Description
Pegloticase injection is used to treat chronic gout in adult patients who have already been treated with other medicines that did not work well. Gout is a condition that is caused by too much uric acid in the blood (hyperuricemia).
Pegloticase injection works by causing less uric acid to be produced by the body. This medicine will not relieve a gout attack that has already started.
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- 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 pegloticase injection in the pediatric population. 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 pegloticase injection 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 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.
- Allopurinol
- Oxypurinol
- Probenecid
- Sulfinpyrazone
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:
- Congestive heart failure—Use with caution. May make this condition worse.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency (a hereditary metabolic disorder affecting red blood cells) or
- Hyperuricemia, asymptomatic (without noticeable symptoms)—Should not be used in patients with these conditions.
Proper Use
A nurse or other trained health professional will give you this medicine in a hospital or clinic. This medicine is given through an IV catheter that is placed into one of your veins. It must be given slowly, so the IV will need to remain in place for at least 2 hours. This medicine is given every 2 weeks.
Your doctor may also give you methotrexate and folic acid or folinic acid supplements at least 4 weeks before starting and during treatment with this medicine.
You may also receive medicines (eg, allergy medicine, steroids) to prevent infusion reactions.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Precautions
It is very important that your doctor check your progress closely while you are receiving this medicine to make sure that it is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, skin rash, trouble breathing, or unusual tiredness or weakness.
This medicine may cause infusion reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, chest pain, dizziness, flushing, headache, trouble breathing, hives, itching, or skin rash, lightheadedness, fainting, fast, pounding, or uneven heartbeat, or trouble breathing after receiving this medicine.
Patients of African, Mediterranean, or Southern Asian ancestry are at higher risk of serious side effects and should be carefully evaluated by their doctor before starting this medicine.
Gout flares may occur in the first 3 months when you start receiving this medicine. Do not stop receiving this medicine even if you have a gout flare. Your doctor may give you medicines (eg, colchicine, non-steroidal antiinflammatory drug or NSAID) to reduce and prevent worsening of the gout.
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
- Chest pain, discomfort, or tightness
- cough
- diarrhea
- difficult breathing
- difficulty in moving
- difficulty with swallowing
- dizziness
- facial swelling
- fast heartbeat
- fever or chills
- flushing or redness of the skin
- gout flare
- headache
- hives or welts, itching, or skin rash
- joint pain
- loss of taste or smell
- muscle aches, pain, or stiffness
- nausea or vomiting
- pain in the arms or legs
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
- unusually warm skin
Less common
- Blurred vision
- nervousness
- pounding in the ears
- slow or fast heartbeat
Rare
- Decreased urine output
- dilated neck veins
- extreme fatigue
- irregular breathing
- irregular heartbeat
- swelling of the face, fingers, feet, or lower legs
- weight gain
Incidence not known
- Bloating or swelling of face, arms, hands, lower legs, or feet
- rapid weight gain
- tingling of the hands or feet
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
- Bruise
- contusion
- difficulty having a bowel movement (stool)
- difficulty in moving
- large, flat, blue, or purplish patches in the skin
Less common
- Arm or leg pain
Incidence not known
- Lack or loss of strength
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.
DRG-20074500
