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Pembrolizumab Dosage

Medically reviewed by Drugs.com. Last updated on Mar 29, 2021.

Applies to the following strengths: 25 mg/mL; 50 mg

Usual Adult Dose for Malignant Melanoma

Monotherapy for unresectable or metastatic melanoma: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes until disease progression or unacceptable toxicity

Adjuvant treatment of melanoma: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 12 months

Uses:
  • Treatment of patients with unresectable or metastatic melanoma
  • Adjuvant treatment of patients with melanoma with Stage IIB, IIC, or III melanoma following complete resection.

Usual Adult Dose for Melanoma - Metastatic

Monotherapy for unresectable or metastatic melanoma: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes until disease progression or unacceptable toxicity

Adjuvant treatment of melanoma: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 12 months

Uses:
  • Treatment of patients with unresectable or metastatic melanoma
  • Adjuvant treatment of patients with melanoma with Stage IIB, IIC, or III melanoma following complete resection.

Usual Adult Dose for Non-Small Cell Lung Cancer

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

COMBINATION THERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months
  • Administer this drug prior to chemotherapy when given on the same day

Uses:
  • As a single agent for the first-line treatment of patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (Tumor Proportion Score [TPS] 1% or greater) as determined by an FDA-approved test with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation OR metastatic
  • As a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1% or greater) as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy; patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving this drug
  • In combination with pemetrexed and platinum chemotherapy for first-line treatment of metastatic NSCLC with no EGFR or ALK genomic tumor aberrations.
  • In combination with carboplatin and either paclitaxel or paclitaxel protein-bound for first-line treatment of patients with metastatic squamous NSCLC.

Usual Adult Dose for Head and Neck Cancer

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

COMBINATION THERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months
  • Administer this drug prior to chemotherapy when given on the same day

Uses:
  • As a single agent for first line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell cancer (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] greater than or equal to 1) as determined by an FDA-approved test
  • As a single agent for treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
  • In combination with platinum and fluorouracil for first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC.

Usual Adult Dose for Hodgkin's Disease

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Use: For the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL)

Usual Adult Dose for Lymphoma

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Use: For the treatment of patients with refractory primary mediastinal large B-cell lymphoma (PMBCL) or who have relapsed after 2 or more prior lines of therapy (not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy)

Usual Adult Dose for Urothelial Carcinoma

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Comments:
  • This drug is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Uses:
  • For the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy
  • For the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Usual Adult Dose for Bladder Cancer

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes until persistent or recurrent high-risk non-muscle invasive bladder cancer (NMIBC), disease progression, unacceptable toxicity, or up to 24 months

Use: For the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, NMIBC with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy

Usual Adult Dose for Colorectal Cancer

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Uses:
  • For treatment of patients with unresectable or metastatic microsatellite instability-high MSI-H or mismatch repair deficient dMMR colorectal cancer (CRC).

Usual Adult Dose for Gastric Cancer

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

COMBINATION THERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months
  • Administer this drug prior to trastuzumab and chemotherapy when given on the same day

Comments:
  • These indications are approved under accelerated approval based on tumor response rate and durability of response; continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Uses:
  • In combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma
  • As a single agent for patients with recurrent locally advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 Positive Score (CPS) 1 or greater as determined by an FDA-approved test, with disease progression on or after 2 or more prior lines of therapy including fluoropyrimidine-and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy

Usual Adult Dose for Cervical Cancer

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

COMBINATION THERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months
  • Administer this drug prior to chemotherapy with or without bevacizumab when given on the same day

Uses:
  • For the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1 or greater) as determined by an FDA-approved test
  • In combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS 1 or greater) as determined by an FDA-approved test

Usual Adult Dose for Hepatocellular Carcinoma

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Comments:
  • This indication is approved under accelerated approval based on tumor response rate and durability of response; continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Use: For the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib

Usual Adult Dose for Merkel Cell Carcinoma

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Comments:
  • This indication is approved under accelerated approval based on tumor response rate and durability of response; continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Use: For the treatment of patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)

Usual Adult Dose for Renal Cell Carcinoma

Adjuvant treatment of renal cell carcinoma (RCC): 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 12 months

COMBINATION THERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months
  • Administer this drug in combination with axitinib 5 mg orally twice a day OR lenvatinib 20 mg orally once a day

Comments:
  • When axitinib is used in combination with this drug, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer.

Uses:
  • In combination with axitinib for the first-line treatment of advanced RCC.
  • In combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC.
  • For the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Usual Adult Dose for Esophageal Carcinoma

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

COMBINATION THERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months
  • Administer this drug prior to chemotherapy when given on the same day

Uses: For the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 cm above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:
  • In combination with platinum- and fluoropyrimidine-based chemotherapy, OR
  • As a single agent after 1 or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS 10 or greater) as determined by an FDA-approved test

Usual Adult Dose for Endometrial Carcinoma

COMBINATION THERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months
  • Administer this drug with lenvatinib 20 mg orally once a day

Comments:
  • Patients should be selected for combination treatment with lenvatinib based on MSI or MMR status in tumor specimens.

