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Fluoroestradiol F-18: Drug information

Fluoroestradiol F-18: Drug information
(For additional information see "Fluoroestradiol F-18: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Cerianna
Pharmacologic Category
  • Radiopharmaceutical
Dosing: Adult
Radioimaging

Radioimaging: IV: 6 mCi (222 MBq); range: 3 to 6 mCi (111 to 222 MBq).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

<1%:

Gastrointestinal: Dysgeusia

Local: Pain at injection site

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Special handling:

• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and health care personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority.

Other warnings/precautions:

• Experienced staff: Images should only be interpreted by specially trained personnel.

• Limitations: Not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) or the progesterone receptor (PR). Tissue biopsy should be used to confirm recurrence of breast cancer and to verify estrogen receptor (ER) status by pathology. Uptake of fluoroestradiol F18 is not specific for breast cancer and may occur in other ER-positive tumors outside of the breast (eg, uterus, ovaries). A negative scan does not rule out ER-positive breast cancer; pathology or clinical characteristics suggestive that patient may benefit from systemic hormone therapy should take precedence over a negative scan.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Cerianna: 148-3,700 MBq/mL (4-100 mCi/mL) (1 ea) [contains alcohol, usp]

Generic Equivalent Available: US

No

Pricing: US

Solution (Cerianna Intravenous)

4-100 mci/mL (per each): $5,280.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

IV: Administer as a single IV bolus injection over 1 to 2 minutes. Administer in a total volume of ≤10 mL; may dilute with NS. Following the injection, flush with NS. Administer prior to starting systemic endocrine therapies that target estrogen receptor (ER) (eg, ER modulators, ER down-regulators). Initiate imaging 80 minutes after injection. Instruct patients to increase their hydration before and after administration (to minimize radiation to the bladder); encourage voiding frequently during the first hours following administration. See manufacturer's prescribing information for complete administration procedure.

Radiopharmaceutical; use appropriate precautions for handling and disposal. Waterproof gloves should be worn, and effective shielding should be used during handling and administration.

Use: Labeled Indications

Radioimaging: For use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.

Medication Safety Issues
Other safety concerns:

Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and health care personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Estrogen Receptor Antagonists: May diminish the diagnostic effect of Fluoroestradiol F18. Management: Image patients with fluoroestradiol F-18 prior to starting systemic endocrine therapies that block the estrogen receptor. Use of fluoroestradiol F-18 should not delay indicated treatment. Risk D: Consider therapy modification

Selective Estrogen Receptor Modulators: May diminish the diagnostic effect of Fluoroestradiol F18. Management: Image patients with fluoroestradiol F-18 prior to starting systemic endocrine therapies that block the estrogen receptor. Use of fluoroestradiol F-18 should not delay indicated treatment. Risk D: Consider therapy modification

Reproductive Considerations

Evaluate pregnancy status prior to use in females of reproductive potential.

Pregnancy Considerations

Animal reproduction studies have not been conducted. All radiopharmaceuticals have the potential to cause fetal harm if exposure occurs during pregnancy.

Breastfeeding Considerations

It is not known if fluoroestradiol F18 is present in breast milk.

To decrease potential exposure to a breastfed infant, breastfeeding is not recommended by the manufacturer for 4 hours following administration.

Monitoring Parameters

Evaluate pregnancy status prior to use in females of reproductive potential.

Mechanism of Action

Fluoroestradiol F18 binds to estrogen receptor (ER); the F18 isotope produces a positron signal that is detected by a positron emission tomography (PET) scanner.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Hepatobiliary system (primary), large and small intestines, heart wall, blood, kidney, uterus, bladder.

Protein binding: 95%.

Metabolism: Hepatic.

Excretion: Biliary and urinary.

  1. Cerianna (fluoroestradiol F18) [prescribing information]. Marlborough, MA; Zionexa US Corp: March 2022.
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