cemiplimab (Rx)

Brand and Other Names:Libtayo, cemiplimab-rwlc
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 50mg/mL (7-mL single-dose vial)

Cutaneous Squamous Cell Carcinoma

Indicated for metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC (laCSCC) in patients who are not candidates for curative surgery or curative radiation

350 mg IV q3Weeks

Continue until disease progression or unacceptable toxicity

Basal Cell Carcinoma

Indicated for advanced basal cell carcinoma (laBCC) OR metastatic basal carcinoma (BCC) in patients who either were previously treated with OR not candidates for a hedgehog pathway inhibitor

350 mg IV q3Weeks

Continue until disease progression or unacceptable toxicity

Non-Small Cell Lung Cancer

Indicated for first-line treatment of locally advanced (ie, patient not a candidate for surgery or chemoradiation) OR metastatic non-small cell lung cancer (NSCLC) in tumors having high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%], with no EGFR, ALK, or ROS1 aberrations

350 mg IV q3Weeks

Continue until disease progression or unacceptable toxicity

Dosage Modifications

No dose reduction recommended

Immune-mediated adverse reactions

  • Grade 3 (severe): Withhold
  • Permanently discontinue
    • Grade 4 (life-threatening)
    • Recurrent severe (Grade 3) that require systemic immunosuppressive treatment
    • Recurrent severe (Grade 3) with an inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids

Pneumonitis

  • Grade 2: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
  • Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
  • Grade 3 or 4: Permanently discontinue

Colitis

  • Grade 2 or 3: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
  • Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
  • Grade 4: Permanently discontinue

Hepatitis with no tumor involvement of the liver

  • AST or ALT increase >3x to ≤8x ULN or total bilirubin increase >1.5x to <3x ULN: Withhold therapy; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
  • Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
  • AST or ALT increase >8x ULN or total bilirubin increase >3x ULN: Permanently discontinue

Hepatitis with tumor involvement of the liver

  • If AST and ALT ≤ULN at baseline, withhold or permanently discontinue based on recommendations for hepatitis where there is no tumor involvement of the liver
  • Withhold therapy
    • Baseline AST/ALT >1 and ≤3x ULN and increase >5x to ≤10x ULN
    • Baseline AST/ALT >3 and ≤5x ULN and increase >8x to ≤10x ULN
    • Resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
    • Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
  • Permanently discontinue
    • AST or ALT increase >10x ULN or total bilirubin increase >3x ULN

Endocrinopathies

  • Grade 3 or 4: Withhold until clinically stable or permanently discontinue depending on severity

Nephritis with renal dysfunction

  • Grade 2 or 3 increased blood creatinine: Withhold; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
  • Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
  • Grade 4 increased blood creatinine: Permanently discontinue

Exfoliative dermatologic conditions

  • Suspected Steven Johnson Syndrome (SJS), toxic epidermal necrosis (TEN), or Drug Rash with Eosinophilia and Systemic Symptoms (DRESS): Withhold
  • Confirmed SJS, TEN, or DRESS: Permanently discontinue

Myocarditis

  • Grade 2, 3, or 4: Permanently discontinue

Neurologic toxicities

  • Grade 2: Withhold; resume when complete or partial resolution occurs (Grade <1) after corticosteroid taper
  • Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone ≤10 mg/day (or equivalent) within 12 weeks of initiating steroids
  • Grade 3 or 4: Permanently discontinue

Infusion-related reactions

  • Grade 1 or 2: Interrupt or slow infusion rate
  • Grade 3 or 4: Permanently discontinue

Renal impairment

  • CrCl ≥21 mL/min: No dosage adjustment necessary

Hepatic impairment

  • Mild-to moderate (total bilirubin >1-3x ULN): No dosage adjustment necessary
  • Severe: Not studied

Dosing Considerations

Verify pregnancy status in females of reproductive potential before initiation

Patient selection

Safety and efficacy not established

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Adverse Effects

>10% (CSCC)

All grades

  • Fatigue (34%)
  • Rash (31%)
  • Diarrhea (25%)
  • Musculoskeletal pain (24%)
  • Nausea (21%)
  • Pruritus (18%)
  • Cough (14%)
  • Constipation (13%)
  • Anemia (11%)
  • Arthralgia (11%)
  • >10% (BCC) H3
  • All grades H4
  • Fatigue (49%)
  • Musculoskeletal pain (33%)
  • Diarrhea (25%)
  • Rash (22%)
  • Pruritus (20%)
  • Upper respiratory tract infection (15%)
  • Decreased appetite (14%)
  • Anemia (13%)
  • Nausea (12%)
  • Urinary tract infection (12%)
  • Headache (12%)
  • Constipation (11%)
  • Dyspnea (11%)
  • Hypertension (11%)

Grade 3 or 4

  • Hyponatremia (3.1%)
  • Activated partial thromboplastin time prolonged (2.3%)
  • Lymphocyte count decreased (2.3%)
  • Hypokalemia (1.5%)

1-10% (CSCC)

All grades

  • Hypothyroidism (10%)
  • Decreased appetite (10%)
  • Vomiting (10%)
  • Pneumonitis (≥2%)
  • Cellulitis (≥2%)
  • Sepsis (≥2%)
  • Pneumonia (≥2%)

Grade 3 or 4

  • Lymphopenia (9%)
  • Anemia (5%)
  • Hyponatremia (5%)
  • Hypophosphatemia (4%)
  • Anemia (4%)
  • Musculoskeletal pain (3%)
  • Fatigue (3%)
  • Hypercalcemia (2%)
  • Increased AST (2%)
  • Increased INR (2%)
  • Rash (1%)
  • Arthralgia (1%)

1-10% (BCC)

All grades

  • Urinary tract infection (≥1.5%)
  • Colitis (≥1.5%)
  • Acute kidney injury (≥1.5%)
  • Adrenal insufficiency (≥1.5%)
  • Anemia (≥1.5%)
  • Infected neoplasm (≥1.5%)
  • Somnolence (≥1.5%)

Grade 3 or 4

  • Hypertension (4.5%)
  • Fatigue (3.8%)
  • Urinary tract infection (2.3%)
  • Musculoskeletal pain (1.5%)
  • Decreased appetite (1.5%)
  • Headache (1.5%)
  • Acute kidney injury (1.5%)
  • Cachexia (1.5%)

<1% (Grade 3 or 4)

CSCC

  • Vomiting (0.5%)
  • Constipation (0.5%)
  • Diarrhea (0.5%)

BCC

  • Nausea (0.8%)
  • Constipation (0.8%)
  • Rash (0.8%)
  • Anemia (0.8%)
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Warnings

Contraindications

None

Cautions

Infusion-related reactions reported (see Dosage Modifications)

Based on cemiplimab’s mechanism of action, can cause fetal harm when administered to pregnant women

Severe and fatal immune-mediated adverse effects

  • May cause a wide variety of immune-mediated adverse effects
  • Programmed death receptor-1 (PD-1) or PD-ligand 1 (PD-L1) inhibitors, including cemiplimab, block the PD-1/PD-L1 pathway, thereby removing inhibition of immune response, potentially breaking of peripheral tolerance and induction of immune-mediated adverse reactions
  • 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 <1% of patients or were reported with other PD-1/PD-L1 blockers
  • Usually manifest during treatment and after discontinuation 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 reported; all dermatologic reactions were treated with systemic corticosteriods in clinical trial; ~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

Complications of allogeneic hematopoietic stem cell transplantation (HSCT)

  • Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 inhibitor
  • Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease after reduced-intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause)
  • These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT
  • Closely monitor for evidence of transplant-related complications and intervene promptly; consider benefit versus risks of treatment with a PD-1/PD-L1 inhibitor before or after an allogeneic HSCT
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Pregnancy

Pregnancy

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

Animal data

  • Studies in mice demonstrated PD-1/PD-L1 can lead to increased risk of immune-mediated rejection of the developing fetus, resulting in fetal death

Contraception

  • Females of reproductive potential: Use effective contraception during treatment and for at least 4 months after last dose

Lactation

There are no data regarding distribution into 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 last dose

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Monoclonal antibody that targets checkpoint inhibitor PD-1 (programmed death 1) and blocks its interaction with PD-L1 and PD-L2, releasing the PD-1 pathway-mediated inhibition of the immune response, including antitumor immune response, thereby decreasing tumor growth

Binding of the PD-1 ligands PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production

Absorption

Peak plasma concentration (steady-state): 171 mcg/mL

Minimum concentration (steady-state): 61 mcg/mL

Steady-state reached: ~4 months

Distribution

Vd: 5.3 L

Elimination

Half-life: 20.3 days (steady-state)

Clearance: 0.29 L/day (after first dose); 0.2 L/day (steady-state)

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Administration

IV Compatibilities

0.9% NaCl

D5W

IV Preparation

Visually inspect for particulate matter and discoloration; solution should appear clear to slightly opalescent, colorless to pale yellow and may contain trace amounts of translucent-to-white particles

Discard if solution is cloudy, discolored, or contains extraneous particulate matter other than trace amounts of translucent-to-white particles

Do not shake

Withdraw 350 mg (7 mL) from vial and dilute with 0.9% NaCl or D5W to a final concentration between 1-20 mg/mL

Mix diluted solution by gentle inversion; do not shake

Discard unused drug or waste material

IV Administration

Infuse over 30 minutes through an IV line containing a sterile, in-line or add-on 0.2 to 5-micron filter

Storage

Unopened vials

  • Refrigerate at 2-8°C (36-46°F) in original carton
  • Protect from light
  • Do not freeze or shake

Diluted solution

  • Store at room temperature up to 25°C (77°F) for no more than 8 hr from time of preparation to end of infusion, OR
  • Refrigerate at 2-8°C (36-46°F) for no more than 24 hr from time of preparation to end of infusion
  • Allow diluted solution to come to room temperature before administration
  • Do not freeze
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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.