Medically reviewed by Drugs.com. Last updated on Jul 4, 2020.
(SEM ip LI mab)
- Anti-PD-1 Monoclonal Antibody REGN2810
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Libtayo: cemiplimab-rwlc 350 mg/7 mL (7 mL) [contains polysorbate 80]
Brand Names: U.S.
- Antineoplastic Agent, Anti-PD-1 Monoclonal Antibody
- Antineoplastic Agent, Immune Checkpoint Inhibitor
- Antineoplastic Agent, Monoclonal Antibody
Cemiplimab is a recombinant human IgG4 monoclonal antibody that inhibits programmed death-1 (PD-1) activity by binding to PD-1 and blocking the interactions with the ligands PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of immune response, including anti-tumor response. PD-1 ligand upregulation may occur in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Blocking PD-1 activity has resulted in decreased tumor growth.
Vd: 5.2 L.
Clearance: First dose: 0.33 L/day; steady state: 0.21 L/day.
Use: Labeled Indications
Cutaneous squamous cell carcinoma, metastatic or locally advanced: Treatment of metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC in patients who are not candidates for curative surgery or curative radiation.
There are no contraindications listed in the manufacturer's labeling.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to cemiplimab or any component of the formulation.
Cutaneous squamous cell carcinoma, metastatic or locally advanced: IV: 350 mg once every 3 weeks, continue until disease progression or unacceptable toxicity.
Refer to adult dosing.
Dosing: Adjustment for Toxicity
Withhold or discontinue cemiplimab to manage any of the following adverse reactions (no dosage reduction is recommended) and institute medical management promptly.
Immune-mediated toxicities: Administer systemic corticosteroids (1 to 2 mg/kg/day prednisone [or equivalent]) or other appropriate therapy for grade 3 or 4 (and certain grade 2) immune-mediated adverse reactions until improvement to grade 1 or lower, then follow with a corticosteroid taper. If immune-mediated adverse reaction is not controlled with systemic corticosteroids, consider administration of other systemic immunosuppressants. Hormone replacement therapy may be required for endocrinopathies (if clinically indicated).
Endocrinopathies: Grades 2, 3 or 4: Withhold treatment if clinically necessary.
Gastrointestinal toxicity: Colitis:
Grade 2 or 3: Withhold treatment; may resume with complete or partial resolution of toxicity (grade 0 or 1) after corticosteroid taper.
Grade 4: Permanently discontinue cemiplimab.
Ocular disorders: Vogt-Koyanagi-Harada-like syndrome: May require systemic corticosteroids to reduce the risk of permanent vision loss.
Pulmonary toxicity: Pneumonitis:
Grade 2: Withhold treatment; may resume with complete or partial resolution of toxicity (grade 0 or 1) after corticosteroid taper.
Grade 3 or 4: Permanently discontinue cemiplimab.
Other immune-mediated reaction involving a major organ:
Grade 3: Withhold treatment; may resume with complete or partial resolution of toxicity (grade 0 or 1) after corticosteroid taper.
Grade 4: Permanently discontinue cemiplimab.
Recurrent or persistent immune-mediated reactions:
Recurrent grade 3 or 4: Permanently discontinue cemiplimab.
Grade 2 or 3 persistent for ≥12 weeks after the last cemiplimab dose: Permanently discontinue cemiplimab.
Requires ≥10 mg/day prednisone (or equivalent) lasting ≥12 weeks after the last cemiplimab dose: Permanently discontinue cemiplimab.
Grade 1 or 2: Interrupt infusion or slow the infusion rate.
Grade 3 or 4: Permanently discontinue cemiplimab.
Withdraw 7 mL from vial and dilute with NS or D5W to final concentration between 1 to 20 mg/mL. Gently invert to mix; do not shake. Do not use if solution in vial is cloudy, discolored, or contains extraneous particulate matter other than trace amounts of translucent to white particles.
IV: Infuse over 30 minutes through a 0.2 to 5 micron inline or add-on filter. Allow solution to reach room temperature prior to infusion. Monitor for infusion reactions (may require infusion rate reduction, infusion interruption, or discontinuation depending on the severity).
Store intact vials at 2°C to 8°C (36°F to 46°F); do not freeze. Store in the original carton. Protect from light. Do not shake. Solutions diluted for infusion should be stored at 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). Do not freeze. Do not shake. Allow the diluted solution to reach room temperature prior to administration.
There are no known significant interactions.
