These highlights do not include all the information needed to use FERRIPROX Tablets safely and effectively. See full prescribing information for FERRIPROX Tablets . FERRIPROX ® (deferiprone) tablets , for oral use Initial U.S. Approval: 2011

Medication Guide FERRIPROX (Feh ri prox) Tablets (deferiprone)
What is the most important information I should know about FERRIPROX Tablets? FERRIPROX Tablets can cause serious side effects, including a very low white blood cell count. 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 Tablets 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 will do a blood test before you start FERRIPROX Tablets and regularly 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. Your healthcare provider may temporarily stop treatment with FERRIPROX Tablets if you develop neutropenia or infection. Stop taking FERRIPROX Tablets and call your healthcare provider or 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 It is important for you to have your white blood cell count checked within 24 hours of developing symptoms of an infection to see if you have severe neutropenia (agranulocytosis). Do not delay getting medical care if you are unable to reach your healthcare provider. See “What are the possible side effects of FERRIPROX Tablets?” for more information about side effects.
What is FERRIPROX Tablets? 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
Do not take FERRIPROX Tablets if you are allergic to deferiprone or any of the ingredients in FERRIPROX Tablets. See the end of this Medication Guide for a complete list of ingredients in FERRIPROX Tablets.
Before taking FERRIPROX Tablets, tell your healthcare provider about all of your medical conditions, including if you: have liver problems are pregnant or plan to become pregnant. FERRIPROX Tablets can harm your unborn baby. You should avoid becoming pregnant during treatment with FERRIPROX Tablets. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with FERRIPROX Tablets. Females who are able to become pregnant: ○ Your healthcare provider should do a pregnancy test before you start treatment with FERRIPROX Tablets. ○ You should use effective birth control during treatment with FERRIPROX Tablets and for at least 6 months after the last dose. Males with female partners who are able to become pregnant: ○ You should use effective birth control during treatment with FERRIPROX Tablets and for at least 3 months after the last dose. are breastfeeding or plan to breastfeed. It is not known if FERRIPROX Tablets passes into your breast milk. Do not breastfeed during treatment with FERRIPROX Tablets and for at least 2 weeks after the last dose. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
How should I take FERRIPROX Tablets? Take FERRIPROX Tablets exactly as your healthcare provider tells you. Your healthcare provider will prescribe FERRIPROX Tablets based on your body weight. Your healthcare provider will check your body iron level during treatment with FERRIPROX Tablets and may change your dose if needed. Your healthcare provider may also change your dose of FERRIPROX Tablets if you have certain side effects. Do not change your dose of FERRIPROX Tablets unless your healthcare provider tells you to. There are 3 types of FERRIPROX Tablets that are taken on different schedules. Be sure you are taking the correct tablet and ask your healthcare provider if unsure.
FERRIPROX Tablets 1,000 mg Twice-a-Day 2 times each day with food			FERRIPROX Tablets 1,000 mg 3 times each day			FERRIPROX Tablets 500 mg 3 times each day
Take your first dose in the morning and the second dose in the evening, about 12 hours apart.			Take your first dose in the morning, the second dose at mid day, and the third dose in the evening.			Take your first dose in the morning, the second dose at mid-day, and the third dose in the evening.
Taking FERRIPROX Tablets with meals may help reduce nausea. If you must take a medicine to treat indigestion (antacid), or supplements that contain iron, aluminum, or zinc during treatment with FERRIPROX Tablets, allow at least 4 hours between taking FERRIPROX Tablets and these products. If you take too much FERRIPROX Tablets, call your healthcare provider. If you 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 should I avoid during treatment with FERRIPROX Tablets? Avoid drinking alcohol during treatment with FERRIPROX Tablets 1,000 mg (2 times a day). This may cause a faster release of the medicine.
What are the possible side effects of FERRIPROX Tablets? FERRIPROX Tablets can cause serious side effects, including: See “What is the most important information I should know about FERRIPROX Tablets?” Increased liver enzyme levels in your blood. Your healthcare provider should do blood tests to check your liver function before you start and then monthly during treatment with FERRIPROX Tablets. Your healthcare provider may temporarily stop treatment with FERRIPROX Tablets if you develop increased liver enzyme levels and they continue to be increased. Decreased levels of zinc in your blood. Your healthcare provider will do blood tests to check your zinc levels before you start and during treatment with FERRIPROX Tablets, and may prescribe a zinc supplement for you if your zinc levels are low.
The most common side effects of FERRIPROX Tablets in people with thalassemia include:
nausea joint paint	vomiting abnormal liver function tests			stomach-area (abdominal) pain low white blood cells
The most common side effects of FERRIPROX Tablets in people with sickle cell disease or other anemias include:
fever headache sickle cell anemia with crisis joint pain low white blood cells		stomach-area (abdominal) pain vomiting back pain mouth and throat pain cough			bone pain pain in arms or legs abnormal liver function tests common cold nausea
FERRIPROX Tablets may cause a change in urine color to reddish-brown. This is not harmful and is expected during treatment with FERRIPROX Tablets. These are not all of the possible side effects of FERRIPROX Tablets. 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 Tablets?
FERRIPROX Tablets 1,000 mg Twice-a-Day 2 times each day with food		FERRIPROX Tablets 1,000 mg 3 times each day			FERRIPROX Tablets 500 mg 3 times each day
Store at room temperature between 68°F to 77°F (20°C to 25°C).		Store at room temperature between 68°F to 77°F (20°C to 25°C). Store in the original bottle and tightly closed to protect from moisture.			Store at room temperature between 68°F to 77°F (20°C to 25°C).
Keep FERRIPROX Tablets and all medicines out of the reach of children.
General information about the safe and effective use of FERRIPROX Tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FERRIPROX Tablets for a condition for which it was not prescribed. Do not give FERRIPROX Tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about FERRIPROX Tablets that is written for health professionals.
What are the ingredients in FERRIPROX Tablets?
FERRIPROX Tablets 1,000 mg Twice-a-Day 2 times each day with food		FERRIPROX Tablets 1,000 mg 3 times each day			FERRIPROX Tablets 500 mg 3 times each day
Active ingredient: deferiprone Inactive ingredients: Tablet core: hypromellose acetate succinate, magnesium oxide, colloidal silicon dioxide and magnesium stearate. Coating: triethyl citrate, talc, titanium dioxide, and methacrylic acid and ethyl acrylate copolymer.		Active ingredient: deferiprone Inactive ingredients: Tablet core: methylcellulose, crospovidone, and magnesium stearate. Coating: hypromellose, hydroxypropyl cellulose, macrogol, and titanium dioxide.			Active ingredient: deferiprone Inactive ingredients: Tablet core: microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide. Coating: hypromellose, polyethylene glycol, and titanium dioxide.
Distributed by: Chiesi USA, Inc., Cary, NC 27518. Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9. CTFD-033-0521-00-SPL-1 For more information, call 1-888-661-9260.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 11/2021

Revised: 7/2023

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Set id: 946718ff-df43-1baa-74d1-e5bcfbe8ad86

Version: 11

Effective Time: 20230701

Chiesi USA, Inc.