Use: In combination with lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation

Usual Adult Dose for Squamous Cell Carcinoma

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Use: For the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation

Usual Adult Dose for Breast Cancer

For treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery:
COMBINATION THERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes; administer this drug prior to chemotherapy when given on the same day
  • Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or
4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity
  • Follow with adjuvant treatment as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicity

For the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS 10 or greater) as determined by an FDA-approved test:
COMBINATION THERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months
  • Administer this drug prior to chemotherapy when given on the same day

Comments:
  • Patients who experience disease progression or unacceptable toxicity related to this drug with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent therapy with this drug.

Usual Adult Dose for Solid Tumors

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks

  • Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Comments:
  • 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.
  • This indication is approved under accelerated approval based on tumor response rate and durability of response; continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Uses:
  • For the treatment of patients with unresectable or metastatic TMB-H (10 mutations/megabase or greater) solid tumors, as determined by an FDA-approved test that have progressed following prior treatment and who have no satisfactory alternative treatment options.
  • For the treatment of patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.

Usual Pediatric Dose for Hodgkin's Disease

MONOTHERAPY: 2 mg/kg IV every 3 weeks; Maximum dose: 200 mg

  • Administer as an IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Use: For the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy

Usual Pediatric Dose for Lymphoma

MONOTHERAPY: 2 mg/kg IV every 3 weeks; Maximum dose: 200 mg

  • Administer as an IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Uses:
  • For the treatment of pediatric patients 6 months or older with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy (this drug is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy)

Usual Pediatric Dose for Merkel Cell Carcinoma

MONOTHERAPY: 2 mg/kg IV every 3 weeks; Maximum dose: 200 mg

  • Administer as an IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Comments:
  • This indication is approved under accelerated approval based on tumor response rate and durability of response; continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Use: For the treatment of pediatric patients 6 months or older with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)

Usual Pediatric Dose for Solid Tumors

MONOTHERAPY: 2 mg/kg IV every 3 weeks; Maximum dose: 200 mg

  • Administer as an IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Comments:
  • 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.
  • The safety and effectiveness in pediatric patients with MSI-H central nervous system cancers have not been established.
  • This indication is approved under accelerated approval based on tumor response rate and durability of response; continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Uses:
  • For the treatment of patients with unresectable or metastatic TMB-H (10 mutations/megabase or greater) solid tumors, as determined by an FDA-approved test that have progressed following prior treatment and who have no satisfactory alternative treatment options.
  • For the treatment of patients with unresectable or metastatic, MSI-H or dMMR solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.

Usual Pediatric Dose for Malignant Melanoma

12 years or older:
Adjuvant treatment of melanoma: 2 mg/kg IV every 3 weeks; Maximum dose: 200 mg

  • Administer as an IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 12 months

Use: Adjuvant treatment of pediatric patients 12 years or older with Stage IIB, IIC, or III melanoma following complete resection.

Usual Pediatric Dose for Melanoma - Metastatic

12 years or older:
Adjuvant treatment of melanoma: 2 mg/kg IV every 3 weeks; Maximum dose: 200 mg

  • Administer as an IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 12 months

Use: Adjuvant treatment of pediatric patients 12 years or older with Stage IIB, IIC, or III melanoma following complete resection.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild liver dysfunction (total bilirubin [TB] less than or equal to upper limit of normal [ULN] and AST greater than ULN or TB greater than 1 to 1.5 x ULN and any AST): No adjustment recommended.
Moderate to severe liver dysfunction (TB greater than 1.5 x ULN and any AST): Data not available

Dose Adjustments

Dose reductions are generally not recommended for this drug; therapy may be held or discontinued to manage adverse reactions:

  • For severe (Grade 3) immune-mediated adverse reactions, therapy may be interrupted and resumed in patients with complete or partial resolution
  • For patients with life-threatening (Grade 4) immune-mediated adverse reactions or recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg/day or less of prednisone (or equivalent) within 12 weeks of initiating steroids, therapy should be discontinued

