Generic name: Human Immunoglobulin G 160mg in 1mL
Dosage form: injection
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For subcutaneous infusion only. DO NOT INJECT INTO A BLOOD VESSEL.
Self-administration is appropriate for some patients. If self-administration is planned, the healthcare professional should provide the patient with instructions and training for subcutaneous infusion in the home or other appropriate setting (see Patient Counseling Information [17.1] and the FDA-Approved Patient Labeling).
Preparation and Handling
Vivaglobin is a colorless to light brown solution. Do not use if the solution is cloudy (turbid) or contains particulates.
- Prior to administration, bring the Vivaglobin vial(s) to room temperature. Then, visually inspect each vial for particulate matter by gently swirling the vial, and check for discoloration by holding it up to the light.
- Check the product expiration date on the vial label. Do not use beyond the expiration date.
- Do not mix Vivaglobin with other products.
- Do not shake the Vivaglobin vial.
- Use aseptic technique when preparing and administering Vivaglobin.
- The Vivaglobin vial is for single-use only. Discard all administration equipment and any unused product immediately after each infusion in accordance with local requirements.
The dose should be individualized based on the patient's clinical response to Vivaglobin therapy and serum immunoglobulin (IgG) trough levels.
Begin treatment with Vivaglobin one week after the patient has received a regularly scheduled Immune Globulin Intravenous (Human) (IGIV) infusion. Prior to receiving treatment with Vivaglobin, patients need to have been receiving IGIV treatment for at least 3 months at dosing intervals of either every 3 weeks or every 4 weeks.
The initial weekly dose of Vivaglobin is established by converting the monthly IGIV dose into a weekly equivalent and increasing it using a dose adjustment factor (see Initial Weekly Dose). The goal is to achieve a systemic serum IgG exposure (area under the concentration-time curve [AUC]) not inferior to the AUC of the previous IGIV treatment (see Pharmacokinetics [12.3]).
Prior to switching treatment from IGIV to Vivaglobin, obtain the patient's serum IgG trough level to guide subsequent dose adjustment (see Dose Adjustment). After 2 to 3 months, weekly administration of Vivaglobin will lead to stable steady-state serum IgG levels with lower IgG peak levels and higher IgG trough levels compared with monthly IGIV treatment.
Initial Weekly Dose
To calculate the initial weekly dose of Vivaglobin, multiply the previous IGIV dose in grams (g) by the dose adjustment factor of 1.37, then divide this dose by the number of weeks between doses during the patient's previous IGIV treatment (i.e., 3 or 4).
|IGSC weekly dose (g) =||1.37 × previous IGIV dose (g)|
|Number of weeks between IGIV doses|
To convert the Vivaglobin dose (g) to milliliters (mL), divide the dose in grams (g) by 0.16.
Over time, the dose may need to be adjusted to achieve the desired clinical response and serum IgG trough level. To determine if a dose adjustment should be considered, measure the patient's serum IgG trough level on IGIV prior to switching to Vivaglobin and every 2 to 3 months after switching from IGIV to Vivaglobin.
To achieve the same AUC with Vivaglobin as with the previous IGIV treatment, follow these steps:
- Estimate the target serum IgG trough level on weekly Vivaglobin treatment, which is derived as follows:
Target concentration (mg/dL) during Vivaglobin treatment = the last trough level during prior IGIV treatment + 180 mg/dL
- In Table 1, find the additional Vivaglobin dose to be administered, based on the patient's body weight, and the difference between the target IgG concentration (mg/dL) and the observed trough level during Vivaglobin treatment.
Additional dosage increments may be indicated based on the patient's clinical response (infection frequency and severity).
|Difference From Target IgG Trough Level* (mg/dL)||Body Weight (kg)|
|Dose Adjustment (mL per Week)†|
For example, if a patient with a body weight of 70 kg has an actual IgG trough level of 900 mg/dL and the target trough level is 1000 mg/dL, this results in a difference of 100 mg/dL. Therefore, increase the weekly dose of Vivaglobin by 7 mL.
Monitor the patient's clinical response, and repeat the dose adjustment process as needed.
Vivaglobin is for subcutaneous infusion only. DO NOT INJECT INTO A BLOOD VESSEL.
Vivaglobin is for subcutaneous infusion, preferably in the abdomen, thigh, upper arm, and/or lateral hip. Multiple injection sites should be at least two inches apart, and the actual point of injection should be changed with each weekly administration.
- Infusion volume – Do not exceed 15 mL per site. Divide doses greater than 15 mL and infuse into a maximum of three simultaneous sites for children weighing less than 45 kg (99 pounds), a maximum of six simultaneous sites for adults up to age 65, and a maximum of four simultaneous sites for patients 65 years of age and older. If necessary, additional sites can be used consecutively during an infusion.
- Infusion rate – The maximum recommended infusion rate is 20 mL per hour per site and should not exceed a total of 3.0 mg/kg/minute (1.13 mL/kg/hour) for all simultaneous injection sites combined.
Ensure that patients are not volume depleted.
Follow the steps below and use aseptic technique to administer Vivaglobin. For information about subcutaneous infusion in the home or other appropriate setting, see Patient Counseling Information (17.1).
After administration, immediately discard any unused product and administration equipment in accordance with local procedures.
More about Vivaglobin (immune globulin subcutaneous)
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- During Pregnancy
- Dosage Information
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- Drug class: immune globulins