Indication
Ferriprox® (deferiprone) is an iron chelator indicated for the treatment of transfusional iron overload in patients with:
- thalassemia syndromes
- sickle cell disease or other anemias
Ferriprox Tablets are indicated in adult and pediatric patients ≥8 years of age; Ferriprox Oral Solution is indicated in patients ≥3 years of age.
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.
Ferriprox (deferiprone) is a bidentate ligand that binds to iron in a 3:1 molecular ratio.
Ferriprox is an iron chelator shown to enter and remove toxic iron from organs and the bloodstream.
Treatment guidelines recommend preventing significant iron loading from the start, not just in an emergency.
The American Heart Association (AHA) recommends yearly MRI T2* assessments of the heart for thalassemia patients.
Ferriprox has been shown to reduce iron levels in the heart and liver and to decrease serum ferritin. To help your patients find a certified MRI T2* facility closest to them, use our facility search tool.
Cardiac and liver iron monitoring by MRI T2* is essential for patients who receive regular blood transfusions. Use the MRI T2* facility search to find the one nearest you.
Yes. No adjustment of the Ferriprox dosage regimen is required in patients with impaired renal function (mild to severe) or impaired hepatic† function (mild to moderate).
† Ferriprox was not studied in a severely hepatically impaired patient population.
Monitoring patients on Ferriprox is straightforward.
Absolute neutrophil count (ANC)
§§§For patients whose Ferriprox has not been interrupted due to any decrease in the neutrophil count the frequency of ANC monitoring may be extended.
¶¶¶ After one year of therapy: Monitor ANC every two to four weeks (or at the patient’s blood transfusion interval) in patients that have not experienced an interruption due to any decrease in ANC.
Reduction in the frequency of ANC monitoring should be considered on an individual patient basis, according to the health care provider’s assessment of the patient’s understanding of the risk minimization measures required during therapy.
Serum liver enzymes are evaluated monthly, on therapy, and plasma zinc concentration is monitored annually.
See more safety information >
If your patient develops a fever, sore throat or mouth sores, flu-like symptoms, or chills and severe shaking they should follow these 3 steps:
Stop the drug immediately
Seek medical attention immediately (i.e., go to the ER or patient’s doctor)
Notify the ER or health care provider they are taking a medication that can cause agranulocytosis
Ferriprox patients receive a wallet card with these three steps printed on it with every medication shipment. To request wallet cards for your office, please contact the Chiesi Total Care team at: 1-866-758-7071.
The FDA-approved dosing for Ferriprox is 75-99 mg/kg/day. Start your patient on 75 mg/kg/day, then titrate up to meet chelation targets. Increasing the dose of Ferriprox up to 99 mg/kg/day may improve efficacy in iron chelation. The incidence of neutropenia and agranulocytosis is not dose-related within the therapeutic range. To minimize gastrointestinal (GI) upset or side effects when first starting therapy, start at 45 mg/kg/day and increase weekly by 15 mg/kg/day until the full prescription dose is achieved.
The incidence of neutropenia and agranulocytosis is not dose-related within the therapeutic range. The FDA-approved dosage of Ferriprox is 75-99 mg/kg/day.
Ferriprox offers twice-a-day and three-times-a-day formulations.
Ferriprox provides iron reduction and an established safety profile.
Serum ferritin‡ reduction
In the clinical trial, 50% of patients experienced at least a 20% reduction in serum ferritin within 1 year of therapy.
Cardiac iron reduction†
In the clinical trial, there was an increase in cardiac MRI T2* from a mean at baseline of 11.8±4.9 ms to a mean of 15.1±7.0 ms after approximately 1 year of treatment.
Liver iron reduction
In the clinical trial, 42% of patients experienced at least a 20% reduction in liver iron within 1 year of therapy (95% CI, 32%-51%).
† The clinical significance of this observation is not known.
‡ Serum ferritin indicates total body iron level.
