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Keytruda Dosage

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

Medically reviewed on December 28, 2018.

Patient Selection for NSCLC, Urothelial Carcinoma, Gastric Cancer, or Cervical Cancer

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

Information on FDA-approved tests for the detection of PD-L1 expression for these indications is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage for Melanoma

The recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

Recommended Dosage for NSCLC

The recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

When administering KEYTRUDA in combination with chemotherapy, administer KEYTRUDA prior to chemotherapy when given on the same day. Refer to the Prescribing Information for the chemotherapy agents administered in combination with KEYTRUDA for recommended dosing information, as appropriate.

Recommended Dosage for HNSCC

The recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Recommended Dosage for cHL

The recommended dose of KEYTRUDA in adults is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

The recommended dose of KEYTRUDA in pediatric patients is 2 mg/kg (up to a maximum of 200 mg), administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Recommended Dosage for PMBCL

The recommended dose of KEYTRUDA in adults is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

The recommended dose of KEYTRUDA in pediatric patients is 2 mg/kg (up to a maximum of 200 mg), administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Recommended Dosage for Urothelial Carcinoma

The recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Recommended Dosage for MSI-H Cancer

The recommended dose of KEYTRUDA in adults is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

The recommended dose of KEYTRUDA in pediatric patients is 2 mg/kg (up to a maximum of 200 mg), administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Recommended Dosage for Gastric Cancer

The recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Recommended Dosage for Cervical Cancer

The recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Recommended Dosage for HCC

The recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Recommended Dosage for MCC

The recommended dose of KEYTRUDA in adults is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

The recommended dose of KEYTRUDA in pediatric patients is 2 mg/kg (up to a maximum of 200 mg), administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Dose Modifications

No dose reductions of KEYTRUDA are recommended. Withhold or discontinue KEYTRUDA to manage adverse reactions as described in Table 1.

Table 1: Recommended Dose Modifications for Adverse Reactions [see Warnings and Precautions (5.1-5.9)]
Adverse Reaction Severity* Dose Modification for KEYTRUDA
*
Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events. Version 4.0 (NCI CTCAE v4)
Resume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper.
Resume in HCC patients when AST or ALT and total bilirubin recover to Grades 0-1 or to baseline.
Immune-mediated pneumonitis Grade 2 Withhold
Grades 3 or 4 or recurrent Grade 2 Permanently discontinue
Immune-mediated colitis Grades 2 or 3 Withhold
Grade 4 Permanently discontinue
Immune-mediated hepatitis in patients with HCC Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to 5 times upper limit of normal (ULN) if baseline less than 2 times ULN;
AST or ALT greater than 3 times baseline if baseline greater than or equal to 2 times ULN
Total bilirubin greater than 2.0 mg/dL if baseline less than 1.5 mg/dL; or
Total bilirubin greater than 3.0 mg/dL, regardless of baseline levels
Withhold
ALT or AST greater than 10 times ULN; or Child-Pugh score greater than or equal to 9 points;
Gastrointestinal bleeding suggestive of portal hypertension; or
New onset of clinically detectable ascites; or encephalopathy
Permanently discontinue
Immune-mediated hepatitis in patients without HCC AST or ALT greater than 3 but no more than 5 times the ULN or total bilirubin greater than 1.5 but no more than 3 times the ULN Withhold
In patients without liver metastases, AST or ALT greater than 5 times ULN or total bilirubin greater than 3 times ULN
In patients with liver metastasis and Grade 2 AST or ALT at baseline, with an increase in AST or ALT of 50% or more relative to baseline that persists for at least 1 week
Permanently discontinue
Immune-mediated endocrinopathies Grades 3 or 4 Withhold until clinically stable
Immune-mediated nephritis Grade 2 Withhold
Grades 3 or 4 Permanently discontinue
Immune-mediated skin adverse reactions Grade 3 or suspected Stevens-Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN) Withhold
Grade 4 or confirmed SJS or TEN Permanently discontinue
Hematologic toxicity in patients with cHL or PMBCL Grade 4 Withhold until resolution to Grades 0 or 1
Other immune-mediated adverse reactions Grades 2 or 3 based on the severity and type of reaction Withhold
Grade 3 based on the severity and type of reaction or Grade 4 Permanently discontinue
Recurrent immune-mediated adverse reactions Recurrent Grade 2 pneumonitis
Recurrent Grades 3 or 4
Permanently discontinue
Inability to taper corticosteroid Requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks after last dose of KEYTRUDA Permanently discontinue
Persistent Grade 2 or 3 adverse reaction (excluding endocrinopathy) Grades 2 or 3 adverse reactions lasting 12 weeks or longer after last dose of KEYTRUDA Permanently discontinue
Infusion-related reactions Grades 1 or 2 Interrupt or slow the rate of infusion
Grades 3 or 4 Permanently discontinue

Preparation and Administration

Reconstitution of KEYTRUDA for Injection (Lyophilized Powder)

  • Add 2.3 mL of Sterile Water for Injection, USP by injecting the water along the walls of the vial and not directly on the lyophilized powder (resulting concentration 25 mg/mL).
  • Slowly swirl the vial. Allow up to 5 minutes for the bubbles to clear. Do not shake the vial.

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) or reconstituted lyophilized powder 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. 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 Reconstituted and Diluted Solutions

The product does not contain a preservative.

Store the reconstituted and diluted solution from the KEYTRUDA 50 mg vial either:

  • At room temperature for no more than 6 hours from the time of reconstitution. This includes room temperature storage of reconstituted vials, 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 24 hours from the time of reconstitution. If refrigerated, allow the diluted solution to come to room temperature prior to administration.

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 24 hours from the time of dilution. If refrigerated, allow the diluted solution to come to room temperature prior to administration.

Discard after 6 hours at room temperature or after 24 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.

Further information

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

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