Dosage & Administration
For Intravenous Use Only
| Indication | Dose | Initial Infusion Rate | Maintenance Dose Rate (if tolerated) |
| PI | 300-600 mg per kg every 3-4 weeks | 0.01 mL per kg per minute (0.5 mg per kg per min) | Increase to 0.10 mL per kg per minute (5 mg per kg per min) |
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Flebogamma DIF 5% Prescribing Information
- Thrombosis may occur with immune globulin products, including FLEBOGAMMA 5% 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 5% 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 death1have 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 5% 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 failure occur more commonly in patients receiving IGIV products containing sucrose as a stabilizer. They account for a disproportionate share of the total number of reported cases of renal dysfunction and acute renal failure. FLEBOGAMMA 5% DIF does not contain sucrose. (see Dosage and Administration [ 2.3] and Warnings and Precautions [ 5.2])
Flebogamma 5% DIF is an immune globulin intravenous (human) solution indicated in adults and pediatric patients 2 years of age and older for the treatment of primary immunodeficiency (PI), including the humoral immune defects in common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency, and Wiskott-Aldrich syndrome.
For Intravenous Use Only
Dosage
Treatment of Primary Immunodeficiency (PI)
| Dose | Initial Infusion Rate | Maintenance Dose Rate (if tolerated) |
| 300-600 mg per kg body weight (6.0-12.0 mL per kg) administered every 3-4 weeks | 0.01 mL per kg per minute (0.5 mg per kg per min) | Increase to 0.10 mL per kg per minute (5 mg per kg per min) |
If a patient has been exposed to measles, it may be prudent to administer an extra dose of IGIV as soon as possible and within 6 days of exposure. A dose of 400 mg/kg should provide a serum level > 240 mIU/mL of measles antibodies for at least two weeks.
If a patient is at risk of future measles exposure and receives a dose of less than 530 mg/kg every 3-4 weeks, the dose should be increased to at least 530 mg/kg. This should provide a serum level of 240 mIU/mL of measles antibodies for at least 22 days after infusion.
As there are significant differences in the half-life of IgG among patients with PI, the frequency and amount of immunoglobulin therapy may vary from patient to patient. Adjust the dose according to the clinical response.
Adjust the dosage over time to achieve the desired trough IgG levels and clinical responses. No randomized controlled trial data are available to determine an optimum target trough serum IgG level.
Preparation and Handling
- Inspect Flebogamma 5% DIF visually for particulate matter and color prior to administration. Do not use the vial if particles are detected. Do not use if turbid.
- Several vials of Flebogamma 5% DIF may be pooled into an empty sterile solution container by using aseptic technique, if large doses are to be administered.
- Do not dilute with intravenous fluids. Do not inject other medications into intravenous tubing being used for Flebogamma 5% DIF.
- Infuse Flebogamma 5% DIF through a separate intravenous line. Do not add any medications or intravenous fluids to the Flebogamma 5% DIF infusion container. Do not mix IGIV products of different formulations or from different manufacturers.
- Discard unused contents and administration devices after use.
- Use promptly any vial that has been entered.
- Discard partially used vials. Do not save for future use because the solution contains no preservative.
- Do not use solution that has been frozen.
Administration
The recommended initial infusion rate of Flebogamma 5% DIF is 0.01 mL per kg body weight per minute (0.5 mg per kg per min). If the infusion is well-tolerated during the first 30 minutes, the rate may be gradually increased to a maximum of 0.10 mL per kg per minute (5 mg per kg per min).
Monitor patient vital signs throughout the infusion. Slow or stop infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.
Flebogamma 5% DIF is a liquid preparation containing 5% IgG (50 mg per mL).
Pregnancy
Risk Summary
There are no studies of Flebogamma 5% DIF use in pregnant women. Animal reproduction studies have not been performed with Flebogamma 5% DIF. It is also not known whether Flebogamma 5% DIF can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Immunoglobulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. Flebogamma 5% DIF should be given to a pregnant woman only if clearly needed.
Lactation
Risk Summary
There is no information regarding the presence of Flebogamma 5% DIF in human milk, its effects on the breastfed infant, or its effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Flebogamma 5% DIF and any potential adverse effects on the breastfed infant from Flebogamma 5% DIF or from the underlying maternal condition.
Pediatric Use
Flebogamma 5% DIF was studied in a multicenter clinical trial for the treatment of PI in 24 subjects aged 2-16 years (seven were 2-5 years of age, seven were 6-11 years, and ten were 12-16 years), and found to be efficacious for the prevention of acute serious bacterial infections. No pediatric-specific dose requirements were necessary to achieve the desired serum IgG levels. Twenty subjects (83.3%) had at least one adverse reaction at some time during the study that was considered product-related. There were no deaths or serious adverse reactions. Treatment-related adverse reactions that occurred with an incidence of at least 5% on a per-subject basis included headache (42%), pyrexia (29%), hypotension (25%), tachycardia (25%), diastolic hypotension (21%), nausea (8%), abdominal pain (8%), diarrhea (8%), pain (8%), and vomiting (8%).
Safety and efficacy of Flebogamma 5% DIF in pediatric patients below the age of 2 years have not been established.
Geriatric Use
Limited information is available for the geriatric use of Flebogamma 5% DIF. Clinical studies of Flebogamma 5% DIF did not include sufficient numbers of subjects over the age of 65 to determine whether they respond differently from younger subjects. Use caution when administering Flebogamma 5% DIF to patients age 65 and over who are judged to be at increased risk for developing thrombosis or renal insufficiency. Do not exceed recommended dose, and administer Flebogamma 5% DIF at the minimum dose and infusion rate practicable, and at less than 0.06 mL per kg per minute (3 mg per kg per min). (see Boxed Warning, Warning and Precautions [ 5.2, 5.4], and Dosage and Administration [ 2.3])
- Flebogamma 5% DIF is contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human immune globulin.
- Flebogamma 5% DIF is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. (see Warnings and Precautions [ 5.1])