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.
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, Malignant Pleural Mesothelioma, Head and Neck Squamous Cell Carcinoma, Esophageal Cancer, Biliary Tract 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.
Locally Advanced Head and Neck Squamous Cell Carcinoma,
- IV (Adults ): 200 mg every 3 wk or 400 mg every 6 wk. As neoadjuvant therapy, administer as monotherapy for 6 wk or until disease progression that precludes definitive surgery or unacceptable toxicity. As adjuvant therapy, administer in combination with radiotherapy with or without cisplatin, and then continue as monotherapy. Continue until disease recurrence or unacceptable toxicity or up to 1 yr.
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.
Resectable Non-Small Cell Lung Cancer
- IV (Adults ): 200 mg every 3 wk. Neoadjuvant treatment in combination with platinum-containing chemotherapy for 12 wk or until disease progression that precludes definitive surgery, or unacceptable toxicity, followed by neoadjuvant treatment as monotherapy after surgery for 39 wk or until disease recurrence or unacceptable toxicity; or 400 mg every 6 wk. Neoadjuvant treatment in combination with platinum-containing chemotherapy for 12 wk or until disease progression that precludes definitive surgery, or unacceptable toxicity, followed by neoadjuvant treatment as monotherapy after surgery for 39 wk or until disease recurrence or unacceptable toxicity
Urothelial Carcinoma, Gastric Cancer, Cervical Cancer, Endometrial Carcinoma, Hepatocellular Carcinoma, 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, chemoradiotherapy, bevacizumab, trastuzumab, paclitaxel, or carboplatin, should be administered prior to these therapies 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.
