Takeda has a 30-year legacy of providing IG treatment options for the PI community.
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OnePath Product Support For Your Patients

Takeda’s OnePath program offers product support for your patients prescribed CUVITRU. Through OnePath, eligible patients are connected with a dedicated Patient Support Manager who can assist them by:

Getting patients and caregivers started with in-home self-administration training, led by a specially trained nurse (if applicable)

Facilitating an insurance benefits investigation

Working with specialty pharmacies to coordinate treatment access

Enrolling eligible* patients in the OnePath Co-Pay Assistance Program or providing information about other financial assistance options

Informing patients and caregivers about educational resources available to them

*At a minimum to be eligible, patients must be enrolled in OnePath and have commercial insurance. Other terms and conditions apply. Contact OnePath for more information.

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OnePath Co-Pay Assistance Program

The OnePath Co-Pay Assistance Program helps eligible patients cover certain out-of-pocket treatment costs.

To enroll a patient in OnePath, complete this start form with your patient and fax it to

IMPORTANT NOTICE: The OnePath Copay Assistance Program (the Program) is not valid for prescriptions eligible to be reimbursed, in whole or in part, by Medicaid, Medicare (including Medicare Part D), Tricare, Medigap, VA, DoD, or other federal or state programs (including any medical or state prescription drug assistance programs). No claim for reimbursement of the out-of-pocket expense amount covered by the Program shall be submitted to any third party payer, whether public or private. The Program cannot be combined with any other rebate/coupon, free trial, or similar offer. Copayment assistance under the Program is not transferable. The Program only applies in the United States, including Puerto Rico and other U.S. territories, and does not apply where prohibited by law, taxed, or restricted. This does not constitute health insuranc Void where use is prohibited by your insurance provider. If your insurance situation changes you must notify the Program immediately at 1-866-888-0660. Coverage of certain administration charges does not apply for patients residing in Massachusetts, Michigan, Minnesota, Rhode Island, and Vermont. Takeda reserves the right to rescind, revoke, or amend the Program at any time without notice.

HelloCUVITRU

Learn if CUVITRU is right for your patients with the HelloCUVITRU Free Trial Program

Eligible PI patients will receive their first 4 infusions of CUVITRU at no charge. Sign up your patient for the HelloCUVITRU Free Trial Program in 2 steps:
Determine if your patient is eligible for the HelloCUVITRU Free Trial Program by completing the request form.
1

Complete the request form

Download HelloCUVITRU Free Trial Request FormDOWNLOAD NOW >
Step 2: Fax HelloCUVITRU Free Trial Program form to 1-833-388-5467
2

Fax HelloCUVITRU Free Trial Program form to
1-833-388-5467

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.

Additional Patient Resources

Connect

MyIGSource is an educational resource where your patients can learn more about primary immunodeficiency and connect with an individual that is living with PI or has a loved one with PI.

MyIgSource is an educational resource where your patients can learn more about PI and connect with an individual who is living with PI or has a loved one with PI.
Have your patients connect at MyIgSource.com or call 1-855-250-5111.

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.

References: 1. CUVITRU [Prescribing Information]. Lexington, MA: 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. 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 May 1, 2019. 6. Data on File. Takeda US Inc. 2019.

For healthcare professionals only

The information on this website is technical in nature and has been specifically created for US healthcare professionals (HCPs). If you are not an HCP and would like to visit the consumer site, please visit CUVITRU.com.

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