Starting a patient on this Fabry treatment?

Subject:
[Subject-choose 1 per email]
Option 1: Starting a patient on this Fabry treatment?
Option 2: Ready to start patients on this Fabry treatment?
Option 3: Get patients started on this Fabry treatment

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Option 1: Our starter kit can help

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{{customText[falseHitrueHellotrueDear]}}
{{customText[false##accTitle## ##accFname## ##accLname##true##accTitle## ##accLname##true##accFname##]}},

If you’re ready to start or switch a patient to Elfabrio, we’re here to help. The Elfabrio Starter Kit provides a seamless process for getting your patients started on their treatment. This kit includes:

Getting Started Guide
Prior Authorization and Access Guide
Dosing and Administration Guide
Copay support information

Getting Started Guide
Prior Authorization and Access Guide
Dosing and Administration Guide
Copay support information

Chiesi Total Care^SM is a one-stop patient support program.
A single call is all it takes to find help for your patients:

Insurance assistance

Prescription refills

Copay programs
(if eligible)*

Home infusions
(if eligible)^†

Individual support

Informational resources

		Insurance assistance
		Prescription refills
		Copay programs (if eligible)*
		Home infusions (if eligible)*
		Individual support
		Informational resources

Government-funded plans are not eligible for patient support services that provide financial support through the Programs. Patients receiving treatment or residing in MA, MI, MN, or RI are not eligible for 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 eligibility requirements.

†

Patients receiving treatment or residing in MA, MI, MN, or RI are not eligible for 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.

Call 1-833-656-1056 or go to chiesitotalcare.com to learn more.

{{customText[falseSincerelytrueBest regardstrueThank you]}},

Indication

Elfabrio^® (pegunigalsidase alfa-iwxj) is indicated for the treatment of adults with confirmed Fabry disease.

Important Safety Information

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

Patients treated with Elfabrio have experienced hypersensitivity reactions, including anaphylaxis. Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available during Elfabrio administration. If a severe hypersensitivity reaction (eg, anaphylaxis) occurs, discontinue Elfabrio immediately and initiate appropriate medical treatment. In patients with severe hypersensitivity reaction, a desensitization procedure to Elfabrio may be considered.

Prior to Elfabrio administration, consider pretreating with antihistamines, antipyretics, and/or corticosteroids. Inform patients and caregivers of the signs and symptoms of hypersensitivity reactions and infusion-associated reactions (IARs), and instruct them to seek medical care immediately if such symptoms occur.

If a severe hypersensitivity reaction (including anaphylaxis) or severe IAR occurs, immediately discontinue Elfabrio administration and initiate appropriate medical treatment.
If a mild to moderate hypersensitivity reaction or IAR occurs, consider slowing the infusion rate or temporarily withholding the dose.

In clinical trials, 20 (14%) Elfabrio-treated patients experienced hypersensitivity reactions. Four Elfabrio-treated patients (3%) experienced anaphylaxis reactions that occurred within 5 to 40 minutes of the start of the initial infusion. The signs and symptoms of hypersensitivity reactions and anaphylaxis included headache, nausea, vomiting, throat tightness, facial and oral edema, truncal rash, tachycardia, hypotension, rigors, urticaria, intense pruritus, moderate upper airway obstructions, macroglossia, and mild lip edema.

In clinical trials, 41 (29%) Elfabrio-treated patients experienced one or more infusion-associated reactions, including hypersensitivity, nausea, chills, pruritus, rash, chest pain, dizziness, vomiting, asthenia, pain, sneezing, dyspnea, nasal congestion, throat irritation, abdominal pain, erythema, diarrhea, burning sensation, neuralgia, headache, paresthesia, tremor, agitation, increased body temperature, flushing, bradycardia, myalgia, hypertension, and hypotension.

A case of membranoproliferative glomerulonephritis with immune depositions in the kidney was reported during clinical trials. Monitor serum creatinine and urinary protein-to-creatinine ratio. If glomerulonephritis is suspected, discontinue treatment until a diagnostic evaluation can be conducted.

When switching to Elfabrio from a prior enzyme replacement therapy, the risk of hypersensitivity reactions and infusion-associated reactions may be increased in certain patients with pre-existing anti-drug antibodies (ADAs). Consider monitoring IgG and IgE ADAs and clinical or pharmacodynamic response (eg, plasma lyso-Gb3 levels).

The most common adverse reactions (≥15%) were infusion-associated reactions, nasopharyngitis, headache, diarrhea, fatigue, nausea, back pain, pain in extremity, and sinusitis.

Please see Full Prescribing Information for Elfabrio.

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