Vivaglobin

Vivaglobin Manufacturers

• Csl Behring Llc
  

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  Vivaglobin | Csl Behring Llc

  

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  For subcutaneous infusion only. DO NOT INJECT INTO A BLOOD VESSEL.

  2.1 Self-Administration

  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).

  2.2 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. 2.3 Dosage

  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.

  Dose Adjustment

  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). Table 1: Adjustment (±mL) of the Weekly Vivaglobin Dose Based on the Difference (±mg/dL) From the Target Serum IgG Trough Level* Difference From Target IgG Trough Level* (mg/dL) Body Weight (kg) 10 15 20 30 40 50 60 70 80 90 100 110 120 Dose Adjustment (mL per Week)† * Target IgG concentration (mg/dL) during Vivaglobin treatment equals the last observed trough level during prior IGIV treatment plus 180 mg/dL. † Dose adjustment in mL is based on the slope of the serum IgG trough level response to Vivaglobin dose increments (6.1 mg/dL per increment of 1 mg/kg per week). 100 1 2 2 3 4 5 6 7 8 9 10 11 12 150 2 2 3 5 6 8 9 11 12 14 15 17 18 200 2 3 4 6 8 10 12 14 16 18 20 23 25 250 3 4 5 8 10 13 15 18 20 23 26 28 31 300 3 5 6 9 12 15 18 22 25 28 31 34 37 350 4 5 7 11 14 18 22 25 29 32 36 39 43 400 4 6 8 12 16 20 25 29 33 37 41 45 49 450 5 7 9 14 18 23 28 32 37 41 46 51 55 500 5 8 10 15 20 26 31 36 41 46 51 56 61

  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.

  2.4 Administration

  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).

  1. Assemble supplies – Place the Vivaglobin vial(s) and all supplies needed for the infusion on a clean, flat surface. 2. Thoroughly wash and dry hands – The use of gloves when preparing and administering Vivaglobin is optional. 3. Clean the vial stopper – Remove the protective cap from the vial to expose the central portion of the rubber stopper. Clean the stopper with alcohol and allow it to dry. 4. Prepare and fill the syringe(s) – Using a sterile syringe and needle, pull back on the plunger to draw air into the syringe that is equal to the amount of Vivaglobin to be withdrawn. Then, insert the needle into the vial stopper and inject the air into the vial. Finally, withdraw the desired volume of Vivaglobin. If multiple vials are required to achieve the desired dose, repeat this step with another syringe. 5. Fill and prime the infusion pump – Follow the manufacturer's instructions for filling the pump reservoir and for 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. 6. Select the injection site(s) – The number and location of injection sites depends on the volume of the total dose. Doses greater than 15 mL should be divided and infused into multiple sites that are at least two inches apart. The recommended number of simultaneous injection sites is up to six for adults, up to three for children who weigh less than 45 kg (99 pounds) and up to four for patients ages 65 and over. If necessary, additional injection sites can be used consecutively. 7. Clean the injection site(s) – Using an antiseptic solution, clean each site beginning at the center and working outward in a circular motion. Allow each site to dry before proceeding. 8. Insert the needle – Based on the patient's body mass, grasp or spread the skin; then insert the needle into the subcutaneous tissue. 9. Check for proper placement of the needle. Vivaglobin must not be injected into a blood vessel – After inserting each needle into the subcutaneous tissue and before starting the infusion, test to make sure that a blood vessel has not been accessed accidentally. To do this, attach a sterile syringe to the end of the primed administration tubing, gently pull back on the plunger, and see if any blood is flowing back into the tubing. If blood is present, remove and discard the needle and administration tubing. Repeat steps 5 and 8 (priming and needle insertion) using a new needle, new administration tubing, and a different injection site. 10. Secure the needle to the skin – Apply sterile gauze or transparent dressing over each site to hold the needle in place. If using multiple, simultaneous injection sites, secure the Y-site connection tubing to the administration tubing. 11. Infuse Vivaglobin – Follow the manufacturer's instructions to turn on the pump. 12. Record the infusion – Remove the peel-off portion of the label from each vial used, and affix it to the patient record.

  After administration, immediately discard any unused product and administration equipment in accordance with local procedures.

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