Deferiprone

Unless your doctor tells you otherwise, continue your normal diet.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Deferiprone is usually taken 3 times per day. Take the first daily dose each morning, the second dose at mid-day, and the third dose in the evening.

Take with food if deferiprone upsets your stomach. You may also take the medicine without food.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Tell your doctor if you have any changes in weight. Deferiprone doses are based on weight, and any changes may affect the dose.

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).

Deferiprone can lower blood cells that help your body fight infections. Your blood will need to be tested weekly while you are taking deferiprone. Your treatments may be delayed based on the results of these tests. Visit your doctor regularly.

Store at room temperature, away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Included as part of the PRECAUTIONS section.

FERRIPROX®
(Feh' ri prox)
(deferiprone) Tablets

Read this Medication Guide before you start taking FERRIPROX and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about FERRIPROX?

FERRIPROX can cause serious side effects, including a very low white blood cell count in your blood. One type of white blood cell that is important for fighting infections is called a neutrophil. If your neutrophil count is low (neutropenia), you may be at risk of developing a serious infection that can lead to death. Neutropenia is common with FERRIPROX and can become severe in some people. Severe neutropenia is known as agranulocytosis. If you develop agranulocytosis, you will be at risk of developing serious infections that can lead to death.

Your healthcare provider should do a blood test before you start FERRIPROX and weekly during treatment to check your neutrophil count. If you develop neutropenia, your healthcare provider should check your blood counts every day until your white blood cell count improves.

Stop taking FERRIPROX and get medical help right away if you develop any of these symptoms of infection:

• fever
• sore throat or mouth sores
• flu-like symptoms
• chills and severe shaking

See “What are the possible side effects of FERRIPROX?” for more information about side effects.

What is FERRIPROX?

FERRIPROX is a prescription medicine used to treat people with thalassemia syndromes who have iron overload from blood transfusions, when current iron removal (chelation) therapy does not work well enough.

It is not known if FERRIPROX tablets are safe and effective:

• to treat iron overload due to blood transfusions in people with any other type of anemia that is long lasting (chronic)
• in children
• in people with severe liver problems

Who should not take FERRIPROX?

Do not take FERRIPROX if you are allergic to deferiprone or any of the ingredients in FERRIPROX. See the end of this Medication Guide for a complete list of ingredients in FERRIPROX.

What should I tell my healthcare provider before taking FERRIPROX?

Before you take FERRIPROX, tell your healthcare provider if you:

• have liver problems
• have any other medical conditions.
• are pregnant or plan to become pregnant. FERRIPROX can harm your unborn baby. You should avoid becoming pregnant while taking FERRIPROX. Tell your healthcare provider right away if you become pregnant or plan to become pregnant while taking FERRIPROX.
• are breastfeeding or plan to breastfeed. It is not known if FERRIPROX passes into your breast milk. You and your healthcare provider should decide if you will take FERRIPROX or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Especially tell your healthcare provider if you take:

• other medicines that can cause a lowering of your neutrophil count
• antacids or mineral supplements that contain: iron, aluminum, and zinc. Allow at least 4 hours between taking FERRIPROX and any of these products.

Ask your healthcare provider or pharmacist if your medicine is one that is listed above.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take FERRIPROX?

• Take FERRIPROX exactly as prescribed by your healthcare provider. Do not change your dose of FERRIPROX unless your healthcare provider tells you to.
• Your healthcare provider will tell you how many FERRIPROX tablets to take.
• FERRIPROX is taken 3 times each day. Take your first dose in the morning, the second dose at mid-day, and third dose in the evening.
• You can take FERRIPROX with or without food.
• Taking FERRIPROX with meals may help reduce nausea.
• If you take too much FERRIPROX, call your healthcare provider.
• If you do miss a dose take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and then continue with your regular schedule. Do not try to catch-up or take 2 doses at the same time to make up for a missed dose.

What are the possible side effects of FERRIPROX?

FERRIPROX can cause serious side effects, including:

• See “What is the most important information I should know about FERRIPROX?”
• Increased liver enzyme levels in your blood. Your healthcare provider should do monthly blood test to check your liver function during treatment with FERRIPROX.

The most common side effects of FERRIPROX include:

• reddish-brown colored urine. This is not harmful and is expected when you are taking FERRIPROX.
• nausea
• vomiting
• stomach-area (abdominal) pain
• joint pain
• low neutrophil count. See “What is the most important information I should know about FERRIPROX?”

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of FERRIPROX. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store FERRIPROX?

• Store FERRIPROX at room temperature between 68°F to 77°F (20°C to 25°C).

Keep FERRIPROX and all medicines out of the reach of children.

General information about the safe and effective use of FERRIPROX.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use

FERRIPROX for a condition for which it was not prescribed. Do not give FERRIPROX to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about FERRIPROX. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about FERRIPROX that is written for health professionals.

For more information call 1-866-949-0995.

What are the ingredients in FERRIPROX?

