Cemiplimab-rwlc
(Redirected from Cemiplimab)
What is Cemiplimab-rwlc?[edit | edit source]
- 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?[edit | edit source]
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?[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:
- 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?[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.
- 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?[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.
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Cemiplimab-rwlc Resources | ||
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Translate to: East Asian
中文,
日本,
한국어,
South Asian
हिन्दी,
Urdu,
বাংলা,
తెలుగు,
தமிழ்,
ಕನ್ನಡ,
Southeast Asian
Indonesian,
Vietnamese,
Thai,
မြန်မာဘာသာ,
European
español,
Deutsch,
français,
русский,
português do Brasil,
Italian,
polski
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