In a recent news release, biotherapeutics company CSL Behring shared that the company received FDA approval to update the Hizentra label for patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Within the update, new guidelines are available on two safe, well-tolerated, and effective Hizentra doses. Following clinical data, these doses now offer the ability to provide a more targeted treatment option for patients with CIDP.
Hizentra
Outside of CIDP, Hizentra is also used to treat primary immunodeficiency (PI). Hizentra, or Immune Globulin Subcutaneous (Human), 20% Liquid, is a subcutaneously-administered immunoglobulin. As Drugs.com explains in easier terms:
Hizentra (immune globulin) is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.
Hizentra was approved to treat CIDP in the U.S. in 2018. In particular, it works to prevent patients from relapsing and experiencing further neuromuscular difficulties. The most recent approval hinged on data from the Phase 3 PATH clinical trial extension study. Altogether, 82 patients enrolled. Over a 48-week period, patients received either 0.2 g/kg or 0.4 g/kg Hizentra weekly. Patients were switched to the lower dose if clinically stable, but readmitted to the higher dose if relapse occurred. Over the course of the trial, 90% of patients who received 0.4 g/kg Hizentra (either throughout the entire trial or at any point) remained relapse-free.
Now, patients who receive a low dose of Hizentra can be switched to a higher dose if relapse occurs. This offers a more accessible and easy treatment option than placing patients on intravenously-administered immune globulin. Hizentra is now the first and only option to use pre-filled syringes at home, offering patients a more efficient treatment option.
Hizentra Safety Information
While Hizentra was relatively safe and well-tolerated, some adverse reactions did occur. These included:
- Thrombosis (blood clots)
- Injection site redness, itching, swelling, or bruising
- Headache
- Joint, back, or chest pain
- Nausea and vomiting
- Diarrhea
- Pruritus (intense itching)
- Fever
- Cough
- Fatigue
- Rash
If you are taking Hizentra and experience any of the following side effects, please see your doctor immediately:
- Difficulty breathing
- Urticaria (hives)
- Fainting
- Wheezing
- Red or brown urine
- Jaundice (yellowing of the skin and eyes)
- Light sensitivity
- Bad headache with nausea and/or vomiting
- Neck stiffness
- Unintended weight gain
- Chest pain that worsens when breathing deeply
- Extremely rapid pulse
- Weakness/numbness on one side of the body
- Reduced urination
- High fever
- Swelling of the lower extremities
- Dizziness or confusion
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Although doctors are not sure of the exact cause of chronic inflammatory demyelinating polyneuropathy (CIDP), many consider it to be an autoimmune disorder. In this case, this rare and progressive neurological disorder is characterized by peripheral nerve damage, myelin sheath (protective nerve coating) destruction, and nerve root inflammation. As these occur, nerve signals are unable to transmit, causing difficulties. CIDP can occur at any age. It more often affects males than females. Symptoms include:
- Fatigue
- Numbness/tingling
- Difficulty breathing
- Abnormal movement
- Loss of balance and coordination
- Changes in voice, such as hoarseness or slurring
- Difficulty walking
- Loss of reflexes
- Progressively worsening muscle weakness that often affects the arms, legs, hands, and feet
