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 a needle placed in one of your veins. It must be given slowly, so the needle will remain in place for a few hours (up to 2 hours or longer).
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, antihistamines, corticosteroids) to help prevent possible allergic reactions to the injection.
This medicine is usually given every 2 weeks. If you miss a dose or forget to receive your medicine, call your doctor for instructions.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Precautions
Your doctor will check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, hives, itching, dizziness, swelling of your hands, face, mouth, or tongue, trouble breathing or swallowing, or chest pain after you receive the medicine.
This medicine may cause infusion reactions, including rash, itching, or redness of the skin, difficulty with breathing, feeling of warmth or redness of the face, neck, arms, and occasionally, upper chest, or chest discomfort or pain while you are receiving the injection or within 2 hours after you receive it. Tell your doctor or nurse right away if you have any of these symptoms.
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
- difficult or labored 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
- muscle 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
- unusual tiredness or weakness
- unusually warm skin
Rare
- Decreased urine output
- dilated neck veins
- extreme fatigue
- irregular breathing
- irregular heartbeat
- swelling of the face, fingers, feet, or lower legs
- weight gain
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)
- large, flat, blue, or purplish patches in the skin
- sore throat
- stuffy or runny nose
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
