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Piflufolastat F 18 Dosage

Usual Adult Dose for Positron Emission Tomography Imaging

Recommended dose: 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

Post-administration instructions:

  • Follow the injection with an intravenous flush of 0.9% Sodium Chloride Injection USP.

Comments:
  • Initiate imaging 60 minutes after administration. Starting more than 90 minutes after injection may adversely impact imaging performance.
  • The patient should void immediately prior to initiation of imaging.
  • Image acquisition should be started from mid-thigh and proceed to the skull vertex, with patient positioned supine with arms above the head.

Use(s): 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 PSA level.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.
This drug is not for use in female patients.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

  • This is a radioactive drug and should be handled by qualified personnel (licensed by the Nuclear Regulatory Commission or relevant regulatory authority), using appropriate safety measures to minimize radiation exposure during administration.
  • Use waterproof gloves and radiation shielding, including syringe shields to prepare and administer.
  • Should be a clear, colorless solution. Do not administer if discolored or contains particulate matter.
  • Post-administration, dispose any unused drug in compliance with applicable regulations.

Storage requirements:
  • Store at room temperature between 20C and 25C (68F to 77F), in the original container with radiation shielding.

Patient advice:
  • Drink water to ensure adequate hydration prior to administration and continue drinking and voiding frequently during the first few hours following administration to reduce radiation exposure.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.