to treat melanoma (a type of skin cancer) that cannot be treated with surgery or has spread to other parts of the body, or in combination with other chemotherapy medications to treat and prevent the return of melanoma after surgery to remove it and any affected lymph nodes;
to treat certain types of non-small-cell lung cancer (NSCLC) that cannot be treated with surgery, other chemotherapy medications, or radiation therapy or that has spread to other parts of the body or worsened during or after it was treated with platinum containing chemotherapy medications (cisplatin, carboplatin), or in combination with other chemotherapy medications (paclitaxel, pemetrexed) to treat certain types of NSCLC that has spread to other parts of the body;
to treat certain types of small-cell lung cancer (SCLC) that has spread to other parts of the body or worsened during or after it was treated with platinum containing chemotherapy medications (cisplatin, carboplatin) and at least one other chemotherapy medication;
to treat a certain type of head and neck cancer that keeps coming back or has spread to other parts of the body and cannot be removed by surgery. It can also be used in combination with fluorouracil and a platinum containing chemotherapy medications (cisplatin, carboplatin) to treat a certain type of head and neck cancer that keeps coming back or has spread to other parts of the body and cannot be treated with surgery. Pembrolizumab is also used to treat a certain type of head and neck cancer that has worsened or spread to other parts of the body during or after treatment with chemotherapy medications;
to treat a certain type of Hodgkin's lymphoma (Hodgkin's disease) in children and adults that did not get better with other chemotherapy treatments or got better but returned after being treated 3 or more times with other chemotherapy medications;
to treat a certain type of primary mediastinal B-cell lymphoma (PMBCL; non-Hodgkin lymphoma) in children and adults that did not get better with other chemotherapy treatments or returned after being treated 2 or more times with other chemotherapy medications;
to treat a certain type of urothelial cancer (cancer of the lining of the bladder and other parts of the urinary tract) that has spread to nearby tissues or other parts of the body in people who cannot receive platinum containing chemotherapy medications (cisplatin, carboplatin), or whose cancer worsened during or after it was treated with these chemotherapy medications;
to treat certain types of colorectal cancer (cancer that begins in the large intestine) and certain types of solid tumors in children and adults that cannot be treated by surgery or that has spread to other parts of the body that worsened after it was treated with other chemotherapy medications;
to treat certain types of gastric cancer (cancer of the stomach) or cancer located in the area where the stomach meets the esophagus (the tube between the throat and stomach) that has returned or that has spread to other parts of the body during or after 2 or more chemotherapy treatments;
to treat a certain type of esophageal cancer that has returned and has spread to nearby tissues or other parts of the body after treatment with one or more other chemotherapy medications;
to treat certain types of cervical cancer (cancer that begins in the opening of the uterus [womb]) that has returned or has spread to other parts of the body during or after treatment with another chemotherapy medication;
to treat certain types of hepatocellular carcinoma (HCC; a type of liver cancer) in people who were previously treated unsuccessfully with sorafenib (Nexafar);
to treat Merkel cell carcinoma (MCC; a type of skin cancer) in children and adults that has returned and spread to nearby tissues or other parts of the body;
and in combination with axitinib (Inlyta) to treat advanced renal cell carcinoma (RCC; a type of cancer that begins in the kidneys).
Pembrolizumab injection is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells.
HOW should this medicine be used?
Pembrolizumab injection comes as a powder to be mixed with liquid and injected intravenously (into a vein) over 30 minutes by a doctor or nurse in a hospital or medical facility. It is usually injected once every 3 weeks for as long as your doctor recommends that you receive treatment.
Pembrolizumab injection may cause serious reactions during, or shortly after the infusion of the medication. If you experience any of the following symptoms, tell your doctor immediately: flushing, fever, chills, shaking, dizziness, feeling faint, shortness of breath, difficulty breathing, itching, rash, or hives.
Your doctor may delay or stop your treatment with pembrolizumab injection, or treat you with additional medications, depending on your response to the medication and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with pembrolizumab injection and each time you receive a dose. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before receiving pembrolizumab injection,
tell your doctor and pharmacist if you are allergic to pembrolizumab, any other medications, or any of the ingredients in pembrolizumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have ever had an organ or bone marrow transplant and if you have or have ever had radiation therapy to your chest area; an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as Crohn's disease (condition in which the immune system attacks the lining of the digestive tract causing pain, diarrhea, weight loss, and fever), ulcerative colitis (condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), or lupus (condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys); diabetes; thyroid problems; any type of lung disease or breathing problems; or kidney or liver disease.
tell your doctor if you are pregnant or plan to become pregnant. You will have to take a pregnancy test before starting treatment. You should not become pregnant while you are receiving pembrolizumab injection and for 4 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving pembrolizumab injection, call your doctor immediately. Pembrolizumab injection may harm the fetus.
tell your doctor if you are breastfeeding or plan to breastfeed. Your doctor may tell you not to breastfeed while receiving pembrolizumab injection, and for 4 months after your final dose.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What SIDE EFFECTS can this medicine cause?
Pembrolizumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
joint or back pain
swelling of the of the body or face
changes in skin color
extreme tiredness or lack of energy
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:
blisters or peeling skin; skin redness; rash; or itching
painful sores or ulcers in mouth, nose, throat, or genital area
shortness of breath
new or worsening cough
stools that are black, tarry, sticky, or contain blood or mucus
severe abdominal pain
severe nausea and vomiting
increased or decreased appetite
pain in the upper right part of the stomach
yellowing of the skin or eyes
easy bleeding or bruising
changes in weight (gain or loss)
deepening of the voice or hoarseness
swelling in the front of the neck (goiter)
tingling and weakness in the feet, legs, hands, and arms
severe or persistent headache, muscle aches
severe muscle weakness
dizziness or lightheadedness
change in the amount or color of urine
pain or a burning sensation while urinating
blood in urine
changes in vision
Pembrolizumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( http://www.fda.gov/Safety/MedWatch ) or by phone (1-800-332-1088).
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online athttps://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to pembrolizumab injection. For some conditions, your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with pembrolizumab.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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