THE BENEFITS OF
Ig STABILITY1,2
SCIg therapy for CIDP
Achieve Ig stability with Hizentra1,2*
Weekly dosing with Hizentra provides steadier Ig levels between infusions vs IVIg1,2
Ig trough levels were higher for patients on the 0.4 g/kg dose vs those on the 0.2 g/kg dose1,2
MEDIAN CONCENTRATIONS PER DOSE AND DOSING REGIMEN1,3†‡
NO DISRUPTION
When transitioning from IVIg to Hizentra 1 week after the last IVIg infusion, immunomodulation is continued without disruption.1
The simulated pharmacokinetic model of Hizentra weekly doses (0.2 g/kg and 0.4 g/kg) maintained steady Ig concentrations over 24 weeks.1
*As demonstrated in the pharmacokinetic analysis of the Polyneuropathy and Treatment with Hizentra (PATH) study (N=172).1,2
†The pharmacokinetic model simulated concentration time plots for Hizentra 0.2 g/kg and 0.4 g/kg compared to IVIg 1 g/kg.1
‡The 0.2 g/kg and 0.4 g/kg weekly doses of Hizentra were 40% lower and 20% higher than the equivalent IVIg weekly dose, respectively.7
Moving from IVIg
Move appropriate patients with CIDP to Hizentra for Ig stability4,6
PATIENTS READY TO MOVE TO HIZENTRA INCLUDE THOSE WHO:
Are controlled on IVIg2
Have achieved disease control with IVIg and are looking for continued immunomodulation
Are burdened by systemic AEs2
Report intolerable systemic AEs, like headache and nausea
Struggle with IVs5
Experience venous access issues and/or port complications
Experience logistical issues5
Have challenges with infusion appointments
“Since self-infusing with Hizentra, systemic side effects no longer prevent me from doing the things I need to do.”
ArthurReal Hizentra user
Patient advocates are compensated by CSL Behring LLC for their time and/or expenses.
SCIg is a strongly recommended option
The 2021 EAN/PNS guideline strongly recommends SCIg as a maintenance treatment option for CIDP8
Abbreviations: AE, adverse event; CIDP, chronic inflammatory demyelinating polyneuropathy; EAN, European Academy of Neurology; Ig, immunoglobulin; IV, intravenous; IVIg, intravenous immunoglobulin; MOA, mechanism of action; PNS, Peripheral Nerve Society; SCIg, subcutaneous immunoglobulin.
References: 1. Tortorici MA, Yuraszeck T, Cornblath D, et al. CPT Pharmacometrics Syst Pharmacol. 2021;10(8):839-850. doi:10.1002/psp4.12647 2. van Schaik IN, Bril V, van Geloven N, et al. Lancet Neurol. 2018;17(1):35-46. doi:10.1016/S1474-4422(17)30378-2 3. Léger JM, De Bleecker JL, Sommer C, et al. J Peripher Nerv Syst. 2013;18(2):130-140. doi:10.1111/jns5.12017 4. Berger M, Rojavin M, Kiessling P, Zenker O. Clin Immunol. 2011;139(1):133-141. doi:10.1016/j.clim.2011.01.006 5. Berger M. Curr Opin Allergy Clin Immunol. 2011;11(6):532-538. doi:10.1097/ACI.0b013e32834c22da 6. Berger M, Allen JA. Muscle Nerve. 2015;51(3):315-326. doi:10.1002/mus.24526 7. Allen JA, Gelinas DF, Freimer M, et al. J Neurol Sci. 2020;408:116497. doi:10.1016/j.jns.2019.116497 8. Van den Bergh PYK, van Doorn PA, Hadden RDM, et al. Eur J Neurol. 2021;28(11):3556-3583. doi:10.1111/ene.14959
IMPORTANT SAFETY INFORMATION
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.
Hizentra is contraindicated in patients with a history of anaphylactic or severe systemic reaction to human immune globulin (Ig) or components of Hizentra (eg, polysorbate 80), as well as in patients with immunoglobulin A deficiency with antibodies against IgA and a history of hypersensitivity. Because Hizentra contains L-proline as stabilizer, use in patients with hyperprolinemia is contraindicated.
IgA-deficient patients with anti-IgA antibodies are at greater risk of severe hypersensitivity and anaphylactic reactions. Thrombosis may occur following treatment with Ig products, including Hizentra.
Monitor patients for aseptic meningitis syndrome (AMS), which may occur following treatment with Ig products, including Hizentra. In patients at risk of acute renal failure, monitor renal function, including blood urea nitrogen, serum creatinine and urine output. In addition, monitor patients for clinical signs of hemolysis or pulmonary adverse reactions (eg, transfusion-related acute lung injury [TRALI]).
Hizentra is derived from human blood. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.
The most common adverse reactions (observed in ≥5% of study subjects) were local infusion-site reactions, as well as headache, diarrhea, fatigue, back pain, nausea, extremity pain, cough, upper respiratory tract infection, rash, pruritus, vomiting, upper abdominal pain, migraine, arthralgia, pain, fall, and nasopharyngitis.
The passive transfer of antibodies can interfere with response to live virus vaccines and lead to misinterpretation of serologic test results.
Indications
Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, is indicated for:
- Treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years and older.
- Maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to prevent relapse of neuromuscular disability and impairment.
- Limitation of Use: Maintenance therapy in CIDP has been systematically studied for 6 months and for a further 12 months in a follow-up study. Continued maintenance beyond these periods should be individualized based on patient response and need for continued therapy.
For subcutaneous infusion only.
Please see full Prescribing Information for Hizentra including boxed warning.
To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Hizentra is manufactured by CSL Behring AG and distributed by CSL Behring LLC.
Hizentra® is a registered trademark of CSL Behring AG.
Hizentra Connect℠ is a service mark of CSL Behring LLC.