Keytruda

Generic name: Pembrolizumab
Dosage form: intravenous solution
Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)

Usage of 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.

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.

Before taking Keytruda

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.

Relate drugs

How to use Keytruda

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.

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.

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.

Disclaimer

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