your child's PI.1
CUVITRU [Immune Globulin Subcutaneous (Human)] 20% is approved for the treatment of PI in people 2 years and older. With an administration that can be tailored to meet your individual treatment needs, CUVITRU allows you to customize without compromising on tolerability.1,2
Reliable infection protection and consistent Ig levels1
CUVITRU was studied in 77 adult and pediatric patients with PI ≥2 years of age in North America. Efficacy was determined in 53 adults aged 16 years or older, 6 adolescents aged 12 to <16 years, and 15 children aged 2 to <12 years. The main goal of the study was to measure how many acute serious bacterial infections (ASBIs) were experienced over the course of 1 year. The FDA standard for efficacy—that is, if an immunoglobulin treatment works—is 1 ASBI per year. ASBIs were evaluated in 74 people taking CUVITRU for an average of 380.5 days (range, 30-629 days).1
Check the facts:
CUVITRU delivers reliable protection against infection and provides consistent Ig levels regardless of dosing frequency1
The annual rate of ASBIs in the clinical study was 0.012 per patient-year. The annual rate of any infections was 2.41 per patient-year*1
People who received CUVITRU experienced about 1 day/year where they were unable to attend work/school or perform normal daily activities due to illness or infection1
*One ASBI that occurred during the study was a case of pneumonia in a 78-year-old subject who had specific antibody deficiency.
How subcutaneous needles compare to intravenous needles
For anyone needing Ig replacement therapy, there are 2 ways Ig can be administered into their body, subcutaneously (under the skin) or intravenously (in a vein).4
CUVITRU may only be administered subcutaneously.1,3
Subcutaneous (or “subQ”) administration1,3
- Ig enters the body through the subQ tissue—which is a layer of tissue between the skin and the muscle—through use of a pump and a small, thin subQ needle
- After training, you can administer at home
Intravenous (or “IV”) administration3
- Ig enters the body through a vein in the hand or arm, through use of an IV needle
- Healthcare providers (HCPs) administer at an infusion center or physician’s office
Needle sizes may vary. Graphics are for illustrative purposes only.
How to make infusion time
Keeping disruptions to a minimum is very important during infusions. To establish infusion time as a routine and reduce potential stress,4 create an “infusion zone.” You can set up your child’s infusion zone however you wish, but here are some suggestions:
Consider using sensory distraction techniques
Some examples include a buzzing toy or a smooth rock that the child can paint and keep in the freezer. Your child can hold the sensory toy or cold rock for comfort and to feel involved in their treatment. You can even decorate your own “comfort item” with your child to remind them that you’re there for them during their infusions
A toy, book, smartphone, or laptop game5
These might help your child stay calm, still, and distracted from needles or pain. These simple, everyday objects can help keep your child’s mind occupied and divert their attention from the infusion experience
If you feel it’s appropriate, involve siblings in the process5
They may feel like the child with PI is receiving all the attention, so getting them involved could help avoid hurt feelings
Hadlie Jo’s doctor customized her administration regimen to help fit her lifestyle
With CUVITRU, Hadlie Jo transitioned from 1 needlestick and a 2.5-hour infusion time every week to 2 needlesticks and a less than 1-hour infusion every 2 weeks—so she could spend less time infusing and more time doing what she loves.
“I like that it’s every other week instead of every week, so I can play or dance or whatever I want to do.”
-Hadlie Jo, 9-year-old PI patient
Actual PI patient. Results represent one patient’s experience. Individual results may vary. Patients should consult their physician as needed.
Get the full details of Hadlie Jo’s treatment with CUVITRU as well as 2 other adult patient studies.See Hadlie Jo’s Story
- CUVITRU [Prescribing Information]. Lexington, MA: Baxalta US Inc.
- 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;36(7):700-712.
- Blaese RM, Winkelstein JA, eds. Patient & Family Handbook for Primary Immunodeficiency Diseases. 4th ed. Towson, MD: Immune Deficiency Foundation; 2007.
- Younger ME, Buckley RH. IDF Guide for Nurses: Immunoglobulin Therapy for Primary Immunodeficiency Diseases. 4th ed. Towson, MD: Immune Deficiency Foundation; 2016.
- Blaese RM, Bonilla FA, Stiehm ER, Younger ME, eds. Patient & Family Handbook for Primary Immunodeficiency Diseases. 5th ed. Towson, MD: Immune Deficiency Foundation; 2013.