Frequently Asked Questions about Libtayo® (cemiplimab-rwlc)

TraceyS

Class: Biological Therapy
Generic Name: cemiplimab-rwlc
Trade Name: Libtayo®

How is Libtayo used? Libtayo is approved to treat patients with cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC) and non-small cell lung cancer (NSCLC) as follows:

  • CSCC: metastatic or locally advanced CSCC patients ineligible for curative surgery or radiation
  • BCC: metastatic or locally advanced BCC patients who have had prior treatment with a hedgehog pathway inhibitor or who are ineligible for treatment with a hedgehog pathway inhibitor
  • NSCLC: first-line treatment for NSCLC patients who have high PD-L1 expression without abnormal EGFR, ALK or ROS1 genes and have either:
    • locally advanced cancer and are ineligible for surgery or chemotherapy with radiation, or
    • metastatic lung cancer.

What is the mechanism of action? Libtayo is a type of drug known as a programmed death receptor-1 (PD-1) blocking antibody. Libtayo blocks PD-1, a protein that interferes with certain types of immune responses and may enhance the ability of the immune system to fight cancer.

How is Libtayo given (administered)? Libtayo is given by intravenous infusion, usually once every three weeks. Each infusion takes about 30 minutes.

How are patients monitored? Patients receiving Libtayo are monitored with blood work and other laboratory tests for the following immune-mediated adverse reactions:

  • Pneumonitis (inflammation of lung tissue)
  • Colitis (inflammation of the colon)
  • Hepatitis
  • Hypophysitis (inflammation of the pituitary gland)
  • Changes in renal (kidney) function
  • Changes in thyroid function

What are the most common side effects of treatment with Libtayo?

  • Musculoskeletal pain
  • Fatigue
  • Rash
  • Diarrhea

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Pay careful attention to your healthcare provider’s instructions and inform your doctor of any side effects.
  • Maintain adequate rest and nutrition.
  • Eat small meals frequently to help alleviate nausea.

Are there any special precautions patients should be aware of before starting treatment?

  • Follow your infusion schedule for Libtayo.
  • Tell your doctor about all medication you take, prescription and over the counter.
  • Tell your doctor about any health conditions such as:
    • Crohn’s disease, ulcerative colitis, lupus or other immune system problems
    • Myasthenia Gravis, Guillain-Barre syndrome or other conditions that affect your nervous system
  • Tell your doctor if you have received an organ transplant or if you have received or plan to receive a stem cell transplant that uses donor stem cells.
  • Keep your scheduled appointments for blood work or other laboratory tests that monitor your response to Libtayo.

· Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. You should not become pregnant during treatment with Libtayo and for at least 4 months after the last dose of Libtayo. It is important to use some kind of birth control while undergoing treatment. It is not known if Libtayo passes into breast milk; avoid breastfeeding during treatment and for 4 months after your last dose.

When should patients notify their physician?

  • If you experience side effects that are bothersome or don’t go away
  • If you have symptoms of lung problems (pneumonitis), including: shortness of breath, chest pain, new or worse cough
  • If you have symptoms of intestinal problems (colitis), including: diarrhea or more bowel movements than usual: stools that are black, tarry, sticky, or have blood or mucus
  • If you have severe stomach pain or tenderness
  • If you have symptoms of liver problems (hepatitis), including: yellowing of your skin or the whites of your eyes, dark urine, nausea or vomiting, feeling less hungry than usual, pain on the right side of your stomach area, bleeding or bruising more easily than normal
  • If you have symptoms of hormone gland problems (especially the thyroid, pituitary, and adrenal glands), including: rapid heart beat, weight loss, increased sweating, weight gain, hair loss, feeling cold, constipation, your voice gets deeper, muscle aches, dizziness or fainting, headaches that will not go away or unusual headache
  • If you have symptoms of kidney problems, such nephritis and kidney failure, including: change in the amount or color of your urine
  • If you have signs of problems with other organs, including: rash, itching, other skin problems, swollen lymph nodes, changes in eyesight, severe or persistent muscle or joint pains, severe muscle weakness.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 2/21.

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