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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
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
CUVITRU contains antibodies from human plasma donated by healthy people. These antibodies help your body fight off bacterial and viral infections.1
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.
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.
*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
Graphics are for illustrative purposes only.
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
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
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
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
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
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.
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.
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.
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. CUVITRU [Prescribing Information]. Lexington, MA: Baxalta US Inc.
- 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
These are some frequently asked questions about PI. For specific questions about PI and treatment, be sure to talk to your doctor.
About PI
Primary immunodeficiency, or PI (also called PIDD and primary immune deficiency), is a condition where part of your immune system is either missing or not working correctly. Most primary immunodeficiencies are inherited. Primary immunodeficiency is an umbrella term that encompasses over 350 different deficiencies of the immune system.1 In 2005, the Immune Deficiency Foundation conducted a survey of 10,000 households in the US estimating a quarter of a million people in the US have been diagnosed with PI.2 The National Institutes of Health estimates that there are half a million people in the United States who currently have primary immunodeficiency and are not yet diagnosed.3
Yes. They are different conditions. With autoimmune diseases, the immune system gets confused and mistakenly attacks a part of the body.4
No. PI and PIDD actually stand for the same thing–primary immunodeficiency.
The Jeffrey Modell Foundation has developed 10 general warning signs for primary immunodeficiency. They are5:
- Four or more new ear infections within 1 year
- Two or more serious sinus infections within 1 year
- Two or more months on antibiotics with little effect
- Two or more pneumonias within 1 year
- Failure of an infant to gain weight or grow normally
- Recurrent, deep skin or organ abscesses
- Persistent thrush in mouth or fungal infection on skin
- Need for intravenous antibiotics to clear infections
- Two or more deep-seated infections including septicemia
- A family history of PI
Primary immunodeficiency can show itself in different ways and at different times throughout a person's life. Although PI was first identified in children, there has been a growing awareness that adults can be diagnosed with PI. Children born with apparently functioning immune systems can go on to develop a primary immunodeficiency disease later in adolescence or adulthood. Unfortunately, patients can go a long time between when they first develop symptoms of PI and when they get diagnosed.6 In fact, in 2007, the Immune Deficiency Foundation did a survey that showed that the average time from the onset of symptoms to diagnosis was 12.4 years in the United States.2
Because primary immunodeficiency often presents with signs and symptoms associated with other common diseases, PI often gets misdiagnosed. Also, low awareness of PI and its treatment by both healthcare professionals and the general public further contributes to the delay in accurate diagnosis.6-8 According to a survey published by the Immune Deficiency Foundation in 2005, a projected 250,000 people in the United States have been diagnosed with different types of PI.2 The National Institutes of Health estimated in 2008 that there were half a million people in the United States who may have had primary immunodeficiency and were undiagnosed.3
In addition to the 10 warning signs for primary immunodeficiency from The Jeffrey Modell Foundation, the Immune Deficiency Foundation uses the S-P-U-R-R acronym to also help identify those who should be tested for PI. S-P-U-R-R stands for ‘Severe, Persistent, Unusual, Recurrent, and Runs in the family.’ Specifically, you should be suspicious of any of the following traits: infections that are severe, or infections that are persistent (won't go away), or infections that are sometimes unusual (caused by an uncommon organism), or infections that are recurrent (keep coming back).9 Finally, you should look for cases in which susceptibility of infection runs in a family.5
If you suspect that you or someone you know may have PI, you should speak with your doctor. If you need assistance locating a physician who has experience diagnosing and treating primary immunodeficiency, both the Immune Deficiency Foundation and Jeffrey Modell Foundation have resources available to help you locate a physician.
Resources
Many organizations have started offering patient assistance programs. To learn more about them in detail, you can visit their specific websites. Additionally, the following websites intermittently offer copay assistance or guidance from time to time:
The Immune Deficiency Foundation has a number of resources that are available for people living with PI. They have local events and every other year in June hold a national conference. The next national conference will be held in 2021 and will feature some of the leading experts in PI. In the off years, they hold family retreat weekends. The Immune Deficiency Foundation is available to help in many ways. Register with them on primaryimmune.org.
The Jeffrey Modell Foundation also has a number of resources that are available to people living with PI. Additionally, they are committed to empowering the community with "Calls to Action," which are meant to bring the global medical community together to help enhance early diagnosis with access to equal and appropriate treatments for all patients around the world. Learn more here.
There are 2 places we recommend:
- The Immune Deficiency Foundation's discussion boards. More information can be found at idffriends.org
- The Jeffrey Modell Foundation has a number of social media sites, such as Facebook, YouTube, Instagram, and Flickr, which can be found at jmfworld.com
World PI Week aims to raise awareness and diagnosis of PI on a global level. On their website, you can learn all about PI and the events that occur all across the world during World PI Week. World PI Week was founded by a variety of organizations, including the Immune Deficiency Foundation and Jeffrey Modell Foundation.