Central nervous system: Fatigue (29%)
Dermatologic: Skin rash (25%), dermatologic disorders (≤2%; with drug reinitiation: 22%), pruritus (15%)
Gastrointestinal: Diarrhea (22%), nausea (19%), constipation (12%)
Neuromuscular & skeletal: Musculoskeletal pain (17%)
1% to 10%:
Cardiovascular: Hypertension (grades 3/4: ≥2%)
Dermatologic: Cellulitis (grades 3/4: ≥2%), skin infection (grades 3/4: ≥2%), erythema multiforme (≤2%), pemphigoid (≤2%)
Endocrine & metabolic: Hypothyroidism (6%), hypophosphatemia (grades 3/4: 4%), hyponatremia (grades 3/4: 3%), hyperthyroidism (2%), hypercalcemia (grades 3/4: 1%), hypoalbuminemia (grades 3/4: 1%)
Gastrointestinal: Decreased appetite (10%)
Genitourinary: Urinary tract infection (grades 3/4: ≥2%)
Hematologic & oncologic: Lymphocytopenia (grades 3/4: 7%), anemia (grades 3/4: 2%), increased INR (grades 3/4: 2%)
Hepatic: Increased serum aspartate aminotransferase (grades 3/4: 3%), hepatitis (2%)
Immunologic: Antibody development (1%)
Infection: Sepsis (grades 3/4: ≥2%)
Respiratory: Pneumonia (grades 3/4: ≥2%), pneumonitis (≥2%)
Frequency not defined: Dermatologic: Stevens-Johnson syndrome, toxic epidermal necrolysis
<1%, postmarketing, and/or case reports: Adrenocortical insufficiency, aplastic anemia, arthritis, blindness, colitis, demyelinating disease, diabetes mellitus, duodenitis, encephalitis, gastritis, Guillain-Barre syndrome, hematologic disease (hemophagocytic lymphohistiocytosis), hemolytic anemia, hypophysitis, immune thrombocytopenia, increased serum amylase, increased serum lipase, infusion related reaction, iritis, lymphadenitis (Kikuchi), meningitis, myasthenia, myasthenia gravis, myelitis, myocarditis, myositis, nephritis, neuropathy (autoimmune), ophthalmic inflammation, organ transplant rejection, pancreatitis, paresis (nerve), pericarditis, polymyalgia rheumatica, renal failure syndrome, retinal detachment, rhabdomyolysis, sarcoidosis, systemic inflammatory response syndrome, uveitis, vasculitis, visual impairment, Vogt-Koyanagi-Harada syndrome
Concerns related to adverse effects:
• Adrenal insufficiency: Adrenal insufficiency has occurred (rarely), including grade 2 or 3 toxicity.
• Adverse events (immune-mediated): PD-1/PD-L1 blockers (including cemiplimab) remove immune response inhibition, thus allowing for the potential for breaking of peripheral tolerance and induction of immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, may occur in any tissue or organ system and may affect more than one organ system simultaneously. While immune-mediated adverse reactions generally manifest during treatment, they may also occur following cemiplimab discontinuation. Early identification and management are essential to ensure safe use of PD-1/PD-L1 blocking antibodies. Monitor for signs/symptoms of immune-mediated adverse reactions. Evaluate serum chemistries (including hepatic and thyroid function tests) at baseline and periodically during treatment. Institute medical management promptly and include specialty consultation if appropriate. In general, withhold cemiplimab for grade 3 or 4 and some grade 2 immune-mediated adverse events. Permanently discontinue cemiplimab for grade 4 (and some grade 3) immune-mediated adverse events. Administer systemic corticosteroids (1 to 2 mg/kg/day prednisone [or equivalent]) or other appropriate therapy for grade 3 or 4 (and certain grade 2) immune-mediated adverse reactions until improvement to grade 1 or lower, then follow with a corticosteroid taper. If the immune-mediated adverse reaction is not controlled with systemic corticosteroids, consider administration of other systemic immunosuppressants. Hormone replacement therapy may be required for endocrinopathies if clinically indicated.
• Dermatologic toxicity: Immune-mediated dermatologic adverse reactions, including erythema multiforme and pemphigoid, have occurred with cemiplimab, including grade 2 and 3 dermatologic toxicity. Stevens-Johnson syndrome and toxic epidermal necrolysis have also been reported with cemiplimab (and with other products in the same class). Systemic corticosteroids were required in all patients with dermatologic reactions, with most requiring prednisone ≥40 mg/day (or equivalent). Dermatologic reactions resolved in one-third of patients, although over one-fifth of patients experienced recurrence of dermatologic toxicity upon re-initiation of cemiplimab.
• Diabetes mellitus: Type 1 diabetes mellitus (which may present with diabetic ketoacidosis) has occurred in a small percentage of patients, including grade 3 and 4 events. Type 1 diabetes mellitus led to permanent cemiplimab discontinuation in a small number of patients.
• GI toxicity: Immune-mediated colitis has been reported in patients treated with cemiplimab (including grade 2 and 3 colitis). Colitis led to permanent discontinuation in a small number of patients. Systemic corticosteroids were required in all patients with colitis, over half of which received prednisone ≥40 mg/day (or equivalent). Colitis resolved in most patients. Pancreatitis (including increased serum amylase and lipase levels), gastritis, and duodenitis have also been reported.
