Pylarify

Last updated on RxList: 6/7/2021
Pylarify Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Pylarify?

Pylarify (piflufolastat F 18) 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 or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

What Are Side Effects of Pylarify?

Side effects of Pylarify include:

  • headache,
  • changes in taste, and
  • fatigue.

Dosage for Pylarify

The recommended dose of Pylarify is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.


Pylarify In Children

The safety and effectiveness of Pylarify in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Pylarify?
 

Pylarify may interact with other medicines such as:

  • androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists.

Tell your doctor all medications and supplements you use.


Pylarify During Pregnancy and Breastfeeding

Pylarify is not indicated for use in females. There is no information on the risk of adverse developmental outcomes in pregnant women with the use of Pylarify. All radiopharmaceuticals, including Pylarify, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. There is no information on the presence of Pylarify in breast milk, the effect on the breastfed infant, or the effect on milk production.

Additional Information

Our Pylarify (piflufolastat F 18) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Pylarify Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of PYLARIFY was evaluated in 593 patients, each receiving one dose of PYLARIFY. The average injected activity was 340 ± 26 MBq (9.2 ± 0.7 mCi).

The adverse reactions reported in >0.5% of patients within the studies are shown in Table 2. In addition, a hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reaction.

Table 2: Adverse Reactions with a Frequency >0.5% in Patients Who Received PYLARIFY(n = 593)

Adverse Reaction n (%)
Headache 13 (2%)
Dysgeusia 10 (2%)
Fatigue 7 (1%)

DRUG INTERACTIONS

Androgen Deprivation Therapy And Other Therapies Targeting The Androgen Pathway

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.

Read the entire FDA prescribing information for Pylarify (Piflufolastat F 18 Injection)

SLIDESHOW

Screening Tests Every Man Should Have See Slideshow

© Pylarify Patient Information is supplied by Cerner Multum, Inc. and Pylarify Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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