KEYTRUDA® (Pembrolizumab)
RCC Selected Safety Information (SSI)
INDICATION
In combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (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.
DOSAGE & ADMINISTRATION
KEYTRUDA is administered 30 minutes intravenous infusion.
Monotherapy: Adjuvant treatment of adult patients with RCC is 200 mg every 3 weeks or 400 mg every 6 weeks, until disease recurrence or unacceptable toxicity, or up to 12 months.
Combination Therapy: Adult patients with RCC is 200 mg every 3 weeks or 400 mg every 6 weeks (administer KEYTRUDA in combination with axitinib 5 mg orally twice daily or administer KEYTRUDA in combination with lenvatinib 20 mg orally once daily), until disease progression or unacceptable toxicity, or for KEYTRUDA, up to 24 months.
CONTRAINDICATIONS
None
PRECAUTIONS/WARNINGS
KEYTRUDA can cause severe and fatal Immune-Mediated Adverse Reactions which 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 axitinib: diarrhea, fatigue/asthenia, hypertension, hepatotoxicity, hypothyroidism, decreased appetite, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation.
- KEYTRUDA in combination with lenvatinib: hypothyroidism, hypertension, fatigue, diarrhea, musculoskeletal disorders, nausea, decreased appetite, vomiting, stomatitis, weight loss, abdominal pain, urinary tract infection, proteinuria, constipation, headache, hemorrhagic events, palmar-plantar erythrodysesthesia, dysphonia, rash, hepatotoxicity, and acute kidney injury.
Please refer to the full prescribing information of KEYTRUDA® for more information.
AE-JRC-00002 | Expiry Date: 31/05/2026