Pronunciation: key-true-duh
Generic name: pembrolizumab
Dosage form: intravenous solution
Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 28, 2023.

What is Keytruda?

Keytruda (pembrolizumab) is a type of immunotherapy that is given by intravenous (into a vein) infusion over 30 minutes to treat many different types of cancer such as melanoma, lung cancer, and some lymphomas (see below for the full list of cancers Keytruda is approved for). It may be used alone or in combination with other medicines, including chemotherapy.

Keytruda works by binding to and blocking the interaction of the PD-1 (programmed death receptor-1) receptor with other proteins including PD-L1 and PD-L2. An upregulation of the PD-1 receptors occurs in some cancers and signaling through this pathway prevents the T-cells in our immune system from finding and attacking cancer cells. Animal studies have found that blocking PD-1 receptors helps the immune system to slow or stop the growth and spread of cancer cells in the body. Keytruda belongs to the class of monoclonal antibodies called PD-1 blocking antibodies.

Keytruda may be used to treat:

• skin cancer (melanoma, Merkel cell carcinoma, squamous cell carcinoma)
• lung cancer, Non-Small Cell Lung Cancer (NSCLC)
• head and neck cancer
• classical Hodgkin lymphoma
• primary mediastinal large B-cell lymphoma
• cancer of the kidney, bladder, and urinary tract
• colorectal cancer
• liver cancer
• triple-negative breast cancer
• cancer of the cervix or uterus
• microsatellite instability-high or mismatch repair deficient solid tumors
• tumor mutational burden-high (TMB-H) cancer
• advanced stomach or esophageal cancer
• locally advanced unresectable or metastatic biliary tract cancer (BTC)
• locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, or
• a type of cancer that laboratory testing proves to have certain specific DNA mutations.

Keytruda is only approved for certain types of cancer and may require a specific treatment history. In some cases, the tumor may need to be tested for particular genetic markers like PD-L1, dMMR, TMB, or pMMR to determine if Keytruda is right for you. Click here for more in-depth information on approved uses:  Keytruda prescribing Information.

Keytruda is often given when the cancer has spread to other parts of the body, or cannot be treated with surgery or radiation, or when other cancer treatments did not work or have stopped working.

Keytruda was first FDA-approved on September 4, 2014.

Warnings

Keytruda can cause serious or life-threatening side effects. Some side effects may occur during the injection. It can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. Your healthcare provider will monitor you for these.

Severe or life-threatening infusion reactions can occur. Tell your healthcare provider if you develop chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feeling like passing out, fever, or back pain during your infusion.

Serious or life-threatening complications, including graft-versus-host disease (GVHD), may occur in people who have received a bone marrow (stem cell) transplant before or after Keytruda that uses donor stem cells (allogeneic). Your healthcare provider will monitor you for these complications.

Rejection of a transplanted organ. Your health care provider should tell you what signs and symptoms you should report and they will monitor you, depending on the type of organ transplant that you have had.

The use of Keytruda to treat other indications, such as multiple myeloma in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Can cause fetal harm. Females of reproductive potential should use effective contraception.

Before taking this medicine

To make sure Keytruda is safe for you, tell your doctor if you have ever had:

• an autoimmune disorder such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, lupus, or psoriasis;
• received or plan to receive a stem cell transplant that uses donor stem cells;
• an organ transplant;
• radiation to your chest; or
• a nerve-muscle disorder such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant
• are breastfeeding.

Pregnancy and breastfeeding

Keytruda may harm an unborn baby. Your healthcare provider will give you a pregnancy test to make sure you are not pregnant. Use effective birth control while using Keytruda and for at least 4 months after your last dose. Tell your doctor right away if you inadvertently become pregnant.

It is not known if Keytruda passes into breast milk. Do not breastfeed while using this medicine and for at least 4 months after your last dose.

How is Keytruda administered?

