Libtayo

Treatment must be initiated and supervised by physicians experienced in the treatment of cancer. 1). Posology Recommended dose Locally advanced or metastatic CSCC, NSCLC, BCC and recurrent or metastatic cervical cancer 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. Adjuvant treatment of high-risk CSCC The recommended dose of cemiplimab administered as an intravenous infusion over 30 minutes is: • 350 mg every 3 weeks for 12 weeks followed by 700 mg every 6 weeks, or • 350 mg every 3 weeks.

Treatment may be continued until disease recurrence, unacceptable toxicity, or up to 48 weeks of total therapy. Dose modifications 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. 8). 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 5 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 6 Other immune-mediated adverse reactions (including but not limited to paraneoplastic encephalomyelitis, meningitis, myositis, solid organ transplant […]

Summary of the safety profile Immune-mediated adverse reactions can occur with cemiplimab. