cemiplimab (Rx)

Brand and Other Names:Libtayo
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 350mg/7mL (50mg/mL) single-dose vial

Cutaneous Squamous Cell Carcinoma

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

350 mg IV q3Weeks infused over 30 min

Continue until disease progression or unacceptable toxicity

Dosage Modifications

Severe and fatal immune-mediated adverse reactions may necessitate withholding or discontinuing the drug

Withhold cemiplimab dosing

  • Grade 2 pneumonitis
  • Grades 2 or 3 colitis
  • Hepatitis (AST or ALT increased >3 and up to 10x ULN, or total bilirubin increased up to 3x ULN)
  • Grades 2, 3, or 4 endocrinopathies (withhold if clinically necessary)
  • Other immune-mediated Grade 3 adverse reaction involving a major organ

Permanently discontinue

  • Grades 3 or 4 penumonitis
  • Grade 4 colitis
  • Hepatitis (AST or ALT increased >10x ULN or total bilirubin increased >3x ULN)
  • Other immune-mediated Grade 4 adverse reaction involving a major organ
  • Grades 3 or 4 infusion-related reactions
  • Recurrent or persistent immune-mediated adverse reactions
    • Recurrent Grade 3 or 4
    • Grade 2 or 3 persistent for ≥12 weeks after last dose
    • Requirement for prednisone ≥10 mg/day (or equivalent) for ≥12 weeks after last cemiplimab dose

Interrupt or slow IV infusion rate

  • Grades 1 or 2 infusion-related reactions

Renal impairment

  • Mild or moderate: No clinically important effect on the exposure of cemiplimab observed
  • CrCl <25 mL/min: Not studied

Hepatic impairment

  • Mild: No clinically important effect on the exposure of cemiplimab observed
  • Moderate or severe: Not studied

Safety and efficacy not established

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Adverse Effects

>10% (All Grades)

Fatigue (29%)

Rash (25%)

Diarrhea (22%)

Nausea (19%)

Musculoskeletal pain (17%)

Pruritus (15%)

Constipation (12%)

1-10% (All Grades)

Decreased appetite (10%)

Immune-mediated pneumonitis (2.4%)

Immune-mediated hepatitis (2.1%)

Immune-mediated dermatologic reactions (1.7%)

1-10% (Grades 3-4)

Lymphopenia (7%)

Hypothyroidism (6%)

Hypophosphatemia (4%)

Hyponatremia (3%)

Musculoskeletal pain (3%)

Increased AST (3%)

Increased INR (2%)

Anemia (2%)

Fatigue (2%)

Hyperthyroidism (1.5%)

Rash (1.2%)

Hypoalbuminemia (1%)

Hypercalcemia (1%)

<1%

Infusion-related reactions

Diarrhea, Grades 3-4

Constipation, Grades 3-4

Immune-mediated colitis, all grades

Immune-mediated nephritis, all grades

Adrenal insufficiency

Hypophysitis

Diabetes mellitus type 1

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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
  • Cemiplimab binds to the programmed death receptor-1 (PD-1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response with the potential for 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 during clinical trials
  • 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
  • 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
  • See Dosage Modifications for when to withhold or permanently discontinue therapy
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Pregnancy

Pregnancy

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

Verify pregnancy status in females of reproductive potential before initiating

Advise women of the potential risk to a fetus

Animal studies

  • 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

  • Advise females of reproductive potential to use effective contraception during treatment with 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

Because of potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for at least 4 months after the 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: 166 mcg/mL

Minimum concentration: 59 mcg/mL

Steady-state reached: ~4 months

Distribution

Vd: 5.3 L

Elimination

Half-life: 19 days (at steady-state)

Clearance: 0.32 L/day (after first dose); 0.21 L/day (continued therapy)

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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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Images

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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.
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  • Compare formulary status to other drugs in the same class.
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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.