Ferriprox tablets are also scored and may be broken in half for easy swallowing or dosage adjustments. Each half is 500 mg. Flexible titration across the dose range helps patients reach their chelation targets.
Talk to your patients about Ferriprox Twice-A-Day.
Ferriprox offers a choice of formulations in oral tablets and oral solution formats.
Ferriprox is available in:
- 1000 mg
- 1000 mg Three-Times-A-Day tablets
- 500 mg Three-Times-A-Day tablets
- 100 mg/mL oral solution Three-Times-A-Day
Ferriprox offers twice-daily dosing. Talk to your patients about switching to Ferriprox Twice-A-Day.
The patient support program is called Chiesi Total CareSM. Chiesi Total Care is a comprehensive support program that provides exceptional service to healthcare professionals and their patients. A single call to your dedicated Chiesi Total Care team is all it takes to guide you through the process of getting patient started on Ferriprox therapy.
IMPORTANT SAFETY INFORMATION
Indication
Ferriprox® (deferiprone) is an iron chelator indicated for the treatment of transfusional iron overload in patients with:
- thalassemia syndromes
- sickle cell disease or other anemias
Ferriprox Tablets are indicated in adult and pediatric patients ≥8 years of age; Ferriprox Oral Solution is indicated in patients ≥3 years of age.
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.
WARNING: AGRANULOCYTOSIS AND NEUTROPENIA
- Ferriprox can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis.
- Measure the absolute neutrophil count (ANC) before starting Ferriprox and monitor regularly while on therapy.
- Interrupt Ferriprox therapy if neutropenia develops.
- Interrupt Ferriprox if infection develops, and monitor the ANC more frequently.
- Advise patients taking Ferriprox to report immediately any symptoms indicative of infection.
Indication
Ferriprox® (deferiprone) is an iron chelator indicated for the treatment of transfusional iron overload in patients with:1
- thalassemia syndromes
- sickle cell disease or other anemias
Ferriprox Tablets are indicated in adult and pediatric patients ≥8 years of age; Ferriprox Oral Solution is indicated in patients ≥3 years of age.
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.
Important Safety Information
Ferriprox is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations.
In pooled clinical trials, 7.5% of 642 patients with thalassemia syndromes treated with Ferriprox developed increased ALT values. Four (0.62%) Ferriprox-treated subjects discontinued the drug due to increased serum ALT levels and 1 (0.16%) due to an increase in both ALT and AST. In pooled clinical trials, 7.7% of 196 patients with sickle cell disease or other anemias treated with Ferriprox developed increased ALT values. Monitor serum ALT values monthly during therapy with Ferriprox and consider interruption of therapy if there is a persistent increase in the serum transaminase levels. Decreased plasma zinc concentrations have been observed on deferiprone therapy. Monitor plasma zinc annually, and supplement in the event of a deficiency.
Ferriprox can cause fetal harm. Advise females of reproductive potential to use an effective method of contraception during treatment with Ferriprox and for at least six months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with Ferriprox and for at least three months after the last dose. Advise females not to breastfeed during treatment with Ferriprox and for at least 2 weeks after the last dose.
Avoid co-administration of Ferriprox with other drugs known to be associated with neutropenia or agranulocytosis; however, if this is unavoidable, closely monitor the absolute neutrophil count. Avoid co-administration with UGT1A6 inhibitors. Allow at least a 4-hour interval between administration of Ferriprox and drugs or supplements containing polyvalent cations (e.g., iron, aluminum, or zinc).
The most common adverse reactions in patients with thalassemia (incidence ≥6%) are nausea, vomiting, abdominal pain, arthralgia, ALT increased and neutropenia. The most common adverse reactions in patients with sickle cell disease or other anemias (incidence ≥6%) are pyrexia, abdominal pain, bone pain, headache, vomiting, pain in extremity, sickle cell anemia with crisis, back pain, ALT increased, AST increased, arthralgia, oropharyngeal pain, nasopharyngitis, neutrophil count decreased, cough and nausea.
