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Libtayo
Cemiplimab‑rwlc
$10855.00
350mg · 1 vial
BrandBranded medicine· By Regeneron
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About Libtayo
Overview
Libtayo (cemiplimab-rwlc) is a prescription antibody medicine given into a vein, used in adults for cutaneous squamous cell carcinoma that has spread or is locally advanced when curative surgery or radiation is not an option, and after surgery and radiation when the risk of recurrence is high. It also treats locally advanced or spreading basal cell carcinoma after treatment with a hedgehog pathway inhibitor, or when that treatment is not appropriate. For non-small cell lung cancer without EGFR, ALK or ROS1 gene abnormalities, it is used as a first treatment with platinum-based chemotherapy, or alone when an FDA-approved test shows high PD-L1 expression (at least 50%); the cancer must have spread or be locally advanced and unsuitable for surgery or definitive chemotherapy with radiation. It works by blocking PD-1, a protein on immune cells, releasing a signal that holds back the immune response against tumors.
What it treats
- Cutaneous squamous cell carcinoma (CSCC) in adults that has spread or is locally advanced and cannot be treated with curative surgery or radiation. Also used after surgery and radiation for CSCC at high risk of returning. - Basal cell carcinoma (BCC) in adults that is locally advanced or has spread, after treatment with a hedgehog pathway inhibitor or when this treatment is not appropriate. - Non-small cell lung cancer (NSCLC) in adults with no EGFR, ALK or ROS1 gene abnormalities, when the cancer has spread or is locally advanced and surgery or definitive chemoradiation is not suitable. Used as first-line treatment with platinum-based chemotherapy, or alone when an FDA-approved test shows high PD-L1 expression (TPS ≥50%).
Safety information
Side effects
Common side effects vary by treatment setting. When Libtayo is used alone for metastatic or locally advanced cutaneous squamous cell carcinoma or basal cell carcinoma, or non-small cell lung cancer with high PD-L1 expression, common side effects include tiredness, muscle and joint pain, rash, diarrhoea and anaemia. When used as additional treatment for cutaneous squamous cell carcinoma at high risk of returning, common side effects include rash and itching. When combined with platinum-based chemotherapy for non-small cell lung cancer, common side effects include hair loss, muscle and joint pain, nausea, tiredness, peripheral nerve damage and reduced appetite. Contact your doctor promptly about suspected serious side effects. Libtayo can cause immune-related reactions in any organ or tissue, which may be severe or fatal. These include inflammation of the lungs, bowel, liver or kidneys; kidney dysfunction; hormone-gland disorders; serious skin reactions; and rejection of a transplanted organ. Blood tests are needed before and during treatment to check liver, kidney and thyroid function. Treatment may need to be paused or permanently stopped depending on the severity. Reactions during the infusion may require the infusion to be slowed, interrupted or permanently stopped. Serious or fatal complications can occur in people who receive a stem cell transplant from a donor before or after Libtayo treatment. Libtayo can also harm an unborn baby; effective contraception is advised for people who can become pregnant.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
The FDA label lists no contraindications for Libtayo. However, it carries important warnings: Libtayo can cause severe or fatal immune-related reactions in any organ or tissue, including inflammation of the lungs, bowel, liver or kidneys, hormone-gland problems, skin reactions and rejection of a transplanted organ. Liver enzymes, kidney function and thyroid function should be checked before and periodically during treatment. Depending on severity, treatment may need to be paused or stopped permanently. Infusion-related reactions may require the infusion to be slowed, interrupted or stopped permanently. Serious or fatal complications can occur in people who receive an allogeneic stem cell transplant before or after treatment with a PD-1/PD-L1 blocking antibody such as Libtayo. Libtayo can harm an unborn baby. Women who could become pregnant should use effective contraception. Do not breastfeed during treatment.
Using Libtayo
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label LIBTAYO (CEMIPLIMAB-RWLC) INJECTION [REGENERON PHARMACEUTICALS, INC.] (DailyMed, retrieved 19 September 2026).
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