Deferasirox Oral Granules 360 mg/1
deferasirox · GRANULE · EPIC PHARMA, LLC
Deferasirox oral granules are a prescription medication that removes excess iron from your body in patients with iron overload conditions. This iron chelator works by binding to iron so your body can eliminate it through bowel movements.
Key Facts
- Brand Name
- Deferasirox Oral Granules
- Generic Name
- deferasirox
- NDC Code (Product)
42806-373- Manufacturer
- EPIC PHARMA, LLC
- Strength
- 360 mg/1
- Dosage Form
- GRANULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA214559
- Drug Class
- Iron Chelator [EPC]
- Marketing Start
- 10/06/2022
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 Deferasirox oral granules 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 ) Deferasirox oral granules 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 (Fe/g dw) and a serum ferritin greater than 300 mcg/L. ( 1.2 ) Limitations of Use : The safety and efficacy of deferasirox oral granules 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) Deferasirox oral granules 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 Deferasirox oral granules is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-depende…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Transfusional Iron Overload: Initial dose for patients with estimated glomerular filtration rate (e GFR) greater than 60 mL/min/1.73 m 2 is 14 mg per kg (calculated to nearest whole sachet content for granules) once daily. ( 2.1 ) NTDT Syndromes: Initial dose for patients with eGFR greater than 60 mL/min/1.73 m 2 is 7 mg per kg (calculated to nearest whole sachet content for granules) once daily. ( 2.2 ) See full prescribing information for information regarding monitoring, administration, and dose-reductions for organ impairment. ( 2.1 , 2.2 , 2.3 , 2.4 ) 2.1 Transfusional Iron Overload Deferasirox oral granules 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) C…
Contraindications
4 CONTRAINDICATIONS Deferasirox oral granules are 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 deferasirox oral granules [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 deferasirox oral granules. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Do not take deferasirox oral granules with aluminum-containing antacid preparations. ( 7.1 ) Deferasirox increases the exposure of repaglinide. Consider repaglinide dose reduction and monitor blood glucose levels. ( 7.3 ) Avoid the use of deferasirox oral granules with theophylline as theophylline levels could be increased. ( 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 deferasirox oral granules and aluminum-containing antacid preparations has not been formally studied. Although deferasirox has a lower affinity for aluminum than for iron, do not take deferasirox oral granules with aluminum-containing antacid preparations. 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, bus…
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 deferasirox-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 Epic Pharma, LLC at 1-888-374-2791 or FDA at 1-800-FDA-1088 or www…
Frequently Asked Questions
What is Deferasirox Oral Granules used for?
Deferasirox oral granules are a prescription medication that removes excess iron from your body in patients with iron overload conditions. This iron chelator works by binding to iron so your body can eliminate it through bowel movements.
Is Deferasirox Oral Granules a controlled substance?
Deferasirox Oral Granules is not classified as a controlled substance by the DEA.
What is the generic name for Deferasirox Oral Granules?
The generic name for Deferasirox Oral Granules is deferasirox. There are 11 other brand versions of deferasirox.
What is the NDC code for Deferasirox Oral Granules 360 mg/1?
The NDC (National Drug Code) for Deferasirox Oral Granules 360 mg/1 is 42806-373, listed by EPIC PHARMA, LLC.