KEYTRUDA® (Pembrolizumab) | Selected Safety Information (SSI)
Indications: Treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters 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 one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by a validated test.
Dosage & Administration: KEYTRUDA is administered 30 minutes intravenous infusion.
Monotherapy: Adult patients with Esophageal Cancer is 200 mg every 3 weeks or 400 mg every 6 weeks, until disease progression or unacceptable toxicity, or up to 24 months.
Combination Therapy: Adult patients with Esophageal Cancer is 200 mg every 3 weeks or 400 mg every 6 weeks (administer KEYTRUDA prior to chemotherapy when given on the same day), until disease progression or unacceptable toxicity, or up to 24 months.
Contraindications: None
Precautions/Warnings: KEYTRUDA can cause severe and fatal Immune-Mediated Adverse Reactions, can occur in any organ system or tissue, as Immune-mediated Pneumonitis, Immune-mediated Colitis, Hepatotoxicity and Immune-Mediated Hepatitis, Immune-mediated Nephritis with Renal Dysfunction, Immune-mediated Endocrinopathies (as adrenal insufficiency, hypophysitis, hyperthyroidism, hypothyroidism, thyroiditis & type 1 diabetes mellitus) & Immune-Mediated Dermatologic Adverse Reactions. KEYTRUDA can cause other immune-mediated adverse reactions as: Myocarditis, pericarditis, vasculitis, Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/ myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy, Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis, Hypoparathyroidism, Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica, Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection, Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss. KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis. KEYTRUDA can cause complications of Allogeneic HSCT. Increased Mortality in Patients with Multiple Myeloma when KEYTRUDA is added to a Thalidomide Analogue and Dexamethasone. KEYTRUDA can cause fetal harm when administered to a pregnant woman.
Adverse 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, and hypothyroidism.
Please refer to the full prescribing information of KEYTRUDA® for more information.
KW-KEY-00184 | Expiry Date: 08-10-2026