Optimizing Diagnostic Imaging with CERIANNA and VIZAMYL by GE HealthCare

Understanding the Indications, Usage, and Safety of GE HealthCare's Imaging Agents

GE HealthCare offers a range of imaging agents designed to assist in the diagnosis and management of various medical conditions. Two notable products include CERIANNA™ and VIZAMYL™, which are used in positron emission tomography (PET) imaging for specific medical indications.

CERIANNA™: Enhancing Breast Cancer Diagnosis

Indications and Usage: CERIANNA is specifically indicated for use with PET imaging to detect estrogen receptor (ER)-positive lesions in patients with recurrent or metastatic breast cancer. It serves as an adjunct to biopsy, helping to identify ER status in breast cancer patients. However, it is not suitable for imaging other receptors like HER2 or PR.

Limitations: While CERIANNA aids in identifying ER-positive lesions, tissue biopsy remains essential for confirming breast cancer recurrence and verifying ER status.

Adverse Reactions: In clinical trials involving 1207 participants, the most common adverse reactions included injection-site pain and dysgeusia, each occurring at a rate of less than 1%.

VIZAMYL™: Assessing Cognitive Impairment

Indications and Usage: VIZAMYL™ (Flutemetamol F 18) injection is used in PET imaging of the brain to estimate β-amyloid neuritic plaque density in adults with cognitive impairment. It assists in evaluating conditions like Alzheimer's disease (AD). A negative scan suggests sparse to no neuritic plaques, reducing the likelihood of AD, whereas a positive scan indicates moderate to frequent amyloid plaques, which may be present in AD or other neurological conditions.

Limitations: VIZAMYL is not intended to diagnose AD solely or predict the development of dementia. It is used as an adjunct in diagnostic evaluations.

Adverse Reactions: Common adverse reactions reported in clinical trials include flushing (2%), increased blood pressure (2%), headache (1%), nausea, and dizziness (1%).

Safety and Reporting

For both CERIANNA and VIZAMYL, no contraindications are listed for CERIANNA, while VIZAMYL should not be used by individuals with known hypersensitivity to its components, including polysorbate 80.

To report suspected adverse reactions, contact GE HealthCare at 800-654-0118 or by email at GPV.drugsafety@gehealthcare.com. Alternatively, reports can be made to the FDA at 800-FDA-1088 or through their website.

For full prescribing information and important safety details, visit the respective links provided by GE HealthCare.