If you have a certain kind of skin or lung cancer, your doctor may recommend Libtayo to treat your condition.
Libtayo is a prescription medication that’s used in adults to treat the following kinds of cancer in certain situations:
To use Libtayo, these cancers must be locally advanced or metastatic. With locally advanced forms, the cancer has spread into nearby tissues. With metastatic forms, the cancer has spread to other parts of your body. To learn more about the uses of Libtayo, see “What is Libtayo used for?” below.
Libtayo is a kind of immunotherapy drug (treatment that helps your immune system attack cancer cells). It contains the active ingredient cemiplimab-rwlc.* (An active ingredient is what makes a drug work.)
Libtayo is a biologic medication, which means it’s made using
A healthcare professional will give you Libtayo as an intravenous (IV) infusion, which is an injection into your vein given over a period of time. You’ll receive Libtayo infusions every 3 weeks at a doctor’s office, clinic, or infusion center.
* The reason “-rwlc” appears at the end of the drug’s name is to show that the drug is distinct from similar medications that may be created in the future.
Like most drugs, Libtayo may cause mild or serious side effects. The lists below describe some of the more common side effects that Libtayo may cause. These lists don’t include all possible side effects.
Keep in mind that side effects of a drug can depend on:
- your age
- other health conditions you have
- other medications you take
Your doctor or pharmacist can tell you more about the potential side effects of Libtayo. They can also suggest ways to help reduce side effects.
Mild side effects
Here’s a list of some of the mild side effects that Libtayo can cause. To learn about other mild side effects of the drug, talk with your doctor or pharmacist, or read Libtayo’s prescribing information.
Mild side effects of Libtayo that have been reported include:
- fatigue (low energy)
- nausea and vomiting
- skin rash
- pain in your muscles, bones, or joints
- loss of appetite
- mild infections, such as the common cold or urinary tract infections (UTIs)
- mild allergic reaction*
* An allergic reaction is possible after using Libtayo. But this side effect wasn’t reported in studies. To learn more about this side effect, see the “Allergic reaction” section below.
Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.
Serious side effects
Serious side effects from Libtayo can occur, but they aren’t common. If you have serious side effects from Libtayo, call your doctor right away. But if you think you’re having a medical emergency, you should call 911 or your local emergency number.
Serious side effects of Libtayo that have been reported include:
- serious infections, such as pneumonia, cellulitis, and sepsis
- problems caused by your immune system attacking healthy tissues in your body, such as your lungs, kidneys, liver, intestines, and skin
- problems caused by your immune system attacking hormone-producing glands in your body, such as your thyroid, adrenal, and pituitary glands
- infusion reactions, such as trouble breathing, skin rash, nausea, and fever
- high blood pressure
- low red blood cell count
- low level of lymphocytes, a kind of white blood cell
- changes in the levels of electrolytes (essential minerals, such as sodium and potassium) in the blood
- severe allergic reaction*
* An allergic reaction is possible after using Libtayo. But this side effect wasn’t reported in studies. To learn more about this side effect, see the “Allergic reaction” section below.
While studies of Libtayo did not report allergic reaction, this side effect can still happen.
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 swelling under your skin, usually in your eyelids, lips, hands, or feet. They can also include swelling of your tongue, mouth, or throat, which can cause trouble breathing.
Call your doctor right away if you have an allergic reaction to Libtayo. But if you think you’re having a medical emergency, call 911 or your local emergency number.
The Food and Drug Administration (FDA) approves prescription medications to treat certain conditions. Conditions that the FDA approves a drug to treat are known as the drug’s indications. See below for details on Libtayo’s indications.
Libtayo for basal cell carcinoma
Libtayo is used to treat a kind of skin cancer called basal cell carcinoma (BCC) in adults. For this purpose, you must have BCC that is locally advanced (has spread into nearby tissues) or metastatic* (has spread to other parts of the body).
In addition, you must have already tried or can’t take a certain kind of drug to treat your BCC. This kind of drug is called a hedgehog inhibitor (HHI, sometimes referred to as HPI). Examples of HHI drugs include vismodegib (Erivedge) and sonidegib (Odomzo).
* The FDA has given Libtayo
Libtayo for squamous cell carcinoma
Libtayo is used to treat a kind of skin cancer called cutaneous squamous cell carcinoma (CSCC). Specifically, Libtayo is used in adults to treat CSCC that’s either:
- metastatic, or
- locally advanced and can’t be put into complete remission* with surgery or radiation
* With complete remission, all signs of the cancer have gone.
Libtayo for non-small cell lung cancer
Libtayo is used in adults to treat non-small cell lung cancer (NSCLC) that’s metastatic or locally advanced. For locally advanced NSCLC, the drug is used if the cancer can’t be treated with surgery or chemotherapy plus radiation.
In addition, the NSCLC must have:
- high levels of an immune protein called PD-L1, and
- doesn’t have mutations (abnormal changes) in the EGFR, ALK, and ROS1 genes
If your doctor determines that Libtayo is right for your NSCLC, you may receive Libtayo as a first treatment for this condition.
