Prescribing Information

What is LIBTAYO?

LIBTAYO (Lib-TiE-oh) is a prescription medicine used to treat people with a type of lung cancer called non-small cell lung cancer (NSCLC). LIBTAYO may be used as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, OR your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high "PD-L1," and your tumor does not have an abnormal "EGFR," "ALK," or "ROS1" gene.

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

What is NSCLC?

Lung cancer is the second-most diagnosed cancer in both men and women in the United States. Non–small cell lung cancer (NSCLC) is cancer that starts in the lungs. Unlike normal cells, cancer cells grow without order or control, destroying the healthy lung tissue around them.

Types of NSCLC that are the most commonly diagnosed:

most-commonly-diagnosed

What is advanced NSCLC?

When NSCLC is diagnosed as stage 3 or stage 4, it is considered advanced.

There are 2 forms: Locally advanced NSCLC and metastatic NSCLC.

Locally advanced NSCLC, when NSCLC is diagnosed as stage 3, occurs when the cancer may have spread to the lymph nodes* farther away from where it started within the chest. The cancer has not spread to other parts of the body and may be larger than those in stage 2.

Metastatic NSCLC, when NSCLC is diagnosed as stage 4, occurs when the cancer has spread to other organs such as the other lung, brain, liver, or to other parts of the body.

*Lymph nodes are like filters that remove germs. They contain immune cells that can help fight infection.

How do I know if LIBTAYO is an option for me?

Your doctor will perform a number of tests in order to make a diagnosis. The first test is usually a painless chest X-ray that can show larger tumors, but may miss smaller or harder-to-find tumors. If something of concern is found on an X-ray or if you need a more detailed test, a CT (computed tomography) scan (kum-PYOO-ted toh-MAH-gruh-fee skan), is typically ordered.

Some treatment options depend on the presence or absence of biomarkers. Biomarker testing is used to determine if you may have a mutation or an abnormality that is treatable or to measure your programmed death ligand 1 (PD-L1) level. The results of these tests help determine whether any of the FDA-approved targeted therapies or immunotherapies may be right for your treatment plan. PD-L1 is currently used to help decide whether your advanced NSCLC may respond to treatment with immunotherapy.

If you test negative for abnormal EGFR, ALK, or ROS1 genes (types of biomarkers) and have a high PD-L1 level (greater than or equal to 50%), LIBTAYO may be an appropriate treatment option for your advanced NSCLC. You can learn more about biomarkers here

Important Safety Information

What is the most important information I should know about LIBTAYO?

LIBTAYO is a medicine that may treat certain cancers 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. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Please see additional Important Safety Information below.

LIBTAYO is not chemotherapy or radiation therapy. It is an immunotherapy that works with your immune system. Download the LIBTAYO patient Brochure

How was LIBTAYO studied?

LIBTAYO was studied in a clinical trial that compared patients with advanced NSCLC who received LIBTAYO at 350 mg every 3 weeks with those who received chemotherapy containing platinum. The study was designed to include patients if their tumor tested positive for the biomarker PD-L1 at a level greater than or equal to 50% and if they did not have abnormal EGFR, ALK, or ROS1 genes. A total of 710 patients were included in the study.

In the study, LIBTAYO was proven to help patients live longer versus chemotherapy

Median overall survival (OS)

†Median overall survival (OS) is the time in a trial—expressed in months or years—when half of the patients are still living.

LIBTAYO may not work for everyone.

What are the possible side effects of LIBTAYO?

  • LIBTAYO can cause serious side effects.
  • Click here to review "What is the most important safety information I should know about LIBTAYO?"
  • The most common side effects of LIBTAYO include muscle or bone pain, tiredness, rash, and diarrhea
  • These are not all the possible side effects of LIBTAYO
  • Call your doctor for medical advice about side effects

In a clinical trial, the most common side effects reported in the 355 patients with advanced NSCLC taking LIBTAYO were:

  • Muscle or bone pain: 92 out of 355 patients (26%) experienced muscle or bone pain
  • Rash: 53 out of 355 patients (15%) experienced having a rash
  • Anemia: 53 out of 355 patients (15%) experienced anemia (low red blood cell count)
  • Tiredness: 50 out of 355 patients (14%) experienced tiredness
  • Loss of appetite: 43 out of 355 patients (12%) experienced loss of appetite
  • Pneumonia: 39 out of 355 patients (11%) experienced pneumonia
  • Cough: 39 out of 355 patients (11%) experienced cough

Talk with your healthcare team anytime you have questions or concerns.

LIBTAYO Surround® is here to help

While your doctor is your trusted source for information about your condition and treatment, LIBTAYO Surround may be able to provide you with resources and support to assist you.

If you or a loved one has been prescribed LIBTAYO, you can register for LIBTAYO Surround. LIBTAYO Surround offers financial and educational tools and resources to eligible patients and their caregivers throughout treatment with LIBTAYO.

Learn about the LIBTAYO Surround Patient Support Program

Talk with your doctor about any questions you may have about LIBTAYO or your condition.

Learn more about accessing a dedicated Patient Navigator

Important Safety Information (continued)

What is the most important information I should know about LIBTAYO (cemiplimab-rwlc)?

LIBTAYO is a medicine that may treat certain cancers 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. You can have more than one of these problems at the same time. 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 new or worsening signs or symptoms, including:

  • Lung problems: cough, shortness of breath, or chest pain
  • Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach-area (abdomen) pain or tenderness
  • Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal
  • Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
  • Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite
  • Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes
  • Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with LIBTAYO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising
  • Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: nausea, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling
  • Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had
  • Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with LIBTAYO. Your healthcare provider will monitor you for these complications

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 also need to delay or completely stop treatment with LIBTAYO if you have severe side effects.

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 received an organ transplant
  • have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
  • have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
  • 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 your last dose of LIBTAYO. Talk with 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 with LIBTAYO

  • are breastfeeding or plan to breastfeed. It is not known if LIBTAYO passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO

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

The most common side effects of LIBTAYO include muscle or bone pain, tiredness, rash, and diarrhea. These are not all the possible side effects of LIBTAYO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals at 1-877-542-8296.

Please see full Prescribing Information, including Medication Guide.

What is LIBTAYO?

LIBTAYO is a prescription medicine used to treat people with a type of lung cancer called non–small cell lung cancer (NSCLC). LIBTAYO may be used as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high “PD-L1,” and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene.

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

Regeneron

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