Ferriprox Side Effects Center

Last updated on RxList: 12/9/2021
Ferriprox Side Effects Center

What Is Ferriprox?

Ferriprox (deferiprone) is an oral iron chelator used to treat patients with iron overload due to the frequent blood transfusions required in certain disorders such as thalassemia.

What Are Side Effects of Ferriprox?

Side effects of Ferriprox include:

  • nausea,
  • vomiting,
  • stomach/abdominal pain,
  • diarrhea,
  • joint pain,
  • back pain,
  • increased appetite,
  • headache,
  • reddish-brown urine discoloration (this is not harmful),
  • a decrease in the number of white blood cells (neutropenia), and
  • an increase in the level of a liver enzyme that may be indicative of tissue or liver damage at unsafe amounts

Dosage for Ferriprox

The recommended initial dose of Ferriprox is 25 mg/kg, orally, three times per day for a total of 75 mg/kg/day. The maximum dose is 33 mg/kg, three times per day for a total of 99 mg/kg/day.

What Drugs, Substances, or Supplements Interact with Ferriprox?

Ferriprox may interact with antacids or mineral supplements taken within 4 hours before or 4 hours after taking Ferriprox, herbal supplements containing milk thistle, or other iron chelating medicines. Tell your doctor all medications and supplements you use.

Ferriprox During Pregnancy and Breastfeeding

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. Women of reproductive potential should be advised to avoid pregnancy when taking Ferriprox. Patients should notify their physicians immediately if they become pregnant or plan to become pregnant while take Ferriprox. Patients should not breastfeed while taking Ferriprox.

Additional Information

Our Ferriprox Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Ferriprox Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with deferiprone. Stop using this medicine and call your doctor right away if you have signs of infection such as:

  • fever, chills, body aches;
  • flu symptoms;
  • skin sores; or
  • sores in your mouth and throat.

Further doses may be delayed until your infection clears up.

Deferiprone may cause your urine to turn a reddish-brown color. This side effect is usually not harmful. Call your doctor if you also have upper stomach pain, clay-colored stools, or jaundice (yellowing of your skin or the whites of your eyes).

Common side effects may include:

  • nausea, vomiting, stomach pain;
  • infections;
  • joint pain; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Ferriprox Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described below and elsewhere in the labeling:

  • Agranulocytosis and Neutropenia [see WARNINGS AND PRECAUTIONS]
  • Liver Enzyme Elevations [see WARNINGS AND PRECAUTIONS]
  • Zinc Deficiency [see WARNINGS AND PRECAUTIONS]

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.

FERRIPROX Tablets (twice a day) were evaluated in trials in healthy subjects. FERRIPROX Tablets (twice a day) contain deferiprone, the same active ingredient as FERRIPROX Tablets (deferiprone) (three times a day) and FERRIPROX Oral Solution (deferiprone).

The following adverse reaction information represents the pooled data collected from single arm or active-controlled clinical trials with FERRIPROX Tablets (deferiprone) (three times a day) or FERRIPROX Oral Solution (deferiprone).

Thalassemia Syndromes

The safety of FERRIPROX was evaluated in the pooled clinical trial database [see Clinical Studies ]. Patients received FERRIPROX Tablets (three times a day) or FERRIPROX Oral Solution . FERRIPROX was administered orally three times a day (total daily dose either 50, 75, or 99 mg/kg), N=642. Among 642 patients receiving FERRIPROX, 492 (76.6%) were exposed for 6 months or longer and 365 (56.9%) were exposed for greater than one year.

The median age of patients who received FERRIPROX was 19 years (range 1, 77 years); 50.2% female; 71.2% White, 17.8% Asian, 9.2% Unknown, 1.2% Multi-racial and 0.6% Black.

The most serious adverse reaction reported in clinical trials with FERRIPROX was agranulocytosis [see WARNINGS AND PRECAUTIONS].

The most common adverse reactions (≥6%) reported during clinical trials were nausea, vomiting, abdominal pain, arthralgia, alanine aminotransferase increased and neutropenia.

The table below lists the adverse drug reactions that occurred in at least 1% of patients treated with FERRIPROX in clinical trials in patients with thalassemia syndromes.

Table 7:Adverse reactions occurring in ≥ 1% of FERRIPROX-treated patients with thalassemia syndromes

Body System
Adverse Reaction
(N=642)
% Patients
BLOOD AND LYMPHATIC SYSTEM DISORDERS
  Neutropenia 6
  Agranulocytosis 2
GASTROINTESTINAL DISORDERS
  Nausea 13
  Abdominal pain/discomfort 10
  Vomiting 10
  Diarrhea 3
  Dyspepsia 2
INVESTIGATIONS
  Alanine aminotransferase increased 7
  Weight increased 2
  Aspartate aminotransferase increased 1
METABOLISM AND NUTRITION DISORDERS
  Increased appetite 4
  Decreased appetite 1
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
  Arthralgia 10
  Back pain 2
  Pain in extremity 2
  Arthropathy 1
NERVOUS SYSTEM DISORDERS
  Headache 2

Gastrointestinal symptoms such as nausea, vomiting, and abdominal pain were the most frequent adverse reactions reported by patients participating in clinical trials and led to the discontinuation of FERRIPROX therapy in 1.6% of patients.

Chromaturia (reddish/brown discoloration of the urine) is a result of the excretion of iron in the urine.

