LIB TA YO® (cemiplimab-r wlc) injections, for intravenous use
Brief Summary of Prescribing Information
1 INDICATIONS AND USAGE
LIBTAYO is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC)
or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
2 DOSAGE AND ADMINISTRATION
2. 1 Recommended Dosage
The recommended dosage of LIB TAYO is 350 mg administered as an intravenous infusion over 30 minutes every
3 weeks until disease progression or unacceptable toxicity.
2. 2 Dosage Modifications for Adverse Reactions
Withhold or discontinue LIBTAYO to manage adverse reactions as described in Table 1. No dose reduction of
LIBTAYO is recommended.
Table 1: Recommended Dosage Modifications for Adverse Reactions
Adverse Reaction Severity* LIBTAYO Dosage Modifications
Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions ( 5. 1)]
Grade 2 Withhold†
Grades 3 or 4 Permanently discontinue
Grades 2 or 3 Withhold†
Grade 4 Permanently discontinue
If AS T or ALT increases to more than
3 and up to 10 times the upper limit
of normal (ULN) or if total bilirubin
increases up to 3 times the ULN.
If AS T or ALT increases to more than
10 times the ULN or total bilirubin
increases to more than 3 times
Endocrinopathies Grades 2, 3, or 4 Withhold if clinically necessary
adverse reactions involving
a major organ
Grade 3 Withhold†
Grade 4 Permanently discontinue
Recurrent or persistent
immune mediated adverse
• Recurrent Grade 3 or 4
• Grade 2 or 3 persistent for
12 weeks or longer after last
LIB TAYO dose
• Requirement for 10 mg per
day or greater prednisone or
equivalent lasting 12 weeks or
longer after last LIB TAYO dose
Other Adverse Reactions
[see Warnings and
Precautions ( 5. 2)]
Grade 1 or 2 Interrupt or slow the rate of infusion
Grade 3 or 4 Permanently discontinue
*Toxicity graded per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0
†Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.
2. 3 Preparation and Administration
• Visually inspect for particulate matter and discoloration prior to administration. LIBTAYO is a clear to
slightly opalescent, colorless to pale yellow solution that may contain trace amounts of translucent to white
particles. Discard the vial if the solution is cloudy, discolored or contains extraneous particulate matter
other than trace amounts of translucent to white particles.
• Do not shake.
• Withdraw 7 mL from a vial and dilute with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection,
USP to a final concentration between 1 mg/mL to 20 mg/mL.
• Mix diluted solution by gentle inversion. Do not shake.
• Discard any unused medicinal product or waste material.
Storage and Infusion Solution
• Store at room temperature up to 25°C (77°F) for no more than 8 hours from the time of preparation to the
end of the infusion or at 2°C to 8°C ( 36°F to 46°F) for no more than 24 hours from the time of preparation to
the end of infusion.
• Allow the diluted solution to come to room temperature prior to administration.
• Do not freeze.
• Administer by intravenous infusion over 30 minutes through an intravenous line containing a sterile, in-line
or add-on 0.2-micron to 5-micron filter.
5 WARNINGS AND PRECAUTIONS
5. 1 Severe and Fatal Immune-Mediated Adverse Reactions
LIB TAYO is a monoclonal antibody that belongs to a class of drugs that binds to the programmed death
receptor- 1 (PD- 1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response with
the potential for breaking of peripheral tolerance and induction of immune-mediated adverse reactions.
Important immune-mediated adverse reactions listed under Warnings and Precautions may not be inclusive of
all possible immune-mediated reactions.
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue.
While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1 blocking
antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/PD-L1
Early identification and management are essential to ensure safe use of PD-1/PD-L1 blocking antibodies.
Monitor for symptoms and signs of immune-mediated adverse reactions. Evaluate clinical chemistries, including
liver tests and thyroid function tests, at baseline and periodically during treatment. Institute medical
management promptly to include specialty consultation as appropriate.
In general, withhold LIB TAYO for Grade 3 or 4 and certain Grade 2 immune-mediated adverse reactions.
Permanently discontinue LIB TAYO for Grade 4 and certain Grade 3 immune-mediated adverse reactions [see
Dosage and Administration ( 2. 2)]. For Grade 3 or 4 and certain Grade 2 immune-mediated adverse reactions,
administer corticosteroids ( 1 to 2 mg/kg/day prednisone or equivalent) or other appropriate therapy until
improvement to Grade 1 or less followed by a corticosteroid taper over one month [see Dosage and Administration
( 2. 2)]. Consider administration of other systemic immunosuppressants in patients whose immune-mediated
adverse reaction is not controlled with corticosteroids. Institute hormone replacement therapy for
endocrinopathies as warranted.
