Libtayo
Libtayo (cemiplimab or cemiplimab-rwlc) is an immunotherapy medication that’s used to treat certain types of skin cancer and non-small cell lung cancer (NSCLC). It turns on your immune system to attack and kill cancer cells. But as a result, it can sometimes cause side effects like rash, diarrhea, and lung problems, which might require special treatment with corticosteroids. Libtayo (cemiplimab) is given through the vein (intravenously, IV) at a provider’s office or infusion center once every three weeks.
What is Libtayo (cemiplimab)?
What is Libtayo (cemiplimab) used for?
Certain skin cancers
Cutaneous squamous cell carcinoma that is metastatic or can’t be treated with surgery or radiation
Basal cell carcinoma that has spread and has been treated with a hedgehog pathway inhibitor, if eligible
Certain non-small cell lung cancers that have spread
Given together with chemotherapy, or
Given alone for cancers with high PD-L1 expression
How Libtayo (cemiplimab) works
Our immune system plays an important role in our body, for example, to fight infections. The immune system can also attack and kill cancer cells it recognizes as abnormal. Some cancer cells can hide from the immune system by using the programmed death-1 (PD-1) pathway. When a cancer cell uses the PD-1 pathway, it stops our immune cells from attacking the cancer cell. This allows the cancer to grow.
Libtayo (cemiplimab) is an immunotherapy medication that blocks the PD-1 pathway, or a PD-1 inhibitor. This helps the immune system recognize and attack cancer cells. As a result, the immune system can kill the cancer cells and stop the cancer from growing.
Drug Facts
What are the side effects of Libtayo (cemiplimab)?
Common Side Effects
- Tiredness (up to 50%)
- Rash (up to 34%)
- Muscle or joint pain (up to 36%)
- Diarrhea (up to 33%)
- Itching (up to 22%)
- Nausea (up to 21%)
Other Side Effects
- Stomach pain
- Constipation
- Lower appetite
- Bleeding
- High blood pressure
- Trouble breathing
- Headache
- Dizziness
- Nerve pain
- Changes in blood test results
Serious Side Effects
- Serious immune-related side effects: rash, diarrhea, trouble breathing, severe stomach pain, chest pain
- Serious reaction during infusion: itching, trouble breathing, fast heart beat, feeling warm or hot
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Dry cough, shortness of breath or trouble breathing
- Eye pain, redness, irritation, or discharge with blurry or decreased vision
- Heart muscle inflammation—unusual weakness or fatigue, shortness of breath, chest pain, fast or irregular heartbeat, dizziness, swelling of the ankles, feet, or hands
- Hormone gland problems—headache, sensitivity to light, unusual weakness or fatigue, dizziness, fast or irregular heartbeat, increased sensitivity to cold or heat, excessive sweating, constipation, hair loss, increased thirst or amount of urine, tremors or shaking, irritability
- Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
- Kidney injury (glomerulonephritis)—decrease in the amount of urine, red or dark brown urine, foamy or bubbly urine, swelling of the ankles, hands, or feet
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
- Rash, fever, and swollen lymph nodes
- Redness, blistering, peeling, or loosening of the skin, including inside the mouth
- Sudden or severe stomach pain, bloody diarrhea, fever, nausea, vomiting
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Bone, joint, or muscle pain
- Diarrhea
- Fatigue
- Loss of appetite
- Nausea
- Skin rash
Pros and cons of Libtayo (cemiplimab)
Pros
Doesn’t cause nausea, vomiting, hair loss, or other side effects commonly seen with traditional chemotherapy
Recommended treatment option for basal cell, squamous cell skin cancer, and NSCLC
Is given every three weeks as an infusion that only takes 30 minutes each time, so it’s convenient
Cons
Might cause immune-related side effects like diarrhea, rash, and lung problems
Might require treatment breaks and a corticosteroid to manage side effects
Given through an IV, which requires using a needle
Pharmacist tips for Libtayo (cemiplimab)
Libtayo (cemiplimab) can cause immune-related side effects, like skin rash, diarrhea, or trouble breathing. Contact your provider right away if you have these symptoms. They could be signs that your immune system has become too active as a result of Libtayo (cemiplimab) treatment.
Don’t use over-the-counter medications to treat any side effects you might have from Libtayo (cemiplimab) without contacting your provider first. Side effects caused by immunotherapy medications like Libtayo (cemiplimab) usually need to be quickly treated with a corticosteroid such as prednisone. Other medications you might otherwise use, like loperamide (Imodium-AD) for diarrhea, for example, won’t work as well.
If you need to take a steroid like prednisone for a few weeks to help with any side effects, don’t stop taking the steroid medication suddenly because this can cause uncomfortable symptoms. When it’s time to stop the steroid medication, your provider will give you a plan to do so slowly and safely (tapering).
It’s important to get your lab work done as your provider recommends during treatment with Libtayo (cemiplimab). This helps your provider check for possible immune-related side effects that don’t typically cause symptoms, such as liver, kidney, or thyroid problems.
Most immune-related side effects will require a pause in treatment, either temporarily or permanently. One exception is with thyroid problems, which, in some cases, can be treated with medication while you continue taking Libtayo (cemiplimab).