Find answers to some commonly asked questions about Libtayo.
What should I know about Keytruda as an alternative to Libtayo?
Keytruda (pembrolizumab) is an immunotherapy drug that works in the same way as Libtayo. (Immunotherapy drugs help your immune system attack cancer cells.)
As with Libtayo, Keytruda is used for non-small cell lung cancer and squamous cell carcinoma. It’s also used to treat several other kinds of cancer. Unlike Libtayo, the Food and Drug Administration (FDA) hasn’t approved Keytruda to treat basal cell carcinoma.
Healthcare professionals administer these drugs by intravenous (IV) infusion (an injection into a vein that’s given over a period of time), usually every 3 weeks. Keytruda can sometimes be given every 6 weeks.
Keytruda can cause side effects that are very similar to Libtayo’s.
To find out more about Keytruda and other treatments for your cancer, talk with your doctor.
Is Libtayo used to treat cervical cancer?
Libtayo hasn’t been approved by the FDA to treat cervical cancer. But the drug may sometimes be used off-label for this purpose. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.
A study found Libtayo effective for treating cervical cancer. As a result, Libtayo’s drugmaker applied to the FDA for the drug to be approved for this use.
But the drugmaker later withdrew the application when it couldn’t reach an agreement with the FDA on further studies that may be needed. The FDA sometimes requires further studies on effectiveness or safety when considering applications for drugs.
If you’re interested in using Libtayo for cervical cancer, talk with your doctor.
What is Libtayo’s mechanism of action (how does it work)?
Libtayo treats certain kinds of skin and lung cancer. It’s an immunotherapy drug that works by helping your immune system attack cancer cells.
Your immune system defends your body against infections and certain diseases, including cancer. Certain cells in your immune system can usually identify and destroy cells that have become abnormal, such as cancer cells.
Some cancer cells have high levels of a protein called PD-L1 on their surface. This protein protects the cancer cells from your immune system. Libtayo stops these proteins from working, so it allows your immune system to destroy the cancer cells.
To learn more about how Libtayo works or its effectiveness for treating cancer, talk with your doctor or pharmacist.
Is Libtayo a chemotherapy drug?
No, Libtayo isn’t a chemotherapy drug. Chemotherapy drugs are traditional cancer treatments. They work by killing cells that are multiplying rapidly in your body. Cancer cells multiply rapidly, but so do many healthy cells. As a result, chemotherapy can cause many side effects.
Instead, Libtayo is an immunotherapy drug. Immunotherapy drugs work by helping your immune system kill cancer cells. They generally tend to cause fewer and less severe side effects than chemotherapy. But Libtayo may still cause serious side effects. (For more information, see the “What are Libtayo’s side effects?” section above.)
To learn more about how immunotherapy differs from chemotherapy, talk with your doctor or pharmacist.
Costs of prescription drugs can vary depending on many factors. These factors include whether you have insurance and what your insurance plan covers. Another factor is how much you have to pay for a visit to a doctor’s office, clinic, or infusion center to receive Libtayo. To find current prices for Libtayo in your area, talk with your doctor or insurance provider.
If you have questions about how to pay for your prescription, your doctor may have suggestions. A program called Libtayo Surround may be able to connect you to resources that could lower your cost for Libtayo.
You can also check out this article to learn more about saving money on prescriptions.
Your doctor will recommend the dosage of Libtayo that’s right for you. Below are commonly used dosages, but your doctor will determine the dosage you receive.
Form and strength
Libtayo comes as a liquid solution in a single-dose vial. Each vial contains 350 milligrams (mg) of Libtayo in 7 milliliters (mL) of solution.
A healthcare professional will dilute Libtayo and administer it by intravenous (IV) infusion. An IV infusion is an injection into a vein, usually in your arm, that’s given over a period of time. You’ll receive the infusions at a doctor’s office, clinic, or infusion center.
The usual dosage of Libtayo for certain kinds of skin and lung cancer is 350 mg once every 3 weeks.
Questions about Libtayo’s dosing
Below are some common questions about Libtayo’s dosing.
- What if I miss a dose of Libtayo? If you miss an appointment to have an infusion of Libtayo, call your doctor’s office right away to reschedule.
- Will I need to use Libtayo long term? Yes, Libtayo is meant to be used as a long-term treatment. If it works for your cancer and you don’t have bothersome side effects, you’ll likely take it for as long as it continues to work for you.
- How long does Libtayo take to work? Libtayo starts working soon after you receive your first infusion, but you might not notice this. And it might take a few months of treatment before your doctor can tell if Libtayo is working for you. Your doctor will likely order tests and scans to monitor your progress.
Your doctor will explain how you’ll receive Libtayo. They’ll also explain how much you’ll receive and how often.
You’ll receive Libtayo by intravenous (IV) infusion. An IV infusion is an injection into a vein, usually in your arm, that’s given over a period of time.
A healthcare professional will administer Libtayo at a doctor’s office, clinic, or infusion center. You’ll likely receive an infusion of Libtayo once every 3 weeks. But if you develop certain side effects, your doctor may recommend delaying your next infusion until your side effects have eased.
