Skip to Content

Keytruda Dosage

Medically reviewed by Drugs.com. Last updated on March 30, 2021.

Generic name: pembrolizumab 50mg in 2mL
Dosage form: injection, powder, lyophilized, for solution

2.1 Patient Selection for NSCLC, HNSCC, Urothelial Carcinoma, Gastric Cancer, Esophageal Cancer, Cervical Cancer, MSI-H or dMMR Cancer, MSI-H or dMMR CRC, TMB-H Cancer, or TNBC

Select patients for treatment with KEYTRUDA as a single agent based on the presence of positive PD-L1 expression in:

For the MSI-H/dMMR indications, select patients for treatment with KEYTRUDA as a single agent based on MSI-H/dMMR status in tumor specimens [see Clinical Studies (14.7, 14.8)].

For the TMB-H indication, select patients for treatment with KEYTRUDA as a single agent based on TMB-H status in tumor specimens [see Clinical Studies (14.16)].

Because the effect of prior chemotherapy on test results for tumor mutation burden (TMB-H), MSI-H, or dMMR in patients with high-grade gliomas is unclear, it is recommended to test for these markers in the primary tumor specimens obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.

Select patients for treatment with KEYTRUDA in combination with chemotherapy based on the presence of positive PD-L1 expression in:

Information on FDA-approved tests for the detection of PD-L1 expression and TMB status is available at: http://www.fda.gov/CompanionDiagnostics. An FDA-approved test for the detection of MSI-H or dMMR is not currently available.

Recommended Dosage

Table 1: Recommended Dosage
Indication Recommended Dosage of
KEYTRUDA
Duration/Timing of Treatment
*
30-minute intravenous infusion
Refer to the Prescribing Information for the agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.
When axitinib is used in combination with KEYTRUDA, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer.
Monotherapy
Adult patients with unresectable or
metastatic melanoma
200 mg every 3 weeks*
or
400 mg every 6 weeks*
Until disease progression or
unacceptable toxicity
Adjuvant treatment of adult patients
with melanoma
200 mg every 3 weeks*
or
400 mg every 6 weeks*
Until disease recurrence, unacceptable
toxicity, or up to 12 months
Adult patients with NSCLC,
HNSCC, cHL, PMBCL, locally
advanced or metastatic Urothelial
Carcinoma, MSI-H or dMMR Cancer,
MSI-H or dMMR CRC, Gastric Cancer,
Esophageal Cancer, Cervical Cancer,
HCC, MCC, TMB-H Cancer, or cSCC
200 mg every 3 weeks*
or
400 mg every 6 weeks*
Until disease progression, unacceptable
toxicity, or up to 24 months
Adult patients with high-risk BCG-
unresponsive NMIBC
200 mg every 3 weeks*
or
400 mg every 6 weeks*
Until persistent or recurrent high-risk
NMIBC, disease progression,
unacceptable toxicity, or up to
24 months
Pediatric patients with cHL, PMBCL,
MSI-H Cancer, MCC, or TMB-H
Cancer
2 mg/kg every 3 weeks (up to a
maximum of 200 mg)*
Until disease progression, unacceptable
toxicity, or up to 24 months
Combination Therapy
Adult patients with NSCLC, HNSCC, or
Esophageal Cancer
200 mg every 3 weeks*
or
400 mg every 6 weeks*
Administer KEYTRUDA prior to
chemotherapy when given on
the same day.
Until disease progression, unacceptable
toxicity, or up to 24 months
Adult patients with RCC 200 mg every 3 weeks*
or
400 mg every 6 weeks*
Administer KEYTRUDA in
combination with axitinib 5 mg
orally twice daily.
Until disease progression, unacceptable
toxicity, or for KEYTRUDA, up to
24 months
Adult patients with Endometrial
Carcinoma
200 mg every 3 weeks*
or
400 mg every 6 weeks*
Administer KEYTRUDA in
combination with lenvatinib
20 mg orally once daily.
Until disease progression, unacceptable
toxicity, or for KEYTRUDA, up to
24 months
Adult patients with locally recurrent
unresectable or metastatic TNBC
200 mg every 3 weeks*
or
400 mg every 6 weeks*
Administer KEYTRUDA prior to
chemotherapy when given on
the same day.
Until disease progression, unacceptable
toxicity, or up to 24 months

Dose Modifications

No dose reduction for KEYTRUDA is recommended. In general, withhold KEYTRUDA for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue KEYTRUDA for Life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating steroids.

Dosage modifications for KEYTRUDA for adverse reactions that require management different from these general guidelines are summarized in Table 2.

