Class: Biological Therapy

Reviewed by C. H. Weaver M.D. Cancer Connect Medical Editor 12/2020

For which conditions is Keytruda approved? Keytruda is approved for certain uses in:

· melanoma,

· non-small cell lung cancer (NSCLC),

· small cell lung cancer (SCLC),

· head and neck squamous cell cancer (HNSCC),

· classical Hodgkin lymphoma (cHL),

· primary mediastinal large B-cell lymphoma (PMBCL),

· urothelial carcinoma,

· microsatellite instability-high or mismatch repair deficient cancer,

· microsatellite instability-high or mismatch repair deficient colorectal cancer (CRC)

· gastric cancer,

· esophageal cancer,

· cervical cancer,

· hepatocellular carcinoma (HCC),

· merkel cell carcinoma (MCC),

· renal cell carcinoma (RCC),

· endometrial cancer,

· tumor mutational burden-high (TMB-H) cancer,

· cutatneous squamous cell carcinoms (cSCC) and

· triple-negative breast cancer (TNBC).

Talk to your doctor to discuss the full indications, usage and limitations of use of Keytruda.

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What is the mechanism of action Keytruda? 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 taking Keytruda 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.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.



The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.