What
when administering
VYEPTI IV?
Dosing and administration1
VYEPTI is administered in a 30-minute intravenous (IV) infusion every 12 weeks*
The recommended dose of VYEPTI is 100 mg
The VYEPTI infusion should be initiated and supervised by a healthcare professional. The treating healthcare professional should observe or monitor patients during and after the infusion in accordance with general practice. Read the dosing and administration information accompanying the vial before preparing VYEPTI for administration
*VYEPTI is only approved for IV administration.1
Considerations
Special warnings and precautions for use1
PATIENTS WITH CARDIOVASCULAR, NEUROLOGICAL OR PSYCHIATRIC DISEASES
Patients with a history of cardiovascular disease, neurological diseases and patients with psychiatric conditions that were uncontrolled and/or untreated were excluded from clinical studies. Limited or no safety data are available in these patient populations, and limited safety data are available in patients with cardiovascular risk factors.
SERIOUS HYPERSENSITIVITY
Serious hypersensitivity reactions, including anaphylactic reactions, have been reported and may develop within minutes of the infusion. Most hypersensitivity reactions occurred during infusion and were not serious. If a serious hypersensitivity reaction occurs, administration of VYEPTI should be discontinued immediately and appropriate therapy initiated. If the hypersensitivity reaction is not serious, continuation of further treatment with VYEPTI is up to the discretion of the treating physician, taking into account the benefit-risk for the individual patient.
EXCIPIENTS
VYEPTI contains sorbitol (E420). Patients with hereditary fructose intolerance (HFI) must not be given this medicinal product unless strictly necessary. A detailed history with regard to HFI symptoms has to be taken of each patient prior to being given this medicinal product.
Other considerations1
ADVERSE EVENTS
The most common side effects are hypersensitivity reactions, infusion-related reaction and fatigue. Most hypersensitivity reactions occurred during infusion and were not serious
(reported in ~4% of VYEPTI patients and 2% of placebo patients in clinical studies). Infusion-related reactions occurred infrequently and in similar proportions of VYEPTI and placebo patients (<1%). Fatigue was most frequent on the day of the first infusion, and reported in ~3% of VYEPTI patients and 2% of placebo patients.1
STORAGE
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original packaging to protect from light; do not freeze or shake if removed from the refrigerator, VYEPTI must be used within 7 days when stored in the original packaging at room temperature (up to 25°C) or discarded.
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