Cemiplimab

Cemiplimab is a cancer medicine that helps your immune system fight certain cancers.

• What it treats
• Advanced or hard-to-treat:
  • Some skin cancers (certain squamous cell and basal cell skin cancers)
  • Some types of lung cancer (non–small cell lung cancer)

Cemiplimab is available under the following different brand names: Libtayo, cemiplimab-rwlc

Common side effects of Cemiplimab include:

• fatigue
• rash
• diarrhea
• itching
• nausea
• constipation
• decreased appetite
• anemia
• hair loss 
• muscle or bone pain
• numbness, pain, tingling, or burning in the hands or feet 

Serious side effects of Cemiplimab include:

• symptoms of lung problems may include cough, shortness of breath, or chest pain
• symptoms of intestinal problems may include diarrhea, black or tarry stools, or severe abdominal pain
• symptoms of liver problems may include yellowing of the skin or whites of the eyes, dark urine, severe nausea or vomiting, bleeding or bruising more than normal, or pain on the right side of the abdomen
• symptoms of hormone gland problems may include unusual headaches, eye problems, eye sensitivity to light, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, voice getting deeper, dizziness or fainting, and changes in mood or behavior such as decreased sex drive, irritability, or forgetfulness
• symptoms of kidney problems may include decreased urine output, blood in the urine, swelling of the ankles, or loss of appetite
• symptoms of skin problems may include rash, itching, skin blistering or peeling, swollen lymph nodes, fever, or painful sores or ulcers in the mouth, nose, throat, or genital area
• symptoms of allergic and injection-related reactions may include chills, itching or rash, flushing, shortness of breath or wheezing, dizziness, fainting, fever, facial swelling, and/or back pain
• risk of organ or tissue transplant rejection
• complications of a donor stem-cell (allogeneic) transplant, including serious problems such as graft-versus-host disease (GVHD)

Rare side effects of Cemiplimab include:

• none

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

• 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;
• 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 the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 50 mg/mL (7-mL single-dose vial)

Cutaneous Squamous Cell Carcinoma (CSCC)

Adult dosage

Treatment for advanced disease

• 350 mg IV every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months

Adjuvant therapy

• 350 mg IV every 3 weeks, or
• 350 mg IV every 3 weeks for 12 weeks, followed by 700 mg IV every 6 weeks
• Continue until disease progression, unacceptable toxicity, or up to 48 weeks

Basal Cell Carcinoma (BCC)

Adult dosage

• 350 mg IV every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months

Non-Small Cell Lung Cancer (NSCLC)

Adult dosage

Single-agent

• 350 mg IV every 3 weeks until disease progression or unacceptable toxicity

Combination therapy with platinum-based chemotherapy

• Cemiplimab 350 mg IV every 3 weeks until disease progression or unacceptable toxicity, plus
• Platinum-based chemotherapy every 3 weeks for 4 cycles
• Refer to prescribing information for agents coadministered with Cemiplimab for recommended dosing information, as appropriate
• Platinum-based chemotherapy used in clinical trial (NCT03409614)
  • Carboplatin AUC of 5 or 6 and paclitaxel 200 mg/m2, or
  • Cisplatin 75 mg/m2 and paclitaxel 200 mg/m2, or
  • Carboplatin AUC of 5 or 6 and pemetrexed 500 mg/m2*, or
  • Cisplatin 75 mg/m2 and pemetrexed 500 mg/m2*
  • *Maintenance pemetrexed was mandatory for patients with non-squamous NSCLC who received a pemetrexed-containing chemotherapy regimen in the initial 4 treatment cycles

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Visit the RxList Drug Interaction Checker for any drug interactions. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Cemiplimab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Cemiplimab?”

Cautions

• Based on Cemiplimab mechanism of action, it can cause fetal harm when administered to pregnant women
• Severe or life-threatening infusion-related reactions reported; monitor patients for signs and symptoms of infusion-related reactions; common symptoms of infusion-related reactions include nausea, pyrexia, and vomiting; interrupt or slow the rate of infusion or permanently discontinue therapy based on the severity of the reaction
• Severe and fatal immune-mediated adverse effects
  • The monoclonal antibody binds to either the programmed death receptor-1 (PD-1) or PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1pathway, thereby removing inhibition of immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions
  • Incidence and severity of immune-mediated adverse reactions reported to be similar when administered as a single agent or in combination with chemotherapy
  • Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue; immune-mediated adverse reactions can occur at any time after starting PD-1/PD-L1 blocking antibody
  • 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 blocking antibodies
  • Immune-mediated adverse reactions affecting more than one body system can occur simultaneously
  • Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of PD-1/PD-L1 blocking antibodies; monitor closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions
  • Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment; in cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection; institute medical management promptly, including specialty consultation as appropriate
  • Withhold or permanently discontinue therapy depending on severity; in general, if therapy requires interruption or discontinuation, administer systemic corticosteroid therapy (1-2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less
  • Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month; consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroids
  • Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, hypophysitis, hypothyroidism or hyperthyroidism, type 1 diabetes mellitus, nephritis, and dermatologic reactions reported
  • Other immune-mediated adverse reactions involving other systems (eg, neurological, cardiovascular, ocular) were also reported in less than 1% of patients or were reported with other PD-1/PD-L1 blockers
  • Usually manifest during treatment and after discontinuation of treatment; immune-mediated adverse reactions affecting more than one body system can occur simultaneously
  • Immune-mediated dermatologic reactions, including erythema multiforme and pemphigoid, SJS, and TEN, were reported; all dermatologic reactions were treated with systemic corticosteroids in a clinical trial; approximately 22% recurrence of reactions after re-initiation of therapy
  • 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
• Immune-mediated hematologic
  • Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection

Pregnancy and Lactation

• May cause fetal harm when administered to pregnant females
• Verify pregnancy status in females of reproductive potential before initiation
• Advise women of the potential risk to a fetus
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for at least 4 months after the last dose
• Lactation
  • There are no data regarding the distribution of human milk or the drug’s effect on breastfed children or on milk production
  • Advise women not to breastfeed during treatment and for at least 4 months after the last dose