Keytruda

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 Sep 9, 2024.

What is Keytruda?

Keytruda (pembrolizumab) is an immunotherapy medication that may be used to treat at least 18 different types of cancer such as melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC), classical Hodgkin Lymphoma, endometrial carcinoma, triple-negative breast cancer, and some colorectal cancers.

Keytruda may be used alone or together with other medicines, including chemotherapy, depending on the specific type of cancer.

Keytruda's mechanism of action involves blocking the PD-1 protein on T cells, preventing its interaction with PD-L1 on cancer cells. This inhibition "takes the brakes off" the immune system, allowing T cells to recognize and attack cancer cells more effectively. By enhancing the body's natural defenses, Keytruda enables a targeted immune response against tumors. Keytruda belongs to the drug class called immune checkpoint inhibitors and may also be called a monoclonal antibody.

Keytruda first gained FDA approval on September 4, 2014, for advanced melanoma. Since then, Keytruda has been approved for at least 18 different types of cancer.

Keytruda uses

Keytruda may be used to treat the following cancers. Note that this is just a summary, see the Keytruda Prescribing Information for specific criteria and prior treatment requirements that may apply for each indication.

Melanoma: Unresectable or metastatic melanoma OR as adjuvant treatment for Stage IIB, IIC, or III melanoma following complete resection.

Non-small cell lung cancer (NSCLC): First-line treatment for metastatic NSCLC with high PD-L1 expression OR in combination with chemotherapy for various NSCLC subtypes.

Head and neck squamous cell cancer (HNSCC): Unresectable, recurrent, or metastatic HNSCC in combination with platinum and FU OR as a single agent for some other types of HNSCC.

Classical Hodgkin lymphoma (cHL): Refractory or relapsed cHL.

Primary Mediastinal Large B-Cell Lymphoma (PMBCL): Refractory or relapsed PMBCL.

Urothelial cancer: Advanced or metastatic urothelial carcinoma in combination with other treatments or alone, and for some types of Bacillus Calmette-Guerin (BCG)-unresponsive urothelial cancers.

Microsatellite instability-high (MSI-H) or mismatch repair deficient cancers including colorectal cancer: Unresectable or metastatic MSI-H or mismatch repair deficient solid tumors.

Gastric cancer: Specific types of advanced, unresectable, or metastatic gastric or gastroesophageal junction adenocarcinomas.

Esophageal cancer. Specific types of advanced or metastatic esophageal or gastroesophageal junction tumors.

Cervical cancer: Specific types of cervical cancer either alone or in combination with chemotherapy or radiotherapy (depends on the type and stage).

Hepatocellular carcinoma (HCC): HCC secondary to hepatitis B who have received prior systemic therapy.

Biliary Tract Cancer (BTC): Locally advanced unresectable or metastatic biliary tract cancer in combination with gemcitabine and cisplatin.

Merkel cell carcinoma (MCC): Recurrent locally advanced or metastatic MCC.

Renal cell carcinoma: First-line for advanced renal cell carcinoma in combination with other treatments OR for RCC at high risk of recurrence.

Endometrial carcinoma: Primary advanced or recurrent endometrial carcinoma in combination with other agents OR as a single agent for other types of endometrial carcinoma.

Tumor mutational burden-high (TMB-H) cancer: Unresectable or metastatic TMB-H solid tumors that have progressed despite prior treatment.

Cutaneous squamous cell carcinoma (cSCC): Recurrent or metastatic cSCC or locally advanced cSCC not curable by surgery or radiation.

Triple-negative breast cancer (TNBC): In combination with chemotherapy for high-risk, early-stage TNBC OR locally recurrent unresectable or metastatic TNBC with PD-L1 expression.

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.

Keytruda side effects

The most common side effects of Keytruda when it is used alone are:

feeling tired/fatigue
pain, including pain in the stomach, muscles, bones, or joints
rash or itching
diarrhea
fever
cough
decreased appetite
shortness of breath
constipation
nausea
low levels of thyroid hormone.

Side effects of Keytruda that are more common in children than adults when it is used alone are:

fever
vomiting
headache
stomach area pain
low levels of white blood cells.

The most common side effects of Keytruda when it is used in combination with chemotherapy or radiotherapy treatments include:

feeling tired or weak
nausea
constipation
diarrhea
decreased appetite
rash
vomiting
cough
trouble breathing
fever
hair loss
inflammation of the nerves that may cause pain
weakness and paralysis in the arms and legs
swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina
mouth sores
headache
weight loss
stomach-area (abdominal), joint, or muscle pain,
trouble sleeping
bleeding
blisters, or rash on the palms of your hands and soles of your feet
urinary tract infection
low levels of thyroid hormone.
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
mouth sores or swelling around your mouth, nose, eyes, throat, intestines, or vagina
tingling or numbness in your arms or legs.

