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\Hi \##accFname##,
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Picture what long-actinga treatment can do for your patients with Fabry disease1
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\I want to thank you for our discussion about Elfabrio® (pegunigalsidase alfa-iwxj).
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Elfabrio is an option for patients being treated for Fabry disease and for the thousands of people with Fabry who may remain untreated—even though they could benefit from therapy.2 Here are some additional data that we can discuss in greater detail next time we meet.
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Elfabrio is infused at a dose of 1 mg/kg every 2 weeks1
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Elfabrio is the first PEGylated ERT for Fabry disease1,3
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Treatment exposure
that increased
over time1,b
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Infusions in as
little as 90 minutes
once patient
tolerance has been
established—in the
clinic or at home1,c
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Elfabrio reduced
a key marker of
disease in patients
with Fabry1
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The Elfabrio safety profile was assessed through several studies.4,5
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- In pooled data from 2 studies (N=40): 92.5% of patients remained on therapy and did not experience an AE leading to treatment discontinuation4,5
- Among patients for whom antibody results were available (n=32), 72% of patients did not experience any treatment-induced antibody formation1
- The most common AEs in Elfabrio-treated patients from 4 clinical studies were nausea (9.4%), dizziness (7.5%), diarrhea (5.7 %), pruritus (5.7%), infusion-related reaction (5.7%), chest discomfort (3.8%), fatigue (3.8%), headache (3.8%), abdominal pain (3.8%), rash maculo-papular (3.8%), sneezing (3.8%), Type I hypersensitivity (3.8%), arthralgia (3.8%), and vertigo (3.8%)1
- 3 patients (5.7%) experienced severe hypersensitivity reactions during the initial infusion.1 In the BRIDGE study, Type I hypersensitivity led to study discontinuation in 2 patients (9.1%)4
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[Fragment 1: Treatment exposure over time]
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Elfabrio: Purposely designed for treatment exposure that increases over time1
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Elfabrio1,c
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- The bioavailability of Elfabrio rose with repeated administration, with AUC increasing from 391±136 mcg/hr/mL on Day 1 to 1428±875 mcg/hr/mL during Month 121
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[Fragment 2: Support (Total Care)]
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One-stop patient support
Chiesi Total Care℠ is a comprehensive support program that provides exceptional service to healthcare providers and their patients
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With a single call, patients will be guided by a dedicated support team through the process of getting started on Elfabrio—regardless of whether they have commercial insurance, Medicaid, or Medicare. And support is available for home infusions. Restrictions apply.
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Our goal is to support starting Elfabrio or transitioning from existing therapy to Elfabrio.
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The Chiesi Total Care℠ Copay Program
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Most patients who qualify pay as little as $0 per month
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Program Eligibility:
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- Patient must be enrolled in Chiesi Total Care. The Enrollment and Authorization form can be mailed to your patient's home
- Patient has commercial insurance and a valid prescription for a US Food and Drug Administration (FDA)–approved indication for Elfabrio
- Patient must be a resident of the United States or one of its territories
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Please refer to the full Terms and Conditions for additional eligibility requirements.
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{{CitationStart}}Chiesi Total Care℠ is a service mark of CHIESI FARMACEUTICI S.p.A.{{CitationEnd}}
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My contact information is below. Please don’t hesitate to reach out with any questions. I look forward to being a resource for you, your staff, and your Fabry patients.
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\If you would like to set up a time to talk on the phone, please contact me with a day and time that works best for you..
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For more information about Elfabrio, you can also visit hcp.elfabrio.com.
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\Sincerely,
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Elfabrio® (pegunigalsidase alfa-iwxj) is indicated for the treatment of adults with confirmed Fabry disease. This indication is approved under accelerated approval based on reduction of globotriaosylceramide (Gb3) inclusion bodies in renal peritubular capillary cells. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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Hypersensitivity reactions including anaphylaxis: Because of the potential for severe allergic reactions including anaphylaxis, appropriate medical support measures should be readily available during Elfabrio administration. If severe reactions occur, immediately discontinue Elfabrio and provide necessary emergency treatment. The risks and benefits of re-administering Elfabrio following a severe hypersensitivity reaction (including anaphylaxis) should be considered.
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Infusion-related reactions: In clinical trials, 21% (11/53) of Elfabrio-treated patients experienced one or more infusion-related reactions, defined as any adverse reaction with onset after start of the infusion and up to 2 hours after the end of infusion. In patients who experienced infusion-related reactions, recommend pre-treatment with an antihistamine prior to subsequent infusions. If an infusion-related reaction occurs, consider decreasing the infusion rate, temporarily stopping the infusion, and/or administering additional antihistamines and/or corticosteroids. If severe infusion-related reactions occur, consider immediate discontinuation and initiation of appropriate medical treatment.
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Compromised cardiac function: Patients with advanced Fabry disease may have compromised cardiac function, which may predispose them to a higher risk of severe complications from infusion-related reactions.
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Immunogenicity: It is unknown if the presence or induction of immunoglobulin G (IgG) antibodies to Elfabrio is associated with a higher risk of adverse events and/or infusion-related reactions during treatment. Patients who demonstrate hypersensitivity reactions during Elfabrio treatment should be monitored for the presence of IgG antibodies to Elfabrio. Physicians should consider testing for immunoglobulin E (IgE) antibodies in patients who experience suspected allergic reactions and consider the risks and benefits of continued treatment in patients with anti-Elfabrio IgE antibodies.
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Common adverse reactions: The most common adverse reactions reported in ≥5% of patients are nausea, dizziness, diarrhea, pruritus, and infusion-related reaction.
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Please see Full Prescribing Information for Elfabrio.
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Reference: 1. Elfabrio. Prescribing information. Chiesi Farmaceutici S.p.A.; 2021. 2. Fabrazyme. Prescribing information. Genzyme Corporation; 2018.
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