Description
Hizentra (Immunoglobulin [Human]) is a 20% subcutaneous immune globulin (SCIG) preparation used for the treatment of primary immunodeficiency (PI) and chronic inflammatory demyelinating polyneuropathy (CIDP) in patients aged two years and older. It is formulated from human plasma and contains a broad spectrum of immunoglobulin G (IgG) antibodies, providing passive immunity for individuals with antibody deficiencies or dysregulation. Hizentra is designed for self-administration at home, offering flexible dosing schedules and enhanced patient convenience. The high-concentration, ready-to-use liquid is stabilized with L-proline and contains no preservatives, making it suitable for long-term therapy in chronic immunological conditions.
| F act Table |
| Formula | Variable (IgG glycoprotein) |
| License | US FDA |
| Bioavailability | ~73–89% (SubQ) |
| Legal status | Prescription only |
| Chemical Name | Immunoglobulin G (Human) |
| Elimination half-life | 21–28 days |
| Dosage (Strength) | 20% solution (200 mg/mL) |
| Pregnancy | Use only if clearly needed |
| Brands | Hizentra |
| Protein binding | >95% |
| PubChem CID | Not applicable (mixture of antibodies) |
| MedlinePlus | a610015 |
| ChEBI | 3824 |
| ATC code | J06BA01 |
| DrugBank | DB00028 |
| KEGG | D01934 |
| Routes of administration | Subcutaneous (SubQ) |
Directions
Hizentra is administered subcutaneously, typically once weekly, though individualized dosing regimens such as biweekly may be appropriate depending on clinical response and patient preference. For PI, the weekly dose is calculated based on body weight and prior intravenous or subcutaneous immunoglobulin therapy. For CIDP, maintenance doses may vary but generally follow a biweekly schedule. Administration should be initiated under medical supervision, with patient training provided for home infusions. The product should be brought to room temperature prior to use and infused using a syringe pump or infusion device with appropriate subcutaneous needles.
Ingredients
Each milliliter of Hizentra contains 200 mg of human normal immunoglobulin G (IgG), stabilized with 250 mg of L-proline in a glycine-free, ready-to-use aqueous solution. The pH is approximately 4.8. Hizentra contains no preservatives, latex, sucrose, or sodium, reducing the risk of allergic or renal complications. The product undergoes several viral inactivation and removal steps, including solvent/detergent treatment and nanofiltration.
Contraindications
Hizentra is contraindicated in individuals with a history of anaphylactic or severe systemic reactions to human immunoglobulin preparations. Patients with IgA deficiency who have developed anti-IgA antibodies and experienced hypersensitivity reactions should not use Hizentra. Known hypersensitivity to L-proline or any other component of the formulation also constitutes a contraindication.
Cautions
Patients with a history of thrombotic events, renal impairment, or other risk factors for vascular complications should be closely monitored during therapy. Hydration should be maintained, and infusion rates should be adjusted to minimize the risk of adverse reactions. Hizentra may interfere with the efficacy of live attenuated vaccines; appropriate timing between immunoglobulin administration and vaccination should be considered. Hemolysis has been reported and should be evaluated in patients presenting with unexplained anemia post-infusion. Monitor for local infusion site reactions and systemic adverse effects, particularly during initiation of therapy.
Side Effects
Reported side effects associated with Hizentra include:
- Injection site reactions (e.g., swelling, redness, itching, or induration)
- Thromboembolic events (rare)
- Hypersensitivity reactions, including anaphylaxis (rare)
Patients should be advised to report persistent or severe side effects and seek immediate medical attention for signs of systemic allergic reactions.
IMPORTANT NOTE:
The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.
Product Code : 15322
Prescription Required
