Flebogamma
What is Flebogamma?
Flebogamma — also known as immune globulin (human) intravenous solution — is a prescription infusion medication used to treat adult and pediatric patients two years of age and older with primary immunodeficiency (PI). This includes those with humoral immune defects, x-linked agammaglobulinemia, severe combined immunodeficiency, and Wiskott-Aldrich syndrome.
Important Safety Information
Patients who receive treatment with immune globulin medications (including Flebogamma) are at risk of thrombosis. This risk is heightened in individuals who are of advanced age, have been in prolonged immobilization, suffer from hypercoagulable conditions, have a history of venous or arterial thrombosis, use estrogen or have indwelling central vascular catheters. Hyperviscosity and cardiovascular issues can also place a patient at risk.
Intravenous immune globulin medications have also been linked to an increased risk of renal dysfunction — especially in patients who are predisposed to kidney issues, are 65 years or older, or are receiving nephrotoxic drugs. Other individuals at a higher risk include those with diabetes mellitus, volume depletion, sepsis, or paraproteinemia.
If you’re at a higher risk of thrombosis or renal dysfunction, your healthcare provider will ensure adequate hydration prior to each infusion therapy. You will also receive the minimum dose and infusion rate possible.
What is the most important information I should know about Flebogamma?
Flebogamma is made from human plasma. Therefore, although unlikely, it does carry the risk of transmitting infectious agents, such as viruses. However, each donor is thoroughly screened, and three virus removal steps are integrated into the manufacturing and formulation of the medication.
Flebogamma may not interact well with other medications. Tell your doctor if you’re taking any additional drugs — whether they’re prescription, over-the-counter, vitamins, or herbal supplements.
Flebogamma Side Effects
As with any prescription medication, Flebogamma carries the risk of side effects. These may vary depending on the patient’s medical history and the condition being treated. The most common ones in adult patients include:
- Headaches
- Fever
- Diarrhea
- Rigors or chills
- Skin rash
- Infusion site reactions
Depending on the age of the patient, other side effects may occur. The most common side effects reported in at least 5% of clinical trial pediatric patients include:
- Fever
- Diarrhea
- Nausea
- Vomiting
- Abdominal pain
- Fast heart rate
- Low blood pressure
Seek emergency medical care immediately if you or your loved one undergoing treatment experience breathing difficulties, seizures, or loss of consciousness. These could result in cardiac arrest.
Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.
Indications
Flebogamma is used to treat adult and pediatric patients two years of age and older with primary immunodeficiency (PI). This includes those with humoral immune defects, x-linked agammaglobulinemia, severe combined immunodeficiency, and Wiskott-Aldrich syndrome. The dosage and infusion rate will vary depending on the condition being treated, as well as the patient’s age and medical history.
Please refer to the full prescribing information.