Drug Interaction:
.
Avoid concomitant use with other drugs known to be associated with neutropenia or
agranulocytosis; however, if this is not possible, closely monitor the absolute
neutrophil count.
.
Allow at least a 4-hour interval between Ferriprox and mineral supplements,
and antacids that contain polyvalent cations (e.g., iron, aluminum, and zinc).
Indication:
FERRIPROX® (deferiprone) tablets, for oral use
Initial U.S. Approval: 2011
WARNING:
AGRANULOCYTOSIS/NEUTROPENIA
See full prescribing information for complete boxed warning.
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
the ANC weekly on therapy.
Interrupt Ferriprox if infection develops and monitor the ANC more frequently.
Advise patients taking Ferriprox to report immediately any symptoms indicative
of infection.
Drug Name- Ferriprox
Active Ingredient - Deferiprone
To treat patients with iron overload due to blood transfusions in patients with
thalessemia, a generic blood disrder that causes anemia, who had an inadequate
response to prior chelation therapy
Indication-
Treat patients with iron overload due to blood transfusions in patients with
thalessemia, a generic blood disorder that causes anemia, who had an inadequate
response to prior chelation therapy
Approved by FDA on 14-10--2011 (Ref- FDA approved List- 2011)
Adverse Reaction:
.
The most common adverse reactions are (incidence . 5%) chromaturia, nausea,
vomiting and abdominal pain, alanine aminotransferase increased, arthralgia
and neutropenia.
Contra-Indications:
CONTRAINDICATION
Hypersensitivity to deferiprone or to any of the excipients in the formulation.
WARNINGS AND PRECAUTIONS
.
If infection occurs while on Ferriprox, interrupt therapy and monitor the ANC more
frequently.
.
Ferriprox can cause fetal harm. Women should be advised of the potential hazard
to the fetus and to avoid pregnancy while on this drug.
Dosages/ Overdosage Etc:
Indication-
Treat patients with iron overload due to blood transfusions in patients with
thalessemia, a generic blood disorder that causes anemia, who had an inadequate
response to prior chelation therapy
INDICATIONS AND USAGE
FERRIPROX® (deferiprone) is an iron chelator indicated for the treatment of patients
with transfusional iron overload due to thalassemia syndromes when current chelation
therapy is inadequate.
Approval is based on a reduction in serum ferritin levels. There are no controlled trials
demonstrating a direct treatment benefit, such as improvement in disease-related
symptoms, functioning, or increased survival.
Limitation of Use
Safety and effectiveness have not been established for the treatment of transfusional
iron overload in patients with other chronic anemias.
DOSAGE AND ADMINISTRATION
25 mg/kg to 33 mg/kg body weight, orally, three times per day, for a total daily dose
of 75 mg/kg to 99mg/kg body weight.
DOSAGE FORMS AND STRENGTHS
500 mg film-coated tablets with a functional score.
Patient Information:
PATIENT COUNSELING INFORMATION
1.Inform patients of the risks of developing agranulocytosis and instruct them to
immediately interrupt therapy and report to their physician if they experience
any symptoms of infection such as fever, sore throat or flu-like symptoms.
2.Advise patients that the amount of Ferriprox prescribed is based on body weight and
on the therapeutic goal (reduction or stabilization of the body iron load).
3.Advise patients to take the first dose of Ferriprox in the morning, the second dose at
midday, and the third dose in the evening. Clinical experience suggests that taking
Ferriprox with meals may reduce nausea.
4. If a dose of this medicine has been missed, take as soon as possible. However,
if it is almost time for the next dose, skip the missed dose and go back to the regular
dosing schedule. Do not catch-up or double doses.
5.Advise patients to contact their physician in the event of overdose.
6.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 of Ferriprox, and it is not harmful.
7.Counsel women of reproductive potential to avoid pregnancy while taking Ferriprox.
Advise patients to immediately notify their physician if they become pregnant,
or if they plan to become pregnant during therapy.
8.Inform patients that they should not breast feed while taking Ferriprox.
9.Inform patients that if they experience palpitations, dizziness, lightheadedness,
syncope, or seizures to immediately seek medical attention.
Pharmacology/ Pharmacokinetics:
1. Mechanism of Action
Deferiprone is a chelating agent with an affinity for ferric ion (iron III). Deferiprone
binds with ferric ions to form neutral 3:1 (deferiprone:iron) complexes that are stable
over a wide range of pH values. Deferiprone has a lower binding affinity for other
metals such as copper, aluminum and zinc than for iron.
2. Pharmacokinetics
Deferiprone is rapidly absorbed from the upper part of the gastrointestinal tract,
appearing in the blood within 5 to 10 minutes of oral administration.
Peak serum concentrations occur approximately 1 hour after a single dose in fasted
healthy subjects and patients, and up to 2 hours after a single dose in the fed state.
Administration with food decreased the Cmax of deferiprone by 38% and the
AUC by 10%. While a food effect cannot be ruled out, the magnitude of the
exposure change does not warrant dose adjustment.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1 Pregnancy
Pregnancy Category D
There are no studies in pregnant women, and available human data are limited.
If Ferriprox is used during pregnancy or if the patient becomes pregnant while
taking Ferriprox, the patient should be apprised of the potential hazard to the fetus.
2. Nursing Mothers
It is not known whether deferiprone is excreted in human milk. Because many drugs
are excreted in human milk and because of the potential for adverse reactions in
nursing infants from Ferriprox, a decision should be made whether to discontinue
nursing or to discontinue the drug, taking into account the importance of the drug
to the mother.
3. Pediatric Use
The safety and effectiveness of Ferriprox tablets for oral use in pediatric patients
have not been established.
4. Geriatric Use
Safety and effectiveness in elderly individuals have not been established.
In general, dose selection for an elderly patient should be cautious, usually
starting at the low end of the dosing range, reflecting the greater frequency
of decreased hepatic, renal, or cardiac function, and of concomitant disease
or other drug therapy.
Manufacturer Details