Each infusion usually takes about 30 minutes unless you have a reaction to the infusion. In this case, your healthcare professional may slow down or pause your infusion until the reaction lessens or goes away. Infusion reactions may include trouble breathing, skin rash, nausea, or fever.
Be sure to tell your healthcare professional about any side effects that you have during your infusion.
Questions for your doctor
You may have questions about Libtayo and your treatment plan. It’s important to discuss all your concerns with your doctor.
Here are a few tips that might help guide your discussion:
- Before your appointment, write down questions such as:
- How will Libtayo affect my body, mood, or lifestyle?
- Bring someone with you to your appointment if doing so will help you feel more comfortable.
- If you don’t understand something related to your condition or treatment, ask your doctor to explain it to you.
Remember, your doctor and other healthcare professionals are available to help you. And they want you to get the best care possible. So don’t be afraid to ask questions or offer feedback on your treatment.
Some important things to discuss with your doctor when considering Libtayo treatment include your overall health and any medical conditions you may have.
Using a medication with certain vaccines, foods, and other things can affect how the medication works. These effects are called interactions.
Before receiving Libtayo, be sure to tell your doctor about all medications you take, including prescription and over-the-counter types. Also describe any vitamins, herbs, or supplements you use. Your doctor or pharmacist can tell you about any interactions these items may cause with Libtayo.
For information about drug-condition interactions, see the “Warnings” section just below.
Interactions with drugs or supplements
There currently aren’t any medications or supplements known to interact with Libtayo. But this doesn’t mean drug interactions with Libtayo won’t be recognized in the future. For example, new medications may become available that interact with Libtayo.
For this reason, you should still tell your doctor and pharmacist about any medications you take besides Libtayo. This way, they can check for any new interactions during your treatment.
Libtayo may not be right for you if you have certain medical conditions. These are known as drug-condition interactions. Other factors may also affect whether Libtayo is a good treatment option for you.
Talk with your doctor about your health history before you take Libtayo. Factors to consider include those described below.
Stem cell transplant. Libtayo could cause serious or life threatening complications if a person uses it before or after an allogeneic stem cell transplant (sometimes called a bone marrow transplant). These complications include graft-versus-host disease. If you’ve had or are planning to have this procedure, your doctor will likely not prescribe Libtayo. Talk with your doctor about other medications that may be better options for you.
Organ transplant. Libtayo could cause your immune system to attack a transplanted organ. This could lead to transplant rejection. If you’ve had or are planning to have an organ transplant, your doctor will likely not prescribe Libtayo. Talk with your doctor about other medications that may be better options for you. If you do take Libtayo, your doctor will monitor you for signs of transplant rejection.
Autoimmune conditions. If you have an autoimmune condition, Libtayo could make your condition worse. Examples of autoimmune conditions include Crohn’s disease, ulcerative colitis, and lupus. Talk with your doctor about whether Libtayo is right for you.
Allergic reaction. If you’ve had an allergic reaction to Libtayo or any of its ingredients, your doctor will likely not prescribe Libtayo. Ask them what other medications are better options for you.
Libtayo and alcohol
Libtayo isn’t known to interact with alcohol. But if you have certain side effects with Libtayo, such as nausea, headache, or diarrhea, drinking alcohol could make these worse.
If you drink alcohol, talk with your doctor about how much is safe to consume while you’re receiving Libtayo treatment.
Pregnancy and breastfeeding
Libtayo is not safe to use during pregnancy. If you’re pregnant or planning to become pregnant, ask your doctor what other treatments are better options for you. If you can become pregnant, you should use birth control while receiving Libtayo and for at least 4 months after your last dose.
It’s not known if Libtayo can pass into breast milk. But if it does, it could cause serious side effects in a child who’s breastfed. You should not breastfeed while having treatment with Libtayo and for 4 months after your last dose.
If you’re breastfeeding or planning to breastfeed, talk with your doctor about safe ways to feed your child during Libtayo treatment.
If you’d like to learn more about Libtayo or other treatment options for your skin or lung cancer, talk with your doctor.
Examples of questions you might want to ask about Libtayo treatment include:
- Can Libtayo make my other conditions worse?
- Will Libtayo cure my cancer?
- Can Libtayo side effects be treated?
- How will I know if Libtayo is making my immune system attack healthy tissue in my body?
- If I miss a dose of Libtayo, could my cancer get worse?
To learn more about Libtayo, see these articles:
You may also find the following articles about skin and lung cancer treatments helpful:
- Skin Cancer Treatment Options
- Your Comfort Checklist and Tips for In-Person Lung Cancer Treatments
- Balancing Non-Small Cell Lung Cancer Treatment with Your Life
- How Long Does Treatment for NSCLC Last? Things to Know
To get information on different conditions and tips for improving your health, subscribe to any of Healthline’s newsletters. You may also want to check out the online communities at Bezzy. It’s a place where people with certain conditions can find support and connect with others.
Disclaimer: Healthline 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.