for patients with estimated glomerular filtration rate (eGFR) greater than 60 mL/min/1.73 m 2 is 20 mg per kg body weight once daily, as oral suspension. Calculate dose to the nearest whole tablet. ( 2.1 ) NTDT Syndromes: Initial dose for patients with eGFR greater than 60 mL/min/1.73 m 2 is 10 mg per kg body weight once daily, as oral suspension. Calculate dose to the nearest whole tablet. ( 2.2 ) 2.1 Transfusional Iron Overload Exjade therapy should only be considered when a patient has evidence of chronic transfusional iron overload. The evidence should include the transfusion of at least 100 mL/kg of packed red blood cells (e.g., at least 20 units of packed red blood cells for a 40 kg person or more in individuals weighing more than 40 kg), and a serum ferritin consistently greater than 1,000 mcg/L. Prior to starting therapy or increasing dose, evaluate: Serum ferritin level Baseline renal function: Obtain serum creatinine in duplicate (due to variations in measurements) to establish accurate baseline Calculate the estimated glomerular filtration rate (eGFR). Use a prediction equation appropriate for adult pa…
Contraindications
4 CONTRAINDICATIONS Exjade is contraindicated in patients with: Estimated GFR less than 40 mL/min/1.73 m 2 [see Dosage and Administration (2.5), Warnings and Precautions (5.1)] ; Poor performance status; [see Warnings and Precautions (5.1, 5.3)] High-risk myelodysplastic syndromes; (this patient population was not studied and is not expected to benefit from chelation therapy) Advanced malignancies. [see Warnings and Precautions (5.1, 5.3)] Platelet counts less than 50 x 10 9 /L [see Warnings and Precautions (5.3, 5.4) Known hypersensitivity to deferasirox or any component of Exjade [see Warnings and Precautions (5.7), Adverse Reactions (6.2)] . Estimated GFR less than 40 mL/min/1.73 m 2 . ( 4 ) Patients with poor performance status. ( 4 ) Patients with high-risk myelodysplastic syndrome (MDS). ( 4 ) Patients with advanced malignancies. ( 4 ) Patients with platelet counts less than 50 x 10 9 /L. ( 4 ) Known hypersensitivity to deferasirox or any component of Exjade. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Do not take Exjade with aluminum-containing antacid preparations. ( 7.1 ) Exjade increases the exposure of the CYP2C8 substrate repaglinide. Consider repaglinide dose reduction and monitor blood glucose levels. ( 7.3 ) Avoid the use of Exjade with CYP1A2 substrate theophylline. ( 7.4 ) Deferasirox increases exposure of busulfan. Monitor plasma concentrations of busulfan when coadministered with deferasirox to allow dose adjustment of busulfan as needed. ( 7.7 ) 7.1 Aluminum-Containing Antacid Preparations The concomitant administration of Exjade and aluminum-containing antacid preparations has not been formally studied. Although deferasirox has a lower affinity for aluminum than for iron, do not take Exjade with aluminum-containing antacid preparations due to the mechanism of action of Exjade. 7.2 Agents Metabolized by CYP3A4 Deferasirox may induce CYP3A4 resulting in a decrease in CYP3A4 substrate concentration when these drugs are coadministered. Closely monitor patients for signs of reduced effectiveness when deferasirox is administered with drugs metabolized by CYP3A4 (e.g., alfentanil, aprepitant, budesonide, buspirone, conivaptan, cyclosporine, darifenacin…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are also discussed in other sections of the labeling: Acute Kidney Injury, Including Acute Renal Failure Requiring Dialysis, and Renal Tubular Toxicity Including Fanconi Syndrome [see Warnings and Precautions (5.1, 5.6)] Hepatic Toxicity and Failure [see Warnings and Precautions (5.2, 5.6)] GI Hemorrhage [see Warnings and Precautions (5.3)] Bone Marrow Suppression [see Warnings and Precautions (5.4)] Hypersensitivity [see Warnings and Precautions (5.7)] Severe Skin Reactions [see Warnings and Precautions (5.8)] Skin Rash [see Warnings and Precautions (5.9)] Auditory and Ocular Abnormalities [see Warnings and Precautions (5.10)] In patients with transfusional iron overload, the most frequently occurring (greater than 5%) adverse reactions are diarrhea, vomiting, nausea, abdominal pain, skin rashes, and increases in serum creatinine. In Exjade-treated patients with NTDT syndromes, the most frequently occurring (greater than 5%) adverse reactions are diarrhea, rash, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 …
Frequently Asked Questions
What is Exjade used for?
Exjade (deferasirox) is an oral iron chelator tablet used to treat chronic iron overload in patients who receive frequent blood transfusions or have certain blood disorders. It works by binding to excess iron in the body so it can be removed through the bowels.
Is Exjade a controlled substance?
Exjade is not classified as a controlled substance by the DEA.
What is the generic name for Exjade?
The generic name for Exjade is deferasirox. There are 11 other brand versions of deferasirox.
What is the NDC code for Exjade 125 mg/1?
The NDC (National Drug Code) for Exjade 125 mg/1 is 0078-0468, listed by Novartis Pharmaceuticals Corporation.