Cemiplimab-rwlc (se-MIP-li-mab - rwlc)

Treats cancer, including skin (cutaneous squamous cell carcinoma and basal cell carcinoma) and lung (non-small cell lung cancer) cancer.

Brand Name(s):

Libtayo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. The medicine must be given slowly, so the IV will have to remain in place for at least 30 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control while you are receiving this medicine and for at least 4 months after your last dose.
• Do not breastfeed while you are receiving this medicine and for 4 months after the last dose.
• Tell your doctor if you have liver disease, diabetes, lung disease, or immune system problems (including Crohn disease, ulcerative colitis, lupus), nervous system problems (including Guillain-Barré syndrome, myasthenia gravis), or any type of infection. Tell your doctor if you have had an organ transplant or other transplant (including cornea transplant).
• This medicine may cause the following problems:
  • Pneumonitis (swelling of the lungs)
  • Colitis (swelling of the colon), which might damage your digestive system
  • Hepatitis (swelling of the liver)
  • Adrenal, pituitary, or thyroid gland problems
  • Changes in blood sugar levels
  • Nephritis (swelling of the kidney)
  • Serious skin reactions (including exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic syndrome (DRESS), or toxic epidermal necrolysis)
  • Infusion reactions, which could be severe
  • Increased risk of possible organ transplant rejection
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or black, tarry stools, diarrhea, severe stomach pain
• Bloody or cloudy urine, swelling of your face, feet, or lower legs
• Blurred vision or vision changes
• Cough, chest tightness, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Increased hunger or thirst, dry mouth, sweating, changes in how much or how often you urinate
• Fever, chills
• Lightheadedness, dizziness, fainting
• Weakness, unusual headaches, tiredness, weight changes, feeling cold

If you notice these less serious side effects, talk with your doctor:

• Joint or muscle pain
• Constipation
• Hair loss or thinning
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088