cerianna
Cerianna (Fluoroestradiol F-18) is a medication used to treat Breast Neoplasms, Hypogonadism, Premature Menopause, Menorrhagia.
Fluoroestradiol F-18 · by Ge Healthcare
Key facts
- Active ingredient
- Fluoroestradiol F-18
- Form
- Injectable
- Strength
- Fluoroestradiol F-18 50ML (4-100mCi/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- breast neoplasms, hypogonadism, premature menopause
- Manufacturer
- Ge Healthcare
- FDA application
- NDA212155
What is Cerianna?
From the FDA label:11.1 Chemical Characteristics CERIANNA contains fluoroestradiol fluorine 18 (F 18), a synthetic estrogen analog. Chemically, fluoroestradiol F 18 is [18F]16α-fluoro-3,17β-diol-estratriene-1,3,5(10). The molecular weight is 289.37, and the structural formula is: CERIANNA is a sterile, clear, colorless solution for intravenous injection, with an osmolarity of 340 mOsm. Its pH ranges between 5.5 to 8.0. The composition of the final product in 40 mL solution is fluoroestradiol no more than 5 mcg, fluoroestradiol F 18 148 MBq/mL to 3,700 MBq/mL (4 mCi/mL to 100 mCi/mL), sodium ascorbate 0.44% w/v in sodium chloride 0.9% w/v, and ethanol no more than 3.2% w/v. Chemical Structure 11.2 Physical Characteristics CERIANNA is radiolabeled with F 18, a cyclotron produced radionuclide that decays by positron emission to stable oxygen 18 with a half-life of 109.8 minutes. The principal photons useful for diagnostic imaging are the coincident pair of 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron (Table 2). Table 2. Principal Radiation Produced From Decay of Fluorine 18 Radiation Radiation Energy Level (keV) % Abundance Positron 249.8 96.9 Gamma 511 193.5 11.3 External Radiation The point source air-kerma coefficient for F 18 is 3.75 × 10 -17 Gy m 2 / (Bq s). The first half-value thickness of lead (Pb) for F 18 gamma rays is approximately 6 mm.…
How to use
Recommended dose is 222 MBq (6 mCi), with a range of 111 MBq to 222 MBq (3 mCi to 6 mCi), administered as an intravenous injection over 1 to 2 minutes. ( 2.2 ) Recommended imaging start time is 80 minutes (range 20 minutes to 80 minutes) after drug administration. ( 2.4 ) See full prescribing information for additional preparation, administration, imaging, and radiation dosimetry information. ( 2 ) 2.1 Radiation Safety - Drug Handling CERIANNA is a radioactive drug. Only authorized persons qualified by training and experience should receive, use, and administer CERIANNA. Handle CERIANNA with appropriate safety measures to minimize radiation exposure during administration [see Warnings and Precautions (5.2) ] . Use waterproof gloves and effective radiation shielding, including syringe shields, when preparing and handling CERIANNA. 2.2 Recommended Dosage and Administration Instructions Recommended Dosage The recommended amount of radioactivity to be administered for PET imaging is 222 MBq (6 mCi), with a range of 111 MBq to 222 MBq (3 mCi to 6 mCi), administered as a single intravenous injection of 10 mL or less over 1 to 2 minutes. Preparation and Administration For patient preparation instructions, see Dosage and Administration 2.3 . Use aseptic technique and radiation shielding when withdrawing and administering CERIANNA. Visually inspect the radiopharmaceutical solution. Do…
Side effects
Reported adverse reactions include: injection-site pain and dysgeusia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 1-800-654-0118 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 CERIANNA was evaluated from published clinical studies of 1,207 patients with breast cancer receiving at least one fluoroestradiol F 18 administration. The following adverse reactions occurred at a rate < 1%: General disorders : injection-site pain Neurological and gastrointestinal disorders : dysgeusia
Warnings
Important safety information
Risk of Misdiagnosis . Do not use CERIANNA in lieu of biopsy when biopsy is indicated in patients with recurrent or metastatic breast cancer. Pathology or clinical characteristics that suggest a patient may benefit from systemic hormone therapy should take precedence over a discordant negative CERIANNA scan. ( 5.1 ) Radiation Risks . Ensure safe drug handling and patient preparation procedures to protect patients and health care providers from unintentional radiation exposure. ( 2.1 , 2.3 , 5.2 ) 5.1 Risk of Misdiagnosis Inadequate Tumor Characterization and Other ER-Positive Pathology Breast cancer may be heterogeneous within patients and across time. CERIANNA images ER and is not useful for imaging other receptors such as HER2 and PR. The uptake of fluoroestradiol F 18 is not specific for breast cancer and may occur in a variety of ER-positive tumors that arise outside of the breast, including from the uterus and ovaries. Do not use CERIANNA in lieu of biopsy when biopsy is indicated in patients with recurrent or metastatic breast cancer. False Negative CERIANNA Scan A negative CERIANNA scan does not rule out ER-positive breast cancer [see Clinical Studies (14) ] . Pathology or clinical characteristics that suggest a patient may benefit from systemic hormone therapy should take precedence over a discordant negative CERIANNA scan. 5.2 Radiation Risks Diagnostic radiopharmaceuticals, including CERIANNA, expose patients to radiation [see Dosage and Administration (2.6) ] . Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe drug handling and patient preparation procedures to protect patients and health care providers from unintentional radiation exposure [see Dosage and Administration (2.1) and (2.3) ] .
Who should not take Cerianna
None . None. ( 4 )
Interactions
Drugs that bind to the estrogen receptor (ER) may compete with the binding of fluoroestradiol F 18 and may reduce the detection of ER-positive lesions with CERIANNA. Before administering CERIANNA, discontinue drugs that bind to the ER, such as SERMs and SERDs, for at least 5 biological half-lives (e.g., elacestrant for 11 days, tamoxifen for 8 weeks, and fulvestrant for 28 weeks) [see Dosage and Administration (2.3) ] . Before administering CERIANNA, discontinue drugs that bind to the ER, such as SERMs and SERDs, for at least 5 biological half-lives (e.g., elacestrant for 11 days, tamoxifen for 8 weeks, and fulvestrant for 28 weeks). ( 2.3 , 7 )
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Cerianna treat?
- Cerianna (Fluoroestradiol F-18) may be used to treat breast neoplasms, hypogonadism, premature menopause, menorrhagia, prostatic neoplasms, primary ovarian insufficiency, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Cerianna?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cerianna. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Cerianna?
- Cerianna is marketed by Ge Healthcare. You can see Ge Healthcare's full profile, rating, and other products on pharmaranks.
- Is Cerianna a brand-name or generic drug?
- Cerianna is a brand-name product with the active ingredient Fluoroestradiol F-18.
- Is Cerianna available over the counter?
- No. Cerianna is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Cerianna come in?
- Cerianna is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Cerianna FDA-registered?
- Cerianna is on record with the U.S. FDA under application number NDA212155. You can verify this on its official FDA label.
- Is Cerianna safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Cerianna. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Cerianna?
- Cerianna's side effects are taken directly from its FDA label. From the label: Reported adverse reactions include: injection-site pain and dysgeusia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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