Cemiplimab-rwlc Injection 50 mg/mL (7 mL)

Instructions

This medicine is given as an IV injection into a vein.

This medicine should be given over 30 minutes.

This medicine should be given by a trained health care provider.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Your doctor may prescribe other medications to reduce side effects. Follow instructions carefully.

Keep using this medicine for the full number of days that it is prescribed. Do not stop the medicine even if you start to feel better.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

May cause mouth sores. Brush teeth gently. Avoid products containing alcohol. Rinse mouth with a mixture of water and baking soda or salt.

This medicine is associated with a rare, but serious problem of the liver. Speak to your doctor about the early signs of liver problems and the benefits and risks of using this medicine.

There is an increased risk of bleeding while on this medicine, please tell your doctor or nurse if you notice any excessive bleeding or bruising.

Tell your doctor or nurse right away if fever, chills, feeling of heat or flushing, dizziness, fainting, headache, nausea, rash or weakness develop while the medicine is being given. The medicine may need to be stopped or given at a slower rate.

This medicine may cause dizziness or fainting, especially after exercising or in hot weather. Be very careful when standing or sitting up quickly.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Please check with your doctor before drinking alcohol while on this medicine.

Contact your doctor if you notice a change in the amount or darkening of your urine.

Call the doctor if there are any signs of confusion or unusual changes in behavior.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Do not breastfeed while on this medicine. You may safely start breastfeeding 4 months after stopping treatment.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women must use reliable forms of birth control while using this medicine and for 4 months after stopping to prevent pregnancy.

Always carry an ID card or wear a medical alert bracelet indicating your medical condition.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• decreased appetite
• diarrhea
• nausea
• pain near injection site

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• severe or persistent abdominal pain
• unusual bruising or discoloration on skin
• chest pain
• changes in memory, mood, or thinking
• constipation
• cough that does not go away
• severe, watery or bloody diarrhea
• dizziness
• swelling of the legs, feet, and hands
• eye pain or redness
• fainting
• feeling of heat or flushing
• fever or chills
• numbness or tingling in hands and feet
• severe or persistent headache
• fast, irregular, or slow heartbeat
• itching
• signs of kidney damage (such as change in urine color or bubbly urine)
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• mouth sores or irritation
• muscle weakness
• joint or muscle pain
• seizures
• sensitivity to light
• shortness of breath
• sore throat
• difficulty adjusting to changes in temperature
• difficulty or discomfort urinating
• blurring or changes of vision
• sudden or unexplained change in weight

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.