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Vivaglobin

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Vivaglobin

Vivaglobin

INDICATIONS

Vivaglobin® Immune Globulin Subcutaneous (Human), is indicated for the treatment of patients with primary immune deficiency (PID).

DOSAGE AND ADMINISTRATION

Vivaglobin® Immune Globulin Subcutaneous (Human), contains no preservative. Therefore, discard unused product immediately after use.

Vivaglobin® (immune globulin subcutaneous (human)) must not be mixed with other products.

Vivaglobin® (immune globulin subcutaneous (human)) is to be injected subcutaneously, preferentially in the abdomen, thighs, upper arms, and/or lateral hip.

DO NOT INJECT INTO A BLOOD VESSEL.

Dosage

All subjects who received Vivaglobin® (immune globulin subcutaneous (human)) in the clinical trials had previously been treated with immune globulin. It is recommended that the patient start treatment with Vivaglobin® (immune globulin subcutaneous (human)) one week after receiving a regularly scheduled IGIV infusion.

The initial weekly Vivaglobin® (immune globulin subcutaneous (human)) dose can be calculated by multiplying the previous IGIV dose by 1.37, then dividing this dose into weekly doses based on the patient's previous IGIV treatment interval; for example, if IGIV was administered every three weeks, divide by 3. This dose of Vivaglobin® (immune globulin subcutaneous (human)) will provide a systemic IgG exposure (AUC) comparable to that of the previous IGIV treatment. Weekly administration of this dose will lead to stable steady-state serum IgG levels with lower IgG peak levels and higher IgG trough levels compared to monthly IGIV treatment (see Table 2 for trough levels).

The recommended weekly dose of Vivaglobin® (immune globulin subcutaneous (human)) is 100 to 200 mg/kg body weight administered subcutaneously. Doses may be adjusted over time to achieve the desired clinical response and serum IgG levels. As there can be differences in the half-life of IgG among patients with primary immune deficiencies, the dose and dosing interval of immunoglobulin therapy may vary.

Doses And Associated IgG Levels

The minimum serum concentration of IgG necessary for protection against infections has not been established in randomized and controlled clinical studies. However, based on clinical experience, a target serum IgG trough level (i.e., prior to the next infusion) of at least 500 mg/dL has been proposed in the literature for IGIV therapy.4

Serum IgG levels can be sampled at any time during routine weekly treatment. Subjects on Immune Globulin Subcutaneous (Human), Vivaglobin® (immune globulin subcutaneous (human)) therapy maintained relatively constant IgG levels, rather than the peak and trough pattern observed with monthly IGIV therapy.

Administration

DO NOT INJECT INTRAVENOUSLY.

In the clinical study with Vivaglobin® (immune globulin subcutaneous (human)) , a volume of 15 mL per injection site at a rate of 20 mL per hour per site was not exceeded. Doses over 15 mL were divided and infused into several sites using an infusion pump. Multiple simultaneous injections were enabled by administration tubing and Y-site connection tubing (CADD-Legacy® pumps were used in the study conducted in the US and Canada). Injection sites were at least two inches apart.

The following areas were used for subcutaneous injection of Vivaglobin® (immune globulin subcutaneous (human)) : abdomen, thighs, upper arms, and/or lateral hip. The actual point of injection was changed with each weekly administration.

Instructions for Administration

Prior to use, allow the solution to reach ambient room temperature. Vivaglobin® (immune globulin subcutaneous (human)) should be inspected visually for discoloration and particulate matter prior to administration. DO NOT SHAKE. The appearance of Vivaglobin® (immune globulin subcutaneous (human)) can vary from colorless to light brown. Do not use if the solution is cloudy or has particulates. Check the product expiration date on the vial. Do not use beyond the expiration date.

