Posted on November 14th, 2014 by
Class: Biological Therapy
Generic Name: Pembrolizumab
Trade Name: Keytruda®
For which conditions is this drug approved? Keytruda is approved for: a) initial treatment of metastatic melanoma, melanoma that is unresectable and metastatic melanoma with disease progression following treatment with Yervoy® (ipilimumab) and, if BRAF V600 mutation positive, treatment with a BRAF inhibitor, b) treatment of metastatic non small cell lung cancers that express PD-1 with disease progression on or after platinum-containing chemotherapy, and c) treatment of head and neck squamous cell cancer (HNSCC) that has returned or metastasized on or after a platinum-containing chemotherapy.
What is the mechanism of action? Keytruda is anti-PD-1 antibody. It blocks PD-1, a protein that interferes with certain types of immune responses and may enhance the ability of the immune system to fight cancer.
How is Keytruda typically given (administered)? Keytruda is given by intravenous infusion, usually once every three weeks. Each infusion takes 30 minutes.
How are patients typically monitored? Patients receiving Keytruda are monitored with blood work and other laboratory tests for the following immune-mediated adverse reactions:
What are the common (occur in 30% or more of patients) side effects of treatment with Keytruda?
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Keytruda?
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
Are there any special precautions patients should be aware of before starting treatment?
When should patients notify their physician?
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
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