Libtayo is a brand-name prescription drug. It’s FDA-approved to treat the following cancers in adults in certain situations:

  • Basal cell carcinoma. Libtayo is used to treat a type of skin cancer called basal cell carcinoma (BCC). The BCC must be either locally advanced or metastatic. The drug may be prescribed when a specific treatment wasn’t effective or can’t be used. Locally advanced means the cancer has spread to nearby tissues. Metastatic means the cancer has spread to other parts of the body.
  • Cutaneous squamous cell carcinoma. Libtayo is used to treat a type of skin cancer called cutaneous squamous cell carcinoma (CSCC). This drug is for use in adults who can’t reach remission with surgery or radiation alone. The CSCC must be either locally advanced or metastatic.
  • Non-small cell lung cancer. Libtayo is used to treat certain tumors in non-small cell lung cancer (NSCLC). This drug is prescribed for adults with locally advanced NSCLC who can’t reach remission with surgery or chemotherapy plus radiation. Libtayo is also used in adults with metastatic NSCLC.

For more details, see the “Libtayo uses” section below.

* Libtayo has received accelerated approval from the Food and Drug Administration (FDA) for metastatic BCC. For details, see “FDA approval” below.

Drug details

Libtayo contains the active ingredient cemiplimab-rwlc, which is a biologic. Biologics are drugs made using living cells.

Libtayo is a type of immunotherapy drug called a programmed death receptor-1 (PD-1) inhibitor.

Libtayo comes as a single-dose vial of solution. A healthcare professional administers it as an IV infusion.

This drug is available in one strength: 350 milligrams/7 milliliters (mg/ mL) per vial.

FDA approval

The Food and Drug Administration (FDA) first approved Libtayo in 2018 to treat cutaneous squamous cell carcinoma. Additional uses were approved in 2021: non-small cell lung cancer and locally advanced basal cell carcinoma.

Libtayo received accelerated approval from the FDA in 2021 to treat metastatic basal cell carcinoma (BCC). The FDA bases accelerated approval on early clinical trial results. After more extensive trials have been completed, the FDA will decide on full approval of Libtayo for metastatic BCC.

The FDA usually grants full approval only after extensive trials have been completed. If there aren’t many effective treatment options for a particular condition, a drug may receive accelerated approval before all the trials are done. This is the case for metastatic BCC.

Effectiveness

For information about the effectiveness of Libtayo, see the “Libtayo uses” section below.

Libtayo is available only as a brand-name medication. It’s not currently available in biosimilar form.

A biosimilar medication is a drug that’s similar to a brand-name biologic drug (the parent drug). Libtayo is a biologic medication, which is also called a biologic.

Biologic drugs are made from living cells. It’s not possible to copy these drugs exactly. A generic, on the other hand, refers to medications made from chemicals. And generics are an exact copy of the active drug in a brand-name medication.

Biosimilars are considered to be just as safe and effective as their parent drug. And like generic name drugs, biosimilars tend to cost less than brand-name medications.

Libtayo can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while receiving Libtayo. The drug’s side effects might differ slightly depending on whether Libtayo is being used to treat skin cancer or lung cancer.

These lists do not include all possible side effects. For more information about the possible side effects of Libtayo, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Libtayo, you can do so through MedWatch.

Mild side effects

Mild side effects* of Libtayo can include:

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Libtayo. To learn about other mild side effects, talk with your doctor or pharmacist, or view Libtayo’s prescribing information.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects can occur in some people during Libtayo treatment. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • High blood pressure. Symptoms don’t typically occur, but very high blood pressure may cause:
    • headache
    • tiredness
  • Serious infections, such as pneumonia or cellulitis (bacterial skin infection). Symptoms vary but can include:
    • areas of skin that are swollen, painful, or have sores
    • cough that may produce yellow or green mucus
    • fatigue
  • Blood disorders, such as lymphopenia (low level of lymphocytes) and anemia (low red blood cells). Symptoms can include:
    • increased risk of infection with lymphopenia
    • fatigue, dizziness, or looking more pale than usual with anemia
  • Other changes in blood test results, including changes in levels of electrolytes, such as sodium, phosphate, and potassium. Symptoms can include:
    • nausea and vomiting
    • dizziness
    • confusion
    • tiredness
    • loss of appetite
  • Infusion-related reaction.*
  • Immune-mediated reaction*
  • Allergic reaction.*

* For more information about this side effect, see “Side effect details” below.

