Pembrolizumab, Injection

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KEY POINTS

• This medicine is given by IV to treat skin cancer.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine can cause serious side effects in your eyes, nerves, glands, intestines, liver, or skin which can lead to death. It may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); monoclonal antibody

Generic and brand names: pembrolizumab, injection; Keytruda

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat skin cancer (melanoma) that has spread or cannot be removed by surgery.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A condition that affects your immune system, such as ulcerative colitis, Crohn’s disease, lupus, or sarcoidosis
• Adrenal gland or pituitary gland problems
• An organ transplant
• Breathing or lung problems such as asthma or COPD
• Liver or kidney disease
• Myasthenia gravis
• Thyroid problems

Also tell your provider if you have recently had any kind of infection or if you are taking chemotherapy, radiation therapy, or steroid medicine.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. Do not become pregnant during treatment with this medicine. Use effective birth control while receiving this medicine and for 4 months after your last dose. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

These infusions are given by your healthcare provider. They are given every 3 weeks (depending on your response to the medicine). Keep all appointments for the infusions.

What should I watch out for?

This medicine can cause serious side effects in your eyes, lungs, nerves, glands, intestines, liver, kidney, or skin which can lead to death. These side effects are most likely to start during treatment, but side effects can show up weeks or months after your last infusion. Talk with your healthcare provider about this.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

You need regular lab tests to find out how this medicine is affecting you. Keep all your appointments for these tests.

This medicine may increase the risk of developing Type 1 diabetes. Talk to your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Fever and chills; numbness or tingling in hands or feet; black, bloody, or tarry bowel movements; severe diarrhea or constipation; unusual severe tiredness or weakness; yellowing of your skin or eyes; dark urine; severe stomach pain, nausea or vomiting; unusual bruising or bleeding; feeling cold all the time; changes in mood or behavior; severe skin rash with or without itching; sores in your mouth; blistering or peeling skin; unusual headaches or headache that won't go away; dizziness or fainting; unexplained swelling; severe muscle or joint pain; trouble breathing; cough; change in vision; trouble urinating; extreme thirst; stiff neck; fast heartbeat; unexplained weight gain or loss; increased sweating; hair loss; deepened voice.

Other: Tiredness, mild itching or rash, decreased appetite, nausea, constipation, diarrhea, trouble sleeping, joint pain.

What products might interact with this medicine?

No significant drug interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.