Frequently Asked Questions

A multicenter, double-blind, randomized, placebo-controlled, parallel-group, phase III study evaluated the efficacy, safety, and tolerability of 2 different weekly doses of Hizentra (0.4 g/kg body weight and 0.2 g/kg body weight) vs. placebo in 172 adult subjects with CIDP and previously treated with IVIg (PATH Study).¹

CIDP relapse was defined as a ≥1-point increase in adjusted Inflammatory Neuropathy Cause and Treatment [INCAT] score compared with baseline.

The main endpoint was the percentage of subjects who had a CIDP relapse or were withdrawn for any other reason during the subcutaneous treatment period. Both Hizentra doses demonstrated superiority over placebo for the main endpoint (32.8% for 0.4 g/kg Hizentra and 38.6% for 0.2 g/kg Hizentra compared with 63.2% for placebo, p<0.001 and p=0.007, respectively), with no statistically significant difference between the Hizentra-treated groups.¹

81% and 67% of Hizentra-treated subjects remained CIDP relapse free (0.4 g/kg body weight and 0.2 g/kg body weight, respectively); 44% of placebo subjects remained relapse free for up to 24 weeks.¹

Initiate therapy 1 week after last IVIg infusion.

• Lowest recommended subcutaneous dose is 0.2 g/kg body weight per week*
  • A dose of 0.4 g/kg body weight per week was also safe and effective
• If CIDP symptoms worsen on 0.2 g/kg, consider increasing to 0.4 g/kg per week^†
• Most patients remained relapse-free on either dosing option, with the 0.4 g/kg dose showing a lower rate of relapse^{‡ §}
  • If CIDP symptoms worsen on the 0.4 g/kg dose, consider reinitiating therapy with IVIg

* Administered in 1 or 2 sessions over 1 or 2 consecutive days. † Administered in 2 sessions per week over 1 or 2 consecutive days. ‡ CIDP relapse was defined as a ≥1-point increase in adjusted Inflammatory Neuropathy Cause and Treatment [INCAT] score compared with baseline. § In the PATH Study, no statistically significant difference was found between the low-dose and the high-dose groups. In the PATH Extension Study, statistical tests between the low and high doses were not conducted.

View additional dosing information for Hizentra

Learn more about the efficacy of Hizentra

Hizentra has been shown to maintain functional ability across multiple secondary endpoints^1*

• Stable MRC score^†: 0.0 median change from baseline; p=0.0026^‡
• Stable INCAT score^†: 0.0 median change from baseline; p<0.0001^‡
• Stable grip strength^†: –1.7 kPa median change from baseline; p=0.0223^‡

Hizentra also demonstrated better I-RODS scores vs placebo^1§

• Median change from baseline to last postdose observation was -3.0 points for the placebo group, -2.0 points for the 0.2 g/kg Hizentra group, and 0.0 for the 0.4 g/kg Hizentra group (p=0.0002 for all).^||

In the PATH Study, the most common adverse reactions (ARs) observed in ≥5% of study subjects receiving Hizentra and at a higher frequency than placebo were local infusion-site reactions*, headache, nasopharyngitis, fatigue, upper respiratory tract infection, fall, back pain, arthralgia, and pain in extremity.¹

Patients on Hizentra reported a 3.6-fold lower rate of systemic adverse reactions per infusion vs IVIg.^† 93% of 4,225 total Hizentra infusions were free of any reported ARs.¹

Overall, safety findings in the Open-Label Extension (OLE) study to PATH were consistent with those from the PATH Study and the established safety profile for Hizentra.

WARNING: Thrombosis may occur with immune globulin products, including Hizentra. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.

For patients at risk of thrombosis, administer Hizentra at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

While IVIg treatment helps control CIDP, challenges may remain for many patients. For example, in some patients, poor venous access can make infusion difficult.² Also, systemic adverse reactions such as headache and fever can occur.² Patients also have lifestyle burdens. IV infusions can be costly and constraining, and traveling to an infusion clinic can be time-consuming and require missing work.³

Consider Hizentra for your patients with CIDP who:

• Benefit from consistent Ig levels
• Require more frequent IV infusions
• Seek flexibility, freedom, and control
• Experience IV-related systemic adverse reactions (ARs)
• Have venous access issues