Flutemetamol F 18

Flutemetamol F 18 is a prescription medicine used as a radioactive, adjunctive diagnostic agent for Positron Emission Tomography (PET) brain imaging to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline.

• Flutemetamol F 18 is available under the following different brand names: Vizamyl.

Common side effects of Flutemetamol F 18 include:

• headache,
• nausea, and
• dizziness

Serious side effects of Flutemetamol F 18 include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• flushing, and
• increased blood pressure

Rare side effects of Flutemetamol 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, loss of coordination, feeling 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, lightheadedness, 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

IV injection

• 150 MBq/mL (4.05 mCi/mL) of flutemetamol F 18)

Beta-Amyloid Plaque Estimation

Adult dosage

• 185 megabecquerels (MBq ), ie 5 millicuries (mCi) IV bolus administered within 40 seconds
• Follow injection with an IV flush of 5-15 mL of 0.9% NaCl.

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, health care provider, or pharmacist first.

• Flutemetamol F 18 has no noted severe interactions with any other drugs.
• Flutemetamol F 18 has no noted serious interactions with any other drugs.
• Flutemetamol F 18 has no noted moderate interactions with any other drugs.
• Flutemetamol 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 your products. 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

• Contraindicated in patients with a history of hypersensitivity reaction, polysorbate 80, or any other inactive ingredient

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Hypersensitivity reactions (e.g., flushing and dyspnea) have been observed within minutes following administration; these reactions may occur in patients with no history of prior exposure
• Before initiating therapy, ask patients about prior reactions to drugs, especially those containing polysorbate
• Resuscitation equipment and trained personnel should be immediately available
• Risk for image misinterpretation
  • Errors may occur in the estimation of brain neuritic plaque density during image interpretation; perform image interpretation independently of the patient’s clinical information
  • Other errors may be due to extensive brain atrophy that limits the ability to distinguish gray and white matter on the scan as well as motion artifacts that distort the image
• Radiation risk
  • Similar to other radiopharmaceuticals, flutemetamol F 18 contributes to a patient’s overall long-term cumulative radiation exposure; long-term cumulative radiation exposure is associated with an increased risk of cancer
  • Ensure safe handling to protect patients and healthcare workers from unintentional radiation exposure

Pregnancy and Lactation

• There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• All radiopharmaceuticals have the potential to cause fetal harm depending on the stage of fetal development, and the magnitude of the radiopharmaceutical dose
• If considering administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on radiation dose from the drug and gestational timing of exposure
• Lactation
  • There are no data on the presence of drugs or metabolites in human milk or its effects on breastfed infants or milk production
  • Exposure to a breastfed infant can be minimized by temporary discontinuation of breastfeeding
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from drugs or an underlying maternal condition
  • To decrease radiation exposure to breastfed infants, advise a lactating woman to interrupt breastfeeding, and pump and discard breast milk for 24 hours after administration of the drug.