Table 2: Recommended Dosage Modifications for Adverse Reactions
Adverse Reaction Severity* Dosage Modification
ALT = alanine aminotransferase, AST = aspartate aminotransferase, DRESS = Drug Rash with Eosinophilia and Systemic Symptoms, SJS = Stevens Johnson Syndrome, TEN = toxic epidermal necrolysis, ULN = upper limit normal
*
Based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Resume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.
If AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue KEYTRUDA based on recommendations for hepatitis with no liver involvement.
Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)]
Pneumonitis Grade 2 Withhold
Grade 3 or 4 Permanently discontinue
Colitis Grade 2 or 3 Withhold
Grade 4 Permanently discontinue


Hepatitis with no tumor involvement
of the liver
AST or ALT increases to more than 3
and up to 8 times ULN
or
Total bilirubin increases to more than
1.5 and up to 3 times ULN
Withhold
For liver enzyme elevations in
patients treated with combination
therapy with axitinib, see Table 3.
AST or ALT increases to more than
8 times ULN
or
Total bilirubin increases to more than
3 times ULN
Permanently discontinue
Hepatitis with tumor involvement of
the liver
Baseline AST or ALT is more than 1
and up to 3 times ULN and increases to
more than 5 and up to 10 times ULN
or
Baseline AST or ALT is more than 3
and up to 5 times ULN and increases to
more than 8 and up to 10 times ULN
Withhold
ALT or AST increases to more than
10 times ULN
or
Total bilirubin increases to more than
3 times ULN
Permanently discontinue
Endocrinopathies Grade 3 or 4 Withhold until clinically stable or permanently
discontinue depending on severity
Nephritis with Renal Dysfunction Grade 2 or 3 increased blood creatinine Withhold
Grade 4 increased blood creatinine Permanently discontinue
Exfoliative Dermatologic Conditions Suspected SJS, TEN, or DRESS Withhold
Confirmed SJS, TEN, or DRESS Permanently discontinue
Myocarditis Grade 2, 3, or 4 Permanently discontinue
Neurological Toxicities Grade 2 Withhold
Grade 3 or 4 Permanently discontinue
Hematologic toxicity in patients with
cHL or PMBCL
Grade 4 Withhold until resolution to Grades 0 or 1
Other Adverse Reactions
Infusion-related reactions
[see Warnings and Precautions (5.2)]
Grade 1 or 2 Interrupt or slow the rate of infusion
Grade 3 or 4 Permanently discontinue

The following table represents dosage modifications that are different from those described above for KEYTRUDA or in the Full Prescribing Information for the drug administered in combination.

Table 3: Recommended Specific Dosage Modifications for Adverse Reactions for Combination
Treatment Adverse Reaction Severity Dosage Modification
ALT = alanine aminotransferase, AST = aspartate aminotransferase, ULN = upper limit normal
*
Consider corticosteroid therapy
Based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Consider rechallenge with a single drug or sequential rechallenge with both drugs after recovery. If rechallenging with axitinib, consider dose reduction as per the axitinib Prescribing Information.
KEYTRUDA in
combination with
axitinib
Liver enzyme elevations* ALT or AST increases to at least 3 times but less than 10 times ULN without concurrent total bilirubin at least 2 times ULN Withhold both KEYTRUDA
and axitinib until resolution to
Grades 0 or 1
ALT or AST increases to more than 3 times ULN with concurrent total bilirubin at least 2 times ULN
or
ALT or AST ≥10 times ULN
Permanently discontinue both
KEYTRUDA and axitinib

When administering KEYTRUDA in combination with lenvatinib for the treatment of endometrial carcinoma, interrupt one or both as appropriate. No dose reductions are recommended for KEYTRUDA. Withhold, dose reduce, or discontinue lenvatinib in accordance with the instructions in the lenvatinib prescribing information.

Preparation and Administration

Preparation for Intravenous Infusion

  • Visually inspect the solution for particulate matter and discoloration. The solution is clear to slightly opalescent, colorless to slightly yellow. Discard the vial if visible particles are observed.
  • Dilute KEYTRUDA injection (solution) prior to intravenous administration.
  • Withdraw the required volume from the vial(s) of KEYTRUDA and transfer into an intravenous (IV) bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Mix diluted solution by gentle inversion. Do not shake. The final concentration of the diluted solution should be between 1 mg/mL to 10 mg/mL.
  • Discard any unused portion left in the vial.

Storage of Diluted Solution

The product does not contain a preservative.

Store the diluted solution from the KEYTRUDA 100 mg/4 mL vial either:

  • At room temperature for no more than 6 hours from the time of dilution. This includes room temperature storage of the diluted solution, and the duration of infusion.
  • Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 96 hours from the time of dilution. If refrigerated, allow the diluted solution to come to room temperature prior to administration. Do not shake.

Discard after 6 hours at room temperature or after 96 hours under refrigeration.

Do not freeze.

Administration

  • Administer diluted solution intravenously over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter.
  • Do not co-administer other drugs through the same infusion line.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.