Flutemetamol F-18
Generic Name: flutemetamol f-18
Brand Names:
Vizamyl
11 DESCRIPTION 11.1 Drug Characteristics VIZAMYL (flutemetamol F 18 injection) is a radioactive diagnostic drug for intravenous use. Chemically, flutemetamol F 18 is 2-[3-[ 18 F]fluoro-4-(methylamino) phenyl]-6-benzothiazolol. It has the molecular formula C 14 H 11 18 FN 2 OS, the molecular weight 273.32, and the following structural formula: VIZAMYL is a sterile, non-pyrogenic, clear, colorless to slightly yellow solution.
Overview
11 DESCRIPTION 11.1 Drug Characteristics VIZAMYL (flutemetamol F 18 injection) is a radioactive diagnostic drug for intravenous use. Chemically, flutemetamol F 18 is 2-[3-[ 18 F]fluoro-4-(methylamino) phenyl]-6-benzothiazolol. It has the molecular formula C 14 H 11 18 FN 2 OS, the molecular weight 273.32, and the following structural formula: VIZAMYL is a sterile, non-pyrogenic, clear, colorless to slightly yellow solution.
Uses
1 INDICATIONS AND USAGE VIZAMYL is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products VIZAMYL is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of...
Dosage
2 DOSAGE AND ADMINISTRATION The recommended amount of radioactivity is 185 MBq (5 mCi) administered as a single intravenous bolus within 40 seconds in a total volume of up to 10 mL. ( 2.2 ) Follow injection with an intravenous flush of 5 mL to 15 mL of 0.9% sodium chloride injection. ( 2.2 ) Obtain 10-minute to 20-minute PET images starting approximately 60 minutes to 120 minutes after drug administration. ( 2.3 ) See full prescribing information for image interpretation and radiation dosimetry. ( 2.4 , 2.5 , 2.6 ) 2.1 Radiation Safety - Drug Handling Handle VIZAMYL with appropriate safety measures to minimize radiation exposure during administration [see Warnings and Precautions (5.3) ] .
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reaction is described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Most common adverse reactions (incidence ≥ 1%) were flushing, increased blood pressure, headache, nausea, and dizziness. ( 6.1 ) 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 clinical practice.
Warnings
5 WARNINGS AND PRECAUTIONS Anaphylaxis and Other Serious Hypersensitivity Reactions: Always have emergency resuscitation equipment and trained personnel available at the time of VIZAMYL administration. ( 5.1 ) Risk of Image Misinterpretation and Other Errors: Image interpretation errors have been observed. ( 5.2 ) Radiation Risk: VIZAMYL contributes to a patient's long-term cumulative radiation exposure. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration. 4 CONTRAINDICATIONS VIZAMYL is contraindicated in patients with a history of hypersensitivity reaction to VIZAMYL or polysorbate 80 [see Warnings and Precautions (5.1) ] . Known hypersensitivity to VIZAMYL or polysorbate 80 ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on VIZAMYL use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with flutemetamol F 18 to evaluate its effect on female reproduction and embryo-fetal development. All radiopharmaceuticals, including VIZAMYL, have the potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiation dose.
Storage
Storage and Handling Store VIZAMYL in the original container within radiation shielding at 2°C to 30°C (36°F to 86°F). VIZAMYL does not contain a preservative. Do not use after the expiry date and time stated on the label. VIZAMYL multiple-dose vial expires 10 hours after end of synthesis (EOS).
Frequently Asked Questions
What is Flutemetamol F-18 used for?▼
1 INDICATIONS AND USAGE VIZAMYL is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products VIZAMYL is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of...
What are the side effects of Flutemetamol F-18?▼
6 ADVERSE REACTIONS The following clinically significant adverse reaction is described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Most common adverse reactions (incidence ≥ 1%) were flushing, increased blood pressure, headache, nausea, and dizziness. ( 6.1 ) 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 clinical practice.
Can I take Flutemetamol F-18 during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on VIZAMYL use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with flutemetamol F 18 to evaluate its effect on female reproduction and embryo-fetal development. All radiopharmaceuticals, including VIZAMYL, have the potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiation dose.
What are the important warnings for Flutemetamol F-18?▼
5 WARNINGS AND PRECAUTIONS Anaphylaxis and Other Serious Hypersensitivity Reactions: Always have emergency resuscitation equipment and trained personnel available at the time of VIZAMYL administration. ( 5.1 ) Risk of Image Misinterpretation and Other Errors: Image interpretation errors have been observed. ( 5.2 ) Radiation Risk: VIZAMYL contributes to a patient's long-term cumulative radiation exposure. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration. 4 CONTRAINDICATIONS VIZAMYL is contraindicated in patients with a history of hypersensitivity reaction to VIZAMYL or polysorbate 80 [see Warnings and Precautions (5.1) ] . Known hypersensitivity to VIZAMYL or polysorbate 80 ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.