Side effect details

Here are some details about certain side effects this drug may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Libtayo.

Infusion-related reaction

A healthcare professional will give Libtayo as an intravenous (IV) infusion. This is an injection into a vein given over a period of time. Libtayo infusions usually last about 30 minutes. It’s possible to have side effects during the infusion. These are called infusion-related reactions.

Symptoms of infusion-related reactions may include:

  • nausea
  • fever
  • skin rash
  • wheezing or trouble breathing
  • shaking or chills
  • flushing
  • dizziness
  • feeling like you might faint

The healthcare professional will monitor you while you receive your infusion. Tell them right away if you have any symptoms. They may slow down or pause the infusion. If you have a severe infusion-related reaction, such as trouble breathing, your doctor may have you stop Libtayo treatment. In clinical trials, severe infusion-related reactions were rare.

If you have questions about infusion-related reactions from Libtayo, talk with your doctor.

Fatigue

Fatigue is a possible side effect of Libtayo. It was one of the more common side effects seen in the drug’s clinical trials.

With fatigue, you may feel weak and tired even if you get your usual amount of sleep.

If this side effect does not go away or becomes severe, talk with your doctor. They may suggest ways to boost your energy level, such as a daily walk or strength training (according to your ability).

Muscle or bone pain

Libtayo may cause pain in muscles or bones. This side effect was commonly seen in people who took Libtayo in clinical trials. Some people also reported pain or stiffness in their joints, neck, and back.

The severity of the muscle or bone pain can vary from mild to severe.

Talk with your doctor if you have pain that’s severe or does not go away. They may suggest ways to manage this side effect, such as trying physical therapy or pain medication. Over-the-counter pain medications can include acetaminophen (Tylenol). Prescription pain relievers can include opioids, such as hydromorphone (Dilaudid).

Immune-mediated reaction

Libtayo treats certain types of cancer by working with your immune system. In some cases, the drug may cause your immune system to mistakenly attack your healthy tissues and organs. This may lead to inflammation and damage in the affected tissues or organs. Doctors call this an “immune-mediated” reaction.

Immune-mediated reactions were not common in clinical trials. When they did occur, the rare cases were serious and, at times, fatal. In some people, immune-related reactions were reported after Libtayo treatment ended.

The symptoms of immune-mediated reactions differ from typical allergic reaction symptoms, such as skin rash. And they vary depending on which tissues and organs are affected.

Here are some examples of immune-mediated reactions than may occur with Libtayo:

Call your doctor right away if you have any of these symptoms with Libtayo. The more quickly you receive treatment for these reactions, the less likely they are to become serious. Depending on the severity, your doctor may pause or stop your Libtayo treatment. They may also recommend medication to help stop the reaction. For example, a corticosteroid such as prednisone (Rayos).

Allergic reaction

As with most drugs, some people can have an allergic reaction after receiving Libtayo.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • skin peeling or blistering
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Libtayo, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Here are answers to some frequently asked questions about Libtayo.

Is Libtayo approved to treat cervical cancer?

The Food and Drug Administration (FDA) has not approved Libtayo to treat cervical cancer. The drug can be used off-label for this condition. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

The manufacturer of Libtayo submitted an application to the FDA for approval of Libtayo to treat cervical cancer. After the FDA reviewed the clinical trial data, the drug manufacturer withdrew its application. Sometimes the FDA wants more specific information included, such as monitoring for a certain side effect. Drug manufacturers may hold additional clinical trials to include the information, then resubmit the application.

If you’d like more information about Libtayo and other treatments for cervical cancer, talk with your doctor.

My doctor referred to Libtayo’s indications. What are those?

In medical terms, a drug’s indications refer to the conditions that a medication is used to treat or help prevent. Your doctor may mention that Libtayo is indicated for certain types of cancer. This means it’s used for treating certain cancers.

For more information about Libtayo’s indications, see the “Libtayo uses” section below.

Is Libtayo a type of chemotherapy?

No, Libtayo is not a chemotherapy drug. Chemotherapy drugs work by attacking any cells that rapidly multiply to make more cells. This includes cancer cells and sometimes healthy cells. This leads to common side effects of chemotherapy drugs, such as hair loss and vomiting.

Libtayo is an immunotherapy drug. These drugs are designed to help your immune system recognize and fight cancer. Side effects of immunotherapy drugs generally occur less frequently and are less severe than chemotherapy side effects.