Immune-mediated pneumonitis occurred in 2.4% of 534 patients receiving LIB TAYO, including Grade 5 (0.2%),
Grade 3 (0.7%) and Grade 2 ( 1.3%) [see Adverse Reactions ( 6. 1)]. Pneumonitis led to permanent discontinuation
of LIB TAYO in 1.3% of patients. Systemic corticosteroids were required in all patients with pneumonitis,
including 85% who received prednisone ≥ 40 mg per day or equivalent. Pneumonitis resolved in 62% of patients.
Immune-mediated colitis occurred in 0.9% of 534 patients receiving LIB TAYO, including Grade 3 (0.4%) and
Grade 2 (0.6%) [see Adverse Reactions ( 6. 1)]. Colitis led to permanent discontinuation of LIB TAYO in 0.2% of
patients. Systemic corticosteroids were required in all patients with colitis, including 60% who received
prednisone ≥ 40 mg per day or equivalent. Colitis resolved in 80% of patients.
Immune-mediated hepatitis occurred in 2.1% of 534 patients receiving LIBTAYO, including Grade 5 (0.2%),
Grade 4 (0.2%), and Grade 3 ( 1.7%) [see Adverse Reactions ( 6. 1)]. Hepatitis led to permanent discontinuation of
LIB TAYO in 0.9% of patients. Systemic corticosteroids were required in all patients with hepatitis, including
91% who received prednisone ≥ 40 mg per day or equivalent. Hepatitis resolved in 64% of patients.
Adrenal insufficiency occurred in 0.4% of 534 patients receiving LIB TAYO, including Grade 3 (0.2%), and Grade
2 (0.2%) [see Adverse Reactions ( 6. 1)].
Hypophysitis, which can result in hypopituitarism, occurred in 0.2% of 534 patients receiving LIBTAYO, which
consisted of one patient with Grade 3 hypophysitis.
Hypothyroidism occurred in 6% of 534 patients receiving LIB TAYO, including Grade 3 (0.2%) and Grade 2
( 5.6%). No patients discontinued hormone replacement therapy.
Hyperthyroidism occurred in 1.5% of 534 patients receiving LIB TAYO, including Grade 3 (0.2%) and Grade 2
(0.4%). Hyperthyroidism resolved in 38% of patients.
Type 1 Diabetes Mellitus
Type 1 diabetes mellitus, which can present with diabetic ketoacidosis, occurred in 0.7% of 534 patients,
including Grade 4 (0.4%) and Grade 3 (0.4%). Type 1 diabetes mellitus led to permanent discontinuation of
LIB TAYO in 0.2% of patients.
Immune-Mediated Nephritis with Renal Dysfunction
Immune-mediated nephritis occurred in 0.6% of 534 patients receiving LIB TAYO, including Grade 3 (0.4%) and
Grade 2 (0.2%) [see Adverse Reactions ( 6. 1)]. Nephritis led to permanent discontinuation of LIB TAYO in 0.2% of
patients. Systemic corticosteroids were required in all patients with nephritis, including 67% who received
prednisone ≥ 40 mg per day or equivalent. Nephritis resolved in all patients.
Immune-Mediated Dermatologic Adverse Reactions
Immune-mediated dermatologic reactions, including erythema multiforme and pemphigoid, occurred in 1.7% of
534 patients receiving LIBTAYO, including Grade 3 ( 1.1%) and Grade 2 (0.6%) [see Adverse Reactions ( 6. 1)]. In
addition, SJS and TEN have been observed with LIB TAYO and with other products in this class. Systemic
corticosteroids were required in all patients with dermatologic reactions, including 89% who received
prednisone ≥ 40 mg per day or equivalent. Dermatologic reactions resolved in 33% of patients. Approximately
22% of patients had recurrence of dermatologic reactions after re-initiation of LIB TAYO.
Other Immune-Mediated Adverse Reactions
The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% in 534
patients who received LIBTAYO [see Adverse Reactions ( 6. 1)] or were reported with the use of other
PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions.
Neurological: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome / myasthenia gravis,
Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy
Cardiovascular: Myocarditis, pericarditis, vasculitides
Ocular: Uveitis, iritis, and other ocular inflammatory toxicities. Some cases can be associated with retinal
detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in
combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada like syndrome,
as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss.
Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis
Musculoskeletal and Connective Tissue: Myositis, rhabdomyolysis and associated sequelae including renal
failure, arthritis, polymyalgia rheumatica
Hematological and Immunological: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis,
systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis),
sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.