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CORPORATE INFORMATION

Lantheus
331 Treble Cove Rd.
N. Billerica, MA 01862

Phone: 1-800-362-2668

Email: info@lantheus.com

CUSTOMER SERVICE

US Customer Service/Order PYLARIFY®

Phone: 1-800-964-0446

Hours: 8:30 am to 8:00 pm ET, Monday to Friday

Email: cspyl@lantheus.com

PYLARIFY® REIMBURSEMENT RESOURCES

Call Toll Free: 844-339-8514

Email: reimbursement@lantheus.com

Lantheus cannot guarantee coverage or payment for products or procedures. Payer policies can vary widely and third party payment for medical products and services is affected by numerous factors. It is always the provider’s responsibility to determine and submit appropriate codes, charges, and modifiers for services rendered. For more specific information, contact your third-party payer directly in order to obtain up-to-date coverage, coding, and payment information.

ADVERSE EVENT AND PRODUCT QUALITY COMPLAINT REPORTS

Adverse Events and Product Quality Complaint Reports must be reported through the following channels:

Phone: 1-800-343-7851
Press Option 2 for Adverse Events
Press Option 2 for Product Quality Complaints

Fax: 978-436-7296

Email: lantheussafety@lantheus.com

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.

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.

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 processes and in normal tissues. 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

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.

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

FDA clearance letter for aPROMISE X. Food and Drug Administration. April 29, 2022.