Xofigo Informed Consent
PLACE LABEL HERE
INFORMED CONSENT FOR
XOFIGO Ra-223 DICHLORIDE
Nuclear Medicine
(This form is designed to comply with the Georgia Informed Consent Law O.C.G.A. 31-9-6.1)
PATIENT NAME: ______DATE: ______TIME: ______
The diagnosis requiring this procedure is: Castration-resistant (cancer that is no longer responding to hormone therapy) prostate cancer with metastases to the bone.
The nature of the procedure is: Intravenous Xofigo Ra-223 dichloride therapy
The purpose of this procedure is:To destroy cancer cells in the bone, potentially delaying the progression of cancer andpossibly relieving the pain associated with cancer in the bone.
Potential side effects of Xofigo Ra-223 dichloride therapy:
Most common adverse reactions from Xofigo include (greater than 10%)
- Nausea and Vomiting
- Diarrhea
- Peripheral edema (swelling of the extremities)
- Infection or bleeding from lowering of blood counts (anemia, lymphocytopenia, leucopenia, thrombocytopenia, and neutropenia)
Less likely side effects (less than 10%)
- Dehydration
- Injection site reactions (redness, pain and swelling at the injection site)
- Increased future cancer risk due to radiation exposure
- Bone marrow failure and death
The likelihood of success of this procedure is: good fair poor
THE PRACTICAL ALTERNATIVES TO THIS PROCEDURE ARE: Analgesics (pain relieving medications), chemotherapy or other medical therapies, palliative radiation therapy, participation in a clinical trial.
If I choose not to have the above procedure, my prognosis (future medical condition) is: Uncertain.
I understand that the practice of medicine is not an exact science and that NO GUARANTEES OR ASSURANCES HAVE BEEN MADE TO ME concerning the results of this procedure.
I have read this consent for or it has been read to me. I have had the opportunity to have all of my questions answered to my satisfaction. I know that I can call my physician or the GHS Nuclear Medicine department with any questions that might arise. I hereby voluntarily request and consent for Dr. ______, as my physician, and any other physician(s), and such associates, assistants or other medical personnel involved in performing such procedure(s), to perform the procedure(s) described or referred to herein.
______
Date Time Person giving consent Relationship to patient
Patient unable to sign due to: ______
Responsible Practitioner’s Statement:
I have reviewed the contents of this form, including the risks, benefits and alternatives to the proposed procedure, with the patient or the patient’s decision-maker, and have provided the patient/decision-maker with an opportunity to ask questions.
______
Date Time Physician Signature PID Number
*1-37785* FORM 1-37785 REV. 12/2016 Page 1 of 1