Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

FERRIPROX (NDA-212269)

(DEFERIPRONE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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03/26/2025 (SUPPL-6)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Agranulocytosis and Neutropenia

Additions and/or revisions underlined:

. . .

For agranulocytosis (ANC less than 0.2 x 109/L) and severe neutropenia (0.2 x 109/L less than or equal to ANC less than 0.5 x 109/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.

. . .

11/30/2021 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Agranulocytosis and Neutropenia

Additions and/or revisions underlined:

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 regularly while on therapy [see Dosage and Administration (2.1)].

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.

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.

The incidence of agranulocytosis was 1.7% of patients in pooled clinical trials of 642 patients with thalassemia syndromes and 1.5% of patients in pooled clinical trials of 196 patients with sickle cell disease or other anemias. 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 109/L):

Consider hospitalization and other management as clinically appropriate.

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 greater than or equal to 1.5 x 109/L).

5.3 Zinc Deficiency

Additions and/or revisions underlined:

Decreased plasma zinc concentrations have been observed on FERRIPROX therapy. Monitor plasma zinc annually, and supplement in the event of a deficiency [see Dosage and Administration (2.1)].

6 Adverse Reactions

6.1 Clinical Trial Experience

Table numbers have been revised; please refer to label

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Extensive changes; please refer to label

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient to read the FDA-approved patient labeling (Medication Guide)

Instruct patients and their caregivers to store FERRIPROX at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature].
FERRIPROX Tablets (twice a day), 1,000 mg:

Advise patients to take the first dose of FERRIPROX Tablets (twice a day) in the morning and the second in the evening.

Advise patients to take FERRIPROX Tablets (twice a day) with food to reduce the risk of nausea and vomiting.

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.

FERRIPROX Tablets (three times a day), 1,000 mg:

Store in the originally supplied bottle, closed tightly to protect from moisture.

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.

FERRIPROX Tablets, 500 mg:

Store in the originally supplied bottle, closed tightly to protect from moisture.

If a dose of this medicine has been missed, take it 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.
Inform patients of the risks of developing agranulocytosis and the need for regular blood testing before and during their treatment to monitor for decreases in their ANC. 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 [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)] in order to check their ANC within 24 hours. Advise them if they are unable to reach their physician, seek care from another provider so as not to delay medical care.
Inform patients of the risk of abnormal liver transaminases and the need for regular blood testing before and during their treatment to monitor for increases in ALT [see Dosage and Administration (2.1) and Warnings and Precautions (5.2)].
Inform patients of the risk of zinc deficiency and the need for regular blood testing before and during their treatment to monitor for reductions in zinc [see Dosage and Administration (2.1) and Warnings and Precautions (5.3)].
Advise patients to contact their physician in the event of overdose.
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.

Embryo-Fetal toxicity

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.4) and Use in Specific Populations (8.1)]. Advise female patients of reproductive potential to use effective contraception during treatment with FERRIPROX and for at least six months after the last dose [see Use in Specific Populations (8.1, 8.3)]. 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 [see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1)].

Lactation

Advise females not to breastfeed during treatment with FERRIPROX and for at least 2 weeks after the last dose [see Use in Specific Populations (8.2)].

04/30/2021 (SUPPL-1)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Agranulocytosis and Neutropenia

(Additions and/or revisions underlined)

5.2 Liver Enzyme Elevations

(Additions and/or revisions underlined)

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.

6 Adverse Reactions

6.1 Clinical Trial Experience

(Extensive changes; please refer to label)

8 Use in Specific Populations

8.5 Pediatric Use

(Extensive changes; please refer to label)

Medication Guide

(Additions and/or revisions underlined)

FERRIPROX Tablets is a prescription medicine used to treat iron overload from blood transfusions in adults and

children 8 years of age and older with:

• thalassemia syndromes.

• sickle cell disease or other anemias.

It is not known if FERRIPROX Tablets is safe and effective to treat iron overload due to blood transfusions:

• in people with myelodysplastic syndrome or Diamond Blackfan anemia

• in children less than 8 years of age

Tell your healthcare provider right away if you

become pregnant or think you may be pregnant during treatment with FERRIPROX

• Your healthcare provider will prescribe FERRIPROX Tablets based on your body weight.

• Take this FERRIPROX Tablets 2 times each day with food. Take your first dose in the morning and the second

dose in the evening, about 12 hours apart.

The most common side effects of FERRIPROX Tablets in people with thalassemia include:

• nausea • vomiting • stomach-area (abdominal) pain

• joint pain • abnormal liver function tests • low white blood cells

The most common side effects of FERRIPROX Tablets in people with sickle cell disease or other anemias

include:

• fever • stomach-area (abdominal) pain • bone pain

• headache • vomiting • pain in arms or legs

• sickle cell anemia with crisis • back pain • abnormal liver function tests

• joint pain • mouth and throat pain • common cold

• low white blood cells • cough • nausea