Active ingredients: deferiprone

Inactive ingredients:

Tablet core: microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide.

Coating: hydroxypropyl methyl cellulose, polyethylene glycol, titanium dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Deferiprone is a prescription medication used to treat an overload of iron in the body. Deferiprone belongs to a group of drugs called iron chelators. These work by attaching to iron so that it can be removed from the body. 

This medication comes as an oral (by mouth) tablet and is usually taken 3 times a day. Deferiprone may be taken with or without food. Taking it with food may help with nausea that may be caused by deferiprone.

Common side effects of deferiprone include reddish-brown urine, nausea, vomiting, and stomach pain.

Deferiprone 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 deferiprone therapy and monitor the ANC weekly on therapy. Interrupt deferiprone therapy if neutropenia develops.

Interrupt deferiprone if infection develops, and monitor the ANC more frequently.

Advise patients taking deferiprone to report immediately any symptoms indicative of infection.

Do not use deferiprone if you are pregnant. It could harm the unborn baby.

You should not use deferiprone if you are allergic to it.

Before taking deferiprone, tell your doctor if you have kidney or liver disease, congestive heart failure, a heart rhythm disorder, an electrolyte imbalance, a weak immune system, a history of Long QT syndrome, or if you take a diuretic (water pill).

Deferiprone can lower blood cells that help your body fight infections. Your blood will need to be tested weekly while you are taking this medication. Your treatments may be delayed based on the results of these tests. Visit your doctor regularly.

Tell your doctor about all other medicines you use, especially drugs that weaken the immune system, such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

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, or sores in your mouth and throat.

Your pharmacist can provide more information about deferiprone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Do not use deferiprone if you are pregnant. It could harm the unborn baby.

Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, body aches, flu symptoms, or sores in your mouth and throat.

Avoid taking an antacid or mineral supplement within 4 hours before or 4 hours after you take deferiprone.

Avoid taking an herbal supplement containing milk thistle while you are taking deferiprone.

Do not use other iron chelating medicines such as deferasirox (Exjade) or deferoxamine (Desferal), unless your doctor has told you to.

Deferiprone is used to remove excess iron from the body in thalassemia patients who have blood transfusions.

Deferiprone combines with iron in the blood. The combination of iron and deferiprone is then removed from the body by the kidneys. If you have too much iron in the body, it can damage various organs and tissues.

deferiprone is available only with your doctor's prescription.

Note: Round dose to the nearest 250 mg (or 1/2 tablet) or 2.5 mL (oral solution). If serum ferritin falls consistently below 500 mcg/L, consider temporary treatment interruption.

Transfusional iron overload: Oral: Initial: 25 mg/kg 3 times/day (75 mg/kg/day); individualize dose based on response and therapeutic goal; maximum dose: 33 mg/kg 3 times/day (99 mg/kg/day)

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied in patients with severe impairment).

Deferiprone 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 deferiprone therapy and monitor the ANC weekly during therapy. Interrupt deferiprone therapy if neutropenia develops. If infection develops, interrupt deferiprone and monitor the ANC more frequently. Advise patients taking deferiprone to report immediately any symptoms indicative of infection.

Applies to deferiprone: oral liquid, oral tablet

General

The most common adverse events were chromaturia, nausea, vomiting, abdominal pain, alanine aminotransferase increased, arthralgia, and neutropenia.[Ref]

Gastrointestinal

Gastrointestinal effects are more frequent at the beginning of therapy, and in most patients resolve within a few weeks without the discontinuation of treatment.[Ref]

Very common (10% or more): Nausea (12.6%), abdominal pain/discomfort (10.4%), vomiting
Common (1% to 10%): Diarrhea, dyspepsia, abdominal discomfort, abdominal pain, abdominal pain upper
Uncommon (0.1% to 1%): Abdominal distension, abdominal pain lower, aphthous stomatitis, constipation, epigastric discomfort, eructation, gastritis, reflux esophagitis, stomach discomfort, gastroenteritis, gastroenteritis viral
Postmarketing reports: Enterocolitis, rectal hemorrhage, gastric ulcer, pancreatitis, parotid gland enlargement, cecitis, dysphagia[Ref]

Genitourinary

Very common (10% or more): Chromaturia (14.6%)
Uncommon (0.1% to 1%): Pollakiuria, amenorrhea, menstruation irregular
Postmarketing reports: Glycosuria, hypospadias, congenital anomaly, non-acute porphyria, urinary tract infection, urine color abnormal, intra-uterine death, balanitis[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia
Common (1% to 10%): Back pain, pain in extremity, arthropathy, joint swelling
Uncommon (0.1% to 1%): Epicondylitis, arthritis, bone pain, joint crepitation, joint effusion, joint range of motion decreased, joint stiffness, metatarsalgia, muscle spasms, muscular weakness, musculoskeletal chest pain, musculoskeletal pain, myalgia, polyarthritis, synovial cyst
Postmarketing reports: Myositis, chondropathy, trismus[Ref]

