Privigen IVIg—safety and efficacy you can trust
Clinically proven to help protect against infections
Privigen helps strengthen the immune system by replacing the immunoglobulin G antibodies that are missing or not working properly to help prevent infections in patients living with PI.
Helping people overcome the effects of PI since 2007
Privigen was evaluated in 2 clinical trials:
- The study looked at how often patients had serious bacterial infections such as pneumonia, blood infections, infections in the bones or joints, infections around the brain and spine, or deep infections inside the body, over 1 year.*
- A 2½ year extension trial studied the long term safety and efficacy of Privigen in 55 adults and children with PI. Patients received doses of Privigen every 3 or 4 weeks.†
In the 1-year study
3.55
infections per
patient per year
0.08
acute serious bacterial
infections per patient per year
In the 2½ year study
1.60
infections per
patient per year
0.02
acute serious bacterial
infections per patient per year
In the clinical studies, patients recorded how they felt every day.‡ On average, patients reported feeling "well."
* In the US study, 80 children and adults (age 3 and older) with primary immunodeficiency were given Privigen through a vein every 3 or 4 weeks for up to one year. All patients had been previously treated with IVIg for at least 6 months before joining the study. The main goal of the study was to see how often patients had serious bacterial infections over one year such as pneumonia, blood infections, infections in the bones or joints, infections around the brain and spine, or deep infections inside the body.
† In this study, 55 children and adults (age 4 and older) with primary immunodeficiency were given Privigen through a vein every 3 or 4 weeks for up to 29 months. Some patients had already taken Privigen before, while others had been on other IVIg treatment for at least 6 months. The study looked at side effects and how tolerated Privigen was by checking how often patients had side effects during or soon after their infusions.
‡ Based on personal assessment, patients' overall feeling of well-being score was classified as "well" on a five-point scale (1 = very well, 2 = well, 3 = fair, 4 = poor, 5 = very poor), with a mean of 2.1 ± 0.8 standard deviation.
Common side effects occurring in >5% of patients with PI
- Headache
- Fatigue
- Nausea
- Chills
- Vomiting
- Back pain
- Pain
- Elevated body temperature
- Abdominal pain
- Diarrhea
- Cough
- Stomach discomfort
- Chest pain
- Joint swelling
- Flu-like symptoms
- Pain in the throat or voice box
- Rash
- Dizziness
Serious side effects in the 1-year study all occurred in one patient, one of three who withdrew from the study due to adverse reactions.† In the long-term study, one patient withdrew because of a mild case of hives.
These are not the only side effects possible; see the full prescribing information, including boxed warning, for a complete list of adverse reactions possible with treatment for each condition.
Call your doctor if you experience any side effects, or if you have any other questions or concerns.
IVIg safety—PI studies showed tolerability of Privigen
Most of the side effects with Privigen were not serious†, and most side effects were of mild or moderate intensity.‡§
1-year study
97%
of side effects
were not serious†
2½-year study
96%
of side effects
were not serious†
† In the 1-year study, 1 patient experienced 5 serious adverse reactions (hypersensitivity, chills, fatigue, dizziness and increased body temperature) deemed severe and related to treatment with Privigen. As a result, this patient stopped participating in the study. Two other patients withdrew from the study due to adverse reactions (chills and headache in one subject; vomiting in the other). In the 2½ year extension study, 11 patients experienced serious adverse reactions.
‡ 90% were rated mild or moderate in severity in the 1-year study.
§ 93% were rated mild or moderate in severity in the 2 1/2 year study.
Would you like to learn about Ig therapy that you can infuse yourself?
Please see Important Safety Information below and full prescribing information for Hizentra, including boxed warning and patient product information.
(Immune Globulin Subcutaneous
[Human] 20% Liquid)
Heritage of safety and
excellence
Receiving Privigen
therapy
The support
you need,
all in one place