Libtayo (cemiplimab) can cause harm to an unborn baby. If you’re a woman who can have children, use effective birth control while receiving Libtayo (cemiplimab) and for 4 months after the last dose. Let your provider know if you become pregnant during or after treatment.
Frequently asked questions about Libtayo (cemiplimab)
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What are the risks and warnings for Libtayo (cemiplimab)?
Libtayo (cemiplimab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Immune-related side effects
Side effects from immunotherapy are typically called immune-related adverse events (irAEs). They happen when the immune system becomes too active and doesn’t just attack cancer cells; it attacks healthy cells, too. These side effects can happen anywhere in your body. They can be mild or very serious. And, they can happen at any time during treatment. Some of these side effects, like changes in lab values that show how well your liver and kidneys are working, might not cause noticeable symptoms. You’ll need blood tests done often so your provider can monitor for those side effects closely. But you might notice certain other immune-related side effects, like diarrhea, skin rash, or shortness of breath. Call your provider right away if you experience any of these symptoms. You might need to pause or stop Libtayo (cemiplimab) and take a corticosteroid depending on how severe your symptoms are.
Infusion reactions
Rarely, people taking Libtayo (cemiplimab) have experienced severe or life-threatening reactions during their infusion. If you feel itchy or warm, have trouble breathing, feel nauseous, or suddenly have a fast heart rate while receiving Libtayo (cemiplimab), let your nurse know right away. Most of the time, giving the infusion slower can help. But sometimes, having a serious reaction means that you shouldn’t take Libtayo (cemiplimab) again to avoid having another one in the future.
Stem cell transplant complications
Risk factors: People who’ve received a stem cell (bone marrow) transplant
Some people who’ve taken immunotherapy medications like Libtayo (cemiplimab) and who’ve also had a stem cell transplant have experienced serious problems like graft-versus-host-disease. If you’ve taken an immunotherapy medication like Libtayo (cemiplimab) and have also had a stem cell transplant, your provider will follow up with you closely for signs and symptoms of these problems.
Harm to unborn baby
Risk factors: Women who are pregnant
Based on animal studies, Libtayo (cemiplimab) might harm an unborn baby or raise the risk for miscarriage (pregnancy loss) when taken during pregnancy. Because of these risks, if you’re a female who can get pregnant, you should use birth control while taking Libtayo (cemiplimab) and for 4 months after the last dose. Let your provider know right away if you become pregnant while taking Libtayo (cemiplimab).
Libtayo (cemiplimab) dosage forms
Typical dosing for Libtayo (cemiplimab)
The usual dose is 350 mg injected through the veins (intravenously, IV) once every 3 weeks.
What are alternatives to Libtayo (cemiplimab)?
Certain skin cancers
Cutaneous squamous cell carcinoma that is metastatic or can’t be treated with surgery or radiation
Basal cell carcinoma that has spread and has been treated with a hedgehog pathway inhibitor, if eligible
Certain non-small cell lung cancers that have spread
Given together with chemotherapy, or
Given alone for cancers with high PD-L1 expression
Non-small cell lung cancer (NSCLC)
Renal cell carcinoma (kidney cancer)
Endometrial carcinoma (uterine cancer)
Cancers with high tumor mutation burden (TMB-H), high microsatellite instability (MSI-H), or deficient mismatch repair (dMMR)
Libtayo (cemiplimab) images
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References
Best studies we foundAmerican Cancer Society. (n.d.). Stem cell or bone marrow transplant.
American Cancer Society. (2020). What are infusion or immune reactions?
American Lung Association. (2022). PD-L1, PD1, TMB and lung cancer.
Conroy, M., et al. (2022). Immune-related adverse events and the balancing act of immunotherapy. Nature Communications.
Han, Y., et al. (2020). PD-1/PD-L1 pathway: Current researches in cancer. American Journal of Cancer Research.
Hodgens, A., et al. (2023). Corticosteroids. StatPearls.
InformedHealth.org. (2020). How does the immune system work? Institute for Quality and Efficiency in Health Care.
National Cancer Institute. (2020). Hair loss (alopecia) and cancer treatment.
National Cancer Institute. (2023). Non-small cell lung cancer treatment (PDQ®)–Patient version.
National Comprehensive Cancer Network. (2022). Basal cell skin cancer.
National Comprehensive Cancer Network. (2022). Immunotherapy side effects: Immune checkpoint inhibitors.
National Comprehensive Cancer Network. (2023). Metastatic non-small cell lung cancer.
National Comprehensive Cancer Network. (2023). Squamous cells skin cancer.
National Marrow Donor Program. (n.d.). Graft-versus-host disease basics.
National Marrow Donor Program. (n.d.). GVHD signs and symptoms.
Regeneron Pharmaceuticals, Inc. (2023). Libtayo- cemiplimab-rwlc injection [package insert]. DailyMed.
Skin Cancer Foundation. (2022). Basal Cell Carcinoma Overview.
Skin Cancer Foundation. (2023). Squamous cell carcinoma overview.
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