Our Therapies

LIBTAYO® Infusion Therapy

Violet Health Outpatient Specialty Infusion Care

About LIBTAYO® Infusion Therapy

LIBTAYO® (cemiplimab-rwlc) is a programmed death receptor-1 blocking antibody, usually shortened to PD-1 inhibitor. PD-1 is a brake on the surface of T cells. Some tumors switch that brake on deliberately, which keeps the immune system from recognizing and attacking them. LIBTAYO® binds PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing the brake so your own T cells can see the cancer again.

That places LIBTAYO® in the same family as KEYTRUDA® and OPDIVO®, and alongside the PD-L1 blockers TECENTRIQ® and IMFINZI® we also offer. What sets it apart is where it is used. LIBTAYO® is the checkpoint inhibitor with the deepest footing in advanced skin cancer, and it is the only one approved for basal cell carcinoma after a hedgehog pathway inhibitor.

Dosing and administration

350 mg given as an intravenous infusion over 30 minutes, every 3 weeks. The dose is fixed, not calculated from your weight.
Advanced cutaneous squamous cell carcinoma and advanced basal cell carcinoma: 350 mg every 3 weeks until the disease progresses, until side effects make it unworkable, or up to 24 months.
Non-small cell lung cancer, alone or with platinum-based chemotherapy: 350 mg every 3 weeks until progression or unacceptable toxicity.
Adjuvant CSCC after surgery and radiation: either 350 mg every 3 weeks for 12 weeks followed by 700 mg every 6 weeks, or 350 mg every 3 weeks throughout. Either way, treatment runs up to 48 weeks and then stops.

That adjuvant schedule is worth pausing on, because nothing else on this site works quite like it. The dose doubles to 700 mg while the interval also doubles to every 6 weeks, so the total amount of medicine stays the same and your visits drop from 17 to roughly nine over the course of a year. Both options are supported by the same trial and produced similar results, so the choice between them is largely about what fits your life. And unlike the advanced-disease settings, adjuvant treatment has a defined end date rather than continuing indefinitely.

There is no premedication protocol and no loading phase. LIBTAYO® is diluted into sodium chloride or dextrose, infused through an in-line filter, and given over half an hour. Liver enzymes, creatinine, and thyroid function are checked before the first dose and periodically after, because those labs are how immune-mediated reactions are usually caught before you feel them.

One practical note on timing: it takes about 4 months to reach steady levels, and the median time to response in the advanced skin cancer trials was just over 2 months. Checkpoint inhibitors work on a slower clock than chemotherapy, and scans are generally done every 9 weeks or so rather than after every few doses.

Conditions treated by this therapy

LIBTAYO® is FDA approved for adults across three cancers:

Cutaneous squamous cell carcinoma (CSCC)

Metastatic CSCC, or locally advanced CSCC in patients who are not candidates for curative surgery or curative radiation
Adjuvant treatment of CSCC at high risk of recurrence after surgery and radiation

Basal cell carcinoma (BCC)

Locally advanced or metastatic BCC in patients previously treated with a hedgehog pathway inhibitor, or for whom a hedgehog pathway inhibitor is not appropriate

Non-small cell lung cancer (NSCLC)

First-line, in combination with platinum-based chemotherapy, for locally advanced NSCLC in patients who are not candidates for surgical resection or definitive chemoradiation, or for metastatic NSCLC, with no EGFR, ALK, or ROS1 aberrations
First-line as a single agent for the same settings when the tumor has high PD-L1 expression, meaning a Tumor Proportion Score of 50% or more on an FDA-approved test, with no EGFR, ALK, or ROS1 aberrations

Two things decide eligibility here as much as the diagnosis does, and both come from the pathology and molecular reports rather than the clinic note:

For BCC, prior hedgehog pathway inhibitor therapy (vismodegib or sonidegib) has to be documented, or the reason one is not appropriate. LIBTAYO® is a second-line option in BCC, not a first-line one.
For single-agent NSCLC, the PD-L1 Tumor Proportion Score has to be 50% or higher. Below that threshold, the combination with chemotherapy is the approved route, and that one does not depend on PD-L1 at all.

Adults only. Safety and effectiveness have not been established in children. LIBTAYO® is also not a treatment for early-stage skin cancers that surgery can cure, and in the adjuvant setting the high-risk features (such as extracapsular extension, three or more involved nodes, perineural invasion, in-transit metastases, or bone and skull base invasion) are what define eligibility.

LIBTAYO® Price

The cost of prescription medications can vary depending on your insurance coverage. If you're concerned about the price of your medication:

Contact your insurance provider to understand your coverage
Ask your doctor or pharmacist about lower-cost alternatives
Check with the drug manufacturer about financial assistance programs
Explore patient assistance options if you're uninsured or underinsured

Remember, many resources exist to help patients access necessary medications. Don't hesitate to ask for help if you're struggling with medication costs. No patient should go without necessary treatment due to financial limitations. If you have questions about financial assistance opportunities, contact a member of our Violet Health team.

