Cemiplimab-rwlc Injection
Cemiplimab-rwlc is an immunotherapy injection used to treat certain types of skin cancer — including cutaneous squamous cell carcinoma and basal cell carcinoma — and non-small cell lung cancer in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Cemiplimab-rwlc Injection: Patient Information Guide
A plain-language walkthrough of Cemiplimab-rwlc Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Libtayo (cemiplimab-rwlc) is an intravenous immunotherapy approved for several cancers in adults. Here is the full list of supported uses:
- Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC): Libtayo is used in adults who are not candidates for curative surgery or curative radiation.
- Adjuvant treatment of CSCC at high risk of recurrence: Libtayo is used after surgery and radiation to lower the chance of cancer coming back.
- Locally advanced or metastatic basal cell carcinoma (BCC): Libtayo is used in adults who have already been treated with a hedgehog pathway inhibitor, or for whom that treatment is not appropriate.
- Non-small cell lung cancer (NSCLC) — single agent: Libtayo is used as first-line treatment in adults whose tumors have high PD-L1 expression (confirmed by an FDA-approved test) and no EGFR, ALK, or ROS1 genetic changes, when the cancer is locally advanced (not eligible for surgery or chemoradiation) or metastatic.
- Non-small cell lung cancer (NSCLC) — in combination with platinum-based chemotherapy: Libtayo is used as first-line treatment in adults with locally advanced or metastatic NSCLC without EGFR, ALK, or ROS1 aberrations.
⚙️How it works▾
Some cancer cells protect themselves by activating a protein called PD-1 on immune T cells. When PD-1 is turned on, it puts the brakes on the immune system — stopping it from attacking the tumor. Libtayo is a monoclonal antibody (a lab-made immune protein) that binds to PD-1 and blocks it from receiving those "stop" signals. This releases the brakes, allowing your immune system's T cells to recognize and attack cancer cells more actively.
💊How it's taken▾
Libtayo is given as an intravenous (IV) infusion — into a vein — by a healthcare professional in a clinical setting. Each infusion takes 30 minutes. The schedule depends on what it is being used for:
- For metastatic or locally advanced CSCC and BCC: given every 3 weeks, for up to 24 months or until the disease progresses or causes unacceptable side effects.
- For adjuvant CSCC treatment: given every 3 weeks for 12 weeks, then every 6 weeks — OR every 3 weeks throughout — for up to 48 weeks total.
- For NSCLC (alone or with chemotherapy): given every 3 weeks, continuing until disease progression or unacceptable side effects.
There is no dose reduction for Libtayo — if side effects are serious, treatment may be paused or stopped entirely. Always follow your oncologist's schedule precisely.
🤒Side effects — in detail▾
Like all immunotherapies, Libtayo can cause a range of side effects. The most commonly reported ones include:
- Fatigue or weakness
- Rash or skin reactions
- Musculoskeletal pain (joint or muscle aches)
- Diarrhea
- Nausea
- Itching (pruritus)
- Anemia (low red blood cell count)
- Decreased appetite
- Hypothyroidism (underactive thyroid) — especially with longer treatment
More serious immune-related reactions — including lung inflammation, liver inflammation, colitis, kidney problems, and severe skin reactions — can also occur and require prompt medical attention. These can happen at any time, even after treatment ends.
⚠️Warnings & precautions▾
The most important risk with Libtayo is immune-mediated adverse reactions — when the immune system, now less restricted, starts attacking healthy organs. These can affect the lungs (pneumonitis), intestines (colitis), liver (hepatitis), kidneys (nephritis), skin, and hormone glands. They can range from manageable to life-threatening and can occur during or even after treatment ends.
- Lung inflammation (pneumonitis): Watch for new cough, shortness of breath, or chest pain.
- Bowel inflammation (colitis): Report severe or persistent diarrhea or abdominal pain.
- Liver inflammation (hepatitis): Yellowing of skin or eyes, dark urine, or severe nausea need urgent evaluation.
- Hormone gland problems (endocrinopathies): Including thyroid disorders, adrenal insufficiency, and pituitary inflammation — watch for unusual fatigue, dizziness, headache, or weight changes.
- Kidney problems (nephritis): Decreased urination or blood in urine should be reported.
- Severe skin reactions: Including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) — blistering or peeling skin requires immediate care.
- Stem cell transplant complications: Serious and fatal complications have occurred in patients who received a donor stem cell transplant before or after a PD-1 blocking antibody.
- Embryo-fetal toxicity: Libtayo can harm a developing fetus. Pregnancy must be avoided during and for 4 months after treatment.
🔀What it interacts with▾
The FDA label for Libtayo does not list specific drug-drug interactions in a traditional sense, but certain situations require special attention:
- Corticosteroids and other immune-suppressing medications: These are used to manage immune-related side effects from Libtayo, but taking them proactively or unnecessarily could reduce Libtayo's effectiveness against cancer.
