Dosing & Uses
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
Single-agent
- 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
Combination therapy with platinum-based chemotherapy
- Indicated in combination with platinum-based chemotherapy for first-line treatment of adults with NSCLC with no EGFR, ALK, or ROSI aberrations and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic
- Cemiplimab 350 mg IV q3Weeks PLUS
- Platinum-based chemotherapy q3Weeks for 4 cycles
- Continue until disease progression or unacceptable toxicity
- 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 initial 4 treatment cycles
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
- Single-agent therapy for NSCLC: Selection based on PD-L1 expression on tumor cells
- Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics
Safety and efficacy not established
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%)
Warnings
Contraindications
None
Cautions
Based on cemiplimab’s mechanism of action, 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 reaction include nausea, pyrexia, and vomiting; interrupt or slow rate of infusion or permanently discontinue therapy based on severity of 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, thyroiditis, 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
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.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)
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
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
Libtayo intravenous - | 50 mg/mL vial | ![]() |
Copyright © 2010 First DataBank, Inc.
Formulary
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