Piflufolastat F 18

Piflufolastat F 18 is an imaging agent used 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.

• Piflufolastat F 18 is available under the following different brand names: Pylarify

Common side effects of Piflufolastat F 18 include:

• headache
• changes in taste
• fatigue

Serious side effects of Piflufolastat F 18 include:

• itching or hives 
• swelling in the face or hands, swelling, or tingling in the mouth or throat 
• chest tightness
• trouble breathing
• fast heartbeat

Rare side effects of Piflufolastat F 18 include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 37-2960 MBq/mL (1-80 mCi/mL) per vial at calibration date and time

Prostate cancer PET imaging

Adult dosage

• 333 MBq (9 mCi), range of 296-370 MBq (8-10 mCi), administered as a single bolus IV injection

Dosage Considerations – Should be Given as Follows: 

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Piflufolastat F 18 has severe interactions with no other drugs.
• Piflufolastat F 18 has serious interactions with no other drugs.
• Piflufolastat F 18 has moderate interactions with no other drugs.
• Piflufolastat F 18 has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Piflufolastat F 18?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Piflufolastat F 18?”

Cautions

• Monitor for hypersensitivity reactions, particularly in patients with a history of allergy to other drugs and foods; reactions may not be immediate; trained staff and resuscitation equipment should always be available
• Risk for image misinterpretation
  • Imaging interpretation errors can occur
  • A negative image does not rule out the presence of prostate cancer, and a positive one does not confirm the presence of prostate cancer
  • Drug uptake is not specific for prostate cancer and may occur with other types of cancer and nonmalignant processes and in normal tissues
  • Clinical correlation, which may include histopathological evaluation of suspected prostate cancer site, is recommended
• Radiation risks
  • Diagnostic radiopharmaceuticals expose patients to radiation
  • Radiation exposure is associated with a dose-dependent increased risk for cancer
  • Ensure safe drug handling and patient preparation procedures to protect patients and healthcare providers from unintentional radiation exposure
• Drug interaction overview
  • Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway
  • ADT and other therapies target the androgen pathway (eg, androgen receptor antagonists) and may result in changes in the uptake of piflufolastat F18 in prostate cancer
  • Effect of these therapies on performance has not been established

Pregnancy and Lactation

• Not indicated for use in women
• There is no information on the risk for adverse developmental outcomes in pregnant women or animals
• All radiopharmaceuticals, including piflufolastat F18, may potentially cause fetal harm depending on the fetal stage of development and magnitude of radiation dose
• Lactation
  • Not indicated for use in women
  • There is no information on drug presence in human milk, its effects on breastfed infants, or milk production