FERRIPROX

FERRIPROX- deferiprone tablet, film coated
ApoPharma USA, Inc.

ferriprox-02ferriprox1000mg-01a

WARNING: AGRANULOCYTOSIS AND NEUTROPENIA

  • FERRIPROX can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis. [see Warnings and Precautions (5.1)]

  • Measure the absolute neutrophil count (ANC) before starting FERRIPROX therapy and monitor weekly while on therapy. Interrupt FERRIPROX therapy if neutropenia develops. [see Warnings and Precautions (5.1) ]

  • Interrupt FERRIPROX if infection develops, and monitor the ANC more frequently. [see Warnings and Precautions (5.1) ]

  • Advise patients taking FERRIPROX to report immediately any symptoms indicative of infection. [see Warnings and Precautions (5.1)]

1 INDICATIONS AND USAGE

FERRIPROX® is 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 [see Clinical Studies (14)].

Limitations of Use

  • Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with other chronic anemias.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Starting Dose

The recommended initial dose of FERRIPROX is 25 mg/kg actual body weight, orally, three times per day for a total of 75 mg/kg/day. Round dose to the nearest 500 mg (half-tablet).

Table 1a: Tablet requirement to achieve a 25 mg/kg dose (rounded to the nearest half-tablet) for administration three times a day.
Body Weight Number of 1,000 mg tablets
(kg) Morning Midday Evening
20 0.5 0.5 0.5
30 1 0.5 1
40 1 1 1
50 1.5 1 1.5
60 1.5 1.5 1.5
70 2 1.5 2
80 2 2 2
90 2.5 2 2.5

Dose Adjustments

Tailor dose adjustments to the individual patient’s response and therapeutic goals (maintenance or reduction of body iron burden). The maximum dose is 33 mg/kg actual body weight, three times per day for a total of 99 mg/kg/day.

Table 1b: Tablet requirement to achieve a 33 mg/kg dose (rounded to the nearest half-tablet) for administration three times a day.
Body Weight Number of 1,000 mg tablets
(kg) Morning Midday Evening
20 0.5 0.5 1
30 1 1 1
40 1.5 1 1.5
50 1.5 1.5 2
60 2 2 2
70 2.5 2 2.5
80 2.5 2.5 3
90 3 3 3

Monitor serum ferritin concentration every two to three months to assess the effect of FERRIPROX on body iron stores. If the serum ferritin is consistently below 500 mcg/L, consider temporarily interrupting FERRIPROX therapy until serum ferritin rises above 500 mcg/L.

2.2 Dosage Modification for Drug Interactions

Allow at least a 4-hour interval between administration of FERRIPROX and other drugs or supplements containing polyvalent cations such as iron, aluminum, or zinc [see Drug Interactions (7.2), Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

Tablets: 1,000 mg film-coated, capsule-shaped, white to off-white tablets with functional scoring, and imprinted with “APO” score “1000” on one side and plain on the other.

4 CONTRAINDICATIONS

FERRIPROX is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulation. 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)].

5 WARNINGS AND PRECAUTIONS

5.1 Agranulocytosis and Neutropenia

Fatal agranulocytosis can occur with FERRIPROX use. FERRIPROX can also cause neutropenia, which may foreshadow agranulocytosis. Measure the absolute neutrophil count (ANC) before starting FERRIPROX therapy and monitor it weekly while on therapy.

Interrupt FERRIPROX therapy if neutropenia develops (ANC < 1.5 x 109 /L).

Interrupt FERRIPROX if infection develops and monitor the ANC frequently.

Advise patients taking FERRIPROX to immediately interrupt therapy and report to their physician if they experience any symptoms indicative of infection.

In pooled clinical trials, the incidence of agranulocytosis was 1.7% of patients. The mechanism of FERRIPROX-associated agranulocytosis is unknown. Agranulocytosis and neutropenia usually resolve upon discontinuation of FERRIPROX, but there have been reports of agranulocytosis leading to death.

Implement a plan to monitor for and to manage agranulocytosis and neutropenia prior to initiating FERRIPROX treatment.

For agranulocytosis (ANC < 0.5 x 10 9 /L):

Consider hospitalization and other management as clinically appropriate.

Do not resume FERRIPROX in patients who have developed agranulocytosis unless potential benefits outweigh potential risks. Do not rechallenge patients who have developed neutropenia with FERRIPROX unless potential benefits outweigh potential risks.

For neutropenia (ANC < 1.5 x 109 /L and > 0.5 x 109 /L):

Instruct the patient to immediately discontinue FERRIPROX and all other medications with a potential to cause neutropenia.

Obtain a complete blood cell (CBC) count, including a white blood cell (WBC) count corrected for the presence of nucleated red blood cells, an absolute neutrophil count (ANC), and a platelet count daily until recovery (ANC ≥ 1.5 x 109 /L).

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