What to Expect During LIBTAYO® Infusion Therapy

LIBTAYO® is a prescription immunotherapy first approved by the FDA in 2018, with the adjuvant skin cancer indication added in October 2025. At Violet Health we're proud to offer it in our spa-like infusion center, a comfortable alternative to traditional hospital settings.

Here is what a typical LIBTAYO® visit looks like:

Labs are drawn before treatment, including liver enzymes, creatinine, and thyroid function. These are checked at baseline and periodically throughout, since they often pick up an immune-mediated reaction before symptoms appear.
Your care team asks about new or changed symptoms since your last visit. With checkpoint inhibitors this conversation is part of the treatment, not small talk.
The infusion runs through a standard peripheral IV over 30 minutes. No premedication is needed, and no port or central line is required.
Most visits run about 90 minutes to two hours from check-in to walking out, with labs and the short observation period included. Most patients drive themselves.
If you are receiving LIBTAYO® with platinum-based chemotherapy for lung cancer, plan on a longer day for the first four cycles. LIBTAYO® is given first, followed by the chemotherapy, and the combined visit typically runs several hours.

The rhythm is straightforward: every three weeks, same dose, same half-hour infusion. If you are on the adjuvant schedule, the interval stretches to every six weeks after the first 12 weeks, which most patients find a welcome change. That schedule also has a finish line at 48 weeks, which is unusual for immunotherapy and worth holding onto.

Responses take time. In the advanced skin cancer trials the median time to a measurable response was about 2.1 months, and some responses took considerably longer. When responses do come, they tend to last: median duration of response in advanced CSCC was roughly 41 months, and 77% of responders were still responding at a year. Scans are generally repeated every 9 to 12 weeks rather than after each dose.

Tell your care team if you have an autoimmune condition, have had an organ or tissue transplant including a corneal graft, have had a donor stem cell transplant, or have had radiation to your chest. Each of these changes how LIBTAYO® is monitored, and in some cases whether it is the right choice at all.

LIBTAYO® Side Effects

The most common side effects reported in at least 15% of patients receiving LIBTAYO® on its own, across advanced CSCC, BCC, and PD-L1-high NSCLC, were:

Fatigue
Muscle, joint, or bone pain
Rash
Diarrhea
Anemia, meaning low red blood cells

Itching, nausea, constipation, cough, decreased appetite, headache, and dizziness were also common. In advanced BCC, fatigue reached 50% and diarrhea 33%, and hypertension was the most frequent severe reaction at 9%.

The picture shifts with the setting

Adjuvant CSCC is the mildest profile on the label. Only rash (37%), itching (16%), and hypothyroidism (12%) occurred in 10% or more of patients with a meaningful difference from placebo. Serious reactions occurred in 18% of patients, compared with 41% in the advanced setting.
With platinum-based chemotherapy for lung cancer, the common list changes shape entirely: hair loss (37%), muscle and bone pain, nausea, fatigue, peripheral neuropathy, and decreased appetite. Most of that comes from the chemotherapy rather than the LIBTAYO®, and low blood counts become a routine part of monitoring.

Immune-mediated reactions

Because LIBTAYO® releases a brake on the immune system, that immune system can also turn on healthy tissue. These reactions can affect any organ, can be severe or fatal, can involve more than one organ at once, and can appear at any point during treatment or even months after the last dose. In clinical trials they included:

Pneumonitis, inflammation of the lungs (2.6% of patients). Report new or worsening cough, chest pain, or shortness of breath.
Colitis, inflammation of the bowel (2%). Report diarrhea, more frequent stools than usual, blood or mucus in the stool, or severe abdominal pain.
Hepatitis, inflammation of the liver (2.4%). Report yellowing of the skin or eyes, dark urine, severe nausea, easy bruising, or pain on the right side of the abdomen.
Hormone gland problems, which are the most common group overall: hypothyroidism (7%), hyperthyroidism (3%), thyroiditis, adrenal insufficiency, hypophysitis (inflammation of the pituitary), and rarely type 1 diabetes. Many patients who develop hypothyroidism need thyroid hormone replacement long term.
Nephritis with kidney dysfunction (0.7%). Report a drop in urine output, blood in the urine, or ankle swelling.
Skin reactions (1.9%), including severe exfoliating conditions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS. Report any new rash, blistering, peeling, or painful sores in the mouth, nose, throat, or genital area.
Less common but serious reactions reported in under 1% of patients, including myocarditis, pericarditis, vasculitis, meningitis, encephalitis, Guillain-Barré syndrome, myasthenia gravis, uveitis and other eye inflammation, pancreatitis, myositis, and rejection of a transplanted organ or tissue.

Most of these are managed with corticosteroids and a pause in treatment rather than stopping for good. Something worth knowing about this drug specifically: there is no dose reduction with LIBTAYO®. If a reaction is severe, treatment is either withheld until it resolves or discontinued permanently. There is no stepping down to a smaller dose.

Infusion-related reactions

Severe infusion reactions are uncommon, occurring in about 0.2% of patients receiving LIBTAYO® alone. Symptoms can include nausea, fever, vomiting, chills or shaking, flushing, itching or rash, dizziness, back or neck pain, facial swelling, or shortness of breath. Mild reactions are usually handled by slowing or briefly interrupting the infusion.

Get emergency help right away if you experience:

Trouble breathing, wheezing, or chest tightness
Swelling of the face, throat, or tongue
Chest pain or an irregular heartbeat
Confusion, stiff neck, balance problems, or numbness and tingling in the arms or legs
Sudden changes in vision, double vision, or eye pain
Skin blistering or peeling, or fever with a spreading rash and swollen lymph nodes

Important Safety Information

LIBTAYO® has no boxed warning and no contraindications listed on its label. That is unusual on this site, and it does not mean the risks are small. It means the important ones are handled through monitoring rather than exclusion.

Stem cell transplant complications

Fatal and other serious complications can occur in people who receive a donor (allogeneic) stem cell transplant before or after treatment with a PD-1 or PD-L1 blocking antibody. These include hyperacute, acute, and chronic graft-versus-host disease, hepatic veno-occlusive disease, and steroid-requiring fever. They can happen even when other treatment is given in between. If a transplant is part of your history or your plan, this needs to be discussed before starting.

Transplant rejection

Rejection of a transplanted solid organ, and of other grafts including corneal transplants, has been reported. This matters more here than on most checkpoint inhibitor pages, because transplant recipients on long-term immunosuppression have a markedly higher risk of aggressive cutaneous squamous cell carcinoma, and are therefore exactly the patients who may be considered for LIBTAYO®. The clinical trials excluded people with a history of solid organ transplant, so any use in that setting is a careful individual decision.

Pregnancy and breastfeeding

LIBTAYO® can cause fetal harm. Blocking the PD-1 pathway can disrupt the immune tolerance that maintains a pregnancy, which in animal models led to fetal loss. Pregnancy status is verified before the first dose. Females of reproductive potential should use effective contraception during treatment and for at least 4 months after the last dose, and should not breastfeed during treatment or for at least 4 months after.

Before you start, tell your care team if you

Have an immune system condition such as Crohn's disease, ulcerative colitis, or lupus
Have received an organ or tissue transplant, including a corneal transplant
Have received or plan to receive a donor stem cell transplant
Have had radiation treatment to your chest, which raises the risk of pneumonitis
Have a nervous system condition such as myasthenia gravis or Guillain-Barré syndrome

Keep the Medication Guide you are given and carry a card noting that you are receiving immunotherapy. If you need urgent care elsewhere, the treating clinician needs to know, because immune-mediated reactions are easy to mistake for ordinary infections or stomach upsets.

What Your Referral Should Include

Eligibility for LIBTAYO® depends on specifics that live in the pathology, radiology, and prior treatment records. A complete referral moves scheduling along considerably. Please include:

Diagnosis and histology, with the pathology report, and whether disease is locally advanced, metastatic, or being treated in the adjuvant setting
For CSCC and BCC, confirmation that curative surgery and curative radiation are not options, with the reason
For adjuvant CSCC, the surgery and radiation dates, confirmation that adjuvant radiation finished within the past 2 to 10 weeks, and the high-risk features present (extracapsular extension, number of involved nodes, perineural invasion, in-transit metastases, T4 or bone and skull base invasion, or a locally recurrent tumor with additional adverse features)
For adjuvant CSCC, which of the two dosing schedules is intended, since it sets the visit interval for the next 48 weeks
For BCC, prior hedgehog pathway inhibitor therapy (vismodegib or sonidegib) with dates and outcome, or documentation of why an HHI is not appropriate
For NSCLC, the PD-L1 Tumor Proportion Score with the assay used, EGFR, ALK, and ROS1 results, histology (squamous or non-squamous), and whether single-agent or chemotherapy-combination treatment is planned with the specific platinum regimen
Prior anti-PD-1, anti-PD-L1, or other checkpoint inhibitor exposure, with dates, and any immune-mediated reaction that followed
Autoimmune disease history and any current systemic immunosuppression, including corticosteroid dose
Solid organ or corneal transplant history, current anti-rejection medications, and any prior or planned allogeneic stem cell transplant
Prior thoracic radiation, since it raises pneumonitis risk, along with baseline respiratory status
Baseline labs: liver enzymes, creatinine, thyroid function with TSH and free T4, CBC, and electrolytes including sodium
HIV, hepatitis B, and hepatitis C status
ECOG performance status, and baseline blood pressure given the hypertension signal in BCC
Neurologic history, specifically myasthenia gravis or Guillain-Barré syndrome
Pregnancy status for females of reproductive potential, and the contraception plan covering treatment plus 4 months
Baseline imaging and, for visible skin lesions, baseline photography, since response in CSCC and BCC is assessed partly by photographic comparison
Venous access notes, including any history of difficult sticks