Description
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.
This product is available in the following dosage forms:
- Tablet
- Solution
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness deferiprone in the elderly.
Breastfeeding
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.
Drug Interactions
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
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.
- For oral dosage forms (oral liquid):
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
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
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.
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