Sickle Cell Disease Or Other Anemias

The safety of FERRIPROX compared to deferoxamine was evaluated in LA38-0411 [see Clinical Studies ]. Patients received FERRIPROX Tablets or FERRIPROX Oral Solution orally three times a day (total daily dose 75-99 mg/kg/day) n=152) or the control arm, deferoxamine, 20-40 mg/kg/day (children) or 40-50 mg/kg/day (adults), by subcutaneous infusion for 5 – 7 days per week, n=76. Among 152 patients receiving FERRIPROX, 120 (78.9%) were exposed for 6 months or longer and 17 (11.2%) were exposed for greater than one year.

The median age of patients who received FERRIPROX was 15 years (range 3, 59 years); 54.6% male; 78.9% White, 15.1% Black and 5.9% Multi-racial.

The most common adverse reactions (≥6%) reported during clinical trials in patients with SCD or other anemias were pyrexia, abdominal pain, bone pain, headache, vomiting, pain in extremity, sickle cell anemia with crisis, back pain, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, arthralgia, oropharyngeal pain, nasopharyngitis, neutrophil count decreased, cough and nausea.

The table below lists the adverse reactions (irrespective of a causal assessment; adverse events) of interest that occurred in patients treated with FERRIPROX in clinical trials in subjects with sickle cell disease or other anemias.

Table 8:Adverse reactions occurring in ≥5% of FERRIPROX-treated patients with sickle cell disease or other anemias

Body System
Adverse Reaction
FERRIPROX
(N=152)
% Patients
DEFEROXAMINE
(N=76)
% Patients
BLOOD AND LYMPHATIC SYSTEM DISORDERS
  Sickle cell anemia with crisis 17 13
GASTROINTESTINAL DISORDERS
  Abdominal pain* 26 13
  Vomiting 19 11
  Nausea 7 9
  Diarrhea 5 8
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
  Pyrexia 28 33
  Pain 5 4
INFECTIONS AND INFESTATIONS
  Nasopharyngitis 9 5
  Upper respiratory tract infection 5 3
INVESTIGATIONS
  Alanine aminotransferase increased 12 0
  Aspartate aminotransferase increased 11 0
  Neutrophil count decreased 8 4
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
  Bone pain 25 34
  Pain in extremity 18 15
  Back pain 13 18
  Arthralgia 10 8
NERVOUS SYSTEM DISORDERS
  Headache 20 13
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
  Oropharyngeal pain 10 15
  Cough 8 15
*Grouped term

Clinically relevant adverse reactions in <5% of patients include neutropenia and agranulocytosis.

Pediatric Patients

FERRIPROX has been studied in 86 pediatric patients with sickle cell disease or other anemias. Pediatric patients (<17 years) had an increase in the following adverse reactions as compared to adults: abdominal pain, neutrophil count decreased, bone pain and oropharyngeal pain.

Postmarketing Experience

The following additional adverse reactions have been reported in patients receiving FERRIPROX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.

Blood and lymphatic system disorders: thrombocytosis, pancytopenia.

Cardiac disorders: atrial fibrillation, cardiac failure.

Congenital, familial and genetic disorders: hypospadias.

Eye disorders: diplopia, papilledema, retinal toxicity.

Gastrointestinal disorders: enterocolitis, rectal hemorrhage, gastric ulcer, pancreatitis, parotid gland enlargement.

General disorders and administration site conditions: chills, edema peripheral, multi-organ failure.

Hepatobiliary disorders: jaundice, hepatomegaly.

Immune system disorders: anaphylactic shock, hypersensitivity.

Infections and infestations: cryptococcal cutaneous infection, enteroviral encephalitis, pharyngitis, pneumonia, sepsis, furuncle, infectious hepatitis, rash pustular, subcutaneous abscess.

Investigations: blood bilirubin increased, blood creatinine phosphokinase increased.

Metabolism and nutrition disorders: metabolic acidosis, dehydration.

Musculoskeletal and connective tissue disorders: myositis, chondropathy, trismus.

Nervous system disorders: cerebellar syndrome, cerebral hemorrhage, convulsion, gait disturbance, intracranial pressure increased, psychomotor skills impaired, pyramidal tract syndrome, somnolence.

Psychiatric disorders: bruxism, depression, obsessive-compulsive disorder.

Renal disorders: glycosuria, hemoglobinuria.

Respiratory, thoracic and mediastinal disorders: acute respiratory distress syndrome, epistaxis, hemoptysis, pulmonary embolism.

Skin, subcutaneous tissue disorders: hyperhidrosis, periorbital edema, photosensitivity reaction, pruritis, urticaria, rash, Henoch- Schönlein purpura.

Vascular disorders: hypotension, hypertension.

DRUG INTERACTIONS

Drugs Associated With Neutropenia Or Agranulocytosis

Avoid co-administration of FERRIPROX 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].

Effect Of Other Drugs On FERRIPROX

UDP-Glucuronosyltransferases (UGT)

Avoid use of UGT1A6 inhibitors (e.g., diclofenac, probenecid, or silymarin (milk thistle)) with FERRIPROX [see DOSAGE AND ADMINISTRATION, ADVERSE REACTIONS, CLINICAL PHARMACOLOGY].

Polyvalent Cations

Deferiprone has the potential to bind polyvalent cations (e.g., iron, aluminum, and zinc); allow at least a 4-hour interval between FERRIPROX and other medications (e.g., antacids), or supplements containing these polyvalent cations [see DOSAGE AND ADMINISTRATION].

Read the entire FDA prescribing information for Ferriprox (Deferiprone)

© Ferriprox Patient Information is supplied by Cerner Multum, Inc. and Ferriprox Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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