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pembrolizumab (Intravenous route)


Commonly used brand name(s)

In the U.S.

  • Keytruda

Available Dosage Forms:

  • Powder for Solution
  • Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

Uses For pembrolizumab

Pembrolizumab injection is used to treat melanoma (a type of skin cancer) that has spread or cannot be removed by surgery. It is only used after receiving ipilimumab and a BRAF inhibitor (if BRAF V600 mutation positive). Pembrolizumab is a monoclonal antibody that changes the immune system to help control the growth of cancer cells in the skin.

pembrolizumab is to be given only by or under the immediate supervision of your doctor.

Before Using pembrolizumab

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pembrolizumab, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to pembrolizumab or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Appropriate studies have not been performed on the relationship of age to the effects of pembrolizumab injection in the pediatric population. Safety and efficacy have not been established.


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pembrolizumab injection in the elderly.


Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of pembrolizumab. Make sure you tell your doctor if you have any other medical problems, especially:

  • Colitis (inflammation of the intestine) or
  • Diabetic ketoacidosis or
  • Hepatitis (inflammation of the liver) or
  • Hyperthyroidism (high levels of thyroid hormone) or
  • Hypophysitis (inflammation of the pituitary gland) or
  • Hypothyroidism (low levels of thyroid hormone) or
  • Nephritis (inflammation of the kidneys) or
  • Pneumonitis (inflammation of the lungs) or
  • Type 1 diabetes—Use with caution. May make these conditions worse.

Proper Use of pembrolizumab

A nurse or other trained health professional will give you pembrolizumab. pembrolizumab is given through a needle placed in one of your veins. It must be given slowly, so the needle will remain in place for 30 minutes and the infusion will be given every 3 weeks.

pembrolizumab comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Missed Dose

pembrolizumab needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Precautions While Using pembrolizumab

It is very important that your doctor check your progress at regular visits to make sure that pembrolizumab is working properly. Blood tests may be needed to check for unwanted effects.

Using pembrolizumab while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during therapy and for 4 months after the last dose of pembrolizumab. If you think you have become pregnant while using the medicine, tell your doctor right away.

Tell your doctor right away if you have a cough, shortness of breath, chest tightness, or any type of breathing problem with pembrolizumab. These could be symptoms of a serious lung problem.

Colitis (inflammation of the colon) may occur with pembrolizumab. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or a fever after receiving the medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, a loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious problems with the adrenal, pituitary, or thyroid glands (hormone glands) may occur while you are receiving pembrolizumab. Tell your doctor if you start having continuing or unusual headaches, changes in mood or behavior (eg, being irritable or forgetful), lightheadedness, dizziness, or fainting, unusual sluggishness, or an increase in weight.

pembrolizumab may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Tell your doctor right away if you have bloody or cloudy urine, nausea or vomiting, trouble breathing, swelling of the face, feet, or lower legs, unusual tiredness or weakness, or unusual weight gain.

Tell your doctor right away if you have a rash, changes in eyesight, severe or persistent muscle or joint pain, or severe muscle weakness after receiving pembrolizumab.

pembrolizumab may cause infusion-related reactions. These can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving pembrolizumab.

pembrolizumab Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • body aches or pain
  • chills
  • constipation
  • cough
  • depressed mood
  • difficulty with breathing
  • difficulty with moving
  • dry skin and hair
  • ear congestion
  • feeling cold
  • fever
  • hair loss
  • headache
  • hoarseness or husky voice
  • loss of voice
  • muscle cramps, pain, and stiffness
  • pain in the joints
  • pale skin
  • rapid weight gain
  • runny or stuffy nose
  • slowed heartbeat
  • sneezing
  • sore throat
  • tingling of the hands or feet
  • trouble breathing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
Less common
  • Chest pain
  • general feeling of discomfort or illness
  • nervousness
  • pain
  • sensitivity to heat
  • stomach cramps
  • sweating
  • tenderness
  • thickening of bronchial secretions
  • trouble sleeping
  • watery or bloody diarrhea
  • weight loss
  • Back, leg, or stomach pains
  • bleeding gums
  • blurred vision or other change in vision
  • cracks in the skin
  • darkened urine
  • difficulty with moving
  • drowsiness
  • eye pain
  • fast heartbeat
  • general body swelling
  • general tiredness and weakness
  • indigestion
  • light-colored stools
  • loss of appetite
  • loss of heat from the body
  • nausea or vomiting
  • nosebleeds
  • pain, swelling, or redness in the joints
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • red, swollen skin
  • redness of the eye
  • scaly skin
  • seizures
  • sensitivity of the eye to light
  • sore throat
  • tearing
  • upper right abdominal or stomach pain
  • yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Decreased appetite
  • diarrhea
  • dizziness
  • headache
  • rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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