Help your patients take the first step toward taking control of their PI treatment. Learn how to get your patient started on CUVITRU [Immune Globulin Subcutaneous (Human)] 20%.

Specialty Pharmacy Providers

Use this resource to find authorized CUVITRU Specialty Pharmacy Providers

Specialty Pharmacy ProvidersHide list view -
Accredo Specialty Pharmacy
CVS Specialty
Diplomat Specialty Infusion Group
Option Care
OptumRx / AxelaCare / BriovaRx

Access Support for CUVITRU

Access support programs for CUVITRU, right from the start

Shire is dedicated to helping patients with PI start and continue treatment with a support program that is with them every step of the way.
Start

HelloCUVITRU

A free-trial program available to eligible patients, age 2 and older, intended to help patients and healthcare professionals determine if the treatment is right for them.

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Continue

MyIgCoPayCard

A program to help eligible patients with commercial insurance save on their out-of-pocket, co-payment, co-insurance, or deductible for medication costs.*

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Support

MyIgSource

Comprehensive support for PI patients, caregivers, and healthcare professionals, regardless of treatment.

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Get your patients started with the HelloCUVITRU Free Trial Program

Eligible PI patients will receive their first 4 infusions of CUVITRU at home for free. Sign up for the HelloCUVITRU Free Trial Program in 2 steps:
Step 1: Determine if you are eligible for the HelloCUVITRU Free Trial Program by completing the request form.
1

Complete the request form

Download a formDOWNLOAD NOW >
Step 2: Fax HelloCUVITRU Free Trial Program form to MyIgSource Insurance Support at 1-855-217-1619
2

Fax HelloCUVITRU Free Trial Program form to MyIgSource Insurance Support at 1-855-217-1619

Any Questions?
Call 1-855-217-1615 for assistance.
*MyIgCoPay Card is not valid for prescriptions reimbursed, in whole or in part, by Medicaid, Medicare, Medigap, VA, DoD, TRICARE 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 (855-250-5111).
Free Trial prescription is valid for one-time use only with no refills. There is no obligation to continue use of CUVITRU after the free trial has been completed. For any future use, the patient must obtain a new prescription for CUVITRU.

Billing Resources and Forms

CUVITRU Billing and Diagnostic Codes and Forms

Use these resources below to start your patients on CUVITRU.

CUVITRU is covered by many insurers for the treatment of patients with primary immunodeficiency disease (PI). The codes below are provided for informational purposes and may not include all necessary codes.

CMS-1500 Form

Sample CMS-1500 Claim Form for CUVITRU

Billing Codes

CUVITRU Billing Codes Reference Guide
Sample CMS-1500 Claim Form for CUVITRU

CMS-1500 Form

Billing Codes

Billing Codes

Next DOSING AND ADMINISTRATION >

Please expand for Indication and Important Safety Information.

Important Safety Information
BOXED WARNING: THROMBOSIS

Thrombosis may occur with immune globulin 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.

Indication and Important Safety Information

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

Please see Full Prescribing Information, including Boxed Warning regarding Thrombosis.

CUVITRU [Immune Globulin Subcutaneous (Human)], 20% Solution

Indication

CUVITRU is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Solution indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older.

CUVITRU is for subcutaneous infusion only.

Important Safety Information

BOXED WARNING: THROMBOSIS

Thrombosis may occur with immune globulin 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

CUVITRU is contraindicated in patients who have had an anaphylactic or severe systemic hypersensitivity reaction to the subcutaneous administration of human immune globulin and in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity to human immune globulin treatment.

WARNINGS and PRECAUTIONS

Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with human immune globulin. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.

Renal Dysfunction/Failure: Monitor renal function and urine output and consider lower, more frequent dosing in patients who are at risk of developing renal dysfunction because of pre-existing renal insufficiency or predisposition to acute renal failure.

Thrombosis: Monitor for signs and symptoms of thrombosis and assess blood viscosity for those at risk for hyperviscosity.

Aseptic Meningitis Syndrome (AMS): Monitor for clinical signs and symptoms of AMS.

Hemolysis: Monitor for clinical signs and symptoms of hemolysis and delayed hemolytic anemia.

Transfusion-Related Acute Lung Injury (TRALI): Monitor for pulmonary adverse reactions associated with TRALI.

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

Interference with Laboratory Tests: False positive serological test results, 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, systemic adverse reactions including headache, nausea, fatigue, diarrhea, and vomiting.

Please see Full Prescribing Information, including Boxed Warning regarding Thrombosis.

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.us@baxalta.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 medinfo.us@baxalta.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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