Dose modifications for adverse reactions that require management different from general guidelines are summarized below:
PNEUMONITIS:
  • Grade 2: Withhold therapy; resume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue therapy if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of initiating steroids.
  • Grade 3 or 4: Permanently discontinue therapy.
COLITIS:
  • Grade 2 or 3: Withhold therapy; resume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue therapy if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of initiating steroids.
Grade 4: Permanently discontinue therapy.
HEPATITIS WITH NO TUMOR INVOLVEMENT OF THE LIVER:
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) increases to more than 3 and up to 8 times upper limit of normal (ULN) OR total bilirubin increases to more than 3 x ULN: Withhold therapy; resume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue therapy if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of initiating steroids
  • AST or ALT increases to more than 8 x ULN OR total bilirubin increases to more than 3 x ULN:
Permanently discontinue therapy.
HEPATITIS WITH TUMOR INVOLVEMENT OF THE LIVER:
  • If AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue therapy based on recommendations for hepatitis with no liver involvement
  • If baseline AST or ALT is more than 1 and up to 3 x ULN and increases to more than 5 and up to 10 x ULN OR baseline AST or ALT is more than 3 and up 5 x ULN and increases to more than 8 and up to 10 times ULN: Withhold therapy; resume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue therapy if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of initiating steroids.
  • If AST or ALT increases to more than 10 x ULN OR total bilirubin increases to more than 3 x ULN: Permanently discontinue therapy.
ENDOCRINOPATHIES:
  • Grade 3 or 4: Withhold therapy until stable or permanently discontinue therapy depending on severity.
NEPHRITIS WITH RENAL DYSFUNCTION:
  • Grade 2 or 3 increased blood creatinine: Withhold therapy; resume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue therapy if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of initiating steroids.
  • Grade 4 increased blood creatinine: Permanently discontinue therapy.
EXFOLIATIVE DERMATOLOGIC CONDITIONS:
  • Suspected Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS): Withhold therapy; resume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue therapy if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of initiating steroids.
  • Confirmed SJS, TEN, or DRESS: Permanently discontinue therapy.
MYOCARDITIS:
  • Grade 2, 3, or 4: Permanently discontinue therapy.
NEUROLOGICAL TOXICITIES:
  • Grade 2: Withhold therapy; resume in patients with complete or partial resolution (Grades 0 to 1) after corticosteroid taper. Permanently discontinue therapy if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg/day or less (or equivalent) within 12 weeks of initiating steroids.
  • Grade 3 or 4: Permanently discontinue therapy.
HEMATOLOGIC TOXICITY IN PATIENTS WITH cHL OR PMBCL:
  • Grade 4: Withhold until resolution to Grade 0 or 1.
INFUSION-RELATED REACTIONS:
  • Grade 1 or 2 Interrupt or slow the rate of infusion.
  • Grade 3 or 4: Permanently discontinue therapy.

DOSE MODIFICATIONS FOR ADVERSE REACTIONS IN COMBINATION WITH AXITINIB:
Liver enzyme elevations (consider corticosteroid therapy):
  • ALT or AST increases to at least 3 but less than 10 x ULN without concurrent total bilirubin at least 2 x ULN: Withhold both pembrolizumab and axitinib until resolution to Grade 0 or 1; 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.
  • ALT or AST increases to more than 3 x ULN with concurrent total bilirubin at least 2 x ULN OR ALT or AST 10 x ULN or greater: Permanently discontinue both pembrolizumab and axitinib.

DOSE MODIFICATIONS FOR ADVERSE REACTIONS IN COMBINATION WITH LENVATINIB:
  • May need to modify 1 or both drugs; withhold or discontinue pembrolizumab as above; refer to lenvatinib prescribing information for additional dose modification information.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 6 months.

  • Safety and effectiveness as a single agent have been established in pediatric patients with melanoma, cHL, PMBCL, MCC, MSI-H, dMMR cancer, and TMB-H cancer; safety and effectiveness for other indications have not been established in pediatric patients.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

  • Administer as IV infusion over 30 minutes through an IV line containing low-protein binding 0.2 micron to 5 micron in-line or add-on filter

Storage requirements:
  • Store diluted solution at room temperature for no more than 6 hours (includes time of infusion); may store under refrigeration for no more than 96 hours from time of reconstitution.
  • If refrigerated, allow to come to room temperature prior to administration, do not shake
  • Do not freeze.

Reconstitution/preparation techniques:
  • Dilute prior to administration; dilute in 0.9% sodium chloride or 5% dextrose; mix diluted solution by gentle inversion; do not shake
  • Final concentration should be between 1 mg/mL and 10 mg/mL

IV compatibility: Do not administer other drugs through the same infusion line

General:
  • An additional Dosing Regimen of 400 mg Every 6 Weeks is approved for use for all approved adult indications. This dosing regimen is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety; continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials.
  • Information on FDA-approved tests used for patient selection is available at: http://www.fda.gov/CompanionDiagnostics .
  • Additional information on patient selection for single-agent and combination therapy may be found in the manufacturer's product information.

Monitoring:
  • Monitor for immune-mediated adverse reactions
  • Obtain liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment
  • For patients with TNBC in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated
  • Monitor for infusion reactions
  • Monitor for hyperglycemia

Patient advice:
  • Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
  • Patients should be informed of the risk of immune-mediated adverse reactions.
  • Females of reproductive potential should be advised to use effective contraception during therapy and for 4 months after their last dose.

Frequently asked questions

Further information

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