Hematologic

Common (1% to 10%): Neutrophil count decreased, neutropenia, agranulocytosis, white blood cell count decreased
Uncommon (0.1% to 1%): Blood disorder, hypersplenism, leukopenia, thrombocytopenia, platelet count decreased, platelet count increased
Postmarketing reports: Thrombocytosis, pancytopenia, febrile neutropenia, thrombocythemia, granulocytopenia, hemoglobin decrease, neutropenic sepsis[Ref]

Hepatic

Common (1% to 10%): Alanine aminotransferase increased, aspartate aminotransferase increased, increased liver enzymes
Uncommon (0.1% to 1%): Hepatic pain, hepatitis, hepatomegaly, jaundice, liver tenderness, cytomegalovirus hepatitis, blood bilirubin increased, hepatic enzyme increased
Postmarketing reports: Hepatic function abnormal, infectious hepatitis[Ref]

Other

Common (1% to 10%): Fatigue, peripheral edema
Uncommon (0.1% to 1%): Deafness, ear pain, tinnitus, vertigo, asthenia, chest pain, discomfort, fatigue, influenza like illness, malaise, pyrexia, thirst, diabetic foot infection, sepsis, Yersinia infection, transfusion reaction, blood creatinine increased, blood phosphorus increased, blood zinc decreased, gamma-glutamyl transferase increased
Frequency not reported: Progression of fibrosis
Postmarketing reports: Chills, multi-organ failure, pharyngitis, pneumonia, sepsis, blood creatinine phosphokinase increased, difficulty in walking, hyperpyrexia, anti-HBs antibody positive, blood arsenic increased[Ref]

Metabolic

Common (1% to 10%): Increased appetite, weight increased, decreased appetite, anorexia
Uncommon (0.1% to 1%): Weight decreased, fluid retention
Postmarketing reports: Metabolic acidosis, dehydration, metabolic disorder[Ref]

Respiratory

Uncommon (0.1% to 1%): Influenza, nasopharyngitis, upper respiratory tract infection, asthma, dry throat, oropharyngeal pain
Postmarketing reports: Acute respiratory distress syndrome, epistaxis, hemoptysis, pulmonary embolism, respiratory acidosis, dyspnea, lung disorder, oropharyngolaryngeal pain, pharyngeal erythema, tonsillitis, parapharyngeal abscess[Ref]

Nervous system

Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness, hypogeusia, migraine, somnolence
Frequency not reported: Psychomotor slowdown, hand movements, axial hypotonia
Postmarketing reports: Cerebellar syndrome, cerebral hemorrhage, convulsion, gait disturbance, intracranial pressure increased, psychomotor skills impaired, pyramidal tract syndrome, dystonia, febrile convulsion, coordination abnormal, hypotonia, nystagmus, depressed level of consciousness, balance disorder, enteroviral encephalitis[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity
Postmarketing reports: Anaphylactic shock[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Arrhythmia, Torsades de Pointes, electrocardiogram T wave inversion
Postmarketing reports: Atrial fibrillation, cardiac failure, hypotension, hypertension, cardiac disorder, congestive cardiac failure, sinus tachycardia[Ref]

Dermatologic

Uncommon (0.1% to 1%): Alopecia, hyperhidrosis, pruritus, rash, rash generalized, rash pruritic, skin hypopigmentation, urticaria, xeroderma
Frequency not reported: Henoch-Schönlein purpura, urticaria, periorbital edema with skin rash
Postmarketing reports: Cryptococcal cutaneous infection, rash pustular, subcutaneous abscess, hyperhidrosis, photosensitivity reaction, rash erythematous, rash maculopapular, face edema, furuncle, subcutaneous abscess[Ref]

Renal

Postmarketing reports: Hemoglobinuria, renal failure, glycosuria, chromaturia[Ref]

Endocrine

Postmarketing reports: Blood corticotrophin decreased, blood cortisol decreased[Ref]

Ocular

Frequency not reported: Lateral nystagmus
Postmarketing reports: Diplopia, papilledema, retinal toxicity, eye movement disorder, periorbital edema, retinal toxicity, visual impairment[Ref]

Oncologic

Postmarketing reports: Hepatic neoplasm malignant[Ref]

Psychiatric

Postmarketing reports: Bruxism, depression, obsessive-compulsive disorder[Ref]

Some side effects of deferiprone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Animal studies showed malformations and fetal death at doses much lower than human clinical doses. There are no controlled data in human pregnancy. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is contraindicated. (AU, UK) Use should be avoided. (US) AU TGA pregnancy category: D US FDA pregnancy category: D Comments: -Advise women to avoid pregnancy while using; contraception is encouraged. -If used during pregnancy, or the patient becomes pregnant, apprise the patient of potential harm to the fetus.

Use is contraindicated. (AU, UK) Use should be avoided. (US) Excreted into human milk: Unknown Excreted into animal milk: Unknown Comments: -If treatment is unavoidable, breastfeeding should be stopped.