pembrolizumab

What is the most important information I should know about pembrolizumab?

What is pembrolizumab?

Pembrolizumab is a cancer medicine that is used alone or in combination with other medicines to treat certain types of cancer such as:

• skin cancer (melanoma, Merkel cell carcinoma, squamous cell carcinoma);
• lung cancer;
• 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;
• advanced stomach or esophageal cancer; or
• a type of cancer that laboratory testing proves to have certain specific DNA mutations.

Pembrolizumab 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.

For some types of cancer, pembrolizumab is given only if your tumor tests positive for "PD-L1", or if the tumor has been tested for a specific genetic marker (including "EGFR," "ALK," "HER2/neu," or "TMB").

Pembrolizumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving pembrolizumab?

Tell your doctor if you have ever had:

• 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;
• an organ transplant or stem cell transplant;
• radiation to your chest; or
• a nerve-muscle disorder such as myasthenia gravis or Guillain-Barré syndrome.

How is pembrolizumab given?

Your doctor will perform a blood test to make sure pembrolizumab is the right treatment for your condition.

Pembrolizumab is given as an infusion into a vein, usually once every 3 to 6 weeks. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at least 30 minutes to complete.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving pembrolizumab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of pembrolizumab?

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, light-headed, itchy, hot, sweaty, chilled, or have back pain or trouble breathing.

Pembrolizumab strengthens your immune system to help your body fight against cancer cells. This may cause the immune system to attack normal healthy tissues or organs. When this happens, you may develop serious or life-threatening medical problems.

• new or worsening cough, chest pain, shortness of breath;
• pale skin, easy bruising or bleeding;
• sores in your mouth, throat, or nose, or on your genital area;
• severe headache, confusion, eye pain, vision problems (your eyes may be more sensitive to light);
• numbness, tingling, burning pain, redness, rash, or blisters on your hands or feet;
• fever, swollen glands, neck stiffness;
• diarrhea or increased stools, severe stomach pain, bloody or tarry stools;
• kidney problems --swelling in your ankles, blood in your urine, little or no urination;
• liver problems --loss of appetite, right-sided stomach pain, vomiting, dark urine, jaundice (yellowing of the skin or eyes);
• transplant rejection --mouth sores, stomach pain, feeling sick or uneasy, rash, pain or swelling near your transplanted organ; or
• signs of a hormonal disorder --frequent or unusual headaches, dizziness, feeling very tired, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, hair loss, sweating, feeling cold, weight gain, or weight loss.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects (some are more likely with combination chemotherapy) may include:

• nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation;
• low sodium levels, abnormal liver or thyroid function tests;
• fever, feeling weak or tired;
• cough, hoarse voice, feeling short of breath;
• itching, rash, hair loss;
• increased blood pressure;
• pain in your muscles, bones, or joints; or
• soreness in or around your mouth, nose, eyes, throat, or vagina.

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 FDA at 1-800-FDA-1088.

What other drugs will affect pembrolizumab?

Other drugs may affect pembrolizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about pembrolizumab.