Cemiplimab (trade name Libtayo) is a human IgG4 monoclonal antibody targeting PD-1, jointly developed by the American companies Regeneron and Sanofi.

1、 Drug name

1. Common name: Cemiplimab rwlc

2. Product Name: LIBTAYO ®

2、 Indications

1. Skin squamous cell carcinoma: used to treat adult patients with metastatic or locally advanced skin squamous cell carcinoma who cannot undergo curative surgery or radiation therapy; It is also used as an adjuvant therapy for skin squamous cell carcinoma with high recurrence risk after surgery and radiotherapy.

2. Basal cell carcinoma: Used for adult patients with locally advanced or metastatic basal cell carcinoma who have previously received hedgehog pathway inhibitor therapy or are not suitable for hedgehog pathway inhibitor therapy.

3. Non small cell lung cancer:

Used in combination with platinum based chemotherapy for first-line treatment of locally advanced or metastatic non-small cell lung cancer in adult patients without EGFR, ALK, or ROS1 mutations.

Monotherapy is used for first-line treatment of locally advanced or metastatic non-small cell lung cancer in adult patients with PD-L1 overexpression (TPS ≥ 50%) and no EGFR, ALK, or ROS1 mutations.

3、 Specifications and characteristics

1. Specification: 350mg/7mL (50mg/mL) per bottle

2. Appearance: Clear to microemulsion light, colorless to light yellow solution, may contain trace amounts of semi transparent to white particles.

4、 Main components

1. Active ingredient: Cemiplimab rwlc

5、 Usage and dosage

1. Administration route: intravenous infusion, diluted and infused for 30 minutes.

2. Recommended dosage:

Metastatic or locally advanced squamous cell carcinoma/basal cell carcinoma: 350mg, once every 3 weeks, until disease progression, unacceptable toxicity, or up to 24 months.

Adjuvant therapy for high recurrence risk skin squamous cell carcinoma: 350mg every 3 weeks for a total of 12 weeks, followed by 700mg every 6 weeks, or 350mg every 3 weeks until disease recurrence, unacceptable toxicity, or total treatment time reaches 48 weeks.

Non small cell lung cancer (monotherapy or combination chemotherapy): 350mg, once every 3 weeks until disease progression or unacceptable toxicity.

6、 Dose adjustment

1. We do not recommend reducing the dosage of medication.

2. Suspend or permanently discontinue medication based on the severity of adverse reactions:

Severe (Level 3) immune-mediated adverse reactions: Discontinue administration.

Life threatening (grade 4) immune-mediated adverse reactions, recurrent grade 3 immune-mediated reactions requiring systemic immunosuppressive therapy, or inability to reduce corticosteroids to prednisone equivalent dose ≤ 10mg/day within 12 weeks after initiating steroids: permanent discontinuation.

7、 Medication precautions

1. Before and after meals: No special requirements.

2. Missed administration: No additional medication should be administered, and the next dose should be administered according to the original plan.

3. Vomiting: No specific treatment was mentioned. If vomiting is suspected to affect the therapeutic effect, a physician should be consulted.

4. Before infusion, visually inspect for particles or discoloration. After dilution, the solution should be left at room temperature (≤ 25 ° C) for no more than 8 hours or refrigerated (2 ° C to 8 ° C) for no more than 10 hours. It should be restored to room temperature before use and should not be frozen.

5. Use an infusion set with a 0.2-5 micron filter for infusion.

8、 Medication for special populations

1. Pregnant women: May cause fetal damage, it is recommended that women with fertility take effective contraceptive measures during treatment and at least 4 months after the last dose.

2. Breastfeeding period: It is recommended not to breastfeed during the treatment period and for at least 4 months after the last dose.

3. Children: Safety and effectiveness have not yet been established.

4. Elderly patients: No overall differences were observed in clinical studies compared to younger patients.

5. Liver and kidney dysfunction: Patients with mild to moderate liver and kidney dysfunction do not need to adjust the dosage, and there is insufficient data for patients with severe liver dysfunction.

9、 Adverse reactions

1. Common adverse reactions (≥ 15%): fatigue, musculoskeletal pain, rash, diarrhea, anemia (monotherapy); Hair loss, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, decreased appetite (combined with chemotherapy).

2. Serious adverse reactions include immune-mediated pneumonia, colitis, hepatitis, endocrine disorders, skin disease adverse reactions, nephritis, infusion related reactions, etc., which may be life-threatening.

3. Other adverse reactions can be found in clinical trial data.

10、 Contraindications

There are no known contraindications.

11、 Drug interactions

Caution should be exercised when combining with other medications, especially immunosuppressants, chemotherapy drugs, etc.

12、 Storage method

Refrigerate in the original packaging at 2 ° C to 8 ° C (36 ° F to 46 ° F), away from light.

Do not freeze or shake.

13、 Manufacturer

Regeneron Pharmaceuticals, Inc

Cemiplimabinformation