Pronunciation:

de-FER-i-prone

Brand Names:

• Ferriprox

Dosage Forms:

• Tablet
• Solution

Warnings:

Agranulocytosis and NeutropeniaDeferiprone 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 regularly while 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

Classifications:

Therapeutic—

Heavy Metal Chelator

Uses of This Medicine:

Deferiprone is used to remove excess iron from the body in patients with thalassemia, sickle cell disease, or anemia who have blood transfusions.

Deferiprone is an iron chelator (binder). It 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.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of deferiprone tablets in children younger than 8 years of age and deferiprone oral liquid in children younger than 3 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness deferiprone in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Busulfan
• Diclofenac
• Exagamglogene Autotemcel
• Lovotibeglogene Autotemcel
• Phenylbutazone
• Probenecid
• Silymarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems (eg, agranulocytosis, neutropenia) or
• Liver disease—Use with caution. May make these conditions worse.

• Diamond Blackfan anemia or
• Myelodysplastic syndrome (bone marrow cancer)—Safety and efficacy have not been established in patients with these conditions.

• Infection—May decrease your body's ability to fight infection.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have questions.

If you are taking the oral liquid or tablet 3 times a day: It is best to take the first dose of this medicine in the morning, the second dose at mid-day, and the third dose in the evening with meals unless your doctor tells you otherwise.

If you are taking the tablet 2 times a day: Take the first dose in the morning and the second dose in the evening with food.

Use a marked measuring spoon, oral syringe, or medicine cup to measure the oral liquid.

If you have trouble swallowing the tablet, you may use the oral liquid form of this medicine.

If you are taking antacids, multivitamins, or supplements containing aluminum, iron, and zinc, take these medicines at least 4 hours before or after taking deferiprone.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For chronic iron overload:
  • For oral dosage forms (oral liquid):
    • Adults and children 3 years of age and older—Dose is based on body weight and must be determined by your doctor. At first, 25 milligrams (mg) per kilogram (kg) of body weight, 3 times a day (75 mg per kg per day). Your doctor may adjust your dose as needed. However, the dose is usually not more than 33 mg per kg of body weight, 3 times a day (99 mg per kg per day).
    • Children younger than 3 years of age—Use and dose must be determined by your doctor.
  • For oral dosage forms (1000-mg tablets):
    • Adults and children 8 years of age and older—Dose is based on body weight and must be determined by your doctor. At first, 75 milligrams (mg) per kilogram (kg) of body weight per day, given in 2 or 3 divided doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 99 mg per kg of body weight per day.
    • Children younger than 8 years of age—Use and dose must be determined by your doctor.
  • For oral dosage forms (500-mg tablets):
    • Adults and children 8 years of age and older—Dose is based on body weight and must be determined by your doctor. At first, 25 milligrams (mg) per kilogram (kg) of body weight, 3 times a day (75 mg per kg per day). Your doctor may adjust your dose as needed. However, the dose is usually not more than 33 mg per kg of body weight, 3 times a day (99 mg per kg per day).
    • Children younger than 8 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

You may store the oral liquid at room temperature for up to 8 weeks. Throw away any unused medicine after 8 weeks.

Keep the bottle tightly closed. Use the tablets dispensed only in its original container.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective birth control to keep from getting pregnant during treatment and for at least 6 months after the last dose of this medicine. Male patients who have female partners who can become pregnant must use an effective birth control during treatment and for at least 3 months after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Deferiprone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Check with your doctor right away if you start to have a cough that will not go away, weight loss, night sweats, a fever, chills, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs that you have an infection.

This medicine may cause your urine to turn red or brownish in color. This is normal and is nothing to worry about.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Black, tarry stools

bone pain

chills

cough

fever

lower back or side pain

painful or difficult urination

pale skin

sore throat

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Fever with or without chills

general feeling of tiredness or weakness

hoarseness

Incidence not known

Anxiety

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

blurred vision

chest pain, discomfort, or tightness

clay-colored stools

confusion

dark urine

decreased urination

dilated neck veins

dizziness or lightheadedness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

dry mouth

fainting

fast or irregular heartbeat

headache

hives, itching, skin rash

increase in heart rate

increased sweating

irregular breathing

irritation

joint pain, stiffness, or swelling

large, flat, blue or purplish patches in the skin

loss of appetite

muscle tremors

nausea

nervousness

painful knees and ankles

pinpoint red spots on the skin

pounding in the ears

raised red swellings on the skin, the buttocks, legs, or ankles

rapid weight gain

rapid, deep or shallow breathing

redness of the skin

restlessness

seizures

severe nausea or vomiting

slow heartbeat

sneezing

spots on your skin resembling a blister or pimple

stomach pain or cramps

sudden trouble breathing

sugar in the urine

sunken eyes

sweating

swelling of the eyelids, around the eyes, face, lips, hands, or feet

thirst

tingling of the hands or feet

trouble with balance

trouble breathing or swallowing

unpleasant breath odor

unusual weight gain or loss

vision changes

vomiting of blood

weight gain

wrinkled skin

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty with moving

muscle pain or stiffness

reddish or brown discoloration of the urine

stomach discomfort

Less common

Back pain

belching

diarrhea

heartburn

increased or decreased appetite

indigestion

pain in the arms or legs

stomach upset

Incidence not known

Bloody nose

clenching, gnashing, or grinding teeth

constipation

coughing or spitting up blood

depression

difficulty opening the mouth

difficulty with speaking

drooling

impaired psychomotor skills

increased sensitivity of the skin to sunlight

lockjaw

loss of balance control

muscle spasm, especially of the neck and back

muscle trembling, jerking, or stiffness

pains in the stomach, side, or abdomen, possibly radiating to the back

severe sunburn

shuffling walk

sleepiness or unusual drowsiness

stiffness of the limbs

stomach bloating, burning, cramping, or pain

twisting movements of the body

uncontrolled movements, especially of the face, neck, and back

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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