Dosing and Administration

  • The recommended dosage is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks.
  • Treatment should be continued until disease progression or unacceptable toxicity.
  • No dose reductions are recommended. Dosing may be withheld or discontinued to manage adverse reactions.

Indications

Cemiplimab-rwlc is indicated for:

  • Cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery/radiation
  • Basal cell carcinoma (BCC) after treatment with a hedgehog pathway inhibitor
  • First-line treatment of advanced non-small cell lung cancer (NSCLC), either as monotherapy or in combination with chemotherapy

Key Adverse Effects

  • Immune-mediated adverse reactions affecting multiple organ systems can occur and may be severe or fatal.
  • Common adverse reactions include fatigue, rash, diarrhea, musculoskeletal pain, and nausea.

Monitoring

  • Monitor liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
  • Assess for signs/symptoms of immune-mediated reactions affecting the lungs, intestines, liver, hormonal glands, skin, or kidneys.

Patient Education

  • Advise patients to report any new or worsening symptoms promptly.
  • Inform patients about potential infusion-related reactions.
  • Counsel females of reproductive potential on the need for effective contraception during treatment and for 4 months after the last dose.

Administration Pearls

  • Administer through an IV line containing a sterile, in-line or add-on 0.2-micron to 5-micron filter.
  • Do not co-administer other medications through the same infusion line.
  • Monitor patients for infusion-related reactions, especially during and after the first infusion.

 

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  1. https://medlineplus.gov/druginfo/meds/a618054.html
  2. https://www.regeneron.com/downloads/libtayo_fpi.pdf
  3. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761097s001lbl.pdf
  4. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761097s014lbl.pdf
  5. https://www.libtayo.com/sfsites/c/resource/libtayo_consumer_downloads/patient/patient-brochure-cscc.pdf
  6. https://www.mayoclinic.org/drugs-supplements/cemiplimab-rwlc-intravenous-route/proper-use/drg-20444105?p=1
  7. https://www.libtayohcp.com
  8. https://www.libtayo.com/nsclc/support-and-resources
  9. https://libtayo.com/nsclc/taking-libtayo