Pembrolizumab (pem-broe-LIZ-ue-mab)

Treats cancer, including bile duct, gallbladder, bladder, breast, colon, esophagus, rectum, skin, kidney, lung, liver, stomach, cervix, uterus, and head and neck cancer. Also treats solid tumors, primary mediastinal B-cell lymphoma, Merkel cell carcinoma, classical Hodgkin lymphoma, and tumor mutational burden-high cancer.

Brand Name(s):

Keytruda

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. It must be given slowly, so the needle will have to stay in place for at least 30 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control while you are receiving this medicine and for at least 4 months after your last dose.
• Do not breastfeed while you are receiving this medicine and for 4 months after the last dose.
• Tell your doctor if you have kidney disease, liver disease, diabetes, lung disease, immune system problems, thyroid problems, or brain or spinal cord cancer. Tell your doctor if you have received an organ transplant (including kidney or liver transplant) or other transplant (including cornea transplant).
• This medicine may cause the following problems:
  • Pneumonitis (lung problems)
  • Colitis (swelling of the colon), which might damage your digestive system
  • Hepatitis (swelling of the liver)
  • Adrenal, pituitary, or thyroid gland problems
  • Changes in blood sugar levels
  • Kidney problems, which could lead to kidney failure
  • Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic syndrome (DRESS), and toxic epidermal necrolysis
  • Increased risk of possible organ transplant rejection
  • Infusion reactions, which could be severe
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Bloody or black, tarry stools, diarrhea, severe stomach pain
• Bloody or cloudy urine, lower back or side pain, swelling of your face, feet, or lower legs
• Blurred vision or vision changes
• Cough, chest pain or tightness, trouble breathing, fast, slow, or pounding heartbeat
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Fever, chills, shaking, rash, itchy skin
• Increased hunger or thirst, dry mouth, sweating, changes in how much or how often you urinate
• Joint, muscle, or bone pain
• Lightheadedness, dizziness, fainting
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
• Unusual bleeding, bruising, or weakness
• Unusual headaches, tiredness, weight changes, feeling cold, voice changes

If you notice these less serious side effects, talk with your doctor:

• Constipation
• Hair loss
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088