KEYTRUDA (pembrolizumab) 395 mg solution for injection Prescribing Information [External link] | KEYTRUDA (pembrolizumab) 790 mg solution for injection Prescribing Information [External link] | KEYTRUDA (pembrolizumab) 25 mg/mL Concentrate Solution for Infusion Prescribing Information [External link]
KEYTRUDA SC Dosing and Administration Video
Watch the KEYTRUDA SC dosing and administration video for considerations for storage, preparation and administration for your eligible patients.
Support and Resources
Dosing, Storage and
Administration Guide
To order a printed version, please contact us at msdukoncology@msd.com
Dosing and Administration Poster
To order a printed version, please contact us at msdukoncology@msd.com
Find out more about KEYTRUDA SC
Find out more about KEYTRUDA SC dosing
Find out more about KEYTRUDA SC clinical data
KEYTRUDA SC is licensed for use across most KEYTRUDA IV indications, whether alone or in combination with other therapies.1,2 One such indication is: KEYTRUDA IV and KEYTRUDA SC, in combination with pemetrexed and platinum chemotherapy, are each indicated for the first-line treatment of metastatic non-squamous non-small cell lung carcinoma in adults whose tumours have no EGFR- or ALK-positive mutations.1,2
Please consult the SmPC for the full list of indications and further information to minimise the risks associated with the use of the medicine before making any prescribing decisions.
The approved adult indications for KEYTRUDA SC have been established based on the MK‑3475A‑D77 study, which demonstrated non‑inferior pharmacokinetics and provides a descriptive analysis for the efficacy and safety profile of KEYTRUDA SC compared to KEYTRUDA.1
The safety and efficacy of KEYTRUDA SC have not been established in paediatric patients, except for adolescents with melanoma or cHL aged 12 years and older who weigh more than 40 kg. For these adolescents, the recommended dose is the same as that for adults. The paediatric safety and efficacy profile of KEYTRUDA SC is based on extrapolation from intravenous pembrolizumab studies, as efficacy and safety in paediatric patients were not directly evaluated in the MK-3475A-D77 study.1
In addition, pharmacokinetic modelling and simulation analyses demonstrated similar pembrolizumab exposure in adolescents aged 12 years and older who weigh more than 40 kg compared with adults, suggesting a similar safety profile. Pembrolizumab exposures with subcutaneous doses of 395 mg every 3 weeks or 790 mg every 6 weeks in adolescents aged 12 years and older who weigh greater than 40 kg are expected to be an average of 30% higher to those of adult patients at the same dose, however this difference is not clinically meaningful.1
Please refer to individual product SmPCs for full information about dosing, preparation and administration.
References
- KEYTRUDA (pembrolizumab) Solution for Injection Summary of Product Characteristics (395 mg and 790mg).
- KEYTRUDA (pembrolizumab) 25 mg/mL Concentrate Solution for Infusion Summary of Product Characteristics.
Supporting documentation
KEYTRUDA (pembrolizumab) 395 mg solution for injection Prescribing Information [External link]
KEYTRUDA (pembrolizumab) 790 mg solution for injection Prescribing Information [External link]
KEYTRUDA (pembrolizumab) 25 mg/mL Concentrate Solution for Infusion Prescribing Information [External link]
By clicking the link above you will leave the MSD Connect website and be taken to the emc PI portal website.
