We can offer a well-established safety profile

Safety in clinical trials

Safety was established based on 2 prospective, open-label, multi-center clinical studies of another formulation of piflufolastat F 18 in men with prostate cancer: OSPREY and CONDOR.

Adverse reactions that occurred in >0.5% of patients in OSPREY and CONDOR (N=593)1

Adverse Reaction n (%)
Headache 13 (2.0%)
Dysgeusia 10 (2.0%)
Fatigue 7 (1.0%)

In addition, a hypersensitivity reaction was reported in 1 patient (0.2%) with a history of allergic reactions. Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may not be immediate. Always have trained staff and resuscitation equipment available.1

Risk of image misinterpretation1

While PYLARIFY TruVu carries a Warning and Precaution about the potential for image misinterpretation, it does not carry an additional specific Warning and Precaution for image misinterpretation in the prostate/prostate bed in patients with BCR.

See Important Safety Information below for the Warnings and Precautions for Risk of Image Misinterpretation for additional information.

Drug interactions1

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

Patient counseling information1

Instruct patients to drink a sufficient amount of water to ensure adequate hydration before their PET study and urge them to drink and urinate as often as possible during the first hours following the administration of PYLARIFY TruVu, in order to reduce radiation exposure.

See study designs

To report suspected adverse reactions for PYLARIFY TRUVU, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information for PYLARIFY TRUVU.

INDICATION

PYLARIFY TRUVU (piflufolastat F 18) Injection is 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

Warnings and Precautions

Risk of Image Misinterpretation

Imaging interpretation errors can occur with PYLARIFY TRUVU 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 TRUVU for imaging biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY TRUVU 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 TRUVU 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, is recommended.

Hypersensitivity Reactions

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

Radiation Risks

PYLARIFY TRUVU exposes 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. 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 TRUVU in prostate cancer. The effect of these therapies on performance of PYLARIFY TRUVU PET has not been established.

To report suspected adverse reactions for PYLARIFY TRUVU, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information for PYLARIFY TRUVU.

REFERENCE

1. PYLARIFY TruVu™ [package insert]. North Billerica, MA: Aphelion LLC, a Lantheus company.