Cemiplimab-rwlc

What is Cemiplimab-rwlc?

• Cemiplimab-rwlc (Libtayo) is a programmed death receptor-1 (PD-1) blocking antibody used to treat cutaneous squamous cell carcinoma.

What are the uses of this medicine?

This medicine is 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.

a type of lung cancer called non-small cell lung cancer (NSCLC). Libtayo may be used as your first treatment when your lung cancer:

• has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or
• your lung cancer has spread to other areas of your body (metastatic lung cancer), and
• your tumor tests positive for high "PD-L1" and
• your tumor does not have an abnormal "EGFR"," ALK "or "ROS1" gene

How does this medicine work?

• A human monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (PD-1, PCD-1) protein, with potential immune checkpoint inhibitory and antineoplastic activity.
• Upon administration, cemiplimab-rwlc binds to PD-1, inhibits its binding to the PD-1 ligand programmed cell death-1 ligand 1 (PD-L1), and prevents the activation of its downstream signaling pathways.
• This may restore immune function through the activation of cytotoxic T cells.
• PD-1, a transmembrane protein in the immunoglobulin superfamily expressed on activated T cells, negatively regulates T-cell activation and effector function when activated by its ligand; it plays an important role in tumor evasion from host immunity.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with Libtayo.

Is this medicine FDA approved?

• It was approved for use in the United States in 2018.

How should this medicine be used?

• Select patients with locally advanced or metastatic NSCLC for treatment with Libtayo based on PD-L1 expression on tumor cells.

Recommended Dosage

• The recommended dosage of Libtayo is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

Administration

• 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 dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Injection: 350 mg/7 mL (50 mg/mL) solution in a single-dose vial.

This medicine is available in fallowing brand namesː

• Libtayo

What side effects can this medication cause?

The most common side effects,laboratory abnormalities of this medicine include:

• musculoskeletal pain
• fatigue
• rash
• diarrhea
• lymphopenia
• hyponatremia
• hypophosphatemia
• increased aspartate aminotransferase
• anemia
• hyperkalemia

Libtayo can cause serious side effects, including:

• Intestinal problems
• Liver problems
• Hormone gland problems
• Kidney problems
• Skin problems

What special precautions should I follow?

• Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection.
• Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
• Withhold or permanently discontinue Libtayo based on the severity of reaction.
• Severe infusion-related reactions (Grade 3) occurred in 0.1% of patients receiving Libtayo. Interrupt, slow the rate of infusion, or permanently discontinue based on severity of reaction.
• Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody.
• Libtayo Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on the use of Libtayo in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Libtayo have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

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

Who manufactures and distributes this medicine?

• Manufactured by: Regeneron Pharmaceuticals, Inc. 777 Old Saw Mill River Road Tarrytown, NY 10591-6707 U.S. License No. 1760
• Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591) and sanofi-aventis U.S. LLC (Bridgewater, NJ 08807)

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Cemiplimab-rwlc
• FDA Cemiplimab-rwlc

Cemiplimab-rwlc Resources
Latest articles Most recent articles Ongoing trials	Wikipedia

Cemiplimab-rwlc Resources
Latest articles Most recent articles Ongoing trials	Wikipedia