- Allogeneic stem cell transplant (HSCT): Patients who undergo a donor stem cell transplant before or after Libtayo treatment face an increased risk of serious, potentially fatal transplant complications such as graft-versus-host disease.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Libtayo can harm a developing baby. Tell your doctor if you are pregnant or might become pregnant. Women of childbearing age must use effective contraception during treatment and for at least 4 months after the last dose.
- Breastfeeding: Do not breastfeed while on Libtayo or for at least 4 months after the last dose, due to risk of serious harm to the infant.
- Autoimmune conditions: If your immune system already attacks your own body (e.g., lupus, rheumatoid arthritis), Libtayo may make it worse. Discuss this with your doctor.
- Stem cell transplant history or plans: Serious complications including death have occurred in patients who received a donor (allogeneic) stem cell transplant around the time of PD-1 blocking antibody treatment.
- Children: Libtayo's safety and effectiveness have not been established in patients under 17 years of age.
- Older adults (65+): Studies included many patients over 65 and 75 — no significant differences in safety or effectiveness were found compared to younger adults.
- Liver impairment: Patients with severe liver impairment have not been well studied; discuss with your doctor if this applies to you.
📡Pharmacodynamics — effects in the body▾
The exposure-response relationship for Libtayo — meaning the precise link between the amount of drug in the body and how well it works or what effects it produces — has not been fully characterized. Your care team will monitor treatment response through clinical assessments rather than drug level measurements.
🔬Pharmacokinetics — how your body processes it▾
After IV infusion, Libtayo distributes into the body with a volume of distribution of about 5.9 liters — meaning it stays largely within the bloodstream and surrounding fluid rather than spreading widely into tissues. It takes roughly 4 months to reach a stable, steady level in the blood with regular dosing. The drug is cleared slowly, with an elimination half-life (the time for half the drug to leave the body) of about 22 days, meaning it stays in the body for several weeks after a dose. No clinically significant differences in how the body handles Libtayo were seen based on age, sex, race, body weight, or mild-to-moderate kidney or liver function changes.
📦How to store it▾
Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton. Protect from light. Do not freeze or shake.
📄 Written from Cemiplimab-rwlc Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Cemiplimab-rwlc Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Libtayo and how does it fight my cancer? ▾
How is Libtayo given and how often will I need to come in? ▾
What side effects should I actually watch out for? ▾
Can I keep taking my other medications while on Libtayo? ▾
Is it safe to get pregnant or breastfeed while on Libtayo? ▾
What happens if I have a bad reaction during the infusion? ▾
Is Cemiplimab-rwlc Injection available over the counter? ▾
When was Cemiplimab-rwlc Injection first available? ▾
Who makes Cemiplimab-rwlc Injection? ▾
💬 Answers drafted from Cemiplimab-rwlc Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Cemiplimab-rwlc Injection comes
Cemiplimab-rwlc Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Libtayo is used to treat adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) not suitable for curative surgery or radiation, and as adjuvant therapy after surgery and radiation in CSCC at high risk of recurrence
- Libtayo is used to treat adults with locally advanced or metastatic basal cell carcinoma (BCC) after prior hedgehog pathway inhibitor therapy or when that therapy is not appropriate
- Libtayo is used alone as first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression and no EGFR, ALK, or ROS1 aberrations
- Libtayo is used in combination with platinum-based chemotherapy as first-line treatment of locally advanced or metastatic NSCLC without EGFR, ALK, or ROS1 aberrations
- Libtayo is given as an intravenous infusion over 30 minutes by a healthcare professional
- Libtayo must be diluted before administration; it should not be shaken
- The infusion line must include a sterile in-line or add-on filter
- Libtayo is given every 3 weeks or every 6 weeks depending on the condition and treatment schedule prescribed by your doctor
📊 Cemiplimab-rwlc Injection across the U.S. market
How Cemiplimab-rwlc Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Cemiplimab-rwlc Injection is used
A general measure of how commonly Cemiplimab-rwlc Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Cemiplimab-rwlc Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Cemiplimab-rwlc Injection prescribed? Of the 1,596 medications we measure, Cemiplimab-rwlc Injection ranks #1,097 by Medicaid prescriptions — more than 31% of them.
Utilization by Cemiplimab-rwlc Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
7 ML cemiplimab-rwlc 50 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2058830
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Cemiplimab-rwlc Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Cemiplimab-rwlc Injection NDCs with Medicaid activity.
🔍 Compare Cemiplimab-rwlc Injection products
A representative set of FDA-listed product records for Cemiplimab-rwlc Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 350 mg/7 mL | — | Catalent Indiana, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 50 mg/mL | Intravenous | Regeneron Pharmaceuticals, Inc. × 4 listings | BLA | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Cemiplimab-rwlc Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Cemiplimab-rwlc Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Cemiplimab-rwlc Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Cemiplimab-rwlc Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2058826 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 2058829In current FDA listingsClinical drug / strength (SCD) 7 ML cemiplimab-rwlc 50 MG/MLRxCUI 2058830
Look up RxCUI 2058826 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Cemiplimab-rwlc Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Cemiplimab-rwlc Injection belongs to the PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Regeneron Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.