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 (NSCLC) that express PD-1 with disease progression on or after platinum-containing chemotherapy whose progression has been determined by an FDA approved test, and for first line of treatment for advanced NSCLC that does not have an abnormal EGFR or ALK gene, 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:

• Pneumonitis (inflammation of lung tissue)
• Colitis (inflammation of the colon)
• Hepatitis
• Hypophysitis (inflammation of the pituitary gland)
• Changes in renal (kidney) function
• Changes in thyroid function

What are the common (occur in 30% or more of patients) side effects of treatment with Keytruda?

• Fatigue
• Nausea
• Cough

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Keytruda?

• Peripheral edema
• Chills
• Fever
• Constipation
• Diarrhea
• Vomiting
• Abdominal pain
• Shortness of breath or breathlessness
• Rash
• Itching
• Loss of skin color in blotches (depigmentation)
• Decreased appetite
• Joint pain
• Pain in extremity
• Muscle pain
• Back pain
• Anemia
• Dizziness
• Insomnia
• Upper respiratory infection 

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?

• Follow your infusion schedule for Keytruda.
• Tell your doctor about any health conditions and concerns and about all medication you take, prescription and over the counter.
• Keep your scheduled appointments for blood work or other laboratory tests that monitor your response to Keytruda.

Are there any special precautions patients should be aware of before starting treatment?

• Keytruda may harm an unborn baby, so women of childbearing age are advised to use highly effective contraception during treatment and for at least four months following the last dose.
• It is not known whether Keytruda is excreted in breast milk, but because many drugs are excreted, women should not nurse during treatment.

When should patients notify their physician?

• If you experience side effects that are bothersome or don’t go away
• If you have symptoms of lung problems (pneumonitis), including: shortness of breath, chest pain, new or worse cough
• If you have symptoms of intestinal problems (colitis), including: diarrhea or more bowel movements than usual: stools that are black, tarry, sticky, or have blood or mucus
• If you have severe stomach pain or tenderness
• If you have symptoms of liver problems (hepatitis), including: yellowing of your skin or the whites of your eyes, dark urine, nausea or vomiting, feeling less hungry than usual, pain on the right side of your stomach area, bleeding or bruising more easily than normal
• If you have symptoms of hormone gland problems (especially the thyroid, pituitary, and adrenal glands), including: rapid heart beat, weight loss, increased sweating, weight gain, hair loss, feeling cold, constipation, your voice gets deeper, muscle aches, dizziness or fainting, headaches that will not go away or unusual headache
• If you have symptoms of kidney problems, such nephritis and kidney failure, including: change in the amount or color of your urine
• If you have signs of problems with other organs, including: rash, changes in eyesight, severe or persistent muscle or joint pains, severe muscle weakness

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.

Last updated on 10/16.

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