Shire has a 30-year legacy of providing IG treatment options for the PI community. Learn about MyIgSource and our insurance assistance programs.6

MyIgSource

Support for you and your patients, upon diagnosis and throughout treatment

We know it can be overwhelming to live with PI—physically, emotionally, and financially. So we put our expertise and experience behind both you and your patients.

  • MyIgSource Answer and Advocates logoCall 1-855-250-5111 and get started!
  • Nurse and patient advocates logoConnect with nurse and patient advocates
  • Access resources and tools for CUVITRUAccess educational resources and tools
  • Get help navigating insurance with CUVITRU treatmentGet help navigating insurance

Whether it's assistance with benefits verification, questions, prior authorization, or administration training, we're here to help

VISIT MYIGSOURCE.COM >

Insurance Support

Coverage and reimbursement support

When it comes to helping your patients with PI gain access to CUVITRU, we can help.

Initiating the coverage and reimbursement processes can be challenging. We can help, with resources to help patients with questions regarding prior authorizations and benefit verifications, billing and coding, and more.*

Get started today
Obtain a copy (front and back) of your patient's Insurance & Pharmacy Benefit Management cardsObtain a copy (front and back) of your patient's Insurance & Pharmacy Benefit Management cards
CUVITRU Prescription Referral Form logoCompletely fill out and sign the CUVITRU Prescription Referral Form
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Fax both to MyIgSource Insurance Support at 1-855-217-1619.

MyIgSource is designed to assist patients, caretakers, and healthcare providers in navigating insurance, connecting to nurse and patient advocates, and accessing educational resources and tools. MyIgSource Insurance Support helps to provide access to coverage and reimbursement by offering support with benefit verifications and prior authorizations, and resources for billing, coding, and more.

What MyIgSource case managers will do
MyIgSource case managers will complete patient- and product-specific benefit verifications.
Conduct patient- and product-specific benefit verifications
  • Confirm your patient's specific insurance benefits and coverage options
  • Return patient-specific benefit information to you, typically within 1 business day
If prior authorization is required
  • Obtain insurance company specific requirements and forms
  • Follow up with the insurance company to obtain approval or denial
If prior authorization is required
  • Obtain reason for denial
  • Determine if an appeal is available
  • Provide supporting resources, such as key contact information, checklists, best practices, and templates
PRIOR AUTHORIZATION CHECKLIST >
MyIgSource case managers will connect you to a Shire Reimbursement Manager.
Connect you to a Shire Reimbursement Manager, who can provide specialized assistance while you continue to work through the approval process
  • Confirm your patient's specific insurance benefits and coverage options
  • Return patient-specific benefit information to you, typically within 1 business day
If the first appeal is denied
  • Connect you to a nurse for Tier 2 appeal support
Once coverage is approved, the information will be triaged to either
  • Your preferred infusion provider, or
  • Your office
Shire has a dedicated Reimbursement Team specializing in coverage assistance and billing and coding resources.
MyIgCoPayCard

Eligible patients with PI on CUVITRU with commercial insurance can save up to a total of $5,000 over 12 months on their out of pocket co-payment, co-insurance, or deductible for medication costs with the MyIgCoPayCard. This program provides financial support for all Shire IG treatments, regardless of household income.

Call 1-855-250-5111 to learn more.
Terms and conditions apply.
Call 1-855-250-5111 to learn more.
Terms and conditions apply.
MyIgCoPayCard logo: Eligible patients with PI on CUVITRU with commercial insurance can save up to a total of $5,000 over 12 months on their out of pocket co-payment, co-insurance, or deductible for medication costs with the MyIgCoPayCard

Coordinate with infusion providers and patient advocates to facilitate the MyIgCoPayCard enrollment process

  • *MyIgSource is open to all PI patients and caregivers, regardless of treatment.
  • With a valid prescription.
  • MyIgCoPay Card is not valid for patients whose prescriptions are reimbursed, in whole or in part, by federal or state health care programs (e.g., Medicaid, Medicare, TRICARE, etc.), or any other federal or state healthcare programs, including state pharmaceutical assistance programs, and where prohibited by the health insurance provider or by law. Commercial insurance must cover medication costs for prescribed Shire Immune Globulin (IG) treatment for primary immunodeficiency (PI) and allow for CoPay or coinsurance assistance. Shire reserves the right to change or discontinue this program at any time without notice. Please see full treatment specific Terms and Conditions on product websites for additional program restrictions and eligibility requirements or call MyIgSource for more information (1-855-250-5111).

