Cemiplimab-rwlc

From WikiMD's Wellness Encyclopedia

What is Cemiplimab-rwlc?[edit | edit source]

What are the uses of this medicine?[edit | edit source]

This medicine is used to treat people with:

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?[edit | edit source]

  • 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 ?[edit | edit source]

  • This medicine have no usage limitations.

What drug interactions can this medicine cause?[edit | edit source]

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

Is this medicine FDA approved?[edit | edit source]

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

How should this medicine be used?[edit | edit source]

  • 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?[edit | edit source]

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?[edit | edit source]

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

Libtayo can cause serious side effects, including:

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

What special precautions should I follow?[edit | edit source]

  • 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?[edit | edit source]

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

Can this medicine be used in pregnancy?[edit | edit source]

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

Can this medicine be used in children?[edit | edit source]

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

What are the active and inactive ingredients in this medicine?[edit | edit source]

  • 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?[edit | edit source]

  • 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?[edit | edit source]

  • 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.
Cemiplimab-rwlc Resources


Cemiplimab-rwlc Resources
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