Immune-mediated endocrinopathies: Withhold LIBTAYO if clinically necessary
for Grade 2, 3, or 4.
• Adrenal insufficiency: Adrenal insufficiency occurred in 0.4% of 534 patients
receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2 (0.2%)
• Hypophysitis: Hypophysitis, which can result in hypopituitarism, occurred in
0.2% of 534 patients receiving LIBTAYO, which consisted of 1 patient with
Grade 3 hypophysitis
• Hypothyroidism: Hypothyroidism occurred in 6% of 534 patients receiving
LIBTAYO, including Grade 3 (0.2%) and Grade 2 ( 5.6%); no patients
discontinued hormone replacement therapy
• Hyperthyroidism: Hyperthyroidism occurred in 1.5% of 534 patients
receiving LIBTAYO, 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 LIBTAYO in 0.2% of patients
Immune-mediated nephritis with renal dysfunction: Immune-mediated
nephritis occurred in 0.6% of 534 patients receiving LIBTAYO, including Grade 3
(0.4%) and Grade 2 (0.2%). Nephritis led to permanent discontinuation of LIBTAYO
in 0.2% of patients. Systemic corticosteroids were required in all patients with
nephritis, including 67% who received prednisone ≥ 40 mg/day or equivalent.
Nephritis resolved in all patients. Withhold LIBTAYO for Grade 3, and permanently
discontinue for Grade 4. Resume in patients with complete or partial resolution
(Grade 0 to 1) after corticosteroid taper.
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%). In addition, SJS and TEN have been observed with LIBTAYO and with other
products in this class. Systemic corticosteroids were required in all patients with
dermatologic reactions, including 89% who received prednisone ≥ 40 mg/day or
equivalent. Dermatologic reactions resolved in 33% of patients. Approximately
22% of patients had recurrence of dermatologic reactions after re-initiation of
LIBTAYO. Withhold LIBTAYO for Grade 3, and permanently discontinue for Grade 4.
Resume in patients with complete or partial resolution (Grade 0 to 1) after
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 or were reported with the use of other
PD- 1–blocking and PD-L1–blocking antibodies. Severe or fatal cases have been
reported for some of these adverse reactions. Withhold LIBTAYO for Grade 3, and
permanently discontinue for Grade 4. Resume in patients with complete or partial
resolution (Grade 0 to 1) after corticosteroid taper.
• Neurological: Meningitis, encephalitis, myelitis and demyelination,
myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome, nerve
paresis, and autoimmune neuropathy
• Cardiovascular: Myocarditis, pericarditis, and 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, and duodenitis
• Musculoskeletal and connective tissue: Myositis, rhabdomyolysis,
and associated sequelae, including renal failure, arthritis, and
• Hematological and immunological: Hemolytic anemia, aplastic anemia,
hemophagocytic lymphohistiocytosis, systemic inflammatory response
syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis),
sarcoidosis, immune thrombocytopenic purpura, and solid organ
Severe infusion-related reactions (Grade 3) occurred in 0.2% of patients
receiving LIBTAYO. Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or 2, and
permanently discontinue for Grade 3 or 4.
LIBTAYO can cause fetal harm when administered to a pregnant woman due to
an increased risk of immune-mediated rejection of the developing fetus resulting
in fetal death. Advise women of the potential risk to a fetus. Advise females
of reproductive potential to use effective contraception during treatment with
LIBTAYO and for at least 4 months after the last dose.
• Serious adverse reactions occurred in 28% of patients. Serious adverse
reactions that occurred in ≥2% of patients were cellulitis, sepsis, pneumonia,
pneumonitis, and urinary tract infection. The most common Grade 3-4
adverse reactions (≥2%) were cellulitis, sepsis, hypertension, pneumonia,
musculoskeletal pain, skin infection, urinary tract infection, and fatigue
• LIBTAYO was permanently discontinued due to adverse reactions in 5%
of patients; adverse reactions resulting in permanent discontinuation were
pneumonitis, autoimmune myocarditis, hepatitis, aseptic meningitis, complex
regional pain syndrome, cough, and muscular weakness
• The most common adverse reactions (incidence ≥20%) were fatigue, rash,
Use in specific populations
• Lactation: Because of the potential for serious adverse reactions in
breastfed children, advise women not to breastfeed during treatment and for
at least 4 months after the last dose of LIBTAYO
• Females and males of reproductive potential: Verify pregnancy status in
females of reproductive potential prior to initiating LIBTAYO
Please see accompanying Brief Summary of
Prescribing Information on the following pages.
Reference: LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information.
Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC.
Important Safety Information
© 2019 Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC.
All rights reserved. LIB. 19.08.0027 08/19
ALT=alanine aminotransferase; AST=aspartate aminotransferase;
PD- 1=programmed death receptor- 1; NDC=National Drug Code.