Krystexxa, also known by its generic name “pegloticase,” is an injectable medicine used to treat severe, treatment-refractory, chronic gout in adults who are nonresponsive to standard gout treatment.
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About Copay AssistanceKrystexxa belongs to the drug class “antihyperuricemic agents or antigout agents,” which works to lower the overproduction of uric acid levels in gout patients. This drug was first approved by the FDA in 2010 based on the results of two clinical trials.
Krystexxa is only available by prescription.
What Is Krystexxa Used To Treat?
The FDA approves Krystexxa for the treatment of chronic gout in adults. Gout is a type of arthritis that occurs due to abnormally high uric acid levels in the body. When a high level of uric acid builds up in the blood or the fluid around the joints, it transforms into uric acid crystals, which cause severe pain, redness, and swelling in the joints.
Over time, the uric acid crystals form masses of white growths around the joints and soft tissues (called tophi), which often become visible under the skin and look like swollen nodules. This further damages the joint, leading to a loss of motion in your joints.
Patients with chronic gout experience repeated episodes of severe pain and inflammation in more than one joint, also known as gout attacks.
When Is Krystexxa Prescribed to Gout Patients?
Krystexxa is usually prescribed as a third-line treatment and can be used alone or in combination with methotrexate in patients with chronic gout under the following circumstances:
- When conventional gout medications do not work well or are contraindicated in some patients. Some commonly prescribed gout medications include xanthine oxidase inhibitors, allopurinol, febuxostat, and probenecid.
- A patient fails to achieve the serum uric acid target.
- A patient continues to have frequent gout flares (≥2 flares/year).
- A patient has non-resolving subcutaneous tophi.
How Does Krystexxa Work?
The active substance in Krystexxa, pegloticase, contains an enzyme called uricase, which is produced through recombinant DNA technology methods in the laboratory. Uricase enzyme breaks down the uric acid deposits (crystals) into more soluble substances (allantoin), which are then excreted out from the body through urine.
When the uric acid level fell below 6 mg/dl, the crystals in the joints started to dissolve, slowly shrinking the tophi.
Can Krystexxa Be Used in Patients with Hyperuricemia?
As per FDA guidelines, Krystexxa is not recommended for treating hyperuricemia (a condition that describes a high level of uric acid) in people without associated symptomatic gout.
Generally, people with hyperuricemia can take other medications to lower uric acid levels in their bodies. However, hyperuricemia could become a risk factor for gout if not treated in a timely manner.
In the case of people with chronic gout, when no conventional gout medications work well, Krystexxa is specifically recommended as a third-line treatment to lower the elevated uric acid levels in these patients.
In short, this medication is not indicated for general use in all cases of hyperuricemia.
In What Pharmaceutical Form Is Krystexxa Available and Supplied?
Krystexxa comes in the form of a clear, sterile 8 mg/ml solution of pegloticase and is supplied in a single-dose vial.
The solution is diluted (mixed) with a 250 ml bag containing 0.9% sodium chloride before use.
What Is the Recommended Dose for Adult Gout Patients?
The recommended dose of Krystexxa for adults with chronic gout is 8 mg, which should be administered once every 2 weeks.
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How Is Krystexxa Given?
Krystexxa is recommended to be given alone or in combination with methotrexate as an intravenous infusion over no less than 120 minutes via an infusion pump. The healthcare provider injects the medicine intravenously (into a vein).
Other important things to note:
- Krystexxa should not be administered as an intravenous push or bolus.
- To minimize the risk of infusion reactions, patients should receive premedication, such as antihistamines and corticosteroids.
What Are the Common Side Effects?
You may experience the following side effects after taking Krystexxa infusion:
- New gout flares (increases in the first 3 months due to changing serum uric acid levels and eventually decreases in the subsequent 3 months of treatment)
- Nausea
- Chest pain
- Vomiting
- Fatigue
- Joint pain
- Constipation
You may also experience serious allergic reactions that can be life-threatening and mostly occur within 2 hours of infusion. Therefore, it is recommended that patients be premedicated with antihistamines and corticosteroids to reduce the risk of infusion and allergic reactions.
How Long Is Krystexxa Therapy?
Patients generally see improvements in their condition after 3 months of treatment with Krystexxa. However, it is suggested to stay on therapy for 6 to 12 months or as long as your doctor recommends.
What Special Precautions Should You Follow?
Before taking Krystexxa infusion, tell your doctor if you:
- Are pregnant or intend to become pregnant
- Are breastfeeding or plan to breastfeed
- Ever had any condition like heart failure, heart disease, or hypertension (high blood pressure)
- Are allergic to pegloticase
- Are taking any medication such as prescription and over-the-counter medicines, vitamins, and herbal supplements
What Drugs Should You Avoid While Taking Krystexxa?
You should not take other uric acid-lowering medication while taking Krystexxa as they can cause unwanted or dangerous effects. Some uric acid-lowering medicines you should not take are allopurinol, febuxostat, and probenecid.
Who Should Not Take Krystexxa?
Patients with a metabolic disease called glucose-6-phosphate dehydrogenase (G6PD) deficiency or favism, which is a rare blood disorder, should not take Krystexxa. This medication can increase the risk of hemolysis and methemoglobinemia in these patients.
Patients who are at higher risk of G6PD deficiency should be screened before starting Krystexxa.
Cost
Krystexxa (8 mg/mL) intravenous solution can cost around $30,882 for a supply of 1 ml. The cost can vary depending on the pharmacy you visit. Patients with low incomes or who are uninsured can participate in patient assistance programs to lower the treatment cost. Contact us if you are interested in receiving financial assistance.
REFERENCES:
- US Food and Drug Administration (FDA). Krystexxa Prescribing Information: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125293s034lbl.pdf
- European Medicines Agency (EMC). Krystexxa Prescribing Information: https://www.ema.europa.eu/en/documents/overview/krystexxa-epar-summary-public_en.pdf
- Guttmann, A., Krasnokutsky, S., Pillinger, M. H., & Berhanu, A. (2017). Pegloticase in gout treatment – safety issues, latest evidence, and clinical considerations. Therapeutic Advances in Drug Safety, 8(12), 379-388. https://doi.org/10.1177/2042098617727714
- Pegloticase injection: MedlinePlus drug information. (n.d.). https://medlineplus.gov/druginfo/meds/a611015.html
- Reinders, M. (2010). New advances in the treatment of gout: review of pegloticase. Therapeutics and Clinical Risk Management, Volume 6, 543–550. https://doi.org/10.2147/tcrm.s6043
- Sundy, J., Baraf, H., Yood, R., Edwards, N., Gutierrez-Urena, S., Treadwell, E., ´zquez-Mellado, J. V., White, W., Lipsky, P., Horowitz, Z., Huang, W., Maroli, A., Waltrip, R., Hamburger, S., & Becker, M. (2011). Efficacy and tolerability of Pegloticase for the treatment of chronic gout in patients refractory to conventional treatment. JAMA, 306(7), 711. https://doi.org/10.1001/jama.2011.1169
