Sierra Rheumatology Inc.
2207 Plaza Drive, Suite 100, Rocklin, CA 95765
Telephone: (916) 677-4744 Fax: (916) 781-2029
Informed Consent for Treatment with Intravenous Krystexxa (pegloticase)
What is KRYSTEXXA?
KRYSTEXXA (pegloticase) is a uric acid specific enzyme which is a PEGylated product that consists of recombinant modified mammalian urate oxidase (uricase) produced by a genetically modified strain of Escherichia coli.
KRYSTEXXA is a prescription medicine used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments.
People with gout have too much uric acid in their bodies. Uric acid crystals collect in joints, kidneys, and other organs. This may cause pain, redness and swelling (inflammation). KRYSTEXXA works to lower blood levels of uric acid.
KRYSTEXXA is NOT for use in people with too much uric acid in their bodies who do not have symptoms (asymptomatic hyperuricemia). It is not known if KRYSTEXXA is safe and effective in children under 18 years of age.
Who should not received KRYSTEXXA?
- If you have a rare blood problem called glucose 6-phosphate dehydrogenase (G6PD) deficiency or favism. Your doctor may test you for G6PD before you start KRYSTEXXA.
- If you have had a serious allergic reaction to KRYSTEXXA or any of its ingredients.
Before you receive KRYSTEXXA, tell your doctor about all your medical conditions, including if you:
- Ever had any heart problems or high blood pressure.
- Are pregnant or plan to become pregnant. It is not known if KRYSTEXXA will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
- Are breastfeeding or plan to breastfeed. It is not known if KRYSTEXXA passes into your breast milk. You and your doctor should decide if you will receive KRYSTEXXA or breastfeed.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not take any other uric acid lowering drug, such as allopurinol, febuxostat (Uloric) or probenecid, while receiving KRYSTEXXA.
How will I receive KYRSTEXXA?
- KRYSTEXXA is recommended to be given with another prescription medicine called methotrexate. KRYSTEXXA may also be used alone. You and your doctor will decide the treatment that is right for you.
- Your doctor may give you medicine before your treatment of KRYSTEXXA to help reduce your risk of getting gout flares or an allergic reaction. Take these medicines as directed by your doctor or nurse.
- You will receive KRYSTEXXA through a needle in your vein (intravenous infusion).
- Your treatment will take about 2 hours or sometimes longer.
- You will receive KRYSTEXXA every 2 weeks.
- If you have side effects, your doctor may stop or slow the infusion and may give you medicine to help the side effects.
- A doctor or nurse will watch you for side effects while you receive KRYSTEXXA and for some time afterwards.
- Your doctor may stop your KRYSTEXXA if your uric acid levels do not become normal and stay controlled or you have certain side effects.
- Your gout flares may increase in the first 3 months when you start receiving KRYSTEXXA. Do not stop receiving KRYSTEXXA even if you have a flare as the amount of flares will decrease after 3 months of treatment. Your doctor may give you other medicines to help reduce your gout flares for the first few months after starting KRYSTEXXA.
Side effects of KRYSTEXXA:
The most common side effects of KRYSTEXXA when given together with methotrexate include:
• gout flares • joint pain • coronavirus disease 2019 (COVID-19) • nausea • fatigue
The most common side effects of KRYSTEXXA include:
• gout flares • allergic reactions (including infusion reactions).
Dose and administration:
8 mg every two weeks given as an intravenous infusion, co-administered with weekly methotrexate 15 mg orally
WARNING AND PRECAUTIONS
- Anaphylaxis: Anaphylaxis may occur with any KRYSTEXXA infusion. Please let us know immediately if you notice tongue edema, urticaria, trouble breathing, chest pain, nausea, dizziness, abdominal pain
- Infusion Reactions
- G6PD Deficiency Associated Hemolysis and Methemoglobinemia: Screen patients at risk for G6PD deficiency. Do not administer KRYSTEXXA to patients with G6PD deficiency.
- Gout Flares: Gout flare prophylaxis is recommended for at least the first 6 months of KRYSTEXXA therapy.
- Congestive Heart Failure: Congestive heart failure exacerbation may occur.
ADVERSE REACTIONS:
- Co-administration with methotrexate: The most common adverse reactions (≥5% of patients) are gout flares, arthralgia, COVID-19, nausea and fatigue.
- KRYSTEXXA alone: The most common adverse reactions (≥5% of patients) are gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis and vomiting.
USE IN SPECIFIC POPULATIONS
- Pregnancy: There are no adequate and well-controlled studies of KRYSTEXXA in pregnant women
- Lactating mothers: It is not known whether this drug is excreted in human milk. Therefore, KRYSTEXXA should not be used when breastfeeding unless the clear benefit to the mother can overcome the unknown risk to the newborn/infant.
EMERGENCY CONTACTS:
In case of an emergency, please call 911 or go to the nearest emergency room. You can contact our office at (916) 677-47444 from 8:00 am to 5:00 pm Monday – Friday.
I certify that I have read and understand this consent form and agree to receive Krystexa intravenous treatment. I have had an opportunity to discuss this treatment with my physician and ask questions regarding the treatment. I will be given a signed copy of this form for my records.