Libtayo Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Libtayo?

Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody 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.

What Are Side Effects of Libtayo?

Libtayo may cause serious side effects including:

hives,
difficulty breathing,
swelling of your face, lips, tongue, or throat,
fever,
sore throat,
burning eyes,
skin pain,
red or purple skin rash with blistering and peeling,
dizziness,
shakiness,
lightheadedness,
chills,
itching,
tingling,
rash,
neck or back pain,
new or worsening cough,
shortness of breath,
chest pain,
fast or irregular heartbeats,
swollen glands,
seizure,
severe headache,
confusion,
hallucinations,
eye pain or redness,
vision problems,
increased sensitivity to light,
severe muscle pain or weakness,
neck stiffness,
severe stomach pain,
nausea,
vomiting,
diarrhea,
bloody or tarry stools,
unusual bruising,
mouth sores,
stomach pain,
feeling sick or uneasy,
rash,
pain or swelling near your transplanted organ,
swelling in your ankles,
blood in your urine,
little or no urination,
right-sided upper stomach pain,
loss of appetite,
drowsiness,
easy bruising,
unusual bleeding,
dark urine,
yellowing of the skin or eyes (jaundice),
frequent or unusual headaches,
dizziness,
feeling very tired,
mood or behavior changes,
hoarse or deepened voice,
increased hunger or thirst,
increased urination,
constipation,
hair loss,
sweating,
feeling cold,
weight gain, and
weight loss

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Libtayo include:

fatigue,
rash,
diarrhea,
itching,
nausea,
constipation,
fatigue,
musculoskeletal pain, and
decreased appetite

Libtayo can cause serious side effects, including:

The most common side effects of Libtayo include tiredness, rash, diarrhea, muscle or bone pain, and nausea.

These are not all the possible side effects of Libtayo.

Seek medical care or call 911 at once if you have the following serious side effects:

Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Libtayo

The recommended dosage of Libtayo is 350 mg as an intravenous infusion over 30 minutes every 3 weeks. Libtayo may interact with other drugs. Tell your doctor all medications and supplements you use.

What Drugs, Substances, or Supplements Interact with Libtayo?

Tell your doctor if you are pregnant or plan to become pregnant before using Libtayo; it can harm a fetus. Females of reproductive potential are advised to use effective contraception during treatment with Libtayo and for at least 4 months after the last dose.

Libtayo During Pregnancy and Breastfeeding

It is unknown if Libtayo passes into breast milk. Because of the potential for serious adverse reactions in breastfed children, breastfeeding is not recommended during treatment with Libtayo and for at least 4 months after the last dose.

Additional Information

Our Libtayo (cemiplimab-rwlc) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Skin Cancer Symptoms, Types, Images See Slideshow

Libtayo Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, shaky, light-headed, nauseated, chilled or feverish, itchy, tingly, or have a rash, neck or back pain, trouble breathing, or swelling in your face.

Cemiplimab strengthens your immune system to help your body fight against cancer cells. This may cause the immune system to attack normal healthy tissues or organs. When this happens, you may develop serious or life-threatening medical problems.

Call your doctor at once if you have:

new or worsening cough, shortness of breath;
chest pain, fast or irregular heartbeats;
swollen glands;
a seizure;
severe headache, confusion, hallucinations, eye pain or redness, vision problems (your eyes may be more sensitive to light);
severe muscle pain or weakness, neck stiffness;
severe stomach pain, nausea, vomiting, diarrhea, bloody or tarry stools;
unusual bruising;
transplant rejection--mouth sores, stomach pain, feeling sick or uneasy, rash, pain or swelling near your transplanted organ;
kidney problems--swelling in your ankles, blood in your urine, little or no urination;
liver problems--right-sided upper stomach pain, loss of appetite, drowsiness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes);
signs of a hormonal disorder--frequent or unusual headaches, dizziness, feeling very tired, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, hair loss, sweating, feeling cold, weight gain, or weight loss.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

tiredness;
muscle or bone pain;
rash, itching; or
nausea, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Libtayo Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling.

