Hizentra, an Immune Globulin Subcutaneous (Human) 20% liquid, is a medication used to provide replacement therapy for individuals with certain immune deficiencies, such as Primary Immunodeficiency (PI) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This therapy delivers antibodies directly under the skin to help the body fight off infections. Because this medication is used regularly at home, proper handling and storage are extremely important to maintain its effectiveness and safety. Unlike many other biologic therapies, Hizentra possesses a unique stability profile that allows for significant flexibility in its storage, which simplifies the process for patients.
Primary Storage Guidelines
The manufacturer’s primary recommendation for Hizentra storage is at room temperature, which simplifies the logistical challenges associated with temperature-sensitive medications. This medication is stabilized with L-proline, a naturally occurring amino acid, which contributes to its long-term stability outside of refrigeration. The product can be stored at a temperature of up to 77°F (25°C) for its entire shelf life, which can be as long as 30 months, depending on the specific product packaging and expiration date.
Storing Hizentra at this stable room temperature means it is always ready for use without the need for pre-warming, offering significant convenience for patients. The medication should remain in its original carton to protect it from light exposure, which can potentially degrade the active ingredients over time. Protection from physical damage and excessive heat is also important to ensure the integrity of the vials or prefilled syringes.
Temperature Limits and Freezing
It is important to avoid temperature extremes that can compromise the product’s effectiveness. The maximum temperature limit for safe storage is 77°F (25°C); exposure to temperatures higher than this can irreversibly damage the immunoglobulin proteins. Patients must take care not to leave the medication in places that can become excessively hot, such as inside a vehicle on a warm day or near a heat source.
Conversely, Hizentra must never be allowed to freeze, as the freezing process renders the solution unusable. If the medication is accidentally frozen, it should be discarded immediately, even if it appears to have thawed without visible damage. The physical stress of freezing alters the protein structure, which affects the medication’s therapeutic properties and safety. Always check the expiration date printed on the outer carton and the vial or prefilled syringe label.
Preparation Before Injection
Before administering the medication, several preparation steps ensure a safe and effective infusion. Visually inspect the Hizentra solution, which should appear clear and range in color from pale yellow to light brown. If the solution looks cloudy, contains visible particles, or has changed color significantly, it must not be used.
The medication should never be shaken, as vigorous movement can create foam and denature the protein components. Using a gentle swirling motion is acceptable if the solution needs to be mixed. After the infusion is complete, any unused portion of the solution and all used administration supplies must be discarded according to local requirements and the instructions provided by the healthcare provider.