Albuquerque Center for Rheumatology, P



Company Name

Address

Address

Phone: ____________

FAX: ___________

Informed Consent for Treatment with KRYSTEXXA

Savient Pharmaceuticals, Inc. announced the FDA approved the use of KRYSTEXXA for gout. Gout is the result of too much uric acid in a person’s body. The uric acid can form crystals that collect in the joints, kidneys, and other organs. KRYSTEXXA (pegloticase) is a uric acid specific enzyme that is a PEGylated product that contains recombinant modified mammalian urate oxidase (uricase) produced by a genetically modified strain of Escherichia Coli (E. coli) and is the only medication currently available that reduces the uric acid levels in patients who have not responded to conventional therapy.

KRYSTEXXA may reduce your serum uric acid level and reduce the size of tophi.

PRECAUTIONS:

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 KRYSTEXXA, the following should be considered:

If you decide not to receive KRYSTEXXA you may have an increase in the frequency, duration and severity of gout flare-ups, develop tophi, and/or develop joint erosion. The development of tophi and joint erosion will result in decrease mobility and deformity of joints, and increased pain.

Anaphylaxis occurred in 6.5% of the patients during clinical trials that were treated with KRYSTEXXA every two weeks. Anaphylaxis may occur with any infusion, including the first infusion, and generally manifests within 2 hours of the infusion. Delayed hypersensitivity has also been reported.

ALLERGIES: Tell you doctor if you have ever had any unusual reaction to KRYSTEXXA.

OTHER MEDICATIONS: Tell your doctor about all the prescription medications, over-the-counter medications, herbal supplements, ointments and all medications prescribed by other doctors.

OTHER MEDICAL PROBLEMS: Tell your doctor if you have ever had an adverse reaction to KRYSTEXXA, have a history of congestive heart failure or have been diagnosed with G6PD (glucose-6-phosphate dehydrogenase) or favism. Your doctor will run lab tests to rule out G6PD prior to your infusion.

LABORATORY MONITORING: Your doctor will order lab tests to be done before your initial infusion and then at specific intervals during your KRYSTEXXA treatments to see if KRYSTEXXA is providing the desired effect on your serum uric acid level.

INFUSION REACTIONS: Infusion reaction symptoms include: wheezing, shortness of breath, cough, chest tightness, chest pain, trouble breathing, dizziness, fainting, fast or weak heartbeat or feeling nervous, reddening of the face, itching, hives, feeling warm, swelling of the throat or tongue, throat tightness, hoarse voice or trouble swallowing.

PREGNANCY & BREAST FEEDING: It is not known if KRYSTEXXA will harm your unborn baby. Tell your doctor right away, if you are pregnant or plan to become pregnant. It is not known if KRYSTEXXA passes into your breast milk. You and your healthcare provider should decide if you will receive KRYSTEXXA or breastfeed. You should not do both. Breast-feeding is not recommended during treatment and for a while after you stop receiving KRYSTEXXA.

DOSAGE AND ADMINISTRATION:

Tylenol, Benadryl and Solu-Medrol will be administered before each infusion as ordered by your doctor.

The most common dose of KRYSTEXXA is 8 mg intravenously every 2 weeks. KRYSTEXXA is administered intravenously (IV) over 2 hours. Your doctor will discontinue KRYSTEXXA treatment if your serum uric acid level increases to more than 6 mg/dl, particularly when 2 consecutive levels above

6 mg/dl are observed.

ADVERSE REACTIONS AND WARNINGS:

KRYSTEXXA therapy does involve risks and may cause unwanted effects. Serious side effects have occurred in patients treated with KRYSTEXXA. These include anaphylaxis, increased gout flares, infusion reaction, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, and vomiting.

YOUR RIGHTS AS A PATIENT: You have the right to stop treatment with KRYSTEXXA at any point in your treatment.

EMERGENCY CONTACTS:

In case of an emergency, you can contact our office at__________ from 8:00am – 4:30pm Monday-Thursday. After business hours, call the answering service at___________ and you will be directed to the physician on call.

I certify that I have read and understand this consent form and agree to receive KRYSTEXXA intravenous treatment. I have had an opportunity to discuss this treatment with my physician and ask questions regarding this treatment. Upon request, I will be given a signed copy of this form for my records.

Patient Name

_____________________________________________DOB:_______________________________

(Printed)

Patient Signature

_____________________________________________________Date_____________________

Witness Signature

_____________________________________________________Date____________________

FINANCIAL RESPONSIBILITY:

Our office will contact your insurance company and the necessary arrangements will be made for approval of the medication and administration. You may want to follow up with your insurance company also to be sure everything is covered and your cost. Our office does NOT provide a guarantee of coverage for any of these services. If coverage is not provided, YOU WILL BE RESPONSIBLE for any charges incurred for treatment and/or follow-up care.

Patient Signature _______________________________________Date ___________________

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download