Florbetaben F 18

Florbetaben F 18 is a radioactive, adjunctive diagnostic agent indicated 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 and other causes of cognitive decline.

• Florbetaben F 18 is available under the following different brand names: Neuraceq

Common side effects of Florbetaben F 18 include:

• injection site reactions such as skin redness
• irritation
• pain

Serious side effects of Florbetaben F 18 include:

• hives, itching, or rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• redness of the skin
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing
• fast heartbeat
• fever

Rare side effects of Florbetaben 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, 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

Injectable solution

• 50-5000 megabecquerels (MBq)/mL (1.4-135 millicuries (mCi)/mL) in 30 mL multidose vials
• At the time of administration, 300 MBq (8.1 mCi) are contained in up to 10 mL solution for injection

Beta-Amyloid Plaque Estimation

Adult dosage

• 300 MBq, ie, 8.1 mCi IV bolus administered by slow IV bolus (1 mL/6 seconds) in a total volume of up to 10 mL
• Follow injection with an IV flush of 10 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, healthcare provider, or pharmacist first.

• Florbetaben F 18 has no noted severe interactions with any other drugs
• Florbetaben F 18 has no noted serious interactions with any other drugs
• Florbetaben F 18 has no noted moderate interactions with any other drugs
• Florbetaben 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 Florbetaben F 18?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Florbetaben F 18?"

Cautions

• 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 owing 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
  • Like other radiopharmaceuticals, florbetaben F18 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 protect patients and healthcare workers from unintentional radiation exposure

Pregnancy and Lactation

• There are no available data on pregnant women to evaluate for a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Lactation
  • There are no data on the presence of drugs in human milk, its effects on breastfed infants, or milk production; exposure to a breastfed infant can be minimized by temporary discontinuation of breastfeeding
  • Developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for the drug and any potential adverse effects on the breastfed child from the drug from the underlying maternal condition
  • To decrease radiation exposure to breastfed infants, advise a lactating woman to pump and discard breast milk for 24 hours after administration of the drug