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?
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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
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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
Side effects of Libtayo (cemiplimab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
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%)
Less Common Side Effects
- Stomach pain
- Constipation
- Lower appetite
- Bleeding
- High blood pressure
- Trouble breathing
- Headache
- Dizziness
- Nerve pain
- Changes in blood test results
Libtayo (cemiplimab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- 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
The following Libtayo (cemiplimab) 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.
Common questions about Libtayo (cemiplimab)
Immunotherapy medications like Libtayo (cemiplimab) help our immune system work. The immune system can usually recognize abnormal cells in the body, such as cancer cells. It then attacks and kills these cells to protect the body from harm. Unfortunately, some cancer cells have found ways to hide from the immune system so they can keep growing. Immunotherapy medications such as Libtayo (cemiplimab) help turn on or activate your immune system to fight and kill cancer cells.
Because immunotherapy like Libtayo (cemiplimab) works differently than traditional chemotherapy, it usually doesn’t cause the side effects most people expect with cancer treatment, like nausea or hair loss. Side effects from immunotherapy are different and are typically called immune-related adverse events or irAEs. They happen when the immune system becomes too active during treatment and starts to attack healthy cells in addition to cancer cells. This immune reaction is a lot like an autoimmune disease. The most common reactions happen in the gut (i.e., diarrhea), skin (i.e., rash), and lungs (i.e., trouble breathing). Let your provider know if you experience these side effects during treatment with Libtayo (cemiplimab) so they can help you manage them.
It depends on how severe the immune-related side effect is. If you have symptoms of an immune-related side effect like a new rash, sudden tiredness, diarrhea, or trouble breathing, let your provider know. They’ll need to examine you and determine what the next steps are. Sometimes, these side effects are serious enough that you have to stop Libtayo (cemiplimab) permanently. Other times, you can pause Libtayo (cemiplimab) for a few weeks and take a corticosteroid medication, like prednisone or dexamethasone, to calm your immune system down. Once the side effect has gotten better, you might be able to restart Libtayo (cemiplimab).
People who take Libtayo (cemiplimab) by itself, such as for skin cancer, don’t typically lose their hair. But sometimes, like when treating lung cancer, Libtayo (cemiplimab) can be given along with other chemotherapy medications like carboplatin (Paraplatin) and paclitaxel that do commonly cause hair loss. If you take Libtayo (cemiplimab) with these medications, you might experience hair loss. Hair usually grows back after you stop treatment.
How long you take Libtayo (cemiplimab) depends on several factors. This includes what type of cancer you have, how well Libtayo (cemiplimab) is working to treat your cancer, and if you have any side effects. Your provider will determine how well Libtayo (cemiplimab) is working for you by examining your scan results and tracking whether your symptoms improve during treatment. If you have side effects from Libtayo (cemiplimab), like changes in lab values, skin rash, or diarrhea, whether you’re able to continue the medication or need to stop treatment depends on how severe they are. In general, people taking Libtayo (cemiplimab) for skin cancer (basal cell or cutaneous squamous cell carcinoma) can take Libtayo (cemiplimab) for up to two years. But, people taking the medication for lung cancer might take it as long as it’s working and they don’t have any serious side effects. Make sure to follow up with your provider regularly about your progress with Libtayo (cemiplimab) treatment.
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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
Typical dosage for Libtayo (cemiplimab)
The usual dose is 350 mg injected through the veins (intravenously, IV) once every 3 weeks.
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