Flebogamma DIF
Generic name:immune globulin g intravenous (human)
Dosage form: injection, solution
Drug class:Immune globulins
Medically reviewed by Drugs.com. Last updated on Oct 22, 2021.
On This Page
- Boxed Warning
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Drug Interactions
- Use In Specific Populations
- Overdosage
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- References
- How Supplied/Storage and Handling
- Patient Counseling Information
WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE
- Thrombosis may occur with immune globulin products, including FLEBOGAMMA 10% DIF. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. (see Warnings and Precautions (5.4) and Patient Counseling Information (17))
- For patients at risk of thrombosis, administer FLEBOGAMMA 10% DIF at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. (see Dosage and Administration (2.3) and Warnings and Precautions (5.4))
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death1 have been related to intravenous immune globulin (IGIV) products. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs.
- Administer FLEBOGAMMA 10% DIF at the minimum dose and rate of infusion practicable in patients at risk for renal dysfunction or failure.
- Reports of renal dysfunction and acute renal ...
