CUVITRU® [Immune Globulin Subcutaneous (Human)], 20% Solution

CUVITRU® is a brand-name medication that contains Immune Globulin Subcutaneous (Human) in a 20% solution. It is used to treat primary immunodeficiency disorders, conditions in which the immune system is compromised and less effective in defending against infections. CUVITRU® is a subcutaneous immunoglobulin therapy that helps supplement the immune system in individuals with primary immunodeficiency disorders. It provides a source of antibodies to help the body fight infections effectively.

Indications and Uses

CUVITRU® is indicated for the following purposes:

• Treatment of primary immunodeficiency disorders, including common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), and other immunodeficiencies.

• It is used to replace deficient or absent immunoglobulins to help the body fight infections effectively.

Dosage and Administration

The dosage of CUVITRU® is individualized based on the patient's specific immunoglobulin needs, body weight, and clinical condition. The medication is administered subcutaneously (under the skin) and can be self-administered after proper training. The dose and frequency of administration are determined by a healthcare provider.

Contraindications

CUVITRU® should not be used in individuals with known hypersensitivity to human immunoglobulin or any of its components. It is essential to discuss any allergies or potential reactions with a healthcare provider.

Adverse Effects and Side Effects

Common side effects of CUVITRU® may include:

• Redness, swelling, or itching at the injection site.

• Mild fatigue.

• Headache.

• Nausea.

Serious side effects are rare but may include:

• Severe allergic reactions, which can manifest as hives, difficulty breathing, and swelling of the face, lips, or tongue.

• Blood clots, which can be a concern if there are other risk factors or pre-existing conditions.

It is crucial to report any adverse effects or unusual reactions to your healthcare provider.

Storage and Shelf Life:

Store CUVITRU® at room temperature (20-25°C or 68-77°F) or in the refrigerator (2-8°C or 36-46°F). Protect it from freezing. Do not use CUVITRU® after the expiration date.

Packaging and Presentation

CUVITRU® is typically available in vials or pre-filled syringes as a sterile solution for subcutaneous administration.

Regulatory Information

CUVITRU® is subject to regulation by health authorities to ensure its safety and efficacy. It is essential to use this medication as directed by a healthcare professional and in accordance with local regulations.

References

Always consult with your healthcare provider and refer to the official prescribing information and product labeling for the most up-to-date and comprehensive information on CUVITRU®. Your healthcare provider will guide you in the proper use of this medication, monitor your progress, and tailor the treatment to your specific medical condition.