  1. Use aseptic technique when preparing and administering Vivaglobin® (immune globulin subcutaneous (human)) for injection.
  2. Remove the protective cap from the vial to expose the central portion of the rubber stopper.
  3. Wipe the rubber stopper with alcohol and allow to dry.
  4. Using a sterile syringe and needle, prepare to withdraw Vivaglobin® (immune globulin subcutaneous (human)) by first injecting air into the vial that is equivalent to the amount of Vivaglobin® (immune globulin subcutaneous (human)) to be withdrawn. Then withdraw the desired volume of Vivaglobin® (immune globulin subcutaneous (human)) . If multiple vials are required to achieve the desired dose, repeat this step. (Fig. 2)
  5. Follow the manufacturer's instructions for filling the pump reservoir and preparing the pump, administration tubing and Y-site connection tubing, if needed. Be sure to prime the administration tubing to ensure that no air is left in the tubing or needle by filling the tubing/needle with Vivaglobin® (immune globulin subcutaneous (human)) .
  6. Select the number and location of injection sites depending on the volume of the total dose. Note: In clinical studies with Vivaglobin® (immune globulin subcutaneous (human)) , a volume of 15 mL per injection site was not exceeded. (Fig. 3)
  7. Cleanse the injection site(s) with antiseptic solution using a circular motion working from the center of the site and moving to the outside. Sites should be clean, dry, and at least two inches apart. (Fig. 4)
  8. Grasp the skin between two fingers and insert the needle into the subcutaneous tissue. (Fig. 5)
  9. Vivaglobin® (immune globulin subcutaneous (human)) must not be injected into a blood vessel. After each needle is inserted into the tissue, test to make sure that a blood vessel has not been accidentally accessed. This must be done prior to starting the infusion. To do this, attach a sterile syringe to the end of the primed administration tubing, gently pull back on the syringe plunger and look to see if any blood is flowing back into the administration tubing. If you see any blood, remove and discard the needle and administration tubing. Repeat priming and needle insertion steps using a new needle, administration tubing and a new infusion site. Secure the needle in place by applying sterile gauze or transparent dressing over the site. (Fig. 6)
  10. If using multiple, simultaneous injection sites, use Y-site connection tubing and secure to the administration tubing.
  11. Infuse Vivaglobin® (immune globulin subcutaneous (human)) following the manufacturer's instructions for the pump. (Fig. 7)
  12. Remove the peel-off label with the product lot number and expiration date from the Vivaglobin® (immune globulin subcutaneous (human)) vial and use this to complete the patient record.

 - Illustration

After administration, discard any unused solution and administration equipment in accordance with biohazard procedures.

Home Treatment

If the physician believes that home administration is appropriate, the physician or health professional should provide the patient with instructions on subcutaneous infusion for home treatment. This should include the type of equipment to be used along with its maintenance, proper infusion techniques, selection of appropriate infusion sites (e.g., abdomen, thighs, upper arms, and/or lateral hip), maintenance of a treatment diary, and measures to be taken in case of adverse reactions.

HOW SUPPLIED

Vivaglobin® Immune Globulin Subcutaneous (Human), is supplied in single-use vials containing 160 mg IgG per mL. The following dosage forms are available:

NDC 0053-7596-03 Box of ten 3 mL vials
NDC
0053-7596-10 10 mL vial
NDC
0053-7596-15 Box of ten 10 mL vials
NDC
0053-7596-20 20 mL vial
NDC
0053-7596-25 Box of ten 20 mL vials

Storage

Store in the refrigerator at 2 - 8°C (36 - 46°F). Vivaglobin® Immune Globulin Subcutaneous (Human), is stable for the period indicated by the expiration date on its label. Do not freeze. Keep vials in storage box until use.

4. Roifmann CM, Levison H, Gelfand EW. High-dose versus low-dose intravenous immunoglobulin in hypogammaglobuli-naemia and chronic lung disease. Lancet1987;1(8451):1075-7.

Manufactured by: CSL Behring GmbH, 35041 Marburg, Germany. Distributed by: CSL Behring LLC, Kankakee, IL 60901 USA. Issued: April, 2007.

Last reviewed on RxList: 3/3/2009
This monograph has been modified to include the generic and brand name in many instances.

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