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CUVITRU for Children

How CUVITRU
may help.1

CUVITRU is approved for the treatment of primary immunodeficiency (PI) in people 2 years and older. When your child is diagnosed with PI there are questions, worries and uncertainties. However, there is also hope. Understanding your child's PI and managing it with treatment that can be tailored to meet your child's individual infusion needs can make a difference.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, 3-629 days).1

Check the facts:

Reliable

CUVITRU delivers reliable protection against infection and provides consistent Ig levels regardless of dosing frequency1

0.012

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

~1 day

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.

Microscope icon depicting CUVITRU®'s side effects.

As a parent, you want to know as much as you can about your child’s treatment. Learning about possible CUVITRU side effects is a big part of that.

See CUVITRU safety info
Two blue bubbles icon.

Having a conversation with your child’s doctor is the best way to get your questions answered.

How to make infusion time more comfortable

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:

Speaking orange duck icon.

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.

Red smartphone icon.

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.

Blue sibling icon.

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, 9
Spends more time dancing, less time infusing

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.

CUVITRU® patient Hadlie Jo in dance class.

"You want what is going to be a convenient treatment for your child, considering the circumstances."

- Susie, Hadlie Jo’s mom

Two blue bubbles icon.

Hadlie and her mom, Susie, made choices for Hadlie after talking with Hadlie’s doctor.

Susie, Hadlie Jo’s mom, braiding her daughter's hair.
Three CUVITRU® patients from kid age to middle-age, smiling.

Get the full details of Hadlie Jo's treatment with CUVITRU as well as 2 other adult patient studies.

See Hadlie Jo's story
  1. CUVITRU [Prescribing Information]. Lexington, MA: Baxalta US Inc.
  2. Data on file. Takeda US Inc. 2015.
  3. Paris K, Haddad E, Borte M, et al. Tolerability of subcutaneous immunoglobulin 20%, Ig20GIy, in pediatric patients with primary immunodeficiencies. Immunotherapy. 2019;11(5):397-406.
  4. Suez D, Stein M, Gupta S, et al. Efficacy, safety, and pharmacokinetics of a human immune globulin subcutaneous, 20% in patients with primary immunodeficiency diseases in North America. J Clin Immunol. 2016;36(7):700-712.