• Keytruda is a brand (trade) name for pembrolizumab which is a type of injected immunotherapy medicine that may be used to treat many different types of cancer including lung cancer, melanoma (a type of skin cancer), and triple-negative breast cancer.
• Keytruda works by blocking the PD-1 (programmed death receptor-1) pathway to help prevent cancer cells from hiding from the immune system. Keytruda helps boost the immune system's response against cancer.
• PD-1 receptors are found on T-cells (also called T-lymphocytes) which are a type of white blood cell. Some cancer cells avoid detection by attaching to these PD-1 receptors. This prevents the activation of the T-cell which normally would target and destroy cancer. The cancer cells can then multiply and spread. When Keytruda binds to the PD-1 receptor on the T-cell, this helps to block the cancer cells from linking to and inactivating the T-cells. Pembrolizumab can allow the re-activation of immune system T-cells to help fight off cancer. While having an effect on the tumor, this could also affect normal healthy cells.
• Keytruda belongs to the class of medicines known as checkpoint inhibitors.

• Keytruda) is approved to treat many different types of cancer in adults and children. Some examples include advanced melanoma (skin cancer), non-small cell lung cancer, classical Hodgkin lymphoma (a type of blood cancer), urothelial (bladder) cancer, gastric (stomach) cancer, cervical cancer, advanced renal cell carcinoma, and many more.
• Keytruda is not a chemotherapy drug or radiation treatment and does not attack cancer cells directly.
• Keytruda may be dosed in adults at either 400 mg every 6 weeks or 200 mg every 3 weeks. It is given by IV infusion for about 30 minutes in an outpatient clinic or hospital.
• Keytruda may be used as a first-line treatment in some people or given in combination with other treatments.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Gastrointestinal side effects (such as nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation); low sodium levels; abnormal liver function or thyroid function tests; tiredness; fever; cough; itching; hair loss; a rash, high blood pressure; soreness in the mouth, nose, throat or vagina; and muscle and joint pain are the most common side effects reported.
• Keytruda is a type of immunotherapy, and uncommonly, this can cause the immune system to attack healthy organs and tissues leading to side effects. These side effects may be serious or life-threatening and can occur anytime during or after treatment with pembrolizumab. If these symptoms occur, Keytruda may need to be stopped temporarily or permanently and other treatments, such as corticosteroids (such as prednisone) or hormone replacement therapy, initiated.
• Lung problems (pneumonitis, swelling in the lungs) may occur in about 3.4% of Keytruda patients. Symptoms include shortness of breath, chest pain, and new or worsening cough, with an average onset of 3.3 months after beginning treatment (range 2 days to 19.3 months).
• Other significant immune system-related side effects include colitis, hepatitis, hormone gland problems, kidney problems, skin reactions, mouth ulcers, confusion, and a change in eyesight.
• Regular laboratory testing and imaging studies are usually required to monitor for side effects, liver and kidney function, or disease progression. Keytruda may cause hyperglycemia, hyperlipidemia, hyponatremia, and increased AST. Anemia and lymphopenia have also been reported. Hypoalbuminemia, increased ALT, and alkaline phosphatase have also been reported.
• Keytruda may not be suitable for people with lung disease or a breathing disorder; liver disease; diabetes, or a thyroid disorder; an adrenal gland disorder; an autoimmune disorder such as lupus, Crohn's disease, or ulcerative colitis; or an organ transplant or stem cell transplant.
• Keytruda should not be given to pregnant women or those intending to become pregnant. Women who are taking Keytruda should also not breastfeed during treatment and for four months after their last dose.
• Keytruda needs to be reconstituted before administration and the reconstituted solution may be kept for up to six hours at room temperature or up to 96 hours under refrigeration. A low-protein binding 0.2-micron to 5-micron in-line or add-on filter should be used and other drugs should not be administered through the same line.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Keytruda can uncommonly cause your immune system to attack healthy organs and glands in your body. Ask your doctor or pharmacist for the Medication Guide, which lists side effects that may occur if your immune system is affected by pembrolizumab. Contact your doctor immediately if you experience any of these side effects to help keep them from becoming more serious.
• Tell your doctor immediately if you develop any severe side effects while taking Keytruda, such as shortness of breath; diarrhea; stools that are black, tarry, sticky, or contain blood or mucus; severe pain or tenderness in the stomach area; yellowing of your skin or the whites of your eyes; nausea or vomiting; dark urine; bleeding or bruising more easily than normal; rapid heartbeat; headaches; weight loss or weight gain; a skin rash; changes in eyesight; or any other side effects that you are concerned about.
• Tell your doctor about any medicines or supplements you take, including those brought from a drug store or grocery because some of these may interact with Keytruda.
• You may need to have a negative pregnancy test before starting Keytruda and use effective birth control to prevent pregnancy. Keytruda can harm a developing baby. Tell your doctor right away if you inadvertently become pregnant.
• Do not breastfeed while you are being administered Keytruda and for four months after your last dose.
• You will need frequent medical tests while you are being treated with Keytruda. Do not miss any follow-up visits.
• If you are caring for somebody who is being given Keytruda, be aware that it can pass into body fluids (such as urine, feces, or vomit) for at least 48 hours after a dose. Wear rubber gloves when handling body fluids, handling contaminated trash or laundry. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

• Many people achieve remission with Keytruda; however, some may not. How well Keytruda works for an individual patient depends on their specific type of cancer, whether they express certain genetic markers on their tumors, their overall health at the time of treatment, previous cancer treatments, and their ability to tolerate the side effects of the medication.
• Some people have experienced significant tumor regression, tumor disappearance, or an extension of their survival time.
• Because Keytruda may be used to treat many different cancers, the response to treatment varies. Please refer to the product information or ask your doctor for specific studies relating to your particular type of cancer.
• Keytruda is usually given every three or six weeks until the person's cancer worsens or they experience intolerable or severe side effects. People who experience no disease progression with Keytruda may continue for 24 months or longer.

Medicines that interact with Keytruda may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with Keytruda. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Keytruda include:

• corticosteroids, such as betamethasone, budesonide, cortisone, dexamethasone, hydrocortisone, or prednisone
• efgartigimod alfa
• lenalidomide or thalidomide.

Increased mortality was reported when Keytruda was added to a thalidomide analog plus dexamethasone.

Note that this list is not all-inclusive and includes only common medications that may interact with Keytruda. You should refer to the prescribing information for Keytruda for a complete list of interactions.