PETNET Solutions PET/CT Reimbursement resources

Indications & usage

Ammonia N 13 Injection (13NH3) is a radioactive diagnostic agent for positron emission tomography (PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.

Important safety information

• Cancer Risk: Ammonia N 13 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and the health care worker.
• Adverse Reactions: No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. The completeness of the sources is not known.

Dosage forms and strengths

Glass vial (30 mL) containing 0.138-1.387 GBq (3.75-37.5 mCi/mL) of Ammonia N 13 Injection in aqueous 0.9 % sodium chloride solution (the total volume in the vial will vary) for intravenous administration.

Ammonia N 13 Injection is manufactured and distributed by:
PETNET Solutions, Inc.
810 Innovation Drive
Knoxville, TN 39732

These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively.

Indications & usage

Axumin® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

Important safety information

• Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.

• Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.

• Axumin use contributes to a patient's overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.

• Adverse reactions were reported in ≤1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.

To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Dosage forms and strengths

Injection: supplied as a clear, colorless solution in a 30 mL multiple-dose vial containing 335 MBq/mL to 8200 MBq/mL (9 mCi/mL to 221 mCi/mL) fluciclovine F 18 at calibration time and date.

Indications & usage

Sodium Fluoride F 18 Injection (18F NaF) is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging bone to define areas of altered osteogenic activity.

Important safety information

• Allergic Reactions: As with any injectable drug, allergic reactions and anaphylaxis may occur. Emergency resuscitation equipment and personnel should be immediately available.
• Cancer Risk: Sodium Fluoride F 18 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker.
• Adverse Reactions: No adverse reactions have been reported based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. The completeness of the sources is not known.

Dosage forms and strengths

Multiple-dose vial containing 370–7,400 MBq/mL (10–200 mCi/mL) of no-carrier-added sodium fluoride F 18 at EOS reference time in aqueous 0.9% sodium chloride solution. Sodium Fluoride F 18 Injection is a clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration.

Sodium Fluoride F 18 Injection is manufactured and distributed by:
PETNET Solutions, Inc.
810 Innovation Drive
Knoxville, TN 39732

These highlights do not include all the information needed to use Sodium Fluoride F 18 Injection safely and effectively.

Indications & usage

Fludeoxyglucose F 18 Injection (18F FDG) is indicated for positron emission tomography (PET) imaging in the following settings:

• Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
• Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
• Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.

Important safety information

• Radiation Risk: Radiation-emitting products, including Fludeoxyglucose F18 Injection, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker.
• Blood Glucose Abnormalities: In the oncology and neurology setting, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels. In these patients, consider medical therapy and laboratory testing to ensure at least two days of normoglycemia prior to Fludeoxyglucose F 18 Injection administration.
• Adverse Reactions: Hypersensitivity reactions with pruritus, edema, and rash have been reported. Have emergency resuscitation equipment and personnel immediately available.

Dosage forms and strengths

Multiple-dose 30 mL and 50 mL glass vial containing 0.74 to 7.40 GBq/mL (20 to 200 mCi/mL) Fludeoxyglucose F 18 Injection and 4.5 mg of sodium chloride with 0.1 to 0.5% w/w ethanol as a stabilizer (approximately 15 to 50 mL volume) for intravenous administration.

Fludeoxyglucose F 18 Injection is manufactured and distributed by:
PETNET Solutions, Inc.
810 Innovation Drive
Knoxville, TN 39732

These highlights do not include all the information needed to use Fludeoxyglucose F 18 Injection safely and effectively. 

Indications & usage

CERIANNA is indicated 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.

Limitations of use
Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR).

Important safety information

Contraindications
None

Warnings and precautions
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. Pathology or clinical characteristics that suggest a patient may benefit from systemic hormone therapy should take precedence over a discordant negative CERIANNA scan.

Radiation risks
Diagnostic radiopharmaceuticals, including CERIANNA, expose patients to radiation. Radiation exposure is associated with dose-dependent increased risk of cancer. Ensure safe drug handling and patient preparation procedures (including adequate hydration and voiding) to protect patients and health care providers from unintentional radiation exposure.

Pregnancy status
Assessment of pregnancy status is recommended in females of reproductive potential before administering CERIANNA.

Adverse reactions
In clinical trials (n=1207) the most common adverse reactions seen occurred at a rate < 1%: were injection-site pain and dysgeusia.

Use in specific populations
Pregnancy risk summary
All radiopharmaceuticals, including CERIANNA, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of radiation dose. Advise a pregnant woman of the potential risks of fetal exposure to radiation from administration of CERIANNA.

There are no available data on CERIANNA use in pregnant women. No animal reproduction studies using fluoroestradiol F 18 have been conducted to evaluate its effect on female reproduction and embryo-fetal development.

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Lactation risk summary
There are no data on the presence of fluoroestradiol F 18 in human milk, or its effects on the breastfed infant or milk production. Lactation studies have not been conducted in animals. Advise a lactating woman to avoid breastfeeding for 4 hours after CERIANNA administration in order to minimize radiation exposure to a breastfed infant.

Pediatric use
The safety and effectiveness of CERIANNA in pediatric patients have not been established.

Geriatric use
Clinical studies of fluoroestradiol F 18 injection did not reveal any difference in pharmacokinetics or biodistribution in patients aged 65 and over.

Drug interactions
Systemic endocrine therapies that target estrogen receptors
Certain classes of systemic endocrine therapies, including ER modulators and ER down-regulators, block ER, reduce the uptake of fluoroestradiol F 18, and may reduce detection of ER-positive lesions after administration of CERIANNA. Drugs from these classes such as tamoxifen and fulvestrant may block ER for up to 8 and 28 weeks, respectively. Do not delay indicated therapy in order to administer CERIANNA. Administer CERIANNA prior to starting systemic endocrine therapies that block ER.

To report SUSPECTED ADVERSE REACTIONS, contact Zionexa US Corp at +1.844.946.6392 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Dosage forms and strengths

Injection: clear, colorless solution in a multiple-dose vial containing 148 MBq/mL to 3,700 MBq/mL (4 mCi/mL to 100 mCi/mL) of Cerianna at end of synthesis.

Patient preparation

• Drink water to ensure adequate hydration prior to administration of 18F FES
• Continue drinking and voiding frequently during the first hours following administration to reduce radiation exposure

Dosage and administration 

• Activity recommended is 222 MBq (6 mCi), with a range of 111 MBq to 222 MBq (3 mCi to 6 mCi)
• Administration : single IV injection of 10 mL or less over 1 to 2 minutes
• Use aseptic technique and radiation shielding when withdrawing and administering FES.
• Visually inspect the radiopharmaceutical solution
• FES may be diluted with 0.9% Sodium Chloride Injection, USP
• Assay the dose in a suitable dose calibrator prior to administration

Post administration

• Follow FES injection with an IV flush of 0.9% Sodium Chloride injection, USP