DEFERIPRONE 1000 mg/1
deferiprone · TABLET, COATED · DR. REDDY'S LABORATORIES, INC.
DEFERIPRONE is a tablet, coated containing deferiprone at 1000 mg/1, taken oral. Manufactured by DR. REDDY'S LABORATORIES, INC..
Key Facts
- Brand Name
- DEFERIPRONE
- Generic Name
- deferiprone
- NDC Code (Product)
75907-348- Manufacturer
- DR. REDDY'S LABORATORIES, INC.
- Strength
- 1000 mg/1
- Dosage Form
- TABLET, COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA220132
- Drug Class
- Iron Chelator [EPC]
- Marketing Start
- 12/15/2025
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. Deferiprone tablets are an iron chelator indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. ( 1 ) Limitations of Use Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia. Limitations of Use Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia. Pediatric use information is approved for Chiesi USA, Inc.'s FERRIPROX ® (deferiprone) tablets. However, due to Chiesi USA, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Deferiprone tablets are available in two formulations. A 1,000 mg formulation and a 500 mg formulation, which have different dosing regimens to achieve the same total daily dosage. ( 2.1 ) To prevent medication errors, before prescribing and dispensing, ensure that the tablet formulation is appropriate for the dosing regimen. Each tablet has distinct identifying characteristics. ( 2.1 , 3 ) Deferiprone tablets (three times a day), 1,000 mg: Starting oral dosage: 75 mg/kg/day (actual body weight) in three divided doses ( 2.3 ) Maximum oral dosage: 99 mg/kg/day (actual body weight) in three divided doses ( 2.3 ) Deferiprone tablets (three times a day), 500 mg: Starting oral dosage: 75 mg/kg/day (actual body weight) in three divided doses ( 2.4 ) Maximum oral dosage: 99 mg/kg/day (actual body weight) in three divided doses ( 2.4 ) 2.1 Important Dosage and Administration Information Deferiprone tablets are available in a 1,000 mg formulation and a 500 mg formulation, which have different oral dosing regimens to achieve the same total daily dosage. Deferiprone tablets (three times a day) - 1,000 mg - given three times a day [see Dosage and Administration (2.3…
Contraindications
4 CONTRAINDICATIONS Deferiprone is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations. The following reactions have been reported in association with the administration of deferiprone: Henoch-Schönlein purpura; urticaria; and periorbital edema with skin rash [see Adverse Reactions (6.2) ]. Hypersensitivity to deferiprone or to any of the excipients in the formulations. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Drugs Associated with Neutropenia or Agranulocytosis: Avoid co-administration. If co-administration is unavoidable, closely monitor the absolute neutrophil count. ( 7.1 ) UGT1A6 Inhibitors: Avoid co-administration. ( 7.2 ) Polyvalent Cations: Allow at least a 4-hour interval between administration of deferiprone and drugs or supplements containing polyvalent cations (e.g., iron, aluminum, or zinc). ( 2.6 , 7.2 ) 7.1 Drugs Associated with Neutropenia or Agranulocytosis Avoid co-administration of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis. If co-administration is unavoidable, closely monitor the absolute neutrophil count [see Warnings and Precautions (5.1) ] . 7.2 Effect of Other Drugs on Deferiprone UDP-Glucuronosyltransferases (UGT) Avoid use of UGT1A6 inhibitors (e.g., diclofenac, probenecid, or silymarin (milk thistle)) with deferiprone [see Dosage and Administration (2) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) ] . Polyvalent Cations Deferiprone has the potential to bind polyvalent cations (e.g., iron, aluminum, and zinc); allow at least a 4-hour interval between deferiprone and other medications (e.…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described below and elsewhere in the labeling: Agranulocytosis and Neutropenia [see Warnings and Precautions (5.1) ] Liver Enzyme Elevations [see Warnings and Precautions (5.2) ] Zinc Deficiency [see Warnings and Precautions (5.3) ] The most common adverse reactions in patients with thalassemia (incidence > 6%) are nausea, vomiting, abdominal pain, arthralgia, ALT increased and neutropenia. (5.1, 6) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse reaction information represents the pooled data collected from single arm or active-controlled clinical trials with deferiprone tablets (three times a day). Thalassemia Syndromes The safety of deferiprone was evaluated in the pooled clinical trial dat…
Frequently Asked Questions
What is DEFERIPRONE used for?
DEFERIPRONE contains deferiprone. It is a tablet, coated taken oral. Consult your doctor for specific uses.
Is DEFERIPRONE a controlled substance?
DEFERIPRONE is not classified as a controlled substance by the DEA.
What is the generic name for DEFERIPRONE?
The generic name for DEFERIPRONE is deferiprone. There are 7 other brand versions of deferiprone.
What is the NDC code for DEFERIPRONE 1000 mg/1?
The NDC (National Drug Code) for DEFERIPRONE 1000 mg/1 is 75907-348, listed by DR. REDDY'S LABORATORIES, INC..