Description
Deferoxamine injection is used to remove excess iron from the body in anemia or thalassemia patients who have many blood transfusions. It is also used with other medicines to treat acute iron poisoning, especially in small children.
Deferoxamine combines with iron in the blood. The combination of iron and deferoxamine 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 to be administered only by or under the immediate supervision of your doctor.
This product is available in the following dosage forms:
- Powder for 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 deferoxamine injection 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 of deferoxamine injection in the elderly. However, elderly patients are more likely to have vision or hearing problems, and age-related kidney or heart problems, which may require caution and an adjustment in the dose for patients receiving deferoxamine injection.
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 receiving 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.
- Ascorbic Acid
- Busulfan
- Exagamglogene Autotemcel
- Lovotibeglogene Autotemcel
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:
- Aluminum overload or
- Dialysis treatment or
- Encephalopathy (brain disease), aluminum-related—May increase risk for more serious side effects.
- Anuria (not able to form urine) or
- Kidney disease, severe—Should not be used in patients with these conditions.
- Hyperparathyroidism (overactive parathyroid) or
- Kidney problems or
- Seizures, history of—Use with caution. May make these conditions worse.
- Infection (e.g., bacteria, fungus)—May decrease your body's ability to fight infection.
Proper Use
A nurse or other trained health professional will give you this medicine in a hospital or clinic. You may also be taught how to give your medicine at home. This medicine is given as a shot under your skin, into a muscle, or into a vein.
Deferoxamine may sometimes be given at home to patients who do not need to be in the hospital. If you are receiving this medicine at home, make sure you clearly understand and carefully follow your doctor's instructions.
Use a new needle, unopened vial, or syringe each time you inject your medicine.
You might not use all of the medicine in each vial (glass container). Use each vial only one time. Do not save an open vial. If the medicine in the vial has changed color, or if you see particles in it, do not use it.
Do not take vitamin C supplements unless your doctor has told you to do so.
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 injection dosage form:
- For acute iron toxicity:
- Adults, teenagers, and children 3 years of age and older—At first, 1000 milligrams (mg) per day injected into a muscle or vein. Your doctor may increase your dose by 500 mg every 4 hours for two doses. However, the total dose is usually not more than 6000 mg in 24 hours.
- Children younger than 3 years of age—Use and dose must be determined by your doctor.
- For chronic iron toxicity:
- Adults, teenagers, and children 3 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 1000 to 2000 milligrams (mg) (20 to 40 mg per kg of body weight) per day, injected under the skin, over a period of 8 to 24 hours.
- Children younger than 3 years of age—Use and dose must be determined by your doctor.
- For acute iron toxicity:
Missed Dose
Call your doctor or pharmacist for instructions.
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. Do not refrigerate. Keep from freezing.
Store the medicine that has been mixed at room temperature and use it within 3 hours. Throw away any mixed medicine that has not been used within this time.
Precautions
It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly and to decide if you should continue to use it. Blood and urine tests must be done regularly to check for unwanted effects .
Deferoxamine may cause some people to have hearing and vision problems within a few weeks after they start using it. This usually occurs if you are receiving high doses of this medicine and using it for a long period of time. If you or your child notice any problems with your hearing or vision, such as blurred vision, difficulty with night vision, or difficulty with seeing colors, check with your doctor as soon as possible.
Check with your doctor right away if you or your child have the following symptoms while using this medicine: agitation, confusion, decreased urine output, lethargy, muscle twitching, rapid weight gain, seizures, or swelling of the face, ankles, or hands. These may be symptoms of a serious kidney problem.
This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight every 3 months to make sure that your child is growing properly.
Stop using this medicine and check with your doctor right away if you or your child develop fever, shortness of breath, chest pain or tightness, trouble with breathing, or wheezing. These could be symptoms of a serious lung condition called acute respiratory distress syndrome.
Before you have any medical tests, tell the medical doctor in charge that you or your child are using this medicine. The results of some tests (e.g., magnetic resonance imaging or MRI) may be affected by this medicine.
This medicine may make you dizzy, drowsy, lightheaded, or trouble in hearing or seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert or able to see well.
This medicine may cause your urine to turn red 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 or nurse immediately if any of the following side effects occur:
More common
- Bluish fingernails, lips, or skin
- blurred vision or other problems with vision
- convulsions (seizures)
- difficulty with breathing or fast breathing
- fast heartbeat
- hearing problems
- redness or flushing of the skin
Less common
- Diarrhea
- difficult urination
- fever
- leg cramps
- nausea
- stomach and muscle cramps
- stomach discomfort
- unusual bleeding or bruising
- vomiting
Incidence not known
- Agitation
- coma
- confusion
- cough
- decreased urine output
- depression
- difficulty with swallowing
- dizziness
- headache
- hives
- hostility
- irritability
- itching
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lethargy
- muscle twitching
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- shortness of breath
- skin rash
- stupor
- swelling of the face, ankles, or hands
- tightness in the chest
- unusual tiredness or weakness
- wheezing
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:
Incidence not known
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
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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