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DEMONSTRATED PROTECTION through reliable Ig replacement
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Experience_Proven_Demonstrated_PI

In the US Phase III pivotal trial† (n=80)1:

  • There were 6 episodes of aSBI* resulting in an annual rate of 0.08 (upper one-sided 99% CI=0.203) and an annual rate of 3.55 for any infections
  • 97% of AR were non-serious§, and 90% were rated mild or moderate in severity

In patients studied up to 29 months in the extension trial‡ (n=55)2:

  • The annual rate of aSBI* was 0.02 and 1.60 for any infections
  • Proportion of infusions with ≥1 temporally-associated AR within 72 hours after infusion was 0.15
  • 96% of AR were non-serious||, and 93% were rated mild or moderate in severity

In clinical studies of patients with PI, the most common adverse reactions to Privigen, observed in >5% of subjects, were headache, fatigue, nausea, chills, vomiting, back pain, pain, elevated body temperature, abdominal pain, diarrhea, cough, stomach discomfort, chest pain, joint swelling/effusion, influenza-like illness, pharyngolaryngeal pain, urticaria, and dizziness.

*aSBI were defined as pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.
† A prospective, open-label, single-arm, clinical study evaluated the efficacy, tolerability, and safety of Privigen in 80 adult and pediatric patients with PI. All subjects received Privigen every 3 or 4 weeks for up to 12 months. The primary end point was the annual rate of aSBI.
‡An open-label, single-arm, prospective, extension study of 55 adult and pediatric patients with PI received Privigen every 3 or 4 weeks for up to 29 months. The primary end point was proportion of infusions with ≥1 temporally-associated AR.
§Serious AR in the PI pivotal trial included hypersensitivity, chills, fatigue, dizziness, and increased body temperature (all severe), occurring in one subject and resulting in the subject’s withdrawal from the study. Two other subjects withdrew from the study due to AR of vomiting in one subject and chills and headache in the other.
||11 (20%) of patients experienced a total of 17 serious AR in the PI extension trial.
Infections per patient per year.

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RAPID IMPROVEMENTS in functional ability*
*The overall median time to first response in PRIMA was 7.5 weeks and in PATH was 3.7 weeks.†
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Experience_Proven_Demonstrated_CIDP
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Largest Ig Study in CIDP

PATH, one of two clinical studies,† was the largest ever in Ig for CIDP, evaluating 207 patients

Privigen improved strength in addition to functional ability in PRIMA and PATH1,2:

  • Average improvement in muscle strength, measured by Medical Research Council (MRC) sum score, was 6.9 points in PRIMA and 3.6 points in PATH
  • Mean improvement in dominant hand grip strength was 14.1 kPa in PRIMA and 12.2 kPa in PATH 

    • Similar results were observed in the nondominant hand

In clinical studies of patients being treated for CIDP, the most common adverse reactions, observed in >5% of subjects, were headache, asthenia, hypertension, nausea, pain in extremity, hemolysis, influenza-like illness, leukopenia, and rash.

† In a prospective, open-label, single-arm, multicenter clinical study (Privigen Impact on Mobility and Autonomy [PRIMA]), 28 subjects with CIDP received a Privigen loading dose of 2 g/kg followed by Privigen maintenance doses of 1 g/kg every 3 weeks for up to 21 weeks with 3-week follow-up. In a second prospective, open-label Privigen pre-randomization phase of a multicenter clinical study (Polyneuropathy and Treatment with Hizentra [PATH]), 207 IVIg-pretreated subjects with CIDP received a Privigen loading dose of 2 g/kg followed by up to 4 Privigen maintenance doses of 1 g/kg every 3 weeks for up to 13 weeks. PATH enrolled only IVIg retreated subjects while PRIMA included both pretreated and naive subjects; cross study comparison should be interpreted with caution.
‡ Overall response rate was defined as percentage of subjects who experienced at least a 1-point decrease in adjusted INCAT (Inflammatory Neuropathy Cause and Treatment Disability) score.
§ Serious AR included hemolysis (2), exacerbation of CIDP (2), acute rash, increased diastolic blood pressure, hypersensitivity, pulmonary embolism, respiratory failure, and migraine. A total of 4 patients discontinued treatment due to serious AR.

Privigen response rates among responders graph
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PROVEN EFFICACY with long-lasting response
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Chronic ITP Patient and Wife Taking a Photograph

In the ITP clinical trial,* platelet counts rose rapidly and the duration of response was lasting1

  • 80.7% of subjects (46 of 57) responded to Privigen with a 150% rise in platelet count within 7 days from ≤20 x 109/L to ≥50 x 109/L1
  • The mean platelet count increased from 13 x 109/L to 52 x 109/L in only 1 day, before the second infusion
  • The median duration of platelet response was 15.4 days (range: 1 to >82 days), with the duration of response being at least 8.8 days in 75% of patients*1
  • Adverse events were generally mild or moderate

In clinical studies of patients being treated for chronic ITP, the most common adverse reactions, seen in >5% of subjects, were laboratory findings consistent with hemolysis, headache, elevated body temperature, anemia, nausea, and vomiting.

* A prospective, open-label, single-arm, multicenter study assessed the efficacy and safety of Privigen in 57 subjects with chronic ITP and a platelet count of 20 x 109/L or less. Subjects received a 2 g/kg dosage of Privigen administered as 1 g/kg daily for 2 consecutive days. The primary endpoint was response rate defined as the percentage of subjects with an increase in platelet counts to at least 50 x 109/L within 7 days after the first infusion.

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Privigen is the first and only IVIg stabilized with proline

Find out what proline is and why it's in Privigen

Learn more about proline

References: 1. Stein MR, Nelson RP, Church JA, et al. Safety and efficacy of Privigen®, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies. J Clin Immunol. 2009;29(1):137-144. 2. National Institutes of Health: ClinicalTrials.gov. Safety and efficacy of intravenous immunoglobulin IgPro10 in patients with primary immunodeficiencies. https://clinicaltrials.gov/study/NCT00322556?id=NCT00322556&viewType=Card&rank=1. Accessed April 1, 2026.

Reference: 1. Robak T, Salama A, Kovaleva L, et al. Efficacy and safety of Privigen®, a novel liquid intravenous immunoglobulin formulation in adolescent and adult patients with chronic immune thrombocytopenic purpura. Hematology. 2009;14(4):227-236.

References: 1. Léger JM, De Bleecker JL, Sommer C, et al. Efficacy and safety of Privigen® in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single-arm, open-label Phase III study (the PRIMA study). J Peripher Nerv Syst. 2013;18(2):130-140. doi:10.1111/jns5.12017. 2. Mielke O, Bril V, Cornblath DR, et al. Restabilization treatment after intravenous immunoglobulin withdrawal in chronic inflammatory demyelinating polyneuropathy: Results from the pre-randomization phase of the Polyneuropathy And Treatment with Hizentra study. J Peripher Nerv Syst. 2019;24(1):72-79. doi:10.1111/jns.12303. 3. Data on file. Available from CSL Behring as DOF PVG-003.

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