Severe and Fatal Immune-Mediated Adverse Reactions [see WARNINGS AND PRECAUTIONS]
Infusion-Related Reactions [see WARNINGS AND PRECAUTIONS]
Complications of Allogeneic HSCT [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described in Warnings and Precautions reflect exposure to LIBTAYO as a single agent in 810 patients in three open-label, single-arm, multicohort studies (Study 1423, Study 1540 and Study 1620), and one open-label randomized multi-center study (Study 1624). These studies included 219 patients with advanced CSCC (Studies 1540 and 1423), 132 patients with advanced BCC (Study 1620), 355 patients with NSCLC (Study 1624), and 104 patients with other advanced solid tumors (Study 1423). LIBTAYO was administered intravenously at doses of 3 mg/kg every 2 weeks (n=235), 350 mg every 3 weeks (n=543), or other doses (n=32; 1 mg/kg every 2 weeks, 10 mg/kg every 2 weeks, 200 mg every 2 weeks). Among the 810 patients, 57% were exposed for 6 months or longer and 25% were exposed for one year or longer. In this pooled safety population, the most common adverse reactions (≥15%) were musculoskeletal pain, fatigue, rash, and diarrhea. The most common Grade 3-4 laboratory abnormalities (≥2%) were lymphopenia, hyponatremia, hypophosphatemia, increased aspartate aminotransferase, anemia, and hyperkalemia.

In addition, the data below reflect exposure to LIBTAYO in combination with platinum-based chemotherapy in 312 patients with NSCLC enrolled in a randomized, active controlled trial (Study 16113).

Cutaneous Squamous Cell Carcinoma (CSCC)

The safety of LIBTAYO was evaluated in 219 patients with advanced CSCC (metastatic or locally advanced disease) in Study 1423 and Study 1540 [see Clinical Studies]. Of these 219 patients, 131 had mCSCC (nodal or distant) and 88 had laCSCC. Patients received LIBTAYO 1 mg/kg every 2 weeks (n=1), 3 mg/kg every 2 weeks (n=162) or 350 mg every 3 weeks (n=56) as an intravenous infusion until disease progression, unacceptable toxicity, or completion of planned treatment. The median duration of exposure was 38 weeks (2 weeks to 110 weeks).

The safety population characteristics were: median age of 72 years (38 to 96 years), 83% male, 96% White, and European Cooperative Oncology Group (ECOG) performance score (PS) of 0 (44%) and 1 (56%).

Serious adverse reactions occurred in 35% of patients. Serious adverse reactions that occurred in at least 2% of patients were pneumonitis, cellulitis, sepsis, and pneumonia.

Permanent discontinuation due to an adverse reaction occurred in 8% of patients. Adverse reactions resulting in permanent discontinuation were pneumonitis, cough, pneumonia, encephalitis, aseptic meningitis, hepatitis, arthralgia, muscular weakness, neck pain, soft tissue necrosis, complex regional pain syndrome, lethargy, psoriasis, rash maculopapular, proctitis, and confusional state.

The most common (≥ 20%) adverse reactions were fatigue, rash, diarrhea, musculoskeletal pain, and nausea. The most common Grade 3 or 4 adverse reactions (≥ 2%) were cellulitis, anemia, hypertension, pneumonia, musculoskeletal pain, fatigue, pneumonitis, sepsis, skin infection, and hypercalcemia. The most common (≥ 4%) Grade 3 or 4 laboratory abnormalities worsening from baseline were lymphopenia, anemia, hyponatremia, and hypophosphatemia.

Table 2 summarizes the adverse reactions that occurred in ≥ 10% of patients and Table 3 summarizes Grade 3 or 4 laboratory abnormalities worsening from baseline in ≥ 1% of patients receiving LIBTAYO.

Table 2: Adverse Reactions in ≥ 10% of Patients with Advanced CSCC Receiving LIBTAYO in Study 1423 and Study 1540