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Please expand for Indication and Important Safety Information.

Important Safety Information
WARNING: THROMBOSIS
  • Thrombosis may occur with immune globulin (IG) products, including CUVITRU. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors.
  • For patients at risk of thrombosis, administer CUVITRU at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.

Please read below for Indication and Important Safety
Information for CUVITRU.

Please click for Full Prescribing Information, including Boxed Warning regarding Thrombosis.

INDICATION

CUVITRU is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients ≥2 years. CUVITRU is for subcutaneous use only.

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOSIS
  • Thrombosis may occur with immune globulin (IG) products, including CUVITRU. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors.
  • For patients at risk of thrombosis, administer CUVITRU at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.
Contraindications
  • History of anaphylactic or severe systemic hypersensitivity reactions to subcutaneous administration of human IG.
  • IgA-deficient patients with antibodies against IgA and a history of hypersensitivity to human IG.
Warnings and Precautions

Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with human IG. If a hypersensitivity reaction occurs, discontinue infusion immediately and institute appropriate treatment. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity reactions, including anaphylaxis.

Renal Dysfunction/Failure: Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis and death may occur with intravenous (IV) use of IG products, especially those containing sucrose. Ensure patients are not volume depleted prior to starting infusion. In patients at risk due to pre-existing renal insufficiency or predisposition to acute renal failure, assess renal function before initiation and throughout treatment, and consider lower, more frequent dosing. If renal function deteriorates, consider discontinuation.

Thrombosis: May occur following treatment with IG products and in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Aseptic Meningitis Syndrome: Has been reported with use of IG and may occur more frequently in females. Conduct a thorough neurological exam on patients exhibiting signs and symptoms to rule out other causes of meningitis. Discontinuing IG treatment has resulted in remission within several days without sequelae.

Hemolysis: CUVITRU contains blood group antibodies which may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for signs and symptoms of hemolysis and delayed hemolytic anemia and, if present, perform appropriate confirmatory lab testing.

Transfusion-Related Acute Lung Injury: Non-cardiogenic pulmonary edema may occur with IV administered IG. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil and anti-HLA antibodies in both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support.

Transmittable Infectious Agents: Because CUVITRU is made from human plasma, it may carry a risk of transmitting infectious agents (e.g., viruses, other pathogens). No confirmed cases of viral transmission or variant Creutzfeldt-Jakob disease (vCJD) have been associated with CUVITRU.

Interference with Lab Tests: False positive serological test results and certain assay readings, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies.

Adverse Reactions

The most common adverse reactions observed in clinical trials in ≥5% of patients were: local adverse reactions including mild or moderate pain, erythema, and pruritus, and systemic adverse reactions including headache, nausea, fatigue, diarrhea, and vomiting.

Drug Interactions

Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella and varicella).

Please click for Full Prescribing Information.

To report suspected adverse reactions, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

To report suspected adverse reactions, contact Shire Drug Safety at 1-800-999-1785 or drugsafety@shire.com.

If you have a medical or clinical question regarding the use of CUVITRU [Immune Globulin Subcutaneous (Human)] 20%, please contact Shire Medical Information at 1-866-424-6724 or medinfoUS@shire.com.

References: 1. CUVITRU [Prescribing Information]. Westlake Village, CA: Baxalta US Inc. 2. Bousfiha A, Jeddane L, Al-Herz W, et al. The 2015 IUIS phenotypic classification for primary immunodeficiencies. J Clin Immunol. 2015;35(8):727-738. doi:10.1007/s10875-015-0198-5. Epub October 7, 2015. 3. Jolles S, Orange JS, Gardulf A, et al. Current treatment options with immunoglobulin G for the individualization of care in patients with primary immunodeficiency disease. Clin Exp Immunol. 2015;179(2):146-160. 4. Suez D, Stein M, Gupta S, et al. Efficacy, safety and pharmacokinetics of a novel human immune globulin subcutaneous, 20% in patients with primary immunodeficiency diseases in North America. J Clin Immunol (2016). DOI 10.1007/s10875-016-0327-9. 5. Data on file. Shire US Inc. Feb 2013. 6. U.S. Food and Drug Administration. User fee billable biologic products and potencies approved under section 351 of the PHS Act. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm122936.htm. Accessed 28 July 2016.

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