Prompt medical attention of these side effects is crucial. Your doctor will monitor you during Keytruda treatment.

Serious side effects and warnings

Keytruda is a medicine that works with your immune system to treat certain cancers. Keytruda can cause your immune system to attack normal organs and tissues in any area of your body and can cause serious side effects.

These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time.
These problems may happen anytime during treatment or even after your treatment has ended

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 in other organs, 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.

For people who have had an organ transplant, Keytruda may cause rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death.

These complications may happen if you underwent transplantation either before or after being treated with Keytruda.
Your healthcare provider will monitor you for these complications.

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).

Keytruda may cause harm to an unborn baby. Females of reproductive potential should use effective contraception.

Getting medical treatment right away for these side effects may help keep these problems from becoming more serious. 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.

Before taking this medicine

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

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
had an organ transplant
had radiation to your chest
a condition that affects your nervous system such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant
are breastfeeding.

Pregnancy

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 healthcare provider right away if you think you may be pregnant or if you become pregnant during
treatment with Keytruda.

Breastfeeding

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 administered as an infusion into your vein through an intravenous line over 30 minutes.

In adults, Keytruda is usually given every 3 weeks or 6 weeks depending on the dose that you
are receiving.
In children, Keytruda is usually given every 3 weeks.
Your healthcare provider will decide how many treatments you need.
Your healthcare provider will do blood tests to check you for side effects.
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

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.

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.

Check for Keytruda interactions here.

Storage

Your healthcare provider will store vials of Keytruda in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect them from light.

Keytruda 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.

Keytruda ingredients

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

Who makes Keytruda?

Merck Sharp & Dohme LLC. makes Keytruda.

Popular FAQ

What is the success rate for treatment?

In general, PD-1 immune checkpoint inhibitors like Keytruda have been shown to significantly prolong overall survival (OS) in some patients with various cancer types, but Keytruda does not always work for everyone. Continue reading

How long does it take for Keytruda to work?

The time it takes for Keytruda to work can vary based on the type and stage of cancer. Typically, a response to treatment becomes apparent within 2-4 months of starting Keytruda. This timeframe is referred to as "time to response," which measures when a patient's cancer begins to show signs of responding to the treatment. You can find the specific "time to response" data from clinical trials in the table below. Continue reading

What are monoclonal antibodies?

Monoclonal antibodies (mAbs) are man-made proteins that mimic the natural antibodies produced by our immune systems. Monoclonal antibodies can be formulated into medicines to treat various types of illnesses, such as cancer, rheumatoid arthritis or psoriasis. Continue reading

What is the difference between Opdivo and Keytruda?

Opdivo (nivolumab) and Keytruda (pembrolizumab) are two immunotherapy drugs for various cancers. Both are monoclonal antibodies, known as PD1 inhibitors, first approved in 2014. Opdivo is from Bristol Myers Squibb, and Keytruda is from Merck & Co. The main differences lie in dosing, combination therapies, and approved cancer types. Continue reading

Pembrolizumab vs. nivolumab: How do they compare?

Pembrolizumab and nivolumab are both prescription medications used to treat various types of cancers, including solid tumors and blood cancers. They may be used alone or in combination with other medicines for cancers that are more advanced, have spread in the body, or are no longer responding to previous treatments. Continue reading

Can you take prednisone with Keytruda?

You should only use prednisone with Keytruda if your doctor has specifically prescribed these medicines for you. Prednisone is in a class of drugs known as corticosteroids. Prednisone may be used to treat serious or life-threatening immune-mediated side effects that may occur due to Keytruda treatment. Continue reading

Is it covered by Medicare / Medicaid?

Keytruda is usually covered by Medicare or Medicaid, but your costs can vary depending upon your plan coverage. For example, with a Medicare Advantage plan, 41% of patients had no out-of-pocket costs for the 200 mg dose of Keytruda. Most patients with Medicaid typically pay from $4 to $8 per Keytruda infusion. Your costs may be different based on your overall income, deductible or health plan. Continue reading

How are Inlyta and Keytruda used in kidney cancer?

Inlyta and Keytruda are given as a combination therapy for first-line treatment of kidney cancer (advanced renal cell carcinoma) in adults. Inlyta is an oral medication given 2 times per day and Keytruda is an intravenous (IV) infusion given every 3 weeks or every 6 weeks. Continue reading

How is it administered?

Pembrolizumab (brand name: Keytruda) is a cancer medicine given into your vein as a slow intravenous (IV) infusion that usually takes about 30 minutes. You will most likely receive this treatment in an outpatient clinic or hospital setting every 3 or 6 weeks. Continue reading

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