Adverse Reactions	LIBTAYO N = 219
Adverse Reactions	All Grades %	Grades 3-4 %
General and Administration Site
Fatigue^a	34	3
Skin and Subcutaneous Tissue
Rash^b	31	1
Pruritus^c	18	0
Gastrointestinal
Diarrhea^d	25	0.5
Nausea	21	0
Constipation	13	0.5
Vomiting	10	0.5
Musculoskeletal and Connective Tissue
Musculoskeletal pain^e	24	3
Arthralgia	11	1
Respiratory
Cough^f	14	0
Hematology
Anemia	11	4
Endocrine
Hypothyroidism	10	0
Metabolism and Nutrition
Decreased appetite	10	0
Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03 ^a. Composite term includes fatigue and asthenia ^b. Composite term includes rash, rash maculopapular, erythema, dermatitis, dermatitis bullous, rash generalized, pemphigoid, rash erythematous, rash macular, rash pruritic, drug eruption, psoriasis, and skin reaction ^c. Composite term includes pruritus and pruritus allergic ^d. Composite term includes diarrhea and colitis ^e. Composite term includes back pain, pain in extremity, myalgia, musculoskeletal pain, and neck pain ^f. Composite term includes cough and upper airway cough syndrome

Table 3: Grade 3 or 4 Laboratory Abnormalities Worsening from Baseline in ≥ 1% of Patients with Advanced CSCC Receiving LIBTAYO in Study 1423 and Study 1540

Laboratory Abnormality	Grade 3-4 (%)^a
Chemistry
Increased aspartate aminotransferase	2
Increased INR	2
Hematology
Lymphopenia	9
Anemia	5
Electrolytes
Hyponatremia	5
Hypophosphatemia	4
Hypercalcemia	2
Toxicity graded per NCI CTCAE v. 4.03 ^a. Percentages are based on the number of patients with at least 1 post-baseline value available for that parameter

Basal Cell Carcinoma (BCC)

The safety of LIBTAYO was evaluated in 132 patients with advanced BCC (mBCC N=48, laBCC N=84) in an open-label, single-arm trial (Study 1620) [see Clinical Studies]. Patients received LIBTAYO 350 mg every 3 weeks as an intravenous infusion for up to 93 weeks or until disease progression or unacceptable toxicity. The median duration of exposure was 42 weeks (range: 2.1 weeks to 94 weeks).

The safety population characteristics were: median age of 68 years (38 to 90 years), 67% male, 74% White, and ECOG performance score (PS) of 0 (62%) and 1 (38%).

Serious adverse reactions occurred in 32% of patients. Serious adverse reactions that occurred in > 1.5% (at least 2 patients) were urinary tract infection, colitis, acute kidney injury, adrenal insufficiency, anemia, infected neoplasm, and somnolence. Fatal adverse reactions occurred in 1.5% of patients who received LIBTAYO, including acute kidney injury and cachexia.

Permanent discontinuation of LIBTAYO due to an adverse reaction occurred in 13% of patients. Adverse reactions resulting in permanent discontinuation of LIBTAYO in > 1.5% (at least 2 patients) were colitis and general physical health deterioration.

Dosage delays of LIBTAYO due to an adverse reaction occurred in 34% of patients. Adverse reactions which required dosage delay in > 2% of patients (at least 3 patients) included blood creatinine increased, diarrhea, colitis, fatigue, headache, pneumonitis, and urinary tract infection.

The most common adverse reactions reported in at least 15% of patients were fatigue, musculoskeletal pain, diarrhea, rash, pruritus, and upper respiratory tract infection.

The most common Grade 3 or 4 adverse reactions (> 2%) were hypertension, colitis, fatigue, urinary tract infection, pneumonia, increased blood pressure, hypokalemia and visual impairment. The most common (> 3%) laboratory abnormality worsening from baseline to Grade 3 or 4 was hyponatremia.

Table 4 summarizes the adverse reactions that occurred in ≥ 10% of patients and Table 5 summarizes Grade 3 or 4 laboratory abnormalities worsening from baseline in ≥ 1% of patients receiving LIBTAYO.