Inform patients that their urine might show a reddish/brown discoloration due to the excretion of the iron-deferiprone complex. This is a very common sign of the desired effect, and it is not harmful.
Advise patients to avoid alcohol while taking Ferriprox tablets (twice-a-day). Consumption of alcohol while taking Ferriprox tablets (twice-a-day) may result in more rapid release of deferiprone.
Please see Full Prescribing Information, including boxed WARNING, and Medication Guide.
IMPORTANT SAFETY INFORMATION
Indication
Ferriprox® (deferiprone) is an iron chelator indicated for the treatment of transfusional iron overload in patients with:
- thalassemia syndromes
- sickle cell disease or other anemias
Ferriprox Tablets are indicated in adult and pediatric patients ≥8 years of age; Ferriprox Oral Solution is indicated in patients ≥3 years of age.
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.
WARNING: AGRANULOCYTOSIS AND NEUTROPENIA
- Ferriprox can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis.
- Measure the absolute neutrophil count (ANC) before starting Ferriprox and monitor regularly while on therapy.
- Interrupt Ferriprox therapy if neutropenia develops.
- Interrupt Ferriprox if infection develops, and monitor the ANC more frequently.
- Advise patients taking Ferriprox to report immediately any symptoms indicative of infection.
Indication
Ferriprox® (deferiprone) is an iron chelator indicated for the treatment of transfusional iron overload in patients with:1
- thalassemia syndromes
- sickle cell disease or other anemias
Ferriprox Tablets are indicated in adult and pediatric patients ≥8 years of age; Ferriprox Oral Solution is indicated in patients ≥3 years of age.
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.
Important Safety Information
Ferriprox is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations.
In pooled clinical trials, 7.5% of 642 patients with thalassemia syndromes treated with Ferriprox developed increased ALT values. Four (0.62%) Ferriprox-treated subjects discontinued the drug due to increased serum ALT levels and 1 (0.16%) due to an increase in both ALT and AST. In pooled clinical trials, 7.7% of 196 patients with sickle cell disease or other anemias treated with Ferriprox developed increased ALT values. Monitor serum ALT values monthly during therapy with Ferriprox and consider interruption of therapy if there is a persistent increase in the serum transaminase levels. Decreased plasma zinc concentrations have been observed on deferiprone therapy. Monitor plasma zinc annually, and supplement in the event of a deficiency.
Ferriprox can cause fetal harm. Advise females of reproductive potential to use an effective method of contraception during treatment with Ferriprox and for at least six months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with Ferriprox and for at least three months after the last dose. Advise females not to breastfeed during treatment with Ferriprox and for at least 2 weeks after the last dose.
Avoid co-administration of Ferriprox with other drugs known to be associated with neutropenia or agranulocytosis; however, if this is unavoidable, closely monitor the absolute neutrophil count. Avoid co-administration with UGT1A6 inhibitors. Allow at least a 4-hour interval between administration of Ferriprox and drugs or supplements containing polyvalent cations (e.g., iron, aluminum, or zinc).
The most common adverse reactions in patients with thalassemia (incidence ≥6%) are nausea, vomiting, abdominal pain, arthralgia, ALT increased and neutropenia. The most common adverse reactions in patients with sickle cell disease or other anemias (incidence ≥6%) are pyrexia, abdominal pain, bone pain, headache, vomiting, pain in extremity, sickle cell anemia with crisis, back pain, ALT increased, AST increased, arthralgia, oropharyngeal pain, nasopharyngitis, neutrophil count decreased, cough and nausea.
Inform patients that their urine might show a reddish/brown discoloration due to the excretion of the iron-deferiprone complex. This is a very common sign of the desired effect, and it is not harmful.
Advise patients to avoid alcohol while taking Ferriprox tablets (twice-a-day). Consumption of alcohol while taking Ferriprox tablets (twice-a-day) may result in more rapid release of deferiprone.
Please see Full Prescribing Information, including boxed WARNING, and Medication Guide.