Blincyto

Blincyto Caution For Usage

blinatumomab

Manufacturer:

Amgen

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Caution For Usage
Reconstitution and Preparation of Solution for Infusion: It is very important that the instructions for preparation (including admixing) and administration provided in this section are strictly followed to minimize medication errors (including underdose and overdose) (see Precautions).
Aseptic Preparation: Strictly observe aseptic technique when preparing the solution for infusion since BLINCYTO vials do not contain antimicrobial preservatives. To prevent accidental contamination, prepare BLINCYTO according to aseptic standards, including but not limited to: Prepare BLINCYTO in a USP <797> compliant facility.
Prepare BLINCYTO in an ISO Class 5 laminar flow hood or better.
Ensure that the admixing area has appropriate environmental specifications, confirmed by periodic monitoring.
Ensure that personnel are appropriately trained in aseptic manipulations and admixing of oncology drugs.
Ensure that personnel wear appropriate protective clothing and gloves.
Ensure that gloves and surfaces are disinfected.
Gather Supplies: NOTE: 1 package BLINCYTO includes 1 vial of BLINCYTO and 1 vial of IV Solution Stabilizer.
IV Solution Stabilizer is provided with the BLINCYTO package and is used to coat the IV bag prior to addition of reconstituted BLINCYTO to prevent adhesion of BLINCYTO to IV bags and IV tubing.
Before preparation, ensure you have the following supplies ready: 1 or 2 package(s) of BLINCYTO as needed for each dosage.
Patients weighing greater than or equal to 45 kg: 2 packages of BLINCYTO are needed for preparation of 28 mcg/day dose infused over 48 hours at a rate of 5 mL/hour.
Patients weighing less than 45 kg: 2 packages of BLINCYTO are needed for preparation of 15 mcg/m2/day dose infused over 48 hours at a rate of 5 mL/hour for patients with a BSA greater than 1.09 m2.
The following supplies are also required, but not included in the package: Supplies to make a 270 mL 0.9% Sodium Chloride IV bag.
An empty IV bag. Use only PVC di-ethylhexylphthalate-free (DEHP-free), polyolefin, or ethyl vinyl acetate (EVA) infusion bags/pump cassettes.
0.9% Sodium Chloride Injection , USP (eg, 1000 mL).
Preservative-free Sterile Water for Injection, USP.
Sterile, single-use disposable syringes.
21-to 23- gauge needle(s) (recommended).
PVC DEHP-free, polyolefin, or EVA IV tubing with a sterile, non-pyrogenic, low protein-binding 0.2 micron in-line filter.
Ensure that the IV tubing is compatible with the infusion pump.
Reconstitution of BLINCYTO: 1. Add 3 mL of preservative-free Sterile Water for Injection, USP by directing the water along the walls of the BLINCYTO vial and not directly on the lyophilized powder (resulting in a final BLINCYTO concentration of 12.5 mcg/mL).
Do not reconstitute BLINCYTO with IV Solution Stabilizer.
2. Gently swirl contents to avoid excess foaming. Do not shake.
3. Visually inspect the reconstituted solution for particulate matter and discoloration during reconstitution and prior to infusion. The resulting solution should be clear to slightly opalescent, colorless to slightly yellow. Do not use if solution is cloudy or has precipitated.
Preparation of BLINCYTO Infusion Bag: Verify the prescribed dose and infusion duration for each BLINCYTO infusion bag. To minimize errors, use the specific volumes described in Tables 7 to 9 to prepare the BLINCYTO infusion bag.
Table 7 for patients weighing greater than or equal to 45 kg.
Tables 8 and 9 for patients weighing less than 45 kg 1.
1. Aseptically add 270 mL 0.9% Sodium Chloride Injection, USP to the IV bag prior to the addition of IV Solution Stabilizer and reconstituted BLINCYTO.
Use only PVC DEHP-free, polyolefin, or EVA IV bags/pump cassettes.
2. Aseptically transfer 5.5 mL IV Solution Stabilizer to the IV bag containing 0.9% Sodium Chloride Injection, USP. Gently mix the contents of the bag to avoid foaming. Discard the vial containing the unused IV Solution Stabilizer.
3. Aseptically transfer reconstituted BLINCYTO into the IV bag containing 0.9% Sodium Chloride Injection, USP and IV Solution Stabilizer. Gently mix the contents of the bag to avoid foaming.
Refer to Tables 7 to 9 for the specific volume of reconstituted BLINCYTO.
4. Under aseptic conditions, attach the IV tubing to the IV bag with the sterile 0.2 micron in-line filter.
Use only PVC DEHP-free, polyolefin, or EVA IV tubing with a sterile, non-pyrogenic, low protein-binding 0.2 micron in-line filter.
Ensure that the IV tubing is compatible with the infusion pump.
5. Remove air from the IV bag. This is particularly important for use with an ambulatory infusion pump. Prime the IV tubing only with the prepared solution for infusion. Do not prime with 0.9% Sodium Chloride Injection, USP.
6. Store at 2°C to 8°C if not used immediately (see Storage). (See Tables 7, 8 and 9).

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