• Metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC in patients who are not candidates for curative surgery or curative radiation.
• Locally advanced basal cell carcinoma (BCC) in patients previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.
• Metastatic BCC in patients previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.
• First-line treatment of non-small cell lung cancer (NSCLC) in patients whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) 50%] (but no EGFR, ALK or ROS1 aberrations), and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or is metastatic.

Contraindicated in:

• OB: Pregnancy (may cause fetal harm)
• Lactation: Lactation.

Use Cautiously in:

• Allogeneic hematopoietic stem cell transplantation recipients (↑ risk of transplant-related complications)
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established in children.

CV: MYOCARDITIS, pericarditis, vasculitis.

Derm: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN), pruritus, rash.

EENT: iritis, uveitis.

Endo: ADRENAL INSUFFICIENCY, hypothyroidism, hyperthyroidism, hypoparathyroidism, hypophysitis, type 1 diabetes.

F and E: hyponatremia, hypophosphatemia.

GI: COLITIS, HEPATITIS, constipation, ↓appetite, diarrhea, nausea, gastritis, pancreatitis.

GU: nephritis.

Hemat: anemia, hemolytic anemia, lymphopenia.

MS: RHABDOMYOLYSIS, pain, myositis.

Neuro: autoimmune neuropathy, Guillain-Barré syndrome, myasthenic syndrome, myelitis , ENCEPHALITIS, MENINGITIS, fatigue.

Resp: PNEUMONITIS.

Misc: INFUSION-RELATED REACTIONS.

Drug-Drug:

• None reported.

• Solution for injection: 50 mg/mL;

• IV (Adults): 350 mg every 3 wk until disease progression or unacceptable toxicity.

Libtayo

• Programmed death receptor-1 (PD-1) blocking antibody (an IgG4 kappa immunoglobulin) that binds to PD-1 and blocks its interaction with its ligands, PD-L1 and PD-L2, resulting in activation of the immune system and decreased tumor growth.

• Decreased progression of metastatic or locally advanced CSCC or BCC.
• Improved survival in NSCLC.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies, programmed death-1 inhibitors

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Unknown.

Half-life: 19 days.

(response)

ROUTE	ONSET	PEAK	DURATION
IV	within 6 mo	unknown	may persist for 8 mo

• Explain purpose of cemiplimab to patient and family and inform of potential adverse reactions.
• Advise patient to notify heath care professional immediately if signs and symptoms of pneumonitis, liver problems (yellowing of skin or whites of eyes, severe nausea or vomiting, pain on right side of abdomen, drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, feeling less hungry than usual), skin rash, or infusion-related reactions occur.
• Advise patient to notify health care professional if signs and symptoms of hormone gland problems (persistent or unusual headaches, rapid heart beat, increased sweating, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, feeling cold, constipation, deepening voice, very low blood pressure, frequent urinating, nausea or vomiting, abdominal pain, changes in mood or behavior [decreased sex drive, irritability, forgetfulness], kidney problems (decrease in amount of urine, blood in urine, ankle swelling, loss of appetite) or problems in other organs (headache, tiredness or weakness, sleepiness, changes in heartbeat [beating fast, seeming to skip a beat, pounding sensation], hallucinations, severe or persistent muscle pain, severe muscle weakness, bruises or bleeding, changes in eyesight, confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, seizures, swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
• Rep: May be teratogenic. Advise females of reproductive potential to use effective contraception and avoid breastfeeding during and for at least 4 mo after last dose. Advise patient to notify health care professional promptly if pregnancy is suspected.

SEM-ip-LI-mab