Flotufolastat F 18

Flotufolastat F 18 is a radioactive diagnostic agent used for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

• Flotufolastat F 18 is available under the following different brand names: Posluma

Common side effects of Flotufolastat F 18 include:

• headache
• changes in taste
• fatigue

Serious side effects of Flotufolastat F 18 include:

• diarrhea
• blood pressure increase
• injection site pain

Rare side effects of Flotufolastat 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, lightheadedness, 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

Injection, solution

• 296-5,846 MBq/mL (8-158 mCi/mL) in approximately 25 mL multidose vials at calibration time and date

Prostate cancer imaging

Adult dosage

• Recommended dose: 296 MBq (8 mCi) IV bolus

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.

• Flotufolastat F 18 has severe interactions with no other drugs
• Flotufolastat F 18 has serious interactions with no other drugs
• Flotufolastat F 18 has moderate interactions with the following drugs:
  • abiraterone
  • bicalutamide
  • degarelix
  • enzalutamide
  • flutamide
  • nilutamide
• Flotufolastat 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 Flotufolastat F 18?”

Long-Term Effects

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

Cautions

• Misinterpretation
  • Image interpretation errors can occur with flotufolastat F 18 PET imaging
  • A negative image does not rule out recurrent prostate cancer, and a positive image does not confirm the presence of recurrent prostate cancer
  • Performance of flotufolastat F 18 for imaging metastatic pelvic lymph nodes in patients before initial definitive therapy seems to be affected by PSA levels and risk grouping
  • Not specific to prostate cancer and may occur with other types of cancer, in nonmalignant processes, and normal tissue
  • Clinical correlation, which may include histopathological evaluation of the suspected recurrence site, is recommended
  • Interpretation may differ depending on imaging readers, particularly in the prostate/prostate bed region
  • Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline
• Radiation Risk
  • Use contributes to a patient's overall long-term cumulative radiation exposure
  • Long-term cumulative radiation exposure is associated with an increased risk for cancer
  • Ensure safe handling to minimize radiation exposure to patients and clinicians
• Drug interaction overview
  • Therapies targeting the androgen pathway
  • Androgen deprivation therapy and other therapies targeting the androgen pathway (eg, androgen receptor antagonists) can result in changes in the uptake of flotufolastat F 18 in prostate cancer
  • The effects of these therapies on flotufolastat F 18 PET's performance have not been established

Pregnancy and Lactation

• Flotufolastat F 18 is not indicated for use in women 
• There is no available data on the use of flotufolastat F 18 in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Animal reproduction studies have not been conducted with flotufolastat F 18
• Radioactive drugs, including flotufolastat F 18, have the potential to cause fetal harm depending on the fetal
• Stage of development and the magnitude of the radiation dose
• Lactation
  • Flotufolastat F 18 is not indicated for use in women
  • There are no data on the presence of Flotufolastat F 18 in human milk, the effect on the breastfed infant, or on milk production