98.2% of infusions resulted in no local side effects such as pain, redness, and itching (4247/4327 infusions)1
consistent Ig levels.1
CUVITRU [Immune Globulin Subcutaneous (Human)] 20% was studied in 77 people with PI ≥2 years of age in North America. 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).
In the North American clinical study:
0.012 ASBIs per patient-year*1
2.41 any infections per patient-year1
0.06 days in hospital due to infection per patient-year1
CUVITRU patients had ~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 patient.
Take on PI with demonstrated tolerability
The rate of local side effects was not associated with a higher infusion rate or increased volume per site.1,2 In a clinical study with CUVITRU:
100% of local side effects were mild or moderate1-3
- A mild side effect causes temporary discomfort that goes away on its own, or with little medical intervention
- A moderate side effect causes a slight decline in function that goes away on its own, or with little medical intervention, and has no further consequences
- 2 out of every 3 people (51 of 74) experienced no local side effects
Most common side effects
The most common side effects overall were local side effects and systemic side effects—that is, reactions that affect the entire body and can occur within 72 hours of infusion (excluding infections)—including1:
Fastest subQ rates and fewest needlesticks1
Whether faster infusions or fewer needlesticks are more important, CUVITRU allows your doctor to customize administration without compromising on tolerability.1,2
In the North American study1:
Average duration of once-weekly infusions was <1 hour†1
Most infusions (84.9%) used 1-2 infusion sites‡1
†Average: 0.95 hours (range: 0.2-6.4 hours).
‡Infuse at up to 4 sites simultaneously.
Your doctor can customize the following administration parameters based on your clinical needs and lifestyle. It’s important that your doctor knows your preferences before making decisions about your administration options. Never change your treatment regimen without specific instruction from your doctor.
For patients looking to minimize infusion time, CUVITRU may deliver a full week’s dose in under 15 minutes as tolerated§
Choose from 1 to 4 infusion sites
Infuse once every 2 weeks, once a week, or once a day. Discuss your preference with your doctor
The rate of local side effects was not associated with a higher infusion rate or increased volume per site
§For example, if you weigh 165 lbs and were prescribed 36 grams of intravenous immune globulin (IVIg) per month, your doctor could switch you to 12 grams of CUVITRU weekly. After the first 2 infusions, your CUVITRU infusion could be completed in 15 minutes at a rate of 60 mL/hour/site using 4 sites simultaneously.
You and your doctor will decide the best CUVITRU regimen for you. Together, you can customize1:
- How many
- How much CUVITRU
to infuse at each site
- How fast to
- How often to
Read how CUVITRU’s administration options helped 3 people with PI fit the treatment into their lives.Get more info
- 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.
- Data on File. Takeda US Inc. 2019.