Additionally, the Jeffrey Modell Foundation is dedicated to global awareness of PI, physician education, research, patient support, and advocacy. In 2004, they created the first-ever public service advertising (PSA) campaign for primary immunodeficiency to coincide with their focus of public awareness and physician education. Since then, they have continued to expand the reach of the campaign to help bring knowledge to both members of the PI community and the public. To learn more about the Jeffrey Modell Foundation's PSA campaign, please visit www.info4pi.org/wjmf/psa-campaign.
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.
Insurance
If enrolled, OnePath can provide assistance with navigating the health insurance process. OnePath is a free program that provides individualized treatment support to people who have been prescribed CUVITRU.
To be eligible for OnePath, your doctor must prescribe CUVITRU in accordance with the approved indication and you must sign a OnePath Start Form. Your signature gives OnePath permission to help you with the insurance process or any other issues that could arise when it comes to accessing CUVITRU.
The Immune Deficiency Foundation has a great handbook on how to handle insurance issues and questions. Search for the IDF Health Insurance Toolkit in the Patient Insurance Center.
As always, your insurer and your insurance policy can affect coverage for any drugs your doctor prescribes, including treatments that you receive on a regular basis, such as Ig. Many insurance companies have a list of prescription medications that they will cover under the benefit plan. This list is called a formulary.
It’s important to know if the drugs you take are on your insurance carrier's formulary. Check the formulary by visiting your insurance company's website, and see if the drug your doctor prescribes is listed. Also look to see if the list includes the type of drug you receive, as well as the specific brand your doctor recommends. Sometimes insurance formularies will list only some of the brands that are available for a medication.
If your brand of medication is (or is not) on the formulary, it can affect how much money you or your family will have to pay for the drug as out-of-pocket costs or copays.
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. OnePath can assist you with gaining access to CUVITRU. See above to learn if you are eligible for OnePath product support.
When it comes to immunoglobulin (Ig) treatment, each brand of Ig is considered to be a different treatment, because there are important differences in how each brand of these plasma-derived products is made. As a result, different brands of Ig treatment are not considered to be interchangeable (or identical), according to medical experts.7
Some insurance carriers have begun limiting access to specific brands of Ig, but many of these insurers also have exception policies in place that may allow continued access to the Ig brand your physician recommends.
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. See above to learn if you are eligible for OnePath product support.
If your insurance plan has special rules for brand-name drugs, you or your family should make sure your doctor is aware of them. For example, tell your doctor if your prescription for Ig needs to be worded in a special way to make sure you get exactly what the doctor wants you to receive. Depending on your state of residence, the doctor may need to write "Dispense as written (DAW)," "Brand necessary," or other statements on the prescription to ensure that the pharmacy dispenses the exact brand of Ig that was prescribed.
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. OnePath can assist you with gaining access to Cuvitru. See above to learn if you are eligible for OnePath product support.
The Patient & Family Handbook for Primary Immunodeficiency Disorders, developed by the Immune Deficiency Foundation, devotes an entire chapter to health insurance. A copy of the 5th edition of the handbook can be downloaded here.
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. See above to learn if you are eligible for OnePath product support.
- 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. Published online October 7, 2015. Accessed October 4, 2019.
- Immune Deficiency Foundation. About primary immunodeficiencies. https://primaryimmune.org/about-primary-immunodeficiencies. Accessed October 4, 2019.
- Modell F, Puente D, Modell V. From genotype to phenotype. Further studies measuring the impact of a Physician Education and Public Awareness Campaign on early diagnosis and management of primary immunodeficiencies. Immunol Res. 2009;44(1-3):132-149.
- 10 warning signs of primary immunodeficiency. Jeffrey Modell Foundation; 2016.
- Immune Deficiency Foundation. Primary immunodeficiency disease in America: 2007. The Third National Survey of Patients. Prepared by Abt. SRBI, Inc. May 1, 2009.
- Blaese RM, Bonilla FA, Stiehm ER, Younger ME, eds. Patient & Family Handbook for Primary Immunodeficiency Disease. 5th ed. Towson, MD: Immune Deficiency Foundation; 2013.
- Gelfand EF. Differences between IGIV products: Impact on clinical outcome. International Immunopharmacology. 2006;6:592-599.
- Modell V, Gee B, Lewis DB, et al. Global study of primary immunodeficiency diseases (PI)–diagnosis, treatment, and economic impact: An updated report from the Jeffrey Modell Foundation. Immunol Res. 2011;51:61-70.
- Immune Deficiency Foundation. Is it just an infection? https://primaryimmune.org/sites/default/files/publications/Is-It-Just-an-Infection-Poster-2015.pdf. Published 2015. Accessed October 4, 2019.