Unopened vial

Kadcyla vials should be stored at 2°C to 8°C.[1]

If Kadcyla was inadvertantly stored outside of this temperature range, a stability assessment can be requested through medinfo.roche.com.

Reconstituted solution

Kadcyla vials reconstituted with sterile water for injection should be used immediately following reconstitution.1 If not used immediately, the reconstituted vials can be stored for up to 24 hours at 2°C to 8°C and must be discarded thereafter.

Do not freeze the reconstituted solution.

Infusion bag containing the diluted solution

The reconstituted Kadcyla solution diluted in 0.9% NaCl Injection, or 0.45% NaCl Injection, may be stored at 2°C to 8°C for up to 24 hours prior to use.[1]

Do not freeze the solution for infusion containing the reconstituted product.

Avoid exposing Kadcyla to direct daylight in all forms, including in the unopened vial, reconstituted solution, and diluted infusion bag.[2] Handling of Kadcyla in ambient light conditions is acceptable. Refer to the locally approved prescribing information for any additional storage recommendations.

Recommended solutions for reconstitution and dilution

Kadcyla lyophilised powder should be reconstituted with sterile water according to the vial size and volume presented in Table 1.[1] The reconstituted solution should be further diluted with 0.9% NaCl or 0.45% NaCl.[1]

Table 1. Sterile water volume for reconstitution

If Kadcyla was inadvertently reconstituted or diluted with a solution other than as described in the prescribing information, contact your local medical information service.

Precaution against using dextrose 5% solution

Roche recommends against reconstituting or diluting with dextrose (or glucose) 5% solution as it causes aggregation of the protein.[1]

Precaution against admixtures

Kadcyla should not be reconstituted, diluted, or mixed with other drugs.[1]

Recommendation for the use of a PES filter

If Kadcyla was diluted in an infusion bag containing 0.9% NaCl solution, a 0.2 or 0.22 µm polyethersulfone (PES) in-line filter is required for administration to remove potential particulates that may occur in storage.[3]

While not required, a 0.2 or 0.22 µm PES in-line filter can be used during administration if Kadcyla was diluted in an infusion bag containing 0.45% NaCl solution.

Using other filters

Roche only recommends the use of a 0.2 or 0.22 µm PES in-line filter with Kadycla. The use of a different filter would be off-label and a clinical decision to be made by the physician after an analysis of the benefit-risk ratio.

Further studies have demonstrated compatibility of diluted Kadcyla solution with

• 0.2 µm polysulphone (PSU) in-line filters (Terumo PB infusion line), [3] and
• 0.2 µm nylon (positively charged Nylon Posidyne® membrane) in-line filters.[4]

No data are available for the compatibility of diluted Kadcyla solutions with

• polyvinyl chloride (PVC) in-line filters, or
• in-line filters with a pore size of >0.22 µm.[2]

1. Roche Internal Regulatory Report. Accessed 12 July 2023.
2. Roche Internal Communications. Accessed 25 July 2023.
3. Roche Internal Technical Report. Accessed 12 July 2023.
4. Roche Internal Technical Report. Accessed 12 July 2023.