Table 4: Adverse Reactions in ≥ 10% of Patients with Advanced BCC Receiving LIBTAYO in Study 1620

Adverse Reactions	LIBTAYO N = 132
Adverse Reactions	All Grades %	Grades 3-4 %
General disorders and administration site conditions
Fatigue^a	49	3.8
Musculoskeletal and connective tissue disorders
Musculoskeletal pain^b	33	1.5
Gastrointestinal disorders
Diarrhea	25	0
Nausea	12	0.8
Constipation	11	0.8
Skin and subcutaneous tissue disorders
Rash^c	22	0.8
Pruritus	20	0
Infections and infestations
Upper respiratory tract infection^d	15	0
Urinary tract infection	12	2.3
Metabolism and nutrition disorders
Decreased appetite	14	1.5
Blood and lymphatic system disorders
Anemia	13	0.8
Nervous system disorders
Headache	12	1.5
Respiratory, thoracic and mediastinal disorders
Dyspnea^e	11	0
Vascular disorders
Hypertension^f	11	4.5
Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03 ^a. Composite term includes fatigue, asthenia, and malaise ^b. Composite term includes arthralgia, back pain, myalgia, pain in extremity, musculoskeletal pain, neck pain, musculoskeletal stiffness, musculoskeletal chest pain, musculoskeletal discomfort, and spinal pain ^c. Composite term includes rash maculo-papular, rash, dermatitis, dermatitis acneiform, erythema, rash pruritic, dermatitis bullous, dyshidrotic eczema, pemphigoid, rash erythematous, and urticaria ^d. Composite term includes upper respiratory tract infection, nasopharyngitis, rhinitis, sinusitis, pharyngitis, respiratory tract infection, and viral upper respiratory tract infection ^e. Composite term includes dyspnea and dyspnea exertional ^f. Composite term includes hypertension and hypertensive crisis

Table 5: Grade 3 or 4 Laboratory Abnormalities Worsening from Baseline in ≥ 1% of Patients with Advanced BCC Receiving LIBTAYO in Study 1620

Laboratory Abnormality	Grade 3-4 (%)^a
Electrolytes
Hyponatremia	3.1
Hypokalemia	1.5
Coagulation
Activated partial thromboplastin time prolonged	2.3
Hematology
Lymphocyte count decreased	2.3
Toxicity graded per NCI CTCAE v. 4.03 ^a. Percentages are based on the number of patients with at least 1 post-baseline value available for that parameter

Non-Small Cell Lung Cancer (NSCLC)

First-line treatment of NSCLC with LIBTAYO in Combination with Platinum-based Chemotherapy

The safety of LIBTAYO in combination with platinum-based chemotherapy was evaluated in 465 patients with locally advanced or metastatic NSCLC in Study 16113 [see Clinical Studies]. Patients received LIBTAYO 350 mg every 3 weeks plus platinum-based chemotherapy every 3 weeks for 4 cycles (n=312), or placebo every 3 weeks plus platinum-based chemotherapy every 3 weeks for 4 cycles (n=153).

Among patients who received LIBTAYO, 70% were exposed for 6 months or longer and 35% were exposed for greater than one year. The safety population characteristics were: median age of 63 years (25 to 82 years), 41% of patients 65 or older, 86% male, 86% White, 14% Asian, 86% had metastatic disease and 14% had locally advanced disease and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 (16%) and 1 (83%).

Serious adverse reactions occurred in 25% of patients. The most frequent serious adverse reactions that occurred in at least 2% of patients were pneumonia, anemia, and neutropenia. Fatal adverse reactions occurred in 6% of patients who received LIBTAYO in combination with chemotherapy, including death not otherwise specified (2.9%), sudden death (1.0%), acute hepatitis (0.3%), acute respiratory distress syndrome (0.3%), mesenteric artery thrombosis (0.3%), pneumonia (0.3%), pneumonitis (0.3%), and pulmonary hemorrhage (0.3%). LIBTAYO was permanently discontinued due to adverse reactions in 5% of patients. Adverse reactions resulting in permanent discontinuation in at least 2 patients were increased alanine aminotransferase and anemia.

Dosage interruptions of LIBTAYO due to an adverse reaction occurred in 33% of patients. Adverse reactions which required dosage interruptions in at least 2% of patients were anemia, pneumonia, neutropenia, thrombocytopenia, fatigue, COVID-19 infection, and pyrexia.

The most common (≥ 15%) adverse reactions were alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite. The most common Grade 3-4 laboratory abnormalities (≥ 2%) were anemia, neutropenia, lymphopenia, leukopenia, hyponatremia, thrombocytopenia, hyperglycemia, hypophosphatemia, increased alanine aminotransferase, hypocalcemia, hyperkalemia, hypermagnesemia, hypokalemia, and increased creatinine.

