Elfabrio: A long-lasting treatment for Fabry1,2*
Why Elfabrio—the PEGylated ERT—may be an option for your patients1,2:
Circulating enzymes between infusions increase over time
Elfabrio has an overall mean half-life of ~80 hours* (from 53 to 121 hours), with blood levels that increase with repeat administration1,2
| * | Elfabrio has an initial half-life of 78.9 ± 10.3 hours. Clinical studies have not established that pharmacological characteristics, including half-life, result in superior efficacy or safety based on clinically relevant endpoints. Infusions are every 2 weeks.1 |
Comparable efficacy to agalsidase beta observed
Annualized rate of change in estimated glomerular filtration rate (eGFR) mean slope was similar for both Elfabrio and agalsidase beta groups in a 2-year study1
Established tolerability
Safety profile was assessed through long-term clinical trials including a head-to-head trial with an agalsidase beta control group1,3,4
Low immune response
Patients who switched to Elfabrio from agalsidase beta experienced a low rate of new anti-drug antibodies (ADAs) (11.5%)1,5†
| † | The effect of IgG ADAs on the effectiveness of Elfabrio has not been fully characterized. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. |
| ERT, enzyme replacement therapy; IgG, immunoglobulin G; PEG, polyethylene glycol. | |
Elfabrio has been validated by a robust, broad-ranging clinical trial program in Fabry disease1,3-7
Broad patient population
Male and female adults, classic or nonclassic Fabry, varying organ function, varying treatment history
Multiple global clinical studies
Controlled pivotal trials and long-term, open-label follow-up across a variety of Fabry patients
See the whole picture and learn what Elfabrio may do for your patients.
Dosing and administration designed with patients in mind1
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Sample infusion schedule for
ERT-experienced patients
Sample infusion schedule for
treatment-naïve patients
- Initial infusions (first 4-6 doses) take as little as 3 hours for ERT-experienced patients based on patient weight and previous ERT experience. Initial infusions should be at least 4 hours for patients who have not been treated with an ERT in the past 6 months
- If the patient is switching from a prior ERT with an infusion duration greater than 3 hours, start Elfabrio at the same infusion rate
- Infusion duration may be decreased by 30 minutes after the initial infusions and at every third follow-up infusion to the minimum recommended duration of 1.5 hours
- Consider whether tolerability has been established at each of these intervals and adjust the infusion rate at your discretion
Once tolerability has been established after the initial 4-6 infusions…
Maintenance infusions in as little as 90 minutes
following gradual decreases in infusion duration1
Infusions in the clinic or at home are available for eligible patients at your discretion1‡
| ‡ | Patients receiving treatment or residing in MA or RI are not eligible for home infusion services. To receive home infusion support, patients must be referred to home infusion by their prescribing physician. Please see the full Terms and Conditions for additional eligibility requirements. |
Which potential patients may be right for Elfabrio?
Rob was just diagnosed with Fabry disease after one of his family members was diagnosed and he was recommended for testing. A genetic counselor confimed his diagnosis. He will be discussing treatment options with his doctor at his upcoming appointment.
| § | Not an actual patient. Patient symptoms will vary; individual evaluation should be done to determine the best course of therapy. |
Sofia is currently on treatment for her Fabry disease. Sofia’s Fabry has affected her kidneys, so her doctor continues to monitor how her kidneys are working. Sofia’s Fabry has been well controlled since she started treatment, but there are some factors that she wants to talk to her doctor about. Sofia's doctor suggested she make an appointment so they can discuss what to do next.
| § | Not an actual patient. Patient symptoms will vary; individual evaluation should be done to determine the best course of therapy. |
