Libtayo

What is Libtayo?

Libtayo is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC). Libtayo may be used to treat CSCC that has spread or cannot be cured by surgery or radiation; a type of skin cancer called basal cell carcinoma (BCC).

Libtayo may be used when your BCC cannot be removed by surgery (locally advanced BCC) and you have received treatment with a hedgehog pathway inhibitor (HHI), or if you cannot receive treatment with a HHI, has spread (metastatic BCC) and you have received treatment with a HHI, or if you cannot receive treatment with a HHI.

It is not known if Libtayo is safe and effective in children.

Description

Cemiplimab-rwlc is a human programmed death receptor-1 (PD-1) blocking antibody. Cemiplimab-rwlc is a recombinant human IgG4 monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2. Cemiplimab-rwlc is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. Cemiplimab-rwlc has an approximate molecular weight of 146 kDa.

LIBTAYO (cemiplimab-rwlc) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution with a pH of 6. The solution may contain trace amounts of translucent to white particles.

Each vial contains 350 mg of cemiplimab-rwlc. Each mL contains cemiplimab-rwlc 50 mg, L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.1 mg), sucrose (50 mg), L-proline (15 mg), Polysorbate 80 (2 mg), and Water for Injection, USP.

Mechanism of Action

Binding of the PD-1 ligands PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors.

Cemiplimab-rwlc is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.

What is the most important information I should know about Libtayo?

Libtayo is a medicine that may treat certain types of skin cancer 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.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

Lung problems.

• cough
• shortness of breath
• chest pain

Intestinal problems.

• diarrhea (loose stools) or more frequent bowel movements than usual
• stools that are black, tarry, sticky, or have blood or mucus
• severe stomach-area (abdomen) pain or tenderness

Liver problems.

• yellowing of your skin or the whites of your eyes
• severe nausea or vomiting
• pain on the right side of your stomach-area (abdomen)
• dark urine (tea colored)
• bleeding or bruising more easily than normal

Hormone gland problems.

• headache that will not go away or unusual headaches
• eye sensitivity to light
• eye problems
• rapid heartbeat
• increased sweating
• extreme tiredness
• weight gain or weight loss
• feeling more hungry or thirsty than usual
• urinating more often than usual
• hair loss
• feeling cold
• constipation
• your voice gets deeper
• dizziness or fainting
• changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems.

• decrease in your amount of urine
• blood in your urine
• swelling of your ankles
• loss of appetite

Skin problems.

• rash
• itching
• skin blistering or peeling
• painful sores or ulcers in mouth or nose, throat, or genital area
• fever or flu-like symptoms
• swollen lymph nodes

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Libtayo. Call or see your healthcare provider right away for any new or worsening signs or symptoms which may include:

• chest pain, irregular heartbeat, shortness of breath or swelling of ankles
• confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• persistent or severe muscle pain or weakness, muscle cramps
• low red blood cells, bruising

Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include:

• chills or shaking
• itching or rash
• flushing
• shortness of breath or wheezing
• dizziness
• feel like passing out
• fever
• back or neck pain
• facial swelling

Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Libtayo. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Libtayo. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Libtayo if you have severe side effects.

What should I tell my healthcare provider before using Libtayo?

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 received 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.

How should I use 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.

What are the possible side effects of Libtayo?

Libtayo can cause serious side effects, including:

• See “What is the most important information I should know about Libtayo?”

The most common side effects of Libtayo include tiredness, rash and diarrhea.
These are not all the possible side effects of Libtayo.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Libtayo

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about Libtayo, talk with your healthcare provider. You can ask your healthcare provider for information about Libtayo that is written for health professionals.

What are the ingredients of Libtayo?

Active ingredient: cemiplimab-rwlc
Inactive ingredients: L-histidine, L-histidine monohydrochloride monohydrate, sucrose, L-proline, Polysorbate 80, and Water for Injection, USP.

Label

PRINCIPAL DISPLAY PANEL – 350 MG/7 ML VIAL CARTON

• NDC 61755-008-01
  Rx only
• LIBTAYO®
  (cemiplimab-rwlc)
  Injection
• 350 mg/7 mL (50 mg/mL)
• For Intravenous Infusion After Dilution
  Single-Dose Vial
• Discard unused portion.
• Do not use vial if seal is broken or missing.
  Dispense the enclosed Medication Guide to each patient.
• REGENERON ∣ SANOFI GENZYME

SRC: NLM .