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Libtayo (cemiplimab-rwlc)
cemiplimab
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = cemiplimab-rwlc
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing including toxicity-related dose adjustments
cutaneous squamous cell CA
- [locally advanced or metastatic disease]
- Dose: 350 mg IV q3wk; Info: for patients not eligible for curative surgery or XRT; give up to 24mo
- [adjuvant tx]
- Dose: 350 mg IV q3wk x12wk, then 700 mg IV q6wk for up to 36wk; Alt: 350 mg IV q3wk for up to 48wk; Info: for patients at high recurrence risk after surgery and XRT
basal cell CA, locally advanced or metastatic
- [350 mg IV q3wk]
- Info: for patients who have received a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate; give up to 24mo
locally advanced or metastatic non-small cell lung CA, first-line tx
- [combo tx]
- Dose: 350 mg IV q3wk; Info: for patients with no EGFR, ALK, or ROS1 genomic tumor aberrations not eligible for curative surgery or XRT
- [monotherapy]
- Dose: 350 mg IV q3wk; Info: for patients with high PD-L1-expressing tumor with no EGFR, ALK, or ROS1 genomic tumor aberrations not eligible for curative surgery or XRT
renal dosing
- [see below]
- CrCl >21: no adjustment; CrCl <21: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-3x ULN: no adjustment; bilirubin >3x ULN: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: breastfeeding during tx and for at least 4mo after D/C
- caution: patients of childbearing potential
- caution: thoracic XRT history
- caution: transplant history
- caution: transplant candidates
Drug Interactions .
Overview
cemiplimab
PD-1 blocking antibody
- immunomodulatory effects
Contraindicated
- adenovirus vaccine, live
- chikungunya vaccine, live
- cholera vaccine, live
- dengue vaccine, live
- influenza nasal vaccine, live
- measles/mumps/rubella vaccine, live
- rotavirus vaccine, live
- smallpox vaccine, live
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Avoid/Use Alternative
- rabies vaccine
Monitor/Modify Tx
- anthrax vaccine
- chikungunya vaccine
- COVID-19 vaccine
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- ebola vaccine, live
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- influenza H5N1 vaccine
- influenza vaccine
- Japanese encephalitis vaccine
- meningococcal vaccine
- pneumococcal vaccine
- poliovirus vaccine
- respiratory syncytial virus vaccine
- smallpox/mpox vaccine, live
- tick-borne encephalitis vaccine
- typhoid vaccine
Adverse Reactions .
Serious Reactions
- immune-mediated reaction
- pneumonitis
- pneumonia
- sepsis
- colitis
- hepatitis
- nephritis
- endocrinopathy
- adrenal insufficiency
- hypophysitis
- thyroiditis
- hypothyroidism
- hyperthyroidism
- hypoparathyroidism
- diabetes mellitus, type 1
- hypopituitarism
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- drug reaction with eosinophilia and systemic symptoms
- meningitis
- encephalitis
- myelitis
- demyelination
- myasthenia gravis
- Guillain-Barre syndrome
- nerve paresis
- autoimmune neuropathy
- myocarditis
- pericarditis
- vasculitis
- uveitis
- Vogt-Koyanagi-Harada-like syndrome
- pancreatitis
- myositis
- rhabdomyolysis
- hemolytic anemia
- aplastic anemia
- immune thrombocytopenic purpura
- hemophagocytic lymphohistiocytosis
- histiocytic necrotizing lymphadenitis
- infusion reaction, severe
- HTN
- infection, serious
Common Reactions
- rash
- musculoskeletal pain
- fatigue
- diarrhea
- pruritus
- appetite decr.
- nausea
- cough
- URI
- anemia
- constipation
- headache
- dizziness
- hypothyroidism
- vomiting
- skin infection
- pneumonia
- actinic keratosis
- hyperthyroidism
- pneumonitis
- hepatitis
- hemorrhage
- HTN
- colitis
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; Cr, LFTs, TFTs at baseline, then periodically; glucose; signs/symptoms of infusion reaction
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of embryo-fetal toxicity, including spontaneous abortion and stillbirth, based on animal data with other PD-1/PD-L1 pathway inhibitors and drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and for at least 4mo after D/C in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and for at least 4mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for cemiplimab: catabolism; CYP450: unknown
Excretion: for cemiplimab: other; Half-life: 22 days
Subclass: Immunotherapy, Immune Checkpoint Inhibitors ; Immunotherapy, PD-1/PD-L1 Inhibitors
Mechanism of Action
for cemiplimab: binds to PD-1 receptor on T-cells, blocking PD-1 pathway-mediated inhibition of anti-tumor immune response, resulting in decreased tumor growth (monoclonal antibody)
Formulary .
No Formulary Selected
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