VIZAMYL Solution for injection Ref.[10089] Active ingredients: Flutemetamol ¹⁸F

5.1 Hypersensitivity Reactions

Hypersensitivity reactions such as flushing and dyspnea have been observed within minutes following Vizamyl administration. These reactions may occur in patients with no history of prior exposure to Vizamyl.

Before administering Vizamyl, ask patients about prior reactions to drugs, especially those containing polysorbate 80.

Have resuscitation equipment and trained personnel immediately available at the time of Vizamyl administration [see Contraindications (4)].

5.2 Risk for Image Misinterpretation and Other Errors

Errors may occur while using Vizamyl PET images to estimate brain neuritic plaque density [see Clinical Studies (14)].

Image interpretation is performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Vizamyl images has not been evaluated and may lead to errors. Extensive brain atrophy may limit the ability to distinguish grey and white matter on a Vizamyl scan [see Dosage and Administration (2.5)]. Motion artifacts may distort the image [see Dosage and Administration (2.3)].

Vizamyl scan results are indicative of the brain neuritic amyloid plaque content only at the time of image acquisition and a negative scan result does not preclude the development of brain amyloid in the future.

5.3 Radiation Risk

Vizamyl, similar to other radiopharmaceuticals, 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 health care workers from unintentional radiation exposure [see Dosage and Administration (2.1)].

Clinical trials are conducted under widely varying conditions and adverse reaction rates observed in the clinical trials of Vizamyl cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In clinical trials, 761 adults (367 men and 394 women, 91% Caucasian) with a mean age of 62 years (range 18-93 years) received Vizamyl. Most subjects (530, 70%) received a dose of 185 MBq (5 mCi).

One subject out of 761 administered Vizamyl experienced a serious hypersensitivity reaction with flushing, dyspnea and chest pressure within minutes following Vizamyl administration and recovered with treatment.

Most adverse reactions were mild to moderate in intensity and resolved spontaneously. The most commonly reported adverse reactions (occurring in at least 1% of subjects) in Vizamyl-treated subjects are shown in Table 2.

Table 2. Adverse Reactions Reported in Clinical Trials of Vizamyl (N=761 subjects):

Pharmacodynamic drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Vizamyl image results.

Within a clinical study of patients with a range of cognitive impairment, some patients were receiving the following medications: donepezil, galantamine, memantine, rivastigmine. Mean cortical Standardized Uptake Value (SUV) ratios did not differ between the patients taking or not taking these concomitant medications.

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. All radiopharmaceuticals, including Vizamyl, have the potential to cause fetal harm depending on the stage of fetal development, and the magnitude of the radiopharmaceutical dose. If considering Vizamyl administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Vizamyl and the gestational timing of exposure.

The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Risk Summary

There are no data on the presence of Flutemetamol (F 18) or metabolites in human milk or its effects on the breastfed infant or milk production. Exposure of Vizamyl to a breastfed infant can be minimized by temporary discontinuation of breastfeeding [see Clinical Considerations]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Vizamyl and any potential adverse effects on the breastfed child from Vizamyl or from the underlying maternal condition.

Clinical Considerations

To decrease radiation exposure to the breastfed infant, advise a lactating woman to interrupt breastfeeding, and pump and discard breast milk for 24 hours after administration of Vizamyl.

Vizamyl is not indicated for use in pediatric patients.

Of the 761 subjects in clinical studies of Vizamyl, 447 (59%) were 65 years or over, while 246 (32%) were 75 years or over. No overall differences in safety were observed between these subjects and younger subjects.