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FAQs

Common questions about CUVITRU and PI.

To help you understand CUVITRU [Immune Globulin Subcutaneous (Human)] 20% and primary immunodeficiency (PI), we’ve provided answers to the most frequently asked questions. As always, be sure to ask your doctor any additional questions you may have.

For specific questions about CUVITRU, be sure to talk to your doctor. To learn more about CUVITRU, read the frequently asked questions below.

About CUVITRU

What is CUVITRU?

CUVITRU is a liquid medicine that contains immunoglobulin (Ig) antibodies, which help protect your body against infection.1

CUVITRU is given under the skin (subcutaneously) to treat primary immunodeficiency (PI) in people 2 years and older.1

How does CUVITRU work?

CUVITRU contains antibodies from human plasma donated by healthy people. These antibodies help your body fight off bacterial and viral infections.1

How should I use CUVITRU?

CUVITRU is given under the skin (subcutaneously). It can be infused at rates up to 60 mL per hour, per site (as tolerated), and volumes up to 60 mL/site, allowing for fewer needlesticks and less infusion time.1 Most of the time, infusions under the skin are given at home by self-infusion or by caregivers after receiving training from a healthcare professional. Only use CUVITRU by yourself after you have been instructed by your healthcare provider.

What equipment do I use to administer CUVITRU?

To administer your CUVITRU treatment, you’ll need vial(s) of CUVITRU and the following infusion supplies:

  • Subcutaneous needle set
  • Transfer device(s)
  • Syringe(s)
  • Sterile tip caps
  • Sterile clear bandage
  • Tape
  • Gauze
  • Sharps container
  • Infusion pump
  • Infusion log

This is not a complete list of all the supplies you may need. When infusing, please remember to refer to your Detailed Instructions for Administration for Patients.

Takeda does not prefer, recommend, or attest to using any specific infusion pump or other ancillary device.

The graphic below is an example of what items you can expect to receive from your specialty pharmacy. Talk to your doctor or specialty pharmacist to ensure you’re receiving the supplies necessary to achieve your intended infusion rate.

Example pump for CUVITRU® Graphic

*To achieve the maximum infusion rate of 60/mL/hour/site with CUVITRU you’ll need a 24-gauge needle.

All subcutaneous needles are small and thin, but they vary in length: 4 millimeters (mm), 6 mm, 9 mm, 12 mm, and 14 mm. Your healthcare team will help determine which needle length is right for your treatment.2

Subcutaneous Needles2 Subcutaneous Needles

Graphics are for illustrative purposes only.

How should I store CUVITRU at home?

Store CUVITRU in the refrigerator at 36℉ to 46℉ (2℃ to 8℃) for up to 36 months, or at room temperature, not to exceed 77℉ (25℃), for up to 24 months. Do not return CUVITRU to the refrigerator if you take it out to room temperature. Do not freeze. Do not shake. Do not use past the expiration date. Protect from light. You can use the original CUVITRU containers to protect it from light.1

Side Effects

What is the most important information I need to know about CUVITRU?

CUVITRU can cause the following serious reactions1:

  • Severe allergic reactions causing difficulty in breathing or skin rashes
  • Decreased kidney function or kidney failure
  • Blood clots in the heart, brain, lungs, or elsewhere in the body
  • Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting
  • Dark colored urine, swelling, fatigue, or difficulty breathing
Who should not use CUVITRU?

Do not use CUVITRU if you have a known history of a severe allergic reaction to immune globulin or other blood products. If you have such a history, discuss this with your healthcare provider to determine if CUVITRU can be given to you. Tell your healthcare provider if you have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.1

What are the serious side effects that can be caused by CUVITRU?

CUVITRU can cause serious side effects. If any of the following problems occur after starting CUVITRU, stop the infusion immediately and contact your HCP or call emergency services1:

  • Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction
  • Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation and swelling of the lining around your brain
  • Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem
  • Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot
  • Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver problem or a blood problem
  • Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem
  • Fever over 100℉. This could be sign of an infection
What are the most common side effects of CUVITRU?

The following one or more possible reactions may occur at the site of infusion. These generally go away within a few hours, and are less likely after the first few infusions.

  • Mild or moderate pain
  • Redness
  • Itching

The most common side effects with CUVITRU are:

  • Headache
  • Nausea
  • Fatigue
  • Diarrhea
  • Vomiting

These are not all of the possible side effects with CUVITRU. Tell your healthcare provider about any side effect that bothers you or that does not go away.

CUVITRU Support

How much does CUVITRU cost?

Your costs for CUVITRU will depend on many factors, including your pharmacy provider and your insurance plan. If you are enrolled in OnePath, you may receive additional information about financial assistance options.

Once you and your HCP have made the decision to begin therapy with CUVITRU, you may be eligible for Takeda’s OnePath product support program. Patients enrolled in this program will be provided with information about financial assistance options. One option includes OnePath’s Co-Pay Assistance Program, which helps eligible* patients cover certain out-of-pocket treatment costs. OnePath can also provide assistance with navigating the health insurance process. To begin the enrollment process, a signed start form is required from your physician.

*At a minimum to be eligible for OnePath’s Co-Pay Assistance program, patients must be enrolled in OnePath and have commercial insurance. Other terms and conditions apply. Contact OnePath for more information.

Will my insurance cover CUVITRU?

CUVITRU is covered similarly to other treatments of PI, but coverage may vary by plan. Your infusion provider may be able to help explain out-of-pocket costs. Or, if you’re enrolled, OnePath can provide assistance with navigating the health insurance process.

What if I need help paying for CUVITRU?

Once you and your HCP have made the decision to begin therapy with CUVITRU, you may be eligible for Takeda’s OnePath product support program. Patients enrolled in this program will be provided with information about financial assistance options. One option includes OnePath’s Co-Pay Assistance Program, which helps eligible* patients cover certain out-of-pocket treatment costs. OnePath can also provide assistance with navigating the health insurance process. To begin the enrollment process, a signed start form is required from your physician.

*At a minimum to be eligible for OnePath’s Co-Pay Assistance program, patients must be enrolled in OnePath and have commercial insurance. Other terms and conditions apply. Contact OnePath for more information.

What if I have general questions about PI?

Learn more about primary immunodeficiency and connect with someone that is living with PI or has a loved one with PI. Go to MyIgSource.com or call 1-855-250-5111.

  1. 1. CUVITRU [Prescribing Information]. Lexington, MA: Baxalta US Inc.
  2. 2. Duff C, Ochoa D, Riely P, Murphy E, Zampelli A. Importance of ancillary supplies for subcutaneous immunoglobulin infusion: management of the local infusion site. J Infus Nurs. 2013;36(6):386