Libtayo is used to treat certain types of skin and lung cancer.

When skin is exposed to direct sunlight, UV light in the sun’s rays can damage the DNA in skin cells. If certain genes become damaged, it can cause abnormal cells to divide and grow uncontrollably. These abnormal cells can form cancerous growths.

Lung cancer occurs when cells in the lungs grow and multiply too quickly, and cancerous tumors develop. Cigarette smoking and exposure to smoke, toxins, or inhaled chemicals can increase the risk of lung cancer.

What is Libtayo’s mechanism of action?

Libtayo’s mechanism of action is how the drug works. To help understand Libtayo’s mechanism of action, here are two terms to know:

  • PD-1. This stands for programmed death receptor-1. It’s a binding site found on many types of cells. (A binding site is a place on a cell where something can attach.)
  • PD-L1. This stands for programmed death-ligand 1. It’s an immune system protein. (Your immune system is your body’s defense against infection and disease, such as cancer.)

Some cancer cells have higher-than-usual amounts of PD-1 and PD-L1.

When the protein PD-L1 attaches to a PD-1 site in cells, PD-L1 tells certain cells in your immune system not to attack. This allows cancer cells to continue growing and replicating (making more cells).

Libtayo works by blocking the PD-1 site so that the PD-L1 protein can’t attach to it. This allows certain cells in your immune system to attack cancer cells and help prevent their continued growth.

How long does Libtayo take to work?

Libtayo starts working soon after your first dose. However, it may take several weeks or a few months until your doctor can tell if Libtayo is working to treat your cancer.

Every couple of months, your doctor will order a scan or other tests to see if your cancer is growing or spreading. Talk with your doctor about how they’ll monitor your progress while you receive Libtayo.

As with all medications, the cost of Libtayo can vary. To find current prices for Libtayo in your area, check out WellRx.com.

The cost you find on WellRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Before approving coverage for Libtayo, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Libtayo, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Libtayo, or if you need help understanding your insurance coverage, help is available.

Regeneron Pharmaceuticals, Inc. and sanofi-aventis U.S. LLC., the developers of Libtayo, offer the Libtayo Surround Patient Support Program. For more information and to find out if you’re eligible for support, call 877-LIBTAYO (877-542-8296) and select option 1. You can also visit the program website.

To learn more about saving money on prescriptions, check out this article.

Biosimilar form

Libtayo is available only as a brand-name medication. It’s not currently available in biosimilar form.

A biosimilar medication is a drug that’s similar to a brand-name biologic drug (the parent drug). Libtayo is a biologic medication, which is also called a biologic.

Biologic drugs are made from living cells. It’s not possible to copy these drugs exactly. A generic, on the other hand, refers to medications made from chemicals. And generics are an exact copy of the active drug in a brand-name medication.

Biosimilars are considered to be just as safe and effective as their parent drug. And like generic name drugs, biosimilars tend to cost less than brand-name medications.

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Libtayo, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when a drug that’s approved by the Food and Drug Administration (FDA) is used for a purpose other than what it’s approved for.

Alternatives for basal cell carcinoma

Examples of other drugs that may be used to treat basal cell carcinoma include:

  • imiquimod (Aldara)
  • fluorouracil or 5-FU (Efudex)
  • sonidegib (Odomzo)
  • vismodegib (Erivedge)

Alternatives for squamous cell carcinoma

Examples of other drugs that may be used to treat cutaneous squamous cell carcinoma include:

  • pembrolizumab (Keytruda)
  • fluorouracil or 5-FU (Efudex)

Alternatives for non-small cell lung cancer

Examples of other drugs that may be used to treat non-small cell lung cancer include:

  • pembrolizumab (Keytruda)
  • atezolizumab (Tecentriq)
  • durvalumab (Imfinzi)
  • ipilimumab (Yervoy) with nivolumab (Opdivo) and paclitaxel

The Food and Drug Administration (FDA) approves prescription drugs such as Libtayo to treat certain conditions. Libtayo may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Libtayo for basal cell carcinoma

Libtayo is used to treat a type of skin cancer called basal cell carcinoma (BCC) that’s locally advanced or metastatic.* Locally advanced means the cancer has spread to nearby tissues. Metastatic means the cancer has spread to other parts of the body.

Libtayo is approved for use in adults when a type of drug known as a hedgehog pathway inhibitor (HPI) drug wasn’t effective or couldn’t be used. Examples of HPI drugs include sonidegib (Odomzo) and vismodegib (Erivedge).

