Hizentra is 20% immunoglobulin for subcutaneous therapy (SCIG) of immunodeficiency

CSL Behring, the maker of Vivaglobin (Immune Globulin Subcutaneous [Human]) announced that Hizentra is now commercially available. Hizentra is the first and currently only subcutaneous 20% liquid immunoglobulin (Ig) therapy indicated for the treatment of patients with primary immunodeficiency disease (PIDD).

This high-concentration product is stabilized with L-proline, a naturally-occurring amino acid. L-proline allows Hizentra to be stored at room temperature (up to 25°C [77°F]) - no refrigeration is necessary.

Hizentra can be self-administered by patients under a physician's care.

Safety Information

Because it contains the stabilizer L-proline, Hizentra is contraindicated in patients with hyperprolinemia. Hizentra is also contraindicated in patients with immunoglobulin A deficiency who have known antibody against IgA and a history of hypersensitivity.

Hizentra is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

The most common drug-related adverse reactions (observed in 5% or more of subjects in the clinical trial) were local reactions (ie, swelling, redness, heat, pain, and itching at the injection site), headache, vomiting, pain, and fatigue.

Ig administration can transiently impair the efficacy of live attenuated virus vaccines, such as measles, mumps and rubella. It can also lead to misinterpretation of serologic testing.

Coding Information

ICD-9-CM Diagnosis Codes

279.0 Deficiency of humoral immunity
279.00 Hypogammaglobulinemia, unspecified
- Agammaglobulinemia NOS
279.01 Selective IgA immunodeficiency
279.02 Selective IgM immunodeficiency
279.03 Other selective immunoglobulin defi ciency
279.04* Congenital hypogammaglobulinemia
- Agammaglobulinemia: Bruton’s type; X-linked
279.05* Immunodeficiency with increased IgM
- Immunodeficiency with hyper-IgM: autosomal recessive; X-linked
279.06* Common variable immunodeficiency
- Dysgammaglobulinemia: acquired, congenital, primary
- Hypogammaglobulinemia: acquired, primary
- Congenital non-sex linked
- Sporadic
279.09 Transient hypogammaglobulinemia of infancy
279.1 Deficiency of cell-mediated immunity
279.10 Immunodeficiency with predominant T-cell defect, unspecified
279.11 DiGeorge syndrome with thymic hypoplasia
279.12* Wiskott-Aldrich syndrome
279.13 Nezelof’s syndrome
- Cellular immunodeficiency with abnormal immunoglobulin deficiency

279.2* Combined immunity deficiency
Autosomal recessive
X-linked recessive
Severe combined immunodefi ciency (SCID)
Thymic: Alymphoplasia, aplasia, or dysplasia with immunodeficiency

*All Medicare-approved codes.

Here are some helpful links regarding SCIG and Hizentra specifically:

Hizentra Dosage Calculator

Nurse Locator helps yo find nurse agencies that staff nurses who completed the SHARE training program for SCIG:

CSL Behring Receives FDA Approval of Hizentra™, First 20 Percent Subcutaneous Immunoglobulin Therapy
HyQvia combines IgG Infusion 10% and hyaluronidase, packaged as a kit for treatment of primary immunodeficiency. Baxter, 2012.
Coding Information (PDF).

Related reading

Possible association between a subcutaneous immune globulin (Vivaglobin) and thrombotic events - ongoing FDA review (PDF).

No comments:

Post a Comment

Blog Widget by LinkWithin