About KEYTRUDA® (pembrolizumab) in melanoma

KEYTRUDA® (pembrolizumab):
bringing over a decade of experience in immunotherapy to Stage IIB–IV melanoma1

Prescribing Information (United Kingdom) [External link]

Illustration of six individuals walking, each labeled with a different stage of melanoma: IIB, IIC, IIIA, IIIB, IIIC, and IV. Below them are three boxes highlighting clinical data: '4 years of data in Stage IIB and IIC with KEYNOTE-716', '7 years of data in Stage III with KEYNOTE-054' and '10 years of data in the metastatic setting with KEYNOTE-006'. Each box includes a button labeled 'Explore the data'.
Illustration of six individuals walking, each labeled with a different stage of melanoma: IIB, IIC, IIIA, IIIB, IIIC, and IV. Below them are three boxes highlighting clinical data: '4 years of data in Stage IIB and IIC with KEYNOTE-716', '7 years of data in Stage III with KEYNOTE-054' and '10 years of data in the metastatic setting with KEYNOTE-006'. Each box includes a button labeled 'Explore the data'.
Explore the data
Illustration of six individuals walking, each labeled with a different stage of melanoma: IIB, IIC, IIIA, IIIB, IIIC, and IV. Below them are three boxes highlighting clinical data: '4 years of data in Stage IIB and IIC with KEYNOTE-716', '7 years of data in Stage III with KEYNOTE-054' and '10 years of data in the metastatic setting with KEYNOTE-006'. Each box includes a button labeled 'Explore the data'.
Explore the data
Illustration of six individuals walking, each labeled with a different stage of melanoma: IIB, IIC, IIIA, IIIB, IIIC, and IV. Below them are three boxes highlighting clinical data: '4 years of data in Stage IIB and IIC with KEYNOTE-716', '7 years of data in Stage III with KEYNOTE-054' and '10 years of data in the metastatic setting with KEYNOTE-006'. Each box includes a button labeled 'Explore the data'.
Explore the data

Images are illustrative of the range of patients diagnosed with melanoma.

Whether it’s reducing the risk of disease progression in the early stage setting or extending survival in advanced melanoma, KEYTRUDA can support your clinical practice with a documented safety profile.1–4

Hear from fellow clinician Dr Clare Barlow to discover how the latest data readouts are impacting clinical practice

KEYTRUDA offers flexibility of dosing1

Administered as an IV infusion
Over 30 minutes
Under 'ADULT DOSING OPTIONS,' two regimens are shown: 200 mg every 3 weeks (Q3W) and 400 mg every 6 weeks (Q6W). Under 'PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER' a regimen of 2mg/kg every 3 weeks is shown, up to a maximum of 200 mg.

Assessment of regimens

The 200 mg Q3W (once every 3 weeks) regimen has been assessed in phase II and III registration studies across a multitude of indications of KEYTRUDA. An exposure-response evaluation, using modelling and simulation, led to the approval of the 400 mg Q6W (once every 6 weeks) dosing for monotherapy and combination therapy. 

The recommended dose of KEYTRUDA as monotherapy in paediatric patients aged 12 years and older with melanoma is 2 mg/kg body weight (up to a maximum of 200 mg), every 3 weeks administered as an intravenous infusion over 30 minutes. 

KEYTRUDA storage and stability information update1

Previously, the recommended storage period for the diluted solution was 96 hours at 2ºC to 8ºC and 6 hours at room temperature (at or below 25ºC).

Products should be used immediately once diluted.
From a microbiological point of view, if not used immediately, use within 7 days if stored at 2–8°C, and within 6 hours at room temperature (≤25°C), unless prepared under validated aseptic conditions.

*Unless dilution has taken place in controlled and validated aseptic conditions. These conditions are the responsibility of the user.

Refrigerated vials or IV bags must be brought to room temperature before use.
The diluted solution must not be frozen.

For stability related enquiries please contact medicalinformationuk@msd.com.

Please refer to the full KEYTRUDA Summary of Product Characteristics and Risk Minimisation Materials for Patients before prescribing KEYTRUDA.

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Licensed indications

KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma.1

KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection (see section 5.1).1

Please consult the SmPC and Risk Minimisation materials before making any prescribing decisions.

Abbreviations

bw, body weight; IV, intravenous; Q3W, every three weeks; Q6W, every six weeks.

References

  1. KEYTRUDA® (pembrolizumab) Summary of Product Characteristics. United Kingdom. Available at: https://www.medicines.org.uk/emc/product/2498. Accessed: May 2025
  2. Luke JJ, et al. J Clin Oncol 2024;42:1619–1629
  3. Eggermont AMM, et al. Eur J Cancer 2024;211:114327
  4. Long GV, et al. Ann Oncol 2024;S0923-7534(24)03910-3

Supporting documentation:

Prescribing Information (United Kingdom) [External link]
By clicking the link above you will leave the MSD Connect website and be taken to the emc PI portal website.

GB-OOC-00889 | Date of preparation: June 2025