BCC is the most common type of skin cancer. It starts in basal cells. These are found in your skin’s deepest layer, at the base of the skin’s surface. Symptoms may include:

  • a brown, blue, or black lesion (sore)
  • a white, skin-colored, or pink bump on the skin
  • a reddish patch of skin

To learn more about skin cancer and its treatment options, see our hubs for dermatology and skin care and cancer.

* Libtayo has received accelerated approval from the FDA for metastatic BCC. See the “What is Libtayo” section above for more details.

Effectiveness for basal cell carcinoma

Libtayo has been found to be effective in treating BCC. Current treatment guidelines include Libtayo as a treatment option for BCC.

For information on how the drug performed in clinical studies, see the drug’s prescribing information.

Libtayo for squamous cell carcinoma

Libtayo is used to treat a type of skin cancer called cutaneous squamous cell carcinoma (CSCC). The drug is used for adults who can’t reach remission with surgery or radiation alone. To be specific, the drug is used in adults for CSCC that’s either:

  • locally advanced, which means the cancer has spread to nearby tissues, or
  • metastatic, which means the cancer has spread to other parts of the body

CSCC starts in cells known as squamous cells, which are found on the skin’s surface. Symptoms can include an open sore, a growth that looks like a wart, and a rough-feeling, scaly patch.

To learn more about skin cancer and its treatment options, see our hubs for dermatology and skin care and cancer.

Effectiveness for squamous cell carcinoma

Libtayo has been found to be effective in treating CSCC. Current treatment guidelines include Libtayo as a treatment option for CSCC.

For information on how the drug performed in clinical studies, see the drug’s prescribing information.

Libtayo for non-small cell lung cancer

Libtayo is used in adults to treat non-small cell lung cancer (NSCLC) in certain situations. For this purpose, Libtayo is prescribed to treat two forms of NSCLC. One form is:

  • locally advanced (the cancer has spread to nearby tissues) and
  • can’t reach remission with surgery or chemotherapy plus radiation

The second form of NSCLC that Libtayo treats is metastatic (the cancer has spread to other parts of the body).

For both of these forms, Libtayo is used to treat NSCLC that:

  • has high levels of an immune system protein called PD-L1* and
  • does not have mutations in certain genes called EGFR, ALK, or ROS1

Your doctor may test for these gene mutations to see if Libtayo is a treatment option for you. Libtayo can be used as a first treatment for NSCLC.

NSCLC is the most common type of lung cancer. This type of cancer occurs when cells divide uncontrollably in the lungs, damaging healthy tissue or causing tumors. Symptoms can include:

  • unexplained chronic cough
  • trouble breathing
  • fatigue
  • coughing up blood
  • chest pain
  • swollen face, neck, or veins in the neck

To learn more about lung cancer and its treatment options, see our lung cancer hub and cancer hub.

* PD-L1 stands for programmed death-ligand 1.
† EGFR stands for epidermal growth factor receptor. ALK stands for anaplastic lymphoma kinase. ROS1 stands for ROS proto-oncogene 1.

Effectiveness for non-small cell lung cancer

Libtayo has been found to be effective in treating NSCLC.

Current treatment guidelines for metastatic NSCLC include Libtayo as a treatment option.

For information on how the drug performed in clinical studies for locally advanced and metastatic NSCLC, see the drug’s prescribing information.

Libtayo and children

Libtayo is used to treat certain cancers in adults. It isn’t known if the drug is safe or effective for people younger than age 18 years.

The following information describes dosing that’s commonly used or recommended. Your doctor will determine the best dosage to fit your needs.

Drug form

Libtayo comes as a solution in a single-dose vial. It’s diluted and given as an IV infusion by a healthcare professional.

Drug strength (350 mg/7 mL)

Libtayo is available in one strength: 350 milligrams (mg) per vial. Each vial contains 7 milliliters (mL) of solution.

Dosage for basal cell carcinoma

Here’s the usual dosage of Libtayo for basal cell carcinoma (BCC):

  • locally advanced BCC: an IV infusion of 350 mg once every 3 weeks
  • metastatic BCC: an IV infusion of 350 mg once every 3 weeks

Dosage for squamous cell carcinoma

Here’s the usual dosage of Libtayo for cutaneous squamous cell carcinoma (CSCC):

  • locally advanced CSCC: an IV infusion of 350 mg once every 3 weeks
  • metastatic CSCC: an IV infusion of 350 mg once every 3 weeks

Dosage for non-small cell lung cancer

Here’s the usual dosage of Libtayo non-small cell lung cancer (NSCLC):

  • locally advanced NSCLC: an IV infusion of 350 mg once every 3 weeks
  • metastatic NSCLC: an IV infusion of 350 mg once every 3 weeks

What if I miss a dose?

