• Unresectable or metastatic melanoma.
• Adjuvant treatment of Stage IIB, IIC, or III melanoma following complete resection.
• First-line treatment of patients with stage III non–small-cell lung cancer (NSCLC), who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC and whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) and have no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations (as monotherapy).
• Metastatic NSCLC expressing PD-L1 (TPS ≥1%) that has progressed on or after platinum-containing chemotherapy (as monotherapy). Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab.
• Adjuvant treatment of Stage IB, II, or IIIA NSCLC following resection and platinum-based chemotherapy (as monotherapy).
• First-line treatment of metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations (in combination with pemetrexed and platinum chemotherapy).
• First-line treatment of metastatic non-squamous NSCLC (in combination with carboplatin and either paclitaxel or nab-paclitaxel [albumin-bound]).
• Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that has progressed on or after platinum-containing chemotherapy.
• First-line treatment of metastatic or unresectable, recurrent HNSCC (in combination with platinum and fluorouracil).
• First-line treatment of metastatic or unresectable, recurrent HNSCC expressing PD-L1 (combined positive score [CPS] ≥1).
• Adults with relapsed or refractory classical Hodgkin lymphoma (cHL).
• Children with refractory cHL or cHL that has relapsed after ≥2 lines of therapy.
• Primary mediastinal large B-cell lymphoma that is refractory or that has relapsed after ≥2 prior lines of therapy (should not be used in patients who require urgent cytoreductive therapy).
• Locally advanced or metastatic urothelial carcinoma in patients who are not eligible for any platinum-containing chemotherapy.
• Locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or following platinum-containing chemotherapy or within 12 mo of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
• Locally advanced or metastatic urothelial carcinoma in patients who are not eligible for cisplatin-containing chemotherapy (in combination with enfortumab vedotin).
• Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors in patients who are not eligible for or have elected not to undergo cystectomy.
• Unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and have no satisfactory alternative treatment options.
• First-line treatment of unresectable or metastatic MSI-H or dMMR colorectal cancer.
• First-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma (in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy).
• Locally advanced or metastatic esophageal or gastroesophageal junction (tumors with epicenter 1–5 cm above the gastroesophageal junction) carcinoma that is not amenable to surgical resection or definitive chemoradiation either as monotherapy after ≥1 prior line of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) or in combination with platinum- and fluoropyrimidine-based chemotherapy.
• Recurrent or metastatic cervical cancer expressing PD-L1 (CPS ≥1) that has progressed on or after chemotherapy.
• Persistent, recurrent, or metastatic cervical cancer expressing PD-L1 (CPS ≥1) (in combination with chemotherapy, with or without bevacizumab).
• Hepatocellular carcinoma in patients previously treated with sorafenib.
• Recurrent locally advanced or metastatic Merkel cell carcinoma.
• First-line treatment of advanced renal cell carcinoma (RCC) (in combination with axitinib or lenvatinib).
• Adjuvant treatment of RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
• Advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H in patients who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation (in combination with lenvatinib).
• Advanced endometrial carcinoma that is MSI-H or dMMR in patients who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
• Unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors that have progressed following prior treatment and have no satisfactory alternative treatment options.
• Recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation.
• Locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in patients whose tumors express PD-L1 (CPS ≥10) (in combination with chemotherapy).
• High-risk early-stage TNBC (in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery).

Contraindicated in:

• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Moderate or severe hepatic impairment
• Solid organ transplant recipients (↑ risk of rejection)
• Allogeneic hematopoietic stem cell transplant recipients (↑ risk of transplantation complications)
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established in children <2 yr (cHL, MSI-H cancer, primary mediastinal large B-cell lymphoma, and Merkel cell carcinoma) <12 yr (melanoma), or children <18 yr (all other indications).

CV: MYOCARDITIS, pericarditis, vasculitis.

Derm: pruritus, rash, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN).

EENT: iritis, uveitis.

Endo: hyperthyroidism, hypothyroidism, ADRENAL INSUFFICIENCY, hypoparathyroidism, hypophysitis, type 1 diabetes.

GI: ↓ appetite, constipation, diarrhea, nausea, COLITIS, gastritis, HEPATITIS, pancreatitis.

GU: nephritis.

Hemat: anemia, hemolytic anemia.

MS: arthralgia, back pain, extremity pain, myalgia, myositis, RHABDOMYOLYSIS.

Neuro: dizziness, fatigue, headache, insomnia, Guillain-Barré syndrome, autoimmune neuropathy, ENCEPHALITIS, MENINGITIS, myasthenic syndrome, myelitis.

Resp: PNEUMONITIS.

Misc: INFUSION-RELATED REACTIONS, SEPSIS.

Drug-Drug:

• None reported.

• Solution for injection: 25 mg/mL;

Melanoma

• IV (Adults): 200 mg every 3 wk until disease progression or unacceptable toxicity or 400 mg every 6 wk until disease progression or unacceptable toxicity.

Adjuvant Treatment of Melanoma

• IV (Adults): 200 mg every 3 wk until disease recurrence, unacceptable toxicity, or up to 12 mo or 400 mg every 6 wk until disease recurrence, unacceptable toxicity, or up to 12 mo.
• IV (Children ≥12 yr): 2 mg/kg (max = 200 mg) every 3 wk until disease recurrence, unacceptable toxicity, or up to 12 mo.

Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Esophageal Cancer, or Locally Recurrent Unresectable or Metastatic Triple Negative Breast Cancer

• IV (Adults): 200 mg every 3 wk until disease progression, unacceptable toxicity, or up to 24 mo or 400 mg every 6 wk until disease progression, unacceptable toxicity, or up to 24 mo. If being administered in combination with chemotherapy, should be administered prior to chemotherapy when given on the same day.

Adjuvant Treatment of Non-Small Cell Lung Cancer

• IV (Adults): 200 mg every 3 wk until disease recurrence, unacceptable toxicity, or up to 12 mo or 400 mg every 6 wk until disease recurrence, unacceptable toxicity, or up to 12 mo.

Urothelial Carcinoma, Gastric Cancer, Cervical Cancer, Endometrial Carcinoma, Hepatocellular Cancer, Renal Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Microsatellite Instability-High/Mismatch Repair Deficient Colorectal Cancer

• IV (Adults): 200 mg every 3 wk until disease progression, unacceptable toxicity, or up to 24 mo or 400 mg every 6 wk until disease progression, unacceptable toxicity, or up to 24 mo. If being administered in combination with chemotherapy, bevacizumab, or trastuzumab, should be administered prior to these medications when given on the same day; if being administered in combination with enfortumab vedotin, should be administered after this medication when given on the same day.

Adjuvant Treatment of Renal Cell Carcinoma

• IV (Adults): 200 mg every 3 wk until disease recurrence, unacceptable toxicity, or up to 12 mo or 400 mg every 6 wk until disease recurrence, unacceptable toxicity, or up to 12 mo.

Bacillus Calmette-Guerin-Unresponsive, High-Risk Non-Muscle Invasive Bladder Cancer

• IV (Adults): 200 mg every 3 wk until persistent or recurrent high-risk non-muscle invasive bladder cancer, disease progression, unacceptable toxicity, or up to 24 mo or 400 mg every 6 wk until persistent or recurrent high-risk non-muscle invasive bladder cancer, disease progression, unacceptable toxicity, or up to 24 mo.

Classical Hodgkin Lymphoma, Microsatellite Instability-High/Mismatch Repair Deficient Cancer, Primary Mediastinal Large B-Cell Lymphoma, Merkel Cell Carcinoma, or Tumor Mutational Burden-High Cancer

• IV (Adults): 200 mg every 3 wk until disease progression, unacceptable toxicity, or up to 24 mo or 400 mg every 6 wk until disease progression, unacceptable toxicity, or up to 24 mo.
• IV (Children ≥2 yr): 2 mg/kg (max = 200 mg) every 3 wk until disease progression, unacceptable toxicity, or up to 24 mo.

High-Risk, Early-Stage Triple Negative Breast Cancer

• IV (Adults): 200 mg every 3 wk for 24 wk (8 doses) (as neoadjuvant treatment in combination with chemotherapy) or until disease progression or unacceptable toxicity followed by 200 mg every 3 wk for up to 27 wk (9 doses) (as monotherapy as adjuvant treatment after surgery) or 400 mg every 6 wk for 24 wk (4 doses) (as neoadjuvant treatment in combination with chemotherapy) or until disease progression or unacceptable toxicity followed by 400 mg every 6 wk for up to 27 wk (5 doses) (as monotherapy as adjuvant treatment after surgery). If being administered in combination with chemotherapy, should be administered prior to chemotherapy when given on the same day.

Keytruda

• Programmed death receptor-1 (PD-1) blocking antibody (an IgG4 kappa immunoglobulin) that binds to PD-1 and blocks its interaction with its ligands, PD-L1 and PD-L2, resulting in activation of the immune system and decreased tumor growth.

• Decreased spread of melanoma, NSCLC, HNSCC, cHL, urothelial carcinoma, MSI-H or dMMR solid tumors, MSI-H or dMMR colorectal cancer, gastric tumors, cervical cancer, endometrial cancer, esophageal cancer, primary mediastinal large B-cell lymphoma, hepatocellular carcinoma, Merkel cell carcinoma, RCC, TMB-H solid tumors, cutaneous squamous cell carcinoma, and TNBC.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies, programmed death-1 inhibitors

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-life: 26 days.

(response)

• Explain purpose of pembrolizumab to patient.
• Advise patient to notify health care professional immediately if signs and symptoms of pneumonitis, colitis, hepatitis, kidney problems (change in amount or color of urine), hormone gland problems (rapid heart beat, weight loss, increased sweating, weight gain, hair loss, feeling cold, constipation, deepening of voice, muscle aches, dizziness or fainting, persistent or unusual headache) occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Rep: May cause fetal harm. Advise females of reproductive potential to use highly effective contraception and avoid breast feeding during and for ≥4 mo after last dose.
• Emphasize importance of keeping scheduled appointments for blood work or other laboratory tests.

pem-broe-LI-zoo-mab

NDC Code^*

• 0006- Merck Sharp and Dohme Corp.
  • 0006-3026- KEYTRUDA
    • 0006-3026-02- 1 VIAL in 1 CARTON (0006-3026-02) > 10 mL in 1 VIAL (0006-3026-01)

• 0006- Merck Sharp and Dohme Corp.
  • 0006-3026- KEYTRUDA
    • 0006-3026-04- 2 VIAL in 1 CARTON (0006-3026-04) > 10 mL in 1 VIAL (0006-3026-01)

• 0006- Merck Sharp and Dohme Corp.
  • 0006-3029- KEYTRUDA
    • 0006-3029-02- 1 VIAL in 1 CARTON (0006-3029-02) > 15 mL in 1 VIAL (0006-3029-01)