Keytruda is given as an infusion into a vein, usually once every 3 to 6 weeks depending on the dosage. In children, Keytruda is usually given every 3 weeks. A healthcare provider will give you this injection.

• This medicine must be given slowly over 30 minutes.
• You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Keytruda and to monitor you for side effects. Do not miss any follow-up visits.

You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Keytruda. Do not miss any follow-up visits.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Keytruda injection.

What happens if I overdose?

In a medical setting, an overdose would be treated quickly.

What should I avoid while receiving Keytruda?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Keytruda side effects

Get emergency medical help if you have signs of an allergic reaction to Keytruda (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

• Lung problems, such as cough, shortness of breath, or chest pain
• Intestinal problems, such as:
• diarrhea (loose stools) or more frequent bowel movements than usual
• stools that are black, tarry, sticky, or have blood or mucus
• severe stomach-area (abdomen) pain or tenderness.
• Liver problems such as
• yellowing of your skin or the whites of your eyes
• dark urine (tea colored)
• severe nausea or vomiting
• bleeding or bruising more easily than normal
• pain on the right side of your stomach area (abdomen).
• Hormone gland problems, such as
• headaches that will not go away or unusual headaches
• urinating more often than usual
• eye sensitivity to light
• hair loss
• eye problems feeling cold
• rapid heartbeat
• constipation
• increased sweating
• your voice gets deeper
• extreme tiredness
• dizziness or fainting
• weight gain or weight loss
• changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
• feeling more hungry or thirsty than usual.
• Kidney problems, such as
• decrease in your amount of urine
• swelling of your ankles
• blood in your urine
• loss of appetite.
• Skin problems, such as
• rash
• painful sores or ulcers in your mouth or your nose, throat, or genital area
• itching
• fever or flu-like symptoms
• skin blistering or peeling
• swollen lymph nodes.
• any new or worsening signs or symptoms, which may include:
• chest pain, irregular heartbeat, shortness of breath, swelling of ankles
• confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or
• numbness of the arms or legs
• double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• persistent or severe muscle pain or weakness, muscle cramps
• low red blood cells, and bruising.
• Infusion reactions can sometimes be severe or life-threatening. Signs and symptoms may include:
• chills or shaking dizziness
• itching or rash
• feeling like passing out
• flushing
• fever
• shortness of breath or wheezing
• back pain.

Common Keytruda side effects (some are more likely with combination chemotherapy) affecting 20% or more people include:

• nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation, weight loss
• low blood sodium levels, abnormal thyroid, liver and kidney function tests
• low blood cell counts
• tingling or numbness in your hands or feet, loss of movement in the arms and legs
• bleeding
• pain and burning when you urinate
• fever, headache, feeling weak or tired, dizziness, trouble sleeping
• cough, hoarse voice, feeling short of breath
• changes in your sense of taste, dry skin, and dry eyes
• itching, hair loss, rash, or blisters on your hands or feet
• increased blood pressure
• pain in your muscles, bones, or joints or
• mouth sores or swelling around your mouth, nose, eyes, throat, intestines, or vagina.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during treatment with Keytruda. They may treat you with corticosteroid or hormone replacement medicines. They may also need to delay or completely stop treatment if you have severe side effects.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What other drugs will affect Keytruda?

Other drugs may interact with Keytruda, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

See the prescribing information for a full list of interactions.

Storage

Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake.

The product does not contain a preservative.

Store the diluted solution either:

• at room temperature for no more than 6 hours from the time of dilution. This includes the time for room temperature storage of the diluted solution and the duration of infusion.
• under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 96 hours from the time of dilution. If refrigerated, allow the diluted solution to come to room temperature before administration. Do not shake.

Discard after 6 hours at room temperature or after 96 hours under refrigeration.

Do not freeze.

Ingredients

Active ingredient: pembrolizumab
Inactive ingredients: L-histidine, polysorbate 80, sucrose, and water for injection

Manufacturer

Merck Sharp & Dohme LLC.

Popular FAQ

View more FAQ

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer