Frequently asked questions

Here are some frequently asked questions that patients may have about advanced CSCC and treatment with LIBTAYO. Remember that this information is not meant to take the place of talking to your doctor. Your doctor is the best source of information about your condition.

Below are questions about advanced CSCC and treatment with LIBTAYO.

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When a squamous cell carcinoma of the skin spreads extensively or aggressively in some cases, or has resisted multiple treatments and returned repeatedly, it is considered to be advanced CSCC because it has spread and cannot be cured by surgery or radiation.

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The stages are based on the size of the tumor, how deeply into the skin it has grown, and whether cancer has spread beyond the tumor to the lymph nodes. Your doctor will look at the results of the biopsy to determine the stage. If you have squamous cell skin cancer, your doctor may also recommend imaging such as a computed tomography (CT) or a combined positron-emission tomography (PET)-CT scan, or testing lymph nodes near the tumor to see if the cancer has spread beyond the skin.

Stage 0: Cancer that is located in the place it started and has not spread to nearby tissues.

Stage I: This stage is usually a small cancer or tumor that has not grown deeply into nearby tissues. It also has not spread to the lymph nodes or other parts of the body.

Stage II and Stage III: In general, these 2 stages indicate larger cancers or tumors that have grown more deeply into nearby tissue. They may have also spread to lymph nodes but not to other parts of the body.

Stage IV: The cancer has spread to other organs or parts of the body. It also may be called advanced or metastatic cancer.

Metastatic CSCC: Occurs when tumors spread beyond the original location to other parts of the body. These CSCCs can be life-threatening.

Locally advanced CSCC: Occurs when tumors become large or have grown deeper into underlying tissues, muscles, or nerves, destroying nearby healthy tissue. These lesions can become swollen, painful, and disfiguring.

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LIBTAYO is not chemotherapy or radiation therapy. LIBTAYO is a type of immunotherapy treatment called a programmed death receptor-1 (PD-1) inhibitor.

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Immunotherapy is a type of systemic drug therapy (a type of drug that moves through the body) that may help your immune system fight cancer. Your body might not attack cancer because the cancer cells have developed ways to avoid the immune system. Immunotherapy helps the immune system recognize, attack, and kill the cancer cells. This treatment is given by an oncologist. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of the body and can affect the way they work.

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LIBTAYO is a medicine that may treat certain cancers by working with your immune system. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

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information about LIBTAYO

LIBTAYO can cause serious side effects.

The most common side effects of LIBTAYO include tiredness, muscle or bone pain, rash, diarrhea, and low levels of red blood cells (anemia). These are not all the possible side effects of LIBTAYO. Make sure to read all of the important information about LIBTAYO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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information about LIBTAYO
See the most common side effects
that occurred in the LIBTAYO study
Before you receive LIBTAYO, tell your healthcare provider about all your medical conditions, including if you:
  • have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
  • have had an organ transplant
  • have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
  • have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
  • are pregnant or plan to become pregnant. LIBTAYO can harm your unborn baby
Females who are able to become pregnant:
  • Your healthcare provider will give you a pregnancy test before you start treatment with LIBTAYO.
  • You should use an effective method of birth control during your treatment and for at least 4 months after the last dose of LIBTAYO. Talk to your healthcare provider about birth control methods that you can use during this time.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LIBTAYO.
  • are breastfeeding or plan to breastfeed. It is not known if LIBTAYO passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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information about LIBTAYO
  • Your healthcare provider will give you LIBTAYO into your vein through an intravenous (IV) line over 30 minutes.
  • LIBTAYO is usually given every 3 weeks.
  • Your healthcare provider will decide how many treatments you will need.
  • Your healthcare provider will do blood tests to check you for side effects.
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
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taking LIBTAYO
Every person is different and not everyone will respond to LIBTAYO the same way. LIBTAYO may not work for some people with advanced CSCC. Some patients may not respond to LIBTAYO at all. If you have any questions about treatment with LIBTAYO, talk to your doctor.

LIBTAYO Surround offers patient support that may help with access to medication, including financial support when eligible patients need assistance with out-of-pocket costs.

LIBTAYO is covered by most major insurers, and LIBTAYO Surround may help you access LIBTAYO and navigate the health insurance process.

Review the most important safety information you should know about LIBTAYO.

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