If you miss your appointment for a Libtayo dose, talk with your doctor’s office right away. They’ll work with you to reschedule your infusion appointment as soon as possible.

It’s important that you do not miss Libtayo infusion appointments. Missing doses can cause the medication not to work as well as usual.

To help make sure that you don’t miss an appointment for your dose, try using a medication reminder. This can include adding it to your calendar or setting an alert on your phone.

Will I need to use this drug long term?

Libtayo is meant to be used as a long-term treatment. If you and your doctor determine that Libtayo is safe and effective for you, you’ll likely take it long term.

There’s no known interaction between Libtayo and alcohol.

If you drink alcohol, talk with your doctor about how much is safe to drink while receiving Libtayo.

There aren’t any known interactions between Libtayo and other medications, herbs, supplements, or foods.

To be safe, talk with your doctor and pharmacist before taking Libtayo. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Your doctor will instruct you on how you will be receiving Libtayo.

A healthcare professional will administer Libtayo as an IV infusion. The infusion is given over 30 minutes.

If you develop bothersome side effects during the infusion, tell the healthcare professional. They may slow down, stop, or pause the infusion. For more details about infusion-related reactions, see “Side effect details” in the “Libtayo side effects” section above.

When it’s given

You’ll receive Libtayo once every 3 weeks.

If you have side effects from an infusion, your doctor may have you wait longer than 3 weeks to receive your next treatment.

To help make sure that you don’t miss an appointment for your dose, try using a medication reminder. This can include adding it to your calendar or setting an alert on your phone.

Libtayo is not safe to use in pregnancy. Because of how the drug works, Libtayo may cause harm to a developing fetus. If you can become pregnant, your doctor will likely have you take a pregnancy test before you start Libtayo treatment. This is to confirm that you are not pregnant.

If you become pregnant while taking Libtayo, talk with your doctor right away. They’ll likely have you stop receiving Libtayo treatment.

Libtayo is not safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Libtayo.

For more information about taking Libtayo during pregnancy, see the “Libtayo and pregnancy” section above.

Note: Sex and gender exist on spectrums. Use of the terms “male” and “female” below refers to sex assigned at birth.

For females using Libtayo

Females using Libtayo should use birth control during treatment and for at least 4 months after their last dose.

For males using Libtayo

There are no specific recommendations for birth control in males using Libtayo.

If you’re a male being treated with Libtayo and your sexual partner can become pregnant, talk with your doctor. They can advise you on your birth control needs, such as condoms, while receiving this drug.

Libtayo is not safe to use while breastfeeding. The drug may harm a child who is breastfed if it passes through breast milk.

Doctors typically will not prescribe Libtayo for use during breastfeeding. You also should not breastfeed for at least 4 months after your last dose of the drug.

If you’re breastfeeding or thinking about breastfeeding, talk with your doctor. They may recommend healthy ways to feed your child or other treatment options for your cancer.

This drug comes with several precautions. Before receiving Libtayo, talk with your doctor about your health history. Libtayo may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Stem cell transplant. If you have had an allogeneic hematopoietic stem cell transplant, Libtayo can cause serious complications. Allogenic means a stem cell transplant using cells from a donor. These complications, such as graft-versus-host disease, can occur before or after treatment with Libtayo. If you’ve had this type of stem cell transplant or are planning to have one, your doctor will likely not prescribe Libtayo. Talk with them about other treatment options.
  • Allergic reaction. If you’ve had an allergic reaction to Libtayo or any of its ingredients, your doctor will likely not prescribe Libtayo. Ask your doctor what other medications may be better options for you.
  • Pregnancy. Libtayo is not safe to use during pregnancy. For more information, see the “Libtayo and pregnancy” section above.
  • Breastfeeding. Libtayo is not safe to use while breastfeeding. For more information, see the “Libtayo and breastfeeding” section above.

Note: For more information about the potential negative effects of Libtayo, see the “Libtayo side effects” section above.

Do not use more Libtayo than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you receive too much Libtayo

If you think you’ve received too much of this drug, tell your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.