Fluciclovine F 18

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.

• Fluciclovine F 18 is available under the following different brand names: Axumin

Common side effects of Fluciclovine F 18 include:

• injection site pain and redness
• changes in taste

Serious side effects of Fluciclovine F 18 include:

• chest tightness
• cough
• difficulty with swallowing
• fast heartbeat
• hives, itching, or skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, throat, or tongue
• trouble breathing
• unusual tiredness or weakness

Rare side effects of Fluciclovine F 18 include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 335-8200 MBq/mL (9-221 mCi/mL) in 30 mL multidose vials at calibration time and date

Prostate Cancer Imaging

Adult dosage

• 370 MBq (10 mCi) IV bolus

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Fluciclovine F 18 has no noted severe interactions with any other drugs
• Fluciclovine F 18 has no noted serious interactions with any other drugs
• Fluciclovine F 18 has no noted moderate interactions with any other drugs
• Fluciclovine F 18 has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Fluciclovine F 18?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Fluciclovine F 18?”

Cautions

• Hypersensitivity reactions, including anaphylaxis, may occur; emergency resuscitation equipment and personnel should be immediately available
• Radiation risk: Use contributes to a patient’s overall long-term cumulative radiation exposure; long-term cumulative radiation exposure is associated with an increased risk for cancer; ensure safe handling to minimize radiation exposure to the patient and healthcare providers
• Misinterpretation
  • Image interpretation errors can occur with fluciclovine F 18 PET imaging; a negative image does not rule out the presence of recurrent prostate cancer and a positive image does not confirm the presence of recurrent prostate cancer
  • Performance of fluciclovine F 18 seems to be affected by PSA levels
  • Not specific for prostate cancer and may occur with other types of cancer and benign prostatic hypertrophy in primary prostate cancer
  • Clinical correlation, which may include histopathological evaluation of the suspected recurrence site, is recommended

Pregnancy and Lactation

• Not indicated in women, and there is no information on development outcomes in pregnant women or animals
• Lactation
  • Not indicated for use in women, and there is no information on the presence in human milk