Pembrolizumab

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma. for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.

Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth. In syngeneic mouse tumor models, combination treatment of a PD-1 blocking antibody and kinase inhibitor lenvatinib decreased tumor-associated macrophages, increased activated cytotoxic T cells, and reduced tumor growth compared to either treatment alone.

Melanoma: 200 mg every 3 weeks or 400 mg every 6 weeks, 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. NSCLC: 200 mg every 3 weeks or 400 mg every 6 weeks. MPM: 200 mg every 3 weeks or 400 mg every 6 weeks. HNSCC: 200 mg every 3 weeks or 400 mg every 6 weeks. cHL or PMBCL: 200 mg every 3 weeks or 400 mg every 6 weeks for adults, 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. Urothelial Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. MSI-H or dMMR Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks for adults, 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics. MSI-H or dMMR CRC: 200 mg every 3 weeks or 400 mg every 6 weeks. Gastric Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. Esophageal Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. Cervical Cancer: 200 mg every 3 weeks or 400 mg every 6 weeks. HCC: 200 mg every 3 weeks or 400 mg every 6 weeks.

None. None.

Immune-Mediated Adverse Reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic adverse reactions, and solid organ transplant rejection. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue based on severity and type of reaction. Infusion-related reactions: Interrupt, slow the rate of infusion, or permanently discontinue KEYTRUDA based on the severity of reaction.

The following clinically significant adverse reactions are described elsewhere in the labeling. Severe and fatal immune-mediated adverse reactions. Infusion-related reactions. Most common adverse reactions (reported in ≥20% of patients) were: KEYTRUDA as a single agent: fatigue, musculoskeletal pain, rash, diarrhea, pyrexia, cough, decreased appetite, pruritus, dyspnea, constipation, pain, abdominal pain, nausea, and hypothyroidism. KEYTRUDA in combination with chemotherapy or chemoradiotherapy: fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, pyrexia, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss, abdominal pain, arthralgia, myalgia, insomnia, palmar-plantar erythrodysesthesia, urinary tract infection, hypothyroidism, radiation skin injury, dysphagia, dry mouth, and musculoskeletal pain.

Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake.