Table 3.
| 1. Preparing for administration |
1.1 First, check the vial label to confirm that the drug being prepared and administered is ABP 980 and not another intravenous (IV) formulation (e.g., ado-trastuzumab emtansine, an antibody drug conjugate). This is an important step to prevent medication errors. Each glass vial contains either 150 mg or 420 mg of active ingredient. 1.2 Next, visually examine the vial and contents of the vial. The ABP 980 product for injection is a sterile lyophilized powder with a white to pale yellow color and cake-like appearance. 1.3 It should be reconstituted and further diluted before administering as an IV infusion. 1.4 It is also preservative-free and therefore should be appropriately prepared and stored, as necessary, under specific conditions before IV administration [1, 2] |
| 2. Reconstitution general considerations |
2.1 Reconstitute each 420-mg vial of the ABP 980 product with 20 mL of bacteriostatic water for injection (BWFI) USP, containing 0.9% to 1.1% benzyl alcohol as a preservative. This will result in a multiple-dose solution of 20 mL containing 21 mg/mL ABP 980 If you are using the 150-mg vial, reconstitute with 7.2 mL of sterile water for injection (SWFI) to yield a 21-mg/mL solution for single use In patients with known hypersensitivity to benzyl alcohol, reconstitute the ABP 980 product with 20 mL of SWFI. Note that SWFI does not contain any preservative. Therefore, reconstitution with SWFI only yields a single-use solution 2.2 After reconstitution with BWFI, the solution may be stored in the vial for up to 28 days at 2–8 °C (36–46 °F); however, after reconstitution with SWFI, the solution must be used immediately 2.3 After reconstitution, the ABP 980 can be further diluted in an IV bag and administered as an IV infusion 2.4 Please note that it is always necessary to use appropriate aseptic technique when performing the reconstitution steps: Take a sterile syringe and slowly inject the 20 mL of BWFI (or SWFI in the case of patients with known hypersensitivity to benzyl alcohol), into the vial containing the lyophilized powder of ABP 980. The stream of BWFI from the syringe should be aimed at the lyophilized cake at the bottom of the vial Then, gently swirl the vial so that the powder mixes with the diluent. This facilitates reconstitution. A note of caution—DO NOT SHAKE the vial vigorously at this time Once the solution is mixed or reconstituted, a slight foaming may be visible. If so, allow the vial to stand undisturbed and settle down for about 5 min Handle the ABP 980 carefully during reconstitution. Again, do not shake the reconstituted solution vigorously as this will result in excessive foaming and may prevent withdrawal of the correct amount of ABP 980 from the vial As with any parenteral drug product, inspect the vial visually for particulate matter and for any signs of discoloration before moving to dilution and IV infusion The ABP 980 reconstituted solution should appear free of any particulate matter, be clear to slightly opalescent, and colorless to pale yellow Store this reconstituted solution in a refrigerator at 2–8 °C (36–46 °F). Do not freeze after reconstitution and discard any solution that is unused after 28 days Note that if the ABP 980 powder is reconstituted with SWFI without preservative, it should be used immediately, and any unused portion of this solution should be discarded right way |
| 3. Dilution |
3.1 The reconstituted solution can be used immediately for IV infusion (or stored as indicated above and used within 28 days if reconstituted with BWFI) 3.2 To do this, calculate the volume of the 21-mg/mL reconstituted ABP 980 solution needed, withdraw this volume from the vial, and add it to an infusion or IV bag containing 250 mL of 0.9% Sodium Chloride Injection, USP. The volume to be withdrawn will be based on the dose required for each patient (as defined in the package insert) Again, a note of caution—Do not use an IV bag with dextrose (5%) solution at this step. Only use an IV bag containing 0.9% Sodium Chloride Injection, USP 3.3 Once the ABP 980 solution is added to the IV bag, gently mix the contents by inverting the bag back and forth This solution of ABP 980 that is diluted in polyvinylchloride (PVC) or polyethylene (PE) IV bags containing 0.9% Sodium Chloride Injection, USP, is now ready for infusion. It can be stored at 2–8 °C (36–46 °F) for up to but not more than 24 h prior to use. This storage time is specific to the IV bag with ABP 980 solution and is additional to the time allowed for reconstitution and storage of reconstituted vial. Note: Do not freeze this solution |