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Generic Name: cemiplimab-rwlc
Dosage Form: Injection
Date of Approval: September 28, 2019
Company: Sanofi

Treatment for: Squamous Cell Carcinoma

Medically reviewed on Oct 9, 2018

FDA Approves Libtayo

The U.S. Food and Drug Administration (FDA) has approved Libtayo (cemiplimab-rwlc), a programmed death receptor-1 (PD-1) blocking antibody for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

Medication Guide

Read this Medication Guide before you start treatment. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Important information

Libtayo is a medicine that may treat a type of skin cancer by working with your immune system. Libtayo can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any symptoms of the following problems or these symptoms get worse:

  • Lung problems (pneumonitis). Signs and symptoms of pneumonitis may include:
    • new or worsening cough
    • shortness of breath
    • chest pain
  • Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include:
    • diarrhea (loose stools) or more frequent bowel movements than usual
    • stools that are black, tarry, sticky, or have blood or mucus
    • severe stomach-area (abdomen) pain or tenderness
  • Liver problems (hepatitis). Signs and symptoms of hepatitis may include:
    • yellowing of your skin or the whites of your eyes
    • severe nausea or vomiting
    • pain on the right side of your stomach area (abdomen)
    • drowsiness
    • dark urine (tea colored)
    • bleeding or bruising more easily than normal
    • feeling less hungry than usual
  • Hormone gland problems (especially the adrenal glands, pituitary, thyroid, and pancreas). Signs and symptoms that your hormone glands are not working properly may include:
    • headache that will not go away or unusual headaches
    • rapid heart beat
    • increased sweating
    • extreme tiredness
    • weight gain or weight loss
    • dizziness or fainting
    • feeling more hungry or thirsty than usual
    • hair loss
    • feeling cold
    • constipation
    • your voice gets deeper
    • very low blood pressure
    • urinating more often than usual
    • nausea or vomiting
    • stomach-area (abdomen) pain
    • changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
  • Kidney problems, including nephritis and kidney failure. Signs of these problems may include:
    • decrease in your amount of urine
    • blood in your urine
    • swelling in your ankles
    • loss of appetite
  • Skin problems. Signs of these problems may include:
    • rash
    • itching
    • skin blistering
    • painful sores or ulcers in mouth or nose, throat, or genital area
  • Problems in other organs. Signs of these problems may include:
    • headache
    • tiredness or weakness
    • sleepiness
    • changes in heartbeat, such as beating fast, or seeming to skip a beat, or pounding sensation
    • seeing or hearing things that are not there (hallucinations)
    • severe muscle weakness
    • low red blood cells (anemia)
    • bruises on the skin or bleeding
    • changes in eyesight
    • confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, or seizures (encephalitis)
    • swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain (sarcoidosis)
  • Rejection of a transplanted organ. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.
  • Infusion (IV) reactions that can sometimes be severe and life-threatening. Signs of these problems may include:
    • chills or shaking
    • itching or rash
    • flushing
    • shortness of breath or wheezing
    • dizziness
    • fever
    • feel like passing out
    • back or neck pain
    • facial swelling

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Libtayo. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may delay or completely stop treatment with Libtayo if you have severe side effects.

What is Libtayo?

Libtayo is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.

It is not known if Libtayo is safe and effective in children.

Before you receive Libtayo

Before you receive Libtayo, tell your healthcare provider about all your medical conditions, including if you:

  • have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
  • have had an organ transplant
  • have lung or breathing problems
  • have liver or kidney problems
  • have diabetes
  • are pregnant or plan to become pregnant. Libtayo can harm your unborn baby. Females who are able to become pregnant:
    • Your healthcare provider will give you a pregnancy test before you start treatment.
    • You should use an effective method of birth control during your treatment and for at least 4 months after the last dose. Talk to your healthcare provider about birth control methods that you can use during this time.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment.
  • are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive Libtayo?

  • Your healthcare provider will give you Libtayo into your vein through an intravenous (IV) line over 30 minutes.
  • Libtayo is usually given every three weeks.
  • Your healthcare provider will decide how many treatments you will need.
  • Your healthcare provider will do blood tests to check you for side effects.
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

Libtayo side effects

Libtayo can cause serious side effects, including:

  • See Important information

The most common side effects include tiredness, rash and diarrhea.

These are not all the possible side effects.

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

General information about the safe and effective use of Libtayo.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information that is written for health professionals.

What are the ingredients of Libtayo?

Active ingredient: cemiplimab-rwlc

Inactive ingredients: L-histidine, L-histidine monohydrochloride monohydrate, sucrose, L-proline, Polysorbate 80, and Water for Injection, USP.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.