Dosing, Preparation, Storage and Administration

Dosing information (ref 1-4)

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 (pembrolizumab) Dosing and Administration Video

Watch the KEYTRUDA SC dosing and administration video for considerations for storage, preparation and administration for your eligible patients.

Two solution-strength vials are available for KEYTRUDA SC1,2

Flexible dosing options. 395 mg*/2.4 mL over† 1 minute, every 3 weeks. 790 mg*/4.8 mL over† 2 minutes, every 6 weeks.

*Pembrolizumab
†Does not account for all aspects of treatment. Actual clinic time may vary.

KEYTRUDA SC offers (ref 1,2): Fast subcutaneous administration - over 1 minute for Q3W and over 2 minutes for Q6W vs 30 minutes for KEYTRUDA IV; Flexible dosing options - Q3W and Q6W, two sites of administration - abdomen or thigh; Low injection volume - 2.4 mL Q3W and 4.8 mL Q6W.

Patients can switch from KEYTRUDA IV to KEYTRUDA SC, or from KEYTRUDA SC to KEYTRUDA IV, at their next scheduled dose1,2,3

KEYTRUDA SC is a distinct product from KEYTRUDA IV: each product has a colour-coded cap to ensure accurate identification

Vial identifications:

KEYTRUDA SC: Q3W, yellow cap. 395 mg pembrolizumab/2.4 mL (165 mg/mL), single dose vials. GTIN: 00366582512479. Carton x 1 vial. 50 mm x 50 mm x 90 mm. KEYTRUDA SC: Q6W, green cap. 790 mg pembrolizumab/4.8 mL (165 mg/mL), single dose vials. GTIN: 00366582512486. Carton x 1 vial. 50 mm x 50 mm x 90 mm. KEYTRUDA IV: navy blue cap. 100 mg pembrolizumab/4 mL (25 mg/mL), single-done vials. GTIN: 00191778025422. Carton x 2 vials. 60 mm x 57 mm x 90 mm.

Vials and cartons shown to scale, not actual size.

The KEYTRUDA SC syringe can be prepared for injection in four steps1,2

Check the vial. Check the vial label to ensure the correct formulation is prepared and administered to the patient as prescribed. Visually inspect the vial for particulate matter and discolouration. The solution is clear to slightly opalescent, colourless to slightly yellow. Discard the vial if visible particles or discolouration are observed!
Bring the vial to room temperature. Allow the refrigerated vial to come to room temperature for at least 30 minutes. Prior to preparation for administration, if needed, the unpunctured vial may be stored at room temperature for up to 24 hours. Do not dilute, do not shake the vial!
Withdraw the required volume. Withdraw either 2.4 mL (395 mg) or 4.8 mL (790 mg) using a sterile syringe and a transfer needle (18–21G recommended). KEYTRUDA SC is compatible with polypropylene and polycarbonate syringe material and stainless-steel transfer and injection needles. KEYTRUDA SC vial is for single use only. Discard the empty vial or any unused portion left in the vial!*
Change to injection needle. To avoid needle clogging, change the needle to a 25–30G, 13 mm hypodermic injection needle immediately prior to subcutaneous injection. Do not attach the hypodermic needle until immediately prior to administration to avoid clogging!

*Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

How to store KEYTRUDA SC vials and prepared injection syringes1,2,3

Storage of unopened vials

Keytruda SC has the same storage requirements as Keytruda IV (ref 1,2). Store in a refrigerator (2-8 degrees centigrade). Store in the original carton to protect from light. Do not shake or freeze vials.

If removed from refrigeration, unpunctured vials can remain at room temperature (≤25°C) for up to 24 hours before preparation for administration. 

Storage of prepared syringes

This product does not contain preservative and should be used immediately after withdrawing from the vial. If not used immediately, store the syringe containing KEYTRUDA SC with the transfer needle and cap in place for:

Up to 8 hours at room temperature.
Or up to 24 hours in the refrigerator (2 to 8 degrees centigrade).

†If refrigerated, the 24-hour period may include up to 8 hours at room temperature.

If refrigerated, the filled syringe must be allowed to come to room temperature for at least 30 minutes prior to administration.

The syringe must not be frozen.
Do not attach the hypodermic needle until immediately prior to administration to avoid clogging. 

Discard if storage time exceeds these limits. 
Do not store any unused portion of the solution for the injection for reuse. Any unused medicine or waste material should be disposed of in accordance with local requirements. 

KEYTRUDA SC is administered over 1 or 2 minutes, with two subcutaneous injection-site options – abdomen or thigh1,2

Should be administered by an HCP and must be administered by subcutaneous injection only.

Q3W: Inject over 1 minute* one dose (395 mg/2.4 mL). Q6W: Inject over 2 minutes* one dose (790 mg/4.8 mL).

*Does not account for all aspects of treatment. Actual clinic time may vary.

Illustration showing injection sites at the thigh and abdomen, and area of 5 cm to avoid around the navel.

Key considerations

Inject into the subcutaneous tissue of the thigh or abdomen, avoiding 5 cm around the navel.

Do not inject into skin that is damaged, sore, bruised, scarred, scaly, or has red patches. 

Rotate injection sites for subsequent injections (ensure the injection site is at least 2.5 cm from the previous injection site). 

During treatment with KEYTRUDA SC do not administer other medications for subcutaneous use at the same site.

For certain patients, treatment with KEYTRUDA SC could offer the opportunity for administration outside an infusion suite.5 

KEYTRUDA SC is licensed for use across most KEYTRUDA IV indications, whether alone or in combination with other therapies.1,2,3 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.1,2,3
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.1,2

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.1,2

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.1,2

Please refer to individual product SmPCs for full information about dosing, preparation and administration.

Abbreviations

ALK = anaplastic lymphoma kinase; EGFR = epidermal growth factor receptor; GTIN = ordering code; HCP = healthcare professional; IV = intravenous; Q3W = every 3 weeks; Q6W = every 6 weeks; SmPC = Summary of Product Characteristics.

References

  1. KEYTRUDA (pembrolizumab) 395 mg Solution for Injection Summary of Product Characteristics.
  2. KEYTRUDA (pembrolizumab) 790 mg Solution for Injection Summary of Product Characteristics.
  3. KEYTRUDA (pembrolizumab) 25 mg/mL Concentrate Solution for Infusion Summary of Product Characteristics.
  4. Felip E, et al. Ann Oncol 2025;36:775–785.
  5. De Cock E, et al. Adv Ther. 2025;42(12):6175–6189. 

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]
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GB-PDS-00129 | Date of Preparation: November 2026