Cemiplimab

What is cemiplimab used for?

• Cemiplimab is used to treat skin cancer.

Before taking cemiplimab, tell your doctor:

• If you are allergic to cemiplimab; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are breast-feeding. Do not breast-feed while you take cemiplimab or for 4 months after your last dose.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take cemiplimab with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take cemiplimab?

• Tell all of your health care providers that you take cemiplimab. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• High blood sugar has happened with cemiplimab. This includes diabetes that is new or worse.
• Check your blood sugar as you have been told by your doctor.
• Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Severe health problems like some organ problems can happen with cemiplimab. This includes lung, liver, thyroid, pituitary, adrenal, pancreas, kidney, and muscle problems. Nerve problems or a very bad rash may also happen. Sometimes, these problems have been deadly. These problems may happen anytime during treatment or after treatment has stopped. Talk with the doctor.
• A certain brain problem has happened with cemiplimab. Rarely, this has been deadly. Call your doctor right away if you are confused, sleepy, very tired or weak, or have a fever, hallucinations, memory problems, seizures, stiff neck, or very bad headache.
• Some people have had side effects during the infusion. Sometimes, these could be severe or life-threatening. Tell your doctor if you have back or neck pain, chills, shaking, dizziness, passing out, fever, flushing, itching, rash, shortness of breath, swelling of the face, or wheezing.
• It is common to have diarrhea with cemiplimab. However, a severe bowel problem (colitis) with diarrhea has happened with cemiplimab. This may lead to tears or holes in the bowels and may be life-threatening. Call your doctor right away if you have bloody stools; dark, tarry, or sticky stools; diarrhea; or severe stomach pain.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• If you have had an organ transplant, talk with your doctor. You will need to watch for signs of organ rejection.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting cemiplimab. Talk with your doctor.
• Use birth control that you can trust to prevent pregnancy while taking cemiplimab and for 4 months after your last dose.
• If you get pregnant while taking cemiplimab or within 4 months after your last dose, call your doctor right away.

How is cemiplimab best taken?

Use cemiplimab as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of cemiplimab that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of thyroid, pituitary, or adrenal gland problems. Some signs may be change in mood or the way you act, change in weight, constipation, deeper voice, dizziness, fainting, feeling cold, feeling very tired, hair loss, headache that lasts or is very bad, or lowered interest in sex.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Very bad muscle or joint pain.
• Muscle weakness.
• Chest pain.
• A heartbeat that does not feel normal.
• Sweating a lot.
• A burning, numbness, or tingling feeling that is not normal.
• Feeling very tired or weak.
• Any unexplained bruising or bleeding.
• Swollen gland.
• Eye problems have happened with cemiplimab. Some types of eye problems may need to be treated right away to lower the chance of long-lasting eyesight loss. Call your doctor right away if you have any changes in eyesight, eye pain, or very bad eye irritation.

What are some other side effects of cemiplimab?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Back pain.
• Muscle pain.
• Diarrhea.
• Constipation.
• Not hungry.
• Upset stomach.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out cemiplimab?

• If you need to store cemiplimab at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time cemiplimab is refilled. If you have any questions about cemiplimab, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take cemiplimab or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to cemiplimab. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.