Flotufolastat f-18
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From MedlinePlus, U.S. National Library of Medicine
Radioactive Diagnostic Agent
Dosing in kidney impairment
The radiation absorbed doses to the critical organs of adrenal glands, kidneys, and submandibular glands for the recommended activity of 296 MBq are 54.3 mGy, 51 mGy, and 43.8 mGy, respectively. When PET/CT is performed, exposure to radiation will increase by an amount dependent on the settings used in the CT acquisition. [See table below.]
| *The absorbed dose value reflects self-irradiation only; no dose contribution from other regions to the glands is added. **A 1-hour bladder voiding interval is assumed. | |
| Organ/Tissue | Absorbed Dose per Unit Administered Activity (mGy/MBq) |
| Mean | |
| Adrenal glands | 0.184 |
| Brain | 0.002 |
| Breasts | 0.004 |
| Gallbladder wall | 0.017 |
| Lower large intestine wall | 0.007 |
| Upper large intestine wall | 0.01 |
| Heart wall | 0.02 |
| Kidneys | 0.172 |
| Lacrimal glands | 0.08 * |
| Liver | 0.062 |
| Lungs | 0.01 |
| Muscle | 0.006 |
| Osteogenic cells | 0.012 |
| Ovaries | 0.005 |
| Pancreas | 0.028 |
| Parotid glands | 0.114 * |
| Red bone marrow | 0.01 |
| Skin | 0.002 |
| Small intestine | 0.012 |
| Spleen | 0.083 |
| Stomach wall | 0.012 |
| Sublingual glands | 0.065 * |
| Submandibular glands | 0.148 * |
| Testes | 0.005 |
| Thymus gland | 0.01 |
| Thyroid | 0.01 |
| Urinary bladder wall | 0.006 ** |
| Uterus | 0.011 |
| Effective dose (mSv/MBq) | 0.014** |
Preparation and administration
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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. Calculate the necessary volume to administer based on calibration time and required dose. The recommended maximum volume of undiluted POSLUMA is 5 mL.
POSLUMA may be diluted with 0.9% Sodium Chloride Injection, USP. Assay the dose in a dose calibrator before administration. Post Administration Instructions After the POSLUMA injection, administer an intravenous flush of sterile 0.9% Sodium Chloride Injection, USP to ensure full delivery of the dose. Dispose of any unused drug in a safe manner in compliance with applicable regulations.
Patient Preparation Instruct patients to drink water prior to administration of POSLUMA to ensure adequate hydration and to continue drinking and voiding frequently for the first few hours following administration to reduce radiation exposure.
Drug interactions
Check flotufolastat f-18 against a medication listLabel text (1 paragraph)
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.
Contraindications
None. None. ( 4 )
Pregnancy and lactation
Pregnancy
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.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.