Table 6 summarizes the adverse reactions that occurred in ≥ 10% of patients and Table 7 summarizes Grade 3 or 4 laboratory abnormalities in patients receiving LIBTAYO and chemotherapy.

Table 6: Adverse Reactions in ≥ 10% of Patients with Locally Advanced or Metastatic NSCLC Receiving LIBTAYO and Chemotherapy in Study 16113

Adverse Reactions	LIBTAYO and Chemotherapy (N=312)		Placebo and Chemotherapy (N=153)
Adverse Reactions	All Grades %	Grades 3 or 4 %	All Grades %	Grades 3 or 4 %
Skin and subcutaneous tissue disorders
Alopecia	37	0	43	0
Rash^a	13	1.3	6	0
Musculoskeletal and connective tissue disorders
Musculoskeletal pain^b	30	1.6	36	0
Gastrointestinal disorders
Nausea	25	0	16	0
Constipation	14	0.3	11	0
Vomiting	12	0	10	0
Diarrhea	11	1.3	7	0
General disorders and administration site conditions
Fatigue^c	23	3.8	18	2
Nervous system disorders
Peripheral neuropathy^d	23	0	19	0
Metabolism and nutrition disorders
Decreased appetite	17	1	12	0
Investigations
Weight decreased	11	1.3	8	0
Respiratory, thoracic and mediastinal disorders
Dyspnea^e	13	2.2	7	0.7
Psychiatric disorders
Insomnia	11	0	7	0
Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03 ^a. Rash is a composite term that includes rash, rash maculo-papular, dermatitis, psoriasis, rash papular, urticaria, dermatitis allergic, erythema, lichen planus, rash macular, rash pruritic, skin reaction, skin toxicity, skin exfoliation, and dermatitis acneiform. ^b. Musculoskeletal pain is a composite term that includes arthralgia, back pain, pain in extremity, non-cardiac chest pain, myalgia, bone pain, musculoskeletal pain, neck pain, musculoskeletal chest pain, arthritis, and spinal pain. ^c. Fatigue is a composite term that includes asthenia, fatigue, and malaise. ^d. Peripheral neuropathy is a composite term that includes peripheral sensory neuropathy, peripheral neuropathy, paresthesia, polyneuropathy, hypoaesthesia, peripheral sensorimotor neuropathy, neuralgia, polyneuropathy in malignant disease, and toxic neuropathy. ^e. Dyspnea is a composite term that includes dyspnea and dyspnea exertional

Table 7: Grade 3 or 4 Laboratory Abnormalities Worsening from Baseline in ≥ 1% of Patients with Locally Advanced or Metastatic NSCLC Receiving LIBTAYO and Chemotherapy in Study 16113

Laboratory Abnormality	LIBTAYO and Chemotherapy	Placebo and Chemotherapy
Laboratory Abnormality	Grades 3 or 4 (%)^a
Chemistry
Hyperglycemia	4	1.5
Increased alanine aminotransferase	3	2.1
Increased creatinine	2	1.4
Hypoalbuminemia	1	0
Hematology
Anemia	10	7
Neutrophil count decreased	10	8
Lymphocyte count decreased	7	8
White blood cell decreased	6	4.1
Platelet count decreased	4.7	0.7
Electrolytes
Hyponatremia	6	4.1
Hypophosphatemia	3.4	7
Hypocalcemia	3	2.1
Hyperkalemia	2.7	2.7
Hypermagnesemia	2.4	2.8
Hypokalemia	2.3	1.4
Hypercalcemia	1.7	0.7
Hypernatremia	1	0
Toxicity graded per NCI CTCAE v. 4.03 ^a The denominator used to calculate the rate varied from 134 to 299 based on the number of patients with a baseline value and at least one post-treatment value.

First-line Treatment of NSCLC with LIBTAYO as a Single Agent

The safety of LIBTAYO was evaluated in 355 patients with locally advanced or metastatic NSCLC in Study 1624 [see Clinical Studies]. Patients received LIBTAYO 350 mg every 3 weeks (n=355) or investigator’s choice of chemotherapy (n=342), consisting of paclitaxel plus cisplatin or carboplatin; gemcitabine plus cisplatin or carboplatin; or pemetrexed plus cisplatin or carboplatin followed by optional pemetrexed maintenance. The median duration of exposure was 27.3 weeks (9 days to 115 weeks) in the LIBTAYO group and 17.7 weeks (18 days to 86.7 weeks) in the chemotherapy group. In the LIBTAYO group, 54% of patients were exposed to LIBTAYO for ≥ 6 months and 22 % were exposed for ≥ 12 months.