• Hepatitis: Immune-mediated hepatitis has been reported, including grade 3 and higher events (some fatal). Hepatitis led to permanent discontinuation in a small percentage of patients. Systemic corticosteroids were required in all patients with hepatitis; most patients required prednisone ≥40 mg/day (or equivalent). Hepatitis resolved in nearly two-thirds of patients.
• Hypophysitis: Hypophysitis (including grade 3 events) has occurred (rarely). Hypophysitis may result in hypopituitarism.
• Infusion reactions: Infusion-related reactions (grade 3) have occurred (rarely) in patients receiving cemiplimab. Monitor for signs/symptoms of infusion-related reactions. Based on the severity of the infusion reaction, interrupt or slow the rate of infusion or permanently discontinue cemiplimab.
• Nephrotoxicity: Immune-mediated nephritis with renal dysfunction has occurred in a small number of patients receiving cemiplimab, including grade 2 and 3 events. Nephritis led to permanent cemiplimab discontinuation rarely. Systemic corticosteroids were required in all patients with nephritis, including two-thirds of patients requiring prednisone ≥40 mg/day (or equivalent). Nephritis resolved in all patients.
• Ocular disorders: Ocular events, including uveitis, iritis, visual impairment (various grades; may include blindness), and other ocular inflammatory toxicities have been reported; some cases may be associated with retinal detachment. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome; may require systemic corticosteroids to reduce the risk of permanent vision loss.
• Pneumonitis: Immune-mediated pneumonitis has been reported with cemiplimab, including grade 2 and higher events (some fatal). Pneumonitis led to permanent discontinuation in a small percentage of patients. Systemic corticosteroids were required in all patients with pneumonitis, most of which received prednisone ≥40 mg/day (or equivalent). Pneumonitis resolved in over half of patients.
• Thyroid disorders: Hypothyroidism occurred in patients receiving cemiplimab, including grade 2 and 3 hypothyroidism (no patients discontinued hormone replacement therapy). Hyperthyroidism has also occurred, including grade 2 and 3 hyperthyroidism, and resolved in over one-third of patients.
• Other immune-mediated toxicities: Other clinically significant immune-mediated adverse reactions have been reported with cemiplimab or with other medications in the same class (some have been severe or fatal). Events have included meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis, Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy, myocarditis, pericarditis, vasculitides, myositis, rhabdomyolysis (and associated sequelae including renal failure), arthritis, polymyalgia rheumatica, hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia (formerly known as immune thrombocytopenic purpura), and solid organ transplant rejection.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Evaluate serum chemistries, hepatic function tests and thyroid function tests (at baseline and periodically during treatment). Pregnancy test (prior to therapy in females of reproductive potential). Monitor for signs/symptoms of adrenal insufficiency, dermatologic toxicity, diabetes mellitus, diarrhea/colitis, hepatitis, hypophysitis, ocular disorders, pneumonitis, thyroid disorders, and other immune-mediated adverse reactions. Monitor for signs/symptoms of infusion-related reactions.
Evaluate pregnancy status prior to therapy. Females of reproductive potential should use effective contraception during therapy and for at least 4 months after the last cemiplimab dose.
Cemiplimab is a recombinant human immunoglobulin (IgG4) monoclonal antibody; human IgG4 is known to cross the placenta. Based on the mechanism of action and information from animal reproduction studies, use of cemiplimab during pregnancy may cause fetal harm.
What is this drug used for?
• It is used to treat skin cancer.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Back, bone, joint, or muscle pain
• Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry
• Feeling tired or weak
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Thyroid, pituitary, or adrenal gland problems like change in mood or the way you act, change in weight, constipation, deeper voice, dizziness, fainting, feeling cold, feeling very tired, hair loss, headache that lasts or is very bad, or lowered interest in sex
• Brain problems like confusion, sleepy, very tired or weak, or have a fever, hallucinations, memory problems, seizures, stiff neck, or very bad headache
• High blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit
• Infusion reaction like back or neck pain, chills, shaking, dizziness, passing out, fever, flushing, itching, rash, shortness of breath, swelling of the face, or wheezing
• Colitis like bloody stools; dark, tarry, or sticky stools; diarrhea; or severe stomach pain
• Stevens-Johnson syndrome/toxic epidermal necrolysis like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in mouth, throat, nose, or eyes
• Kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain
• Liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes
• Lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever
• Low sodium like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance
• Pancreatitis like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up
• Muscle weakness
• Chest pain or pressure
• Fast or abnormal heartbeat
• Sweating a lot
• Burning, numbness, or tingling feeling that is not normal
• Any unexplained bruising or bleeding
• Swollen gland
• Eye problems like changes in eyesight, eye pain, or very bad eye irritation
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about cemiplimab
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- En Español
- 2 Reviews
- Drug class: anti-PD-1 monoclonal antibodies
Other brands: Libtayo