Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Hizentra for CIDP Treatment

CSL Behring news release; 2018 Mar 16

CSL Behring recently announced that the US Food and Drug Administration (FDA) has approved Hizentra (immune globulin subcutaneous [human] 20% liquid) as the first and only subcutaneous immunoglobulin (SCIg) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. CIDP is a rare autoimmune disorder that affects the peripheral nerves and may cause permanent nerve damage. CSL Behring is headquartered in Melbourne, Australia, and King of Prussia, PA, in the US.

Indications: Hizentra is indicated for the treatment of:

  • Primary immunodeficiency (PI) in adults and pediatric patients aged ≥2 years.
  • Maintenance therapy in adults with CIDP.

Dosage/administration: Hizentra is for subcutaneous infusion only. Before switching to Hizentra, physicians should obtain the patient’s serum IgG trough level to guide subsequent dose adjustments. Additional information about dosing can be found here:

Adverse reactions: The most common adverse reactions observed in ≥5% of study subjects were local infusion site reactions, headache, diarrhea, fatigue, back pain, nausea, pain in extremity, cough, upper respiratory tract infection, rash, pruritus, vomiting, abdominal pain (upper), migraine, arthralgia, pain, fall and nasopharyngitis.


FDA approves Hizentra (immune globulin subcutaneous [human] 20% liquid) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP). [news release]. Melbourne, Australia, and King of Prussia, PA: CSL Behring. March 16, 2018. Accessed March 27, 2018.

This Week's Must Reads

MS Risk Factors Contribute to Onset Heterogeneity, Mult Scler Relat Disord; ePub 2018 Dec 3; Briggs, et al

Severe Fatigue in MS Predicts EDSS Worsening, Mult Scler; ePub 2018 Dec 3; Vaughn, et al

Cerebrospinal Fluid Biomarkers and MS Severity, Mult Scler Relat Disord; ePub 2018 Dec 5; Masvekar, et al

Research-to-Practice Gaps in Multiple Sclerosis, Int J MS Care; ePub 2018 Nov 27; Walker, et al

Head Trauma, Autoimmune Diseases: No Link with MS , Neuroepidemiol; ePub 2018 Nov 26; Abdollahpour, et al

Must Reads in FDA Actions

FDA Approves Ajovy for Migraine in Adults, Teva Pharmaceutical news release; 2018 Sep 14

FDA Approves Tiglutik for Treatment of ALS, ITF Pharma news release; 2018 Sep 6

FDA Approves Diacomit for Treatment of Seizures, Biocodex news release; 2018 Aug 23