Anaphylaxis and infusion reactions have been reported to occur during and after administration of pegloticase. Pegloticase should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Patients should be premedicated with antihistamines and corticosteroids and be closely monitored for an appropriate period of time for anaphylaxis after administration of pegloticase. Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed .
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 administered only by or under the immediate supervision of your doctor.
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:
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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pegloticase injection in the elderly.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
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:
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.
This medicine must be given slowly, so the needle will remain in place for a few hours (up to 2 hours or longer). You may also receive medicines (e.g., 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.
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. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, hives, itching, dizziness, shortness of breath, swelling of your hands, face, mouth, or tongue, trouble with breathing or swallowing, or chest pain after you receive the medicine.
This medicine may cause infusion reactions, such as a 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 or Mediterranean 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 three 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 (e.g., 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.
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:
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:
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.