One-stop Patient Support
Chiesi Total CareSM provides your patients with the exceptional support they need, when and where they need it. To enroll your patients, download and complete the enrollment form below.
A single call to your dedicated Chiesi Total Care Team and the completed Physician Order/Prescription Form is all it takes to begin the process of getting a patient started on Elfabrio® (pegunigalsidase alfa-iwxj) therapy.*
| * | Chiesi Total Care provides nonfinancial assistance to patients with and without prescription drug coverage. Government-funded plans are not eligible for patient support services that provide financial support through the programs. If your patient is receiving treatment or residing in MA or RI, they are not eligible for infusion assistance. Please see the full Terms and Conditions for additional eligibility requirements. |
Call toll free:
1-833-656-1056
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.
The Chiesi Total Care Program Assists With:
Commercial insurance
If your patients have private insurance through their job or their own business
Government insurance
If your patients have Medicare, Medicaid, Veterans Affairs healthcare, or other government insurance
No insurance
If your patients have no insurance, they may be eligible for financial assistance
Dedicated Chiesi Total Care Team:
- Pharmacists
- Patient Service Coordinators
- Reimbursement Support Specialists
- Nursing support
Infusion assistance†
- Ensures medication is delivered right to where your patients need it
- Assists in finding an appropriate infusion facility
- Answers questions about administration, storage and disposal, and more
- Reviews eligibility for home infusion assistance†
Routine testing
Healthcare providers should consider monitoring for the presence of IgG and IgE antibodies in patients who demonstrate hypersensitivity reactions and should consider the risks and benefits of continued treatment in patients with anti-Elfabrio IgG and IgE antibodies. There are no marketed tests for these antibodies against Elfabrio. If monitoring is warranted, Chiesi Total Care may be able to help
| † | Patients receiving treatment or residing in MA or RI are not eligible for infusion assistance. To receive home infusion support, patient must be referred to home infusion by their prescriber. Please refer to the Terms and Conditions for additional eligibility requirements. |
| IgE, immunoglobulin E; IgG, immunoglobulin G. | |
Prior Authorization and Appeals
Download an Elfabrio Starter Kit Today
If you are ready to start a patient on Elfabrio, an Elfabrio Starter Kit can help streamline the process. The Elfabrio Starter Kit provides you with everything you need to get a patient started on Elfabrio, including:
- Getting Started Guide
- Physician Order/Prescription Form
- Enrollment and Authorization Form
- Home Infusion Nursing Order Form
- Prior Authorization and Access Guide
- Dosing and Administration Guide
- Copay support information
- Chiesi Total Care Fact Sheet
- US Full Prescribing Information
- Contact information card
Infusion Resources
Contact Information
Phone
Fax
Hours of operation
Monday to Friday
7:00 AM – 6:00 PM (Central Time)
Location
17877 Chesterfield Airport Road
Chesterfield, MO 63005
Helpful Links for Your Patients
For more information about Elfabrio, visit elfabrio.com
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.
Indication
Elfabrio® (pegunigalsidase alfa-iwxj) is indicated for the treatment of adults with confirmed Fabry disease.
Please see Full Prescribing Information for Elfabrio.
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.
Indication
Elfabrio® (pegunigalsidase alfa-iwxj) is indicated for the treatment of adults with confirmed Fabry disease.
Please see Full Prescribing Information for Elfabrio.