The safety population characteristics were: median age of 63 years (31 to 79 years), 44% of patients 65 or older, 88% male, 86%White, 82% had metastatic disease and 18% had locally advanced disease and ECOG performance score (PS) of 0 (27%) and 1 (73%).

LIBTAYO was permanently discontinued due to adverse reactions in 6% of patients; adverse reactions resulting in permanent discontinuation in at least 2 patients were pneumonitis, pneumonia, ischemic stroke and increased aspartate aminotransferase. Serious adverse reactions occurred in 28% of patients. The most frequent serious adverse reactions in at least 2% of patients were pneumonia and pneumonitis.

Table 8 summarizes the adverse reactions that occurred in ≥ 10% of patients and Table 9 summarizes Grade 3 or 4 laboratory abnormalities in patients receiving LIBTAYO.

Table 8: Adverse Reactions in ≥ 10% of Patients with Locally Advanced or Metastatic NSCLC Receiving LIBTAYO in Study 1624

Adverse Reactions	LIBTAYO N=355		Chemotherapy N=342
Adverse Reactions	All Grades %	Grades 3-4 %	All Grades %	Grades 3-4 %
Musculoskeletal and connective tissue disorders
Musculoskeletal pain^a	26	0.6	27	1.5
Skin and subcutaneous tissue disorders
Rash^b	15	1.4	6	0
Blood and lymphatic system disorders
Anemia	15	3.4	50	16
General disorders and administration site conditions
Fatigue^c	14	1.1	26	2
Metabolism and nutrition disorders
Decreased appetite	12	0.6	18	0.3
Infections and infestations
Pneumonia^d	11	5	12	5
Respiratory, thoracic and mediastinal disorders
Cough^e	11	0	8	0.3
Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03 ^a. Musculoskeletal pain is a composite term that includes back pain, arthralgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, bone pain, myalgia, neck pain, spinal pain, and musculoskeletal stiffness ^b. Rash is a composite term that includes rash, dermatitis, urticaria, rash maculo-papular, erythema, rash erythematous, rash pruritic, psoriasis, autoimmune dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis atopic, dermatitis bullous, drug eruption, dyshidrotic eczema, lichen planus, and skin reaction ^c. Fatigue is a composite term that includes fatigue, asthenia, and malaise ^d. Pneumonia is a composite term that includes atypical pneumonia, embolic pneumonia, lower respiratory tract infection, lung abscess, paracancerous pneumonia, pneumonia, pneumonia bacterial, and pneumonia klebsiella ^e. Cough is a composite term that includes cough and productive coughs

Table 9: Grade 3 or 4 Laboratory Abnormalities Worsening from Baseline in ≥1% of Patients with Locally Advanced or Metastatic NSCLC Receiving LIBTAYO in Study 1624

Laboratory Abnormality	LIBTAYO N=355	Chemotherapy N=342
Laboratory Abnormality	Grades 3-4^a %
Chemistry
Increased aspartate aminotransferase	3.9	1.2
Increased alanine aminotransferase	2.7	0.3
Increased alkaline phosphatase	2.4	0.3
Increased blood bilirubin	2.1	0.3
Hypoalbuminemia	1.8	1.3
Increased creatinine	1.2	1.6
Hematology
Lymphopenia	7	9
Anemia	2.7	16
Electrolytes
Hyponatremia	6	7
Hyperkalemia	4.2	1.9
Hypocalcemia	3.9	3.4
Hypophosphatemia	2.4	4.1
Hypermagnesemia	2.1	1.6
Hypokalemia	1.5	2.2
Hypercalcemia	1.2	2.2
Toxicity graded per NCI CTCAE v. 4.03 ^a. Percentages are based on the number of patients with at least 1 post-baseline value available for that parameter.

DRUG INTERACTIONS

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Read the entire FDA prescribing information for Libtayo (Cemiplimab-rwlc Injection)