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.

Your doctor will make sure you have the correct tumor type to be treated with pembrolizumab.

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:

• an autoimmune disorder such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, lupus, or psoriasis;
• received or plan to receive a stem cell transplant that uses donor stem cells;
• an organ transplant;
• radiation to your chest; or
• a nerve-muscle disorder such as myasthenia gravis or Guillain-Barré syndrome.

How is pembrolizumab given?

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 over 30 minutes.

What happens if I miss a dose?

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

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 medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Pembrolizumab causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.

• new or worsening cough, chest pain, shortness of breath;
• pale skin, easy bruising or bleeding;
• severe muscle pain, cramps, weakness, neck stiffness;
• double or blurry vision;
• confusion, sleep or memory problems, changes in mood or behavior, balance problems;
• numbness, tingling, burning pain, redness, rash, or blisters on your hands or feet;
• fever or flu-like symptoms, swollen glands, sores in your mouth, throat, nose, or on your genital area;
• diarrhea, severe stomach pain or tenderness, bloody or tarry stools;
• feeling sick or uneasy, with pain or swelling near your transplanted organ;
• high blood sugar --increased thirst, increased urination, dry mouth, fruity breath odor;
• kidney problems --swelling, blood in your urine, urinating less, loss of appetite, feeling tired or short of breath;
• liver problems --swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• hormonal problems --unusual headaches, sensitivity to light, eye problems, rapid heartbeats, increased sweating, extreme tiredness, weight gain or weight loss, increased hunger or thirst, increased urination, hair loss, feeling cold, constipation, hoarse or deepened voice, dizziness, fainting, decreased sex drive; or
• low red blood cells (anemia) --pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet.

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, weight loss;
• low blood sodium levels, abnormal thyroid, liver and kidney function tests;
• low blood cell counts;
• tingling or numbness in your hands or feet, loss of movement in the arms and legs;
• bleeding;
• pain and burning when you urinate;
• fever, headache, feeling weak or tired, dizziness, trouble sleeping;
• cough, hoarse voice, feeling short of breath;
• changes in your sense of taste, dry skin and dry eyes;
• itching, hair loss, rash or blisters on your hands or feet;
• increased blood pressure;
• pain in your muscles, bones, or joints; or
• mouth sores or swelling around your mouth, nose, eyes, throat, intestines 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?

Tell your doctor about all other cancer treatments you are receiving.

Other drugs may affect pembrolizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Where can I get more information?

Your doctor or pharmacist can provide more information about pembrolizumab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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