TALVEY®
(talquetamab-tgvs)
Medical inquiries
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TALVEY® (talquetamab-tgvs)
Medical Information
Temperature Excursion Guidelines for TALVEY Vials
Last Updated: 07/29/2024
SUMMARY
- Please refer to local prescribing information for storage and stability information.
- Janssen cannot recommend any practices, procedures, or storage conditions that deviate from product labeling and are not approved by the regulatory agencies.
Temperature Excursion Data
- TALVEY 2 mg/mL vial and TALVEY 40 mg/mL vial are supplied as ready-to-use solutions that do not need dilution prior to administration.1
- TALVEY 2 mg/mL vial and TALVEY 40 mg/mL vial should be stored at 2°C to 8°C (36°F to 46°F) in the original carton in order to protect from light. Do not freeze.1
- There is no anticipated adverse impact to the TALVEY 2 mg/mL vial and
TALVEY 40 mg/mL vial when exposed to temperature excursions described in Table:Temperature Excursion Guidelines for TALVEY Vials.2 - The response provides information on specific scenarios for which we have data. If there is no tracking of time and temperature, Janssen cannot provide recommendations.
| Temperature Excursions (24 months shelf-life) | -20°C to <2°C (-4°F to <36°F) | No more than 5 total exposures at maximum 48 hours each and maximum of 10 days, cumulative exposure (all excursions) |
| >8°C to 30°C (>46°F to 86°F) | No more than 5 total exposures at maximum 48 hours each and maximum of 10 days, cumulative exposure (all excursions) |
Literature Search
A literature search of MEDLINE®
References
| 1 | Data on File. Talquetamab. CCDS. Janssen Research & Development, LLC. EDMS-RIM-620984; version 002; 2023. |
| 2 |