Monday, 2 April 2012

Pegloticase


Pronunciation: peg-LOE-ti-kase
Generic Name: Pegloticase
Brand Name: Krystexxa

Serious, life threatening allergic reactions may occur in some people who receive Pegloticase. These reactions usually occur within 2 hours after receiving Pegloticase, but can occur at any time during or after you receive Pegloticase. Tell your doctor or nurse immediately if you experience any of the following symptoms: dizziness; fainting; fast or weak heartbeat; nervousness; rash; hives; itching; chest pain or tightness; cough; trouble breathing; wheezing; trouble swallowing; swelling of the mouth, face, lips, tongue, or throat; or unusual hoarseness.


Pegloticase is given in a doctor's office, hospital, or clinic where serious allergic reactions can be treated if one occurs. Your health care provider will watch you for any signs of a serious allergic reaction during and after your treatment with Pegloticase. Your doctor will prescribe other medicines to help decrease the risk of an allergic reaction or infusion-related side effects.


Lab tests, including blood uric acid levels, will be monitored before and while you use Pegloticase. Contact your doctor if you have any questions or concerns about this information.





Pegloticase is used for:

Treating chronic gout in certain patients.


Pegloticase is a uric acid-specific enzyme (uricase). It works by allowing uric acid to be more easily removed from the body by the kidneys.


Do NOT use Pegloticase if:


  • you are allergic to any ingredient in Pegloticase

  • you have high blood uric acid levels without symptoms

  • you have a history of blood problems, such as methemoglobinemia (a bluish discoloration to the skin and mucous membranes) or hemolysis, after receiving Pegloticase

  • you have a metabolic condition called glucose 6-phosphate dehydrogenase (G6PD) deficiency or favism

Contact your doctor or health care provider right away if any of these apply to you.



Before using Pegloticase:


Some medical conditions may interact with Pegloticase. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you are of African or Mediterranean ancestry

  • if you have a history of heart problems (eg, congestive heart failure [CHF]) or high blood pressure

Some MEDICINES MAY INTERACT with Pegloticase. Tell your health care provider if you are taking any other medicines. However, no specific interactions with Pegloticase are known at this time.


Ask your health care provider if Pegloticase may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Pegloticase:


Use Pegloticase as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Pegloticase comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Pegloticase refilled.

  • Pegloticase is usually given as an injection at your doctor's office, hospital, or clinic.

  • You may receive certain other medicines, including an antihistamine (eg, diphenhydramine) and a corticosteroid (eg, prednisone), before each treatment with Pegloticase. This will help to decrease the chance of an allergic reaction to Pegloticase. Discuss any questions with your doctor.

  • Do not use Pegloticase if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

  • If you miss a dose of Pegloticase, contact your doctor immediately to establish a new dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Pegloticase.



Important safety information:


  • Patients with a metabolic condition called G6PD deficiency should not use Pegloticase because it can severely damage your red blood cells (hemolysis), leading to anemia. It may also cause a condition that affects the ability of your red blood cells to carry oxygen (methemoglobinemia). If you are of African or Mediterranean descent, you may be at higher risk of G6PD deficiency and should be tested to see if you have this condition before starting Pegloticase. Contact your doctor with any questions or concerns.

  • Gout flares may increase in the first 3 months after you start taking Pegloticase. Do not stop taking Pegloticase if you develop increased gout flares. Your doctor may prescribe certain other medicines (eg, a nonsteroidal anti-inflammatory drug [NSAID] [eg, ibuprofen], colchicine) to decrease the risk of gout flares. Contact your doctor with any questions or concerns.

  • Lab tests, including uric acid levels, may be performed while you use Pegloticase. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Pegloticase should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: It is not known if Pegloticase can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pegloticase while you are pregnant. It is not known if Pegloticase is found in breast milk. Do not breast-feed while taking Pegloticase.


Possible side effects of Pegloticase:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Bruising; constipation; mild sore throat; nausea; vomiting.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; chest pain or tightness; trouble breathing; wheezing; swelling of the mouth, face, lips, tongue, or throat; or unusual hoarseness); cough; dizziness; fainting; fast or irregular heartbeat; nervousness; new or worsening joint pain or swelling; persistent sore throat; reddening of the face or feeling warm; severe or persistent nausea or vomiting; shortness of breath; swelling of the stomach, feet, or ankles; trouble swallowing.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Pegloticase side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of Pegloticase:

Pegloticase is usually handled and stored by a health care provider. If you are using Pegloticase at home, store Pegloticase as directed by your pharmacist or health care provider. Keep Pegloticase out of the reach of children and away from pets.


General information:


  • If you have any questions about Pegloticase, please talk with your doctor, pharmacist, or other health care provider.

  • Pegloticase is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Pegloticase. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Pegloticase resources


  • Pegloticase Side Effects (in more detail)
  • Pegloticase Use in Pregnancy & Breastfeeding
  • Pegloticase Drug Interactions
  • Pegloticase Support Group
  • 2 Reviews for Pegloticase - Add your own review/rating


  • Pegloticase Professional Patient Advice (Wolters Kluwer)

  • Pegloticase Monograph (AHFS DI)

  • pegloticase Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Krystexxa Prescribing Information (FDA)

  • Krystexxa Consumer Overview



Compare Pegloticase with other medications


  • Gout

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