Imaging Site Locator Registration Form

Imaging site locator registration form

Please complete this form to authorize the addition of your imaging site's information.

Imaging site information

This information will be displayed in imaging site locator.

Fields marked * are required

Imaging site name

Address

Floor number, Suite number, etc.

City

State

ZIP/Postal Code

Phone

Phone extension

Website

*Type of imaging center

Hospital-based

Stand-alone imaging center

The following information will not be displayed in imaging site locator.

*Has your facility completed reader training?

Yes

Contact name

Contact phone number

Contact email address

To remove your facility from this list or request a specific change/update to a current site already in the Locator, contact us at pylcenters@lantheus.com.

*I agree

By submitting this form, I confirm that the above imaging site will be added to the PYLARIFY.com Imaging Site Locator. I also consent to being contacted to confirm/answer questions about the imaging site information.

Enrollment and participation is free, and does not impose any requirements on the manner in which the facility provides service to patients. Progenics Pharmaceuticals, Inc. (“Progenics”), a Lantheus company, does not recommend or endorse any site included in the PYLARIFY® Imaging Site Locator for any purpose. Participating sites on the PYLARIFY® Imaging Site Locator are listed based on the geographical search information entered. Progenics will host this information on Progenics websites, including but not limited to PYLARIFY.com, and provide the information shared here to other vendors for the same purpose. Progenics retains the right to remove sites from the PYLARIFY® Imaging Site Locator, and agrees to remove the facility’s name upon written request.

INDICATION & IMPORTANT
SAFETY INFORMATION

PYLARIFY (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy.

with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Radiation Risks

Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

INDICATION

PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy.

with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

INDICATION

with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

IMPORTANT SAFETY INFORMATION

Contraindications

None.

Warnings and Precautions

Risk of Image Misinterpretation

Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant tissue. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Hypersensitivity Reactions

Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks

Adverse Reactions

The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug Interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

To report suspected adverse reactions for PYLARIFY, call 1-800-362-26681-80‌0-36‌2-2668 or contact FDA at 1-800-332-10881-800-FDA-1088 or www.fda.gov/medwatch.

For important risk and use information about PYLARIFY Injection, please see Full Prescribing information.

References

Imaging site locator registration form

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