Libtayo Side Effects Center

Last updated on RxList: 7/27/2022
Libtayo Side Effects Center

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?

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.

Read the entire detailed patient monograph for Libtayo (Cemiplimab-rwlc Injection)

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 and 25% were exposed for ≥ 12 months. 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.

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 ReactionsLIBTAYO
N = 219
All Grades %Grades 3-4 %
General and Administration Site
Fatiguea343
Skin and Subcutaneous Tissue
Rashb311
Pruritusc180
Gastrointestinal
Diarrhead250.5
Nausea210
Constipation130.5
Vomiting100.5
Musculoskeletal and Connective Tissue
Musculoskeletal paine243
Arthralgia111
Respiratory
Coughf140
Hematology
Anemia114
Endocrine
Hypothyroidism100
Metabolism and Nutrition
Decreased appetite100
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 AbnormalityGrade 3-4 (%)a
Chemistry
Increased aspartate aminotransferase2
Increased INR2
Hematology
Lymphopenia9
Anemia5
Electrolytes
Hyponatremia5
Hypophosphatemia4
Hypercalcemia2
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 ReactionsLIBTAYO
N = 132
All Grades %Grades 3-4 %
General disorders and administration site conditions
Fatiguea493.8
Musculoskeletal and connective tissue disorders
Musculoskeletal painb331.5
Gastrointestinal disorders
Diarrhea250
Nausea120.8
Constipation110.8
Skin and subcutaneous tissue disorders
Rashc220.8
Pruritus200
Infections and infestations
Upper respiratory tract infectiond150
Urinary tract infection122.3
Metabolism and nutrition disorders
Decreased appetite141.5
Blood and lymphatic system disorders
Anemia130.8
Nervous system disorders
Headache121.5
Respiratory, thoracic and mediastinal disorders
Dyspneae110
Vascular disorders
Hypertensionf114.5
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 AbnormalityGrade 3-4 (%)a
Electrolytes
Hyponatremia3.1
Hypokalemia1.5
Coagulation
Activated partial thromboplastin time prolonged2.3
Hematology
Lymphocyte count decreased2.3
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)

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 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.

Table 6: Adverse Reactions in ≥ 10% of Patients with Locally Advanced or Metastatic NSCLC Receiving LIBTAYO in Study 1624

Adverse ReactionsLIBTAYO
N=355
Chemotherapy
N=342
All Grades %Grades 3-4 %All Grades %Grades 3-4 %
Musculoskeletal and connective tissue disorders
Musculoskeletal paina260.6271.5
Skin and subcutaneous tissue disorders
Rashb151.460
Blood and lymphatic system disorders
Anemia153.45016
General disorders and administration site conditions
Fatiguec141.1262
Metabolism and nutrition disorders
Decreased appetite120.6180.3
Infections and infestations
Pneumoniad115125
Respiratory, thoracic and mediastinal disorders
Coughe11080.3
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 cough

Table 7: 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 AbnormalityLIBTAYO
N=355
Chemotherapy
N=342
Grades 3-4a %
Chemistry
Increased aspartate aminotransferase3.91.2
Increased alanine aminotransferase2.70.3
Increased alkaline phosphatase2.40.3
Increased blood bilirubin2.10.3
Hypoalbuminemia1.81.3
Increased creatinine1.21.6
Hematology
Lymphopenia79
Anemia2.716
Electrolytes
Hyponatremia67
Hyperkalemia4.21.9
Hypocalcemia3.93.4
Hypophosphatemia2.44.1
Hypermagnesemia2.11.6
Hypokalemia1.52.2
Hypercalcemia1.22.2
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.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to cemiplimab-rwlc in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

Anti-drug antibodies (ADA) were tested in 823 patients who received LIBTAYO. The incidence of cemiplimab-rwlc treatment-emergent ADAs was 2.2% using an electrochemiluminescent (ECL) bridging immunoassay; 0.4% were persistent ADA responses. In the patients who developed anti-cemiplimab-rwlc antibodies, there was no evidence of an altered pharmacokinetic profile of cemiplimab-rwlc.

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

© Libtayo Patient Information is supplied by Cerner Multum, Inc. and Libtayo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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