What is KEYTRUDA (pembrolizumab)?
KEYTRUDA is a prescription medicine used to treat:
- A kind of skin cancer called melanoma. KEYTRUDA may be used: When your melanoma has spread or cannot be removed by surgery (advanced melanoma), or To help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.
- A kind of lung cancer called non-small cell lung cancer (NSCLC). KEYTRUDA may be used with the Chemotherapy medicines pemetrexed and a platinum as your first treatment when your lung cancer: Has spread (advanced NSCLC), and is a type called “nonsquamous”, and your tumor does not have an abnormal “EGFR” or “ALK” gene
- KEYTRUDA may be used with the chemotherapy medicines carboplatin and either paclitaxel or nab-paclitaxel as your first treatment when your lung cancer: Has spread (advanced NSCLC), and is a type called “squamous”.
- A kind of cancer called head and neck squamous cell cancer (HNSCC) that: has returned or spread and you have received chemotherapy that contains platinum and it did not work or is no longer working.
- A kind of cancer called classical Hodgkin lymphoma (cHL) in adults and children when: You have tried a treatment and it did not work or your cHL has returned after you received 3 or more types of treatment.
- A kind of cancer called primary mediastinal B-cell lymphoma (PMBCL) in adults and children when: You have tried a treatment and it did not work or your PMBCL has returned after you received 2 or more types of treatment.
- A kind of bladder and urinary tract cancer called urothelial carcinoma. KEYTRUDA may be used when your bladder or urinary tract cancer: Has spread or cannot be removed by surgery (advanced urothelial cancer) and, You are not able to receive chemotherapy that contains a medicine called cisplatin, and your tumor tests positive for PD-L1, or You are not able to receive a medicine called cisplatin or carboplatin, or You have received chemotherapy that contains platinum, and it did not work or is no longer working
- A kind of cancer that is shown by a laboratory test to be a microsatellite instability-high (MSI-H) or a mismatch repair deficient (dMMR) solid tumor. KEYTRUDA may be used in adults and children to treat: Cancer that has spread or cannot be removed by surgery (advanced cancer), and Has progressed following treatment, and you have no satisfactory treatment options, or you have colon or rectal cancer, and you have received chemotherapy with fluoropyrimidine, oxaliplatin, and irinotecan but it did not work or is no longer working.
- A kind of stomach cancer called gastric or gastroesophageal junction (GEJ) adenocarcinoma that tests positive for “PD-L1.” KEYTRUDA may be used when your stomach cancer: Has returned or spread (advanced gastric cancer), and you have received 2 or more types of chemotherapy including fluoropyrimidine and chemotherapy that contains platinum, and it did not work or is no longer working, and if your tumor has an abnormal “HER2/neu” gene, you also received a HER2/neu-targeted medicine and it did not work or is no longer working
- A kind of cancer called cervical cancer that tests positive for “PD-L1.” KEYTRUDA may be used when your cervical cancer: Has returned, or has spread or cannot be removed by surgery (advanced cervical cancer), and You have received chemotherapy, and it did not work or is no longer working.
- A kind of liver cancer called hepatocellular carcinoma, after you have received the medicine sorafenib
- A kind of skin cancer called Merkel cell carcinoma (MCC) in adults and children. KEYTRUDA may be used to treat your skin cancer when it has spread or returned.
It is not known if KEYTRUDA is safe and effective in children with MSI-H cancers of the brain or spinal cord (central nervous system cancers).
What is the most important information I should know about KEYTRUDA?
KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause
your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended.
KEYTRUDA can cause serious side effects. These serious side effects include:
- Lung problems (pneumonitis). Symptoms of pneumonitis may include: Shortness of breath, Chest pain, New or worse cough.
- Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include:
- Diarrhea or more bowel movements than usual
- Stools that are black, tarry, sticky, or have blood or mucus
- Severe stomach-area (abdomen) pain or tenderness
- Liver problems (hepatitis). Signs and symptoms of hepatitis may include:
- Yellowing of your skin or the whites of your eyes
- Nausea or vomiting
- Pain on the right side of your stomach area (abdomen)
- Dark urine
- Feeling less hungry than usual
- Bleeding or bruising more easily than normal
- Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas). Signs and symptoms that your hormone glands are not working properly may include:
- Rapid heart beat
- Weight loss or weight gain
- Increased sweating
- Feeling more hungry or thirsty
- Urinating more often than usual
- Dizziness or fainting
- Hair loss
- Feeling cold
- Constipation
- Your voice gets deeper
- Headaches that will not go away or unusual headache
- Muscle aches
- Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include: Change in the amount or color of your urine
- Skin problems. Signs of skin problems may include: Rash, Itching, Blisters, peeling or skin sores, Painful sores or ulcers in your mouth or in your nose, throat, or genital area
- Problems in other organs. Signs and symptoms of these problems may include:
- Changes in eyesight
- Severe or persistent muscle or joint pains
- Severe muscle weakness
- Low red blood cells (anemia)
- Swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain (sarcoidosis)
- Confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, or seizures (encephalitis)
- Shortness of breath, irregular heartbeat, feeling tired, or chest pain (myocarditis)
- Infusion (IV) reactions that can sometimes be severe and life-threatening. Signs and symptoms of infusion reactions may include:
- Chills or shaking
- Shortness of breath or wheezing
- Itching or rash
- Flushing
- Dizziness
- Fever
- Feeling like passing out
- Rejection of a transplanted organ. People who have had an organ transplant may have an increased risk of organ transplant rejection. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ 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 severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with KEYTRUDA. Your doctor will monitor you for the following signs and symptoms: skin rash, liver inflammation, stomach-area (abdominal) pain, and diarrhea.
- Common side effects of KEYTRUDA when used alone include: feeling tired, pain, including pain in muscles, bones or joints and stomach-area (abdominal) pain, decreased appetite, itching, diarrhea, nausea, rash, fever, cough, shortness of breath, and constipation.
- Common side effects of KEYTRUDA when given with certain chemotherapy medicines include: feeling tired or weak, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, trouble breathing, fever, hair loss, and inflammation of the nerves that may cause pain, weakness, and paralysis in the arms and legs
- In children, feeling tired, vomiting and stomach-area (abdominal) pain, and increased levels of liver enzymes and decreased levels of salt (sodium) in the blood are more common than in adults.
Getting medical treatment right away may help keep these problems from becoming more serious. Your doctor will check you for these problems during treatment with KEYTRUDA. Your doctor may treat you with corticosteroid or hormone replacement medicines. Your doctor may also need to delay or completely stop treatment with KEYTRUDA, if you have severe side effects.
How should I take KEYTRUDA?
- Your doctor will give you KEYTRUDA into your vein through an intravenous (IV) line over 30 minutes
- KEYTRUDA is usually given every 3 weeks.
- Your doctor will decide how many treatments you need.
- Your doctor will do blood tests to check you for side effects
- If you miss any appointments, call your doctor as soon as possible to reschedule your appointment.
Important Safety Information
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- You should use an effective method of birth control during and for at least 4 months after the final dose of KEYTRUDA. Talk to your doctor about birth control methods that you can use during this time.
- Do not breastfeed during treatment with KEYTRUDA and for 4 months after your final dose of KEYTRUDA.
- Call or see your doctor right away if you develop any side effects.
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking KEYTRUDA?
Before you receive KEYTRUDA, tell your doctor if you:
- Have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
- Have received an organ transplant, such as a kidney or liver
- Have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
- Have lung or breathing problems
- Have liver problems
- Have any other medical problems
- Are pregnant or plan to become pregnant
- Are breastfeeding or plan to breastfeed
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
General information about KEYTRUDA?
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about KEYTRUDA, talk with your doctor.
What are the ingredients in KEYTRUDA?
Active ingredient: Pembrolizumab
Inactive ingredient:
KEYTRUDA for injection: L-histidine, polysorbate 80, and sucrose. May contain hydrochloric acid/sodium hydroxide.
KEYTRUDA injection: L-histidine, polysorbate 80, sucrose, and Water for Injection, USP.