pharmacopeia

Flotufolastat

Positron Emitting ActivityUS-FDASourced from openFDA
GET
/api/v1/drug/flotufolastat

Mechanism of action

Sourced from openFDA

Flotufolastat F 18 binds to PSMA (IC50 = 4.4 nM) expressed on cells, including prostate cancer cells, and is internalized. Prostate cancer cells usually overexpress PSMA.

Indications

Sourced from openFDA
  • POSLUMA 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.ICD-10: C61

Contraindications

Sourced from openFDA
  • None. None.contraindicated

Dosage & administration

Sourced from openFDA

Recommended amount of radioactivity of POSLUMA is 296 MBq (8 mCi) administered as an intravenous bolus injection. ( 2.2 ) Initiate imaging approximately 60 minutes after administration. Scanning should start from mid-thigh and proceed to base of skull. ( 2.4 ) See full prescribing information for additional preparation, handling, administration, imaging, and radiation dosimetry information. ( 2.3 , 2.4 ) 2.1 Radiation Safety - Drug Handling Handle POSLUMA with safety measures to minimize radiation exposure [ see Warnings and Precautions ( 5.2 )] . Use waterproof gloves, effective radiation shielding, including syringe shields, and other appropriate safety measures when handling and administering POSLUMA. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. 2.2 Recommended Dose and Administration Instructions Recommended Dose The recommended amount of radioactivity to be administered in adults is 296 MBq (8 mCi) as an intravenous bolus injection. Preparation and Administration Instructions Inspect POSLUMA visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored. Use aseptic technique and radiation shielding when withdrawing and administering POSLUMA.

Warnings & precautions

Sourced from openFDA

Risk of Image Misinterpretation: Image interpretation errors can occur with POSLUMA imaging. Interpretation of POSLUMA PET may differ depending on imaging readers in patients with suspected recurrence of prostate cancer. Consider multidisciplinary consultation and histopathological confirmation. ( 5.1 , 14.2 ) Radiation risk: POSLUMA contributes to a patient's long-term cumulative radiation exposure. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure. ( 2.1 , 5.2 ) 5.1 Risk of Image Misinterpretation Image interpretation errors can occur with POSLUMA PET. 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 POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping [See Clinical Studies ( 14.1 )] . The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels [See Clinical Studies ( 14.2 )] . Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.

Adverse reactions

Sourced from openFDA

The most common adverse reactions (≥0.4%) are diarrhea, blood pressure increase, and injection site pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Blue Earth Diagnostics Ltd at 1-844-POSLUMA (1-844-767-5862) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 POSLUMA was evaluated in 747 patients with prostate cancer [see Clinical Studies ( 14.1 , 14.2 )] . All patients received a single administration of POSLUMA with an administered radioactivity (mean ± SD) of 307 ± 23 MBq (8.3 ± 0.6 mCi). The mean age of patients was 67 years (range: 43 to 86 years); distribution by race was 78% White, 12% Black or African American, 2% other, and 7% unreported; and distribution by ethnicity was 5% Hispanic/Latino, 87% non-Hispanic/Latino, and 8% unreported. The adverse reactions reported in ≥ 0.4% of patients are shown in Table 2 . Table 2: Adverse Reactions in ≥ 0.4% of Patients with Prostate Cancer Receiving POSLUMA Adverse Reaction POSLUMA N = 747 n (%) Diarrhea 5 (0.7%) Blood pressure increase 4 (0.5%) Injection site pain 3 (0.4%)

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary POSLUMA is not indicated for use in females. There are no available data on the use of POSLUMA 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 POSLUMA, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. 8.2 Lactation Risk Summary POSLUMA is not indicated for use in females. There are no data on the presence of flotufolastat F 18 in human milk, the effect on the breastfed infant, or the effect on milk production. 8.4 Pediatric Use The safety and effectiveness of POSLUMA have not been established in pediatric patients. 8.5 Geriatric Use Among the total number of patients receiving POSLUMA in clinical studies of prostate cancer, 463 (62%) were 65 years of age and older, while 118 (16%) were 75 years of age and older [see Clinical Studies ( 14.1 , 14.2 )] . No overall differences in safety or effectiveness were observed between these patients and younger adult patients.

Pharmacokinetics

Sourced from openFDA
Metabolism
Distribution Following intravenous administration, flotufolastat F 18 distributes to liver (15.8% of administered activity), heart blood pool (7.4%), and kidneys (3.2%) and is cleared from the blood. Elimination Metabolism Flotufolastat F 18 does not undergo metabolism up to 50 minutes post injection.

Overdosage

Sourced from openFDA

In the event of an overdose of POSLUMA, maintain hydration of the patient and frequent voiding to minimize radiation exposure. A diuretic might also be considered. If possible, an estimate of the radiation effective dose administered to the patient should be made.

Approval history

Sourced from openFDA
  • May 25, 2023NDANDA216023Blue Earth

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
38 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Positron Emission Tomogram Abnormal1026%
  2. 2No Adverse Event924%
  3. 3Drug Effect Less Than Expected821%
  4. 4Overdose411%
  5. 5Incorrect Dose Administered37.9%
  6. 6Wrong Product Administered37.9%
  7. 7Drug Ineffective25.3%
  8. 8Product Dispensing Error25.3%
  9. 9Accidental Exposure To Product12.6%
  10. 10Acute Respiratory Failure12.6%
  11. 11Asthenia12.6%
  12. 12Chest Pain12.6%
  13. 13Covid-1912.6%
  14. 14Death12.6%
  15. 15Diarrhoea12.6%

Clinical trials

View JSON

The 10 most recently updated of 23 ClinicalTrials.gov registrations naming Flotufolastat as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Flotufolastat work?
Flotufolastat F 18 binds to PSMA (IC50 = 4.4 nM) expressed on cells, including prostate cancer cells, and is internalized. Prostate cancer cells usually overexpress PSMA.
What is Flotufolastat used for?
According to FDA labeling, Flotufolastat carries indications including: POSLUMA 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Flotufolastat?
Flotufolastat is classified as Positron Emitting Activity.
What are the contraindications for Flotufolastat?
Flotufolastat labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.
Note. Data for flotufolastat is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients