Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Regeneron Ireland Designated Activity Company (DAC), One Warrington Place, Dublin 2, D02 HH27, Ireland
LIBTAYO as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation.
LIBTAYO as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).
LIBTAYO as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ≥50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have:
LIBTAYO in combination with platinum-based chemotherapy is indicated for the first‐line treatment of adult patients with NSCLC expressing PD-L1 (in ≥1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have:
LIBTAYO as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.
Treatment must be initiated and supervised by physicians experienced in the treatment of cancer.
Patients with NSCLC should be evaluated for treatment based on the tumour expression of PD-L1 confirmed by a validated test (see section 5.1).
The recommended dose is 350 mg cemiplimab every 3 weeks (Q3W) administered as an intravenous infusion over 30 minutes.
Treatment may be continued until disease progression or unacceptable toxicity.
No dose reductions are recommended. Dosing delay or discontinuation may be required based on individual safety and tolerability. Recommended modifications to manage adverse reactions are provided in Table 1.
Detailed guidelines for the management of immune-mediated adverse reactions are described in Table 1 (see also sections 4.4 and 4.8).
Table 1. Recommended treatment modifications:
| Adverse reactiona | Severityb | Dose modification | Additional intervention |
|---|---|---|---|
| Immune-mediated adverse reactions | |||
| Pneumonitis | Grade 2 | Withhold LIBTAYO | Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper |
| Resume LIBTAYO if pneumonitis improves and remains at Grade 0 to 1 after corticosteroid taper to ≤ 10 mg/day prednisone or equivalent | |||
| Grade 3 or 4 or recurrent Grade 2 | Permanently discontinue | Initial dose of 2 to 4 mg/kg/day prednisone or equivalent followed by a taper | |
| Colitis | Grade 2 or 3 | Withhold LIBTAYO | Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper |
| Resume LIBTAYO if colitis or diarrhoea improves and remains at Grade 0 to 1 after corticosteroid taper to ≤ 10 mg/day prednisone or equivalent | |||
| Grade 4 or recurrent Grade 3 | Permanently discontinue | Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper | |
| Hepatitis | Grade 2 with AST or ALT > 3 and ≤ 5 × ULN or total bilirubin > 1.5 and ≤ 3 × ULN | Withhold LIBTAYO | Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper |
| Resume LIBTAYO if hepatitis improves and remains at Grade 0 to 1 after corticosteroid taper to ≤ 10 mg/day prednisone or equivalent or returns to baseline AST or ALT after completion of corticosteroid taper | |||
| Grade ≥ 3 with AST or ALT > 5 × ULN or total bilirubin > 3 × ULN | Permanently discontinue | Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper | |
| Hypothyroidism | Grade 3 or 4 | Withhold LIBTAYO | Initiate thyroid hormone replacement as clinically indicated |
| Resume LIBTAYO when hypothyroidism returns to Grade 0 to 1 or is otherwise clinically stable | |||
| Hyperthyroidism | Grade 3 or 4 | Withhold LIBTAYO | Initiate symptomatic management |
| Resume LIBTAYO when hyperthyroidism returns to Grade 0 to 1 or is otherwise clinically stable | |||
| Thyroiditis | Grade 3 to 4 | Withhold LIBTAYO | Initiate symptomatic management |
| Resume LIBTAYO when thyroiditis returns to Grade 0 to 1 or is otherwise clinically stable | |||
| Hypophysitis | Grade 2 to 4 | Withhold LIBTAYO | Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper and hormone replacement as clinically indicated |
| Resume LIBTAYO if hypophysitis improves and remains at Grade 0 to 1 after corticosteroid taper to ≤ 10 mg/day prednisone or equivalent or is otherwise clinically stable | |||
| Adrenal insufficiency | Grade 2 to 4 | Withhold LIBTAYO | Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper and hormone replacement as clinically indicated |
| Resume LIBTAYO if adrenal insufficiency improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent or is otherwise clinically stable | |||
| Type 1 diabetes mellitus | Grade 3 or 4 (hyperglycaemia) | Withhold LIBTAYO | Initiate treatment with anti-hyperglycaemics as clinically indicated |
| Resume LIBTAYO when diabetes mellitus returns to Grade 0 to 1 or is otherwise clinically stable | |||
| Skin adverse reactions | Grade 2 lasting longer than 1 week, Grade 3 or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) | Withhold LIBTAYO | Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper |
| Resume LIBTAYO if skin reaction improves and remains at Grade 0 to 1 after corticosteroid taper to ≤ 10 mg/day prednisone or equivalent | |||
| Grade 4 or confirmed SJS or TEN | Permanently discontinue | Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper | |
| Immune-mediated skin reaction or other immune-mediated adverse reactions in patients with prior treatment with idelalisib | Grade 2 | Withhold LIBTAYO | Initiate management immediately, including initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper |
| Resume LIBTAYO if skin reaction or other immune-mediated adverse reaction improves and remains at Grade 0 to 1 after corticosteroid taper to ≤ 10 mg/day prednisone or equivalent | |||
| Grade 3 or 4 (excluding endocrinopathies) or recurrent Grade 2 | Permanently discontinue | Initiate management immediately, including initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper | |
| Nephritis with renal dysfunction | Grade 2 creatinine increased | Withhold LIBTAYO | Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper |
| Resume LIBTAYO if nephritis improves and remains at Grade 0 to 1 after corticosteroid taper to ≤ 10 mg/day prednisone or equivalent | |||
| Grade 3 or 4 creatinine increased | Permanently discontinue | Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper | |
| Other immune-mediated adverse reactions (including but not limited to paraneoplastic encephalomyelitis, meningitis, myositis, solid organ transplant rejection, graft-vs-host disease, Guillain-Barre syndrome, central nervous system inflammation, chronic inflammatory demyelinating polyradiculoneuropathy, encephalitis, myasthenia gravis, neuropathy peripheral, myocarditis, pericarditis, immune thrombocytopaenia, vasculitis, arthralgia, arthritis, muscular weakness, myalgia, polymyalgia rheumatica, Sjogren’s syndrome, pruritus, keratitis, immune-mediated gastritis, stomatitis and haemophagocytic lymphohistiocytosis) | Grade 2 or 3 based on type of reaction | Withhold LIBTAYO | Initiate symptomatic management including initial dose of 1 to 2 mg/kg/day prednisone or equivalent as clinically indicated followed by a taper |
| Resume LIBTAYO if other immune-mediated adverse reaction improves and remains at Grade 0 to 1 after corticosteroid taper to ≤ 10 mg/day prednisone or equivalent | |||
| – Grade 3 based on type of reaction or Grade 4 (excluding endocrinopathies) – Grade 3 or 4 neurologic toxicity – Grade 3 or 4 myocarditis or pericarditis – Confirmed haemophagocytic lymphohistiocytosis – Recurrent Grade 3 immune-mediated adverse reaction – Persistent Grade 2 or 3 immune-mediated adverse reactions lasting 12 weeks or longer (excluding endocrinopathies) – Inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks | Permanently discontinue | Initial dose of 1 to 2 mg/kg/day prednisone or equivalent as clinically indicated followed by a tape | |
| Infusion-related reactionsa | |||
| Infusion-related reaction | Grade 1 or 2 | Interrupt or slow rate of infusion | Initiate symptomatic management |
| Grade 3 or 4 | Permanently discontinue | ||
ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal.
a See also sections 4.4 and 4.8
b Toxicity should be graded with the current version of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
All prescribers of LIBTAYO should be familiar with the educational materials and inform the patients about the Patient Alert Card explaining what to do should they experience any symptom of immune-mediated adverse reactions and infusion-related reactions. The physician will provide the Patient Alert Card to each patient.
The safety and efficacy of LIBTAYO in children and adolescents below the age of 18 years have not been established. No data are available.
No dose adjustment is recommended for elderly patients. Cemiplimab exposure is similar across all age groups (see sections 5.1 and 5.2). Data are limited in patients ≥75 years on cemiplimab monotherapy.
No dose adjustment of LIBTAYO is recommended for patients with renal impairment. There are limited data for LIBTAYO in patients with severe renal impairment CLcr 15 to 29 ml/min (see section 5.2).
No dose adjustment is recommended for patients with mild or moderate hepatic impairment. LIBTAYO has not been studied in patients with severe hepatic impairment. There are insufficient data in patients with severe hepatic impairment for dosing recommendations (see section 5.2).
LIBTAYO is for intravenous use. It is administered by intravenous infusion over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding, in-line or add-on filter (0.2 micron to 5 micron pore size).
Other medicinal products should not be co-administered through the same infusion line.
For instructions on dilution of the medicinal product before administration, see section 6.6.
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
Unopened vial:
4 years.
After opening:
Once opened, the medicinal product should be diluted and infused immediately (see section 6.6 for instructions on dilution of the medicinal product before administration).
After preparation of infusion:
From a microbiological point of view the prepared solution for infusion should be used immediately. If diluted solution is not administered immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Chemical and physical in-use stability has been demonstrated as follows:
Or
Do not freeze.
Unopened vial:
Store in a refrigerator (2°C to 8°C).
Do not freeze.
Store in the original carton in order to protect from light.
For storage conditions after first opening or dilution of the medicinal product, see section 6.3.
LIBTAYO is provided in a 10 ml clear Type 1 glass vial, with a grey chlorobutyl stopper with FluroTec coating and seal cap with a flip-off button.
Each carton contains 1 vial.
Preparation and administration:
LIBTAYO is for single use only. Dispose of any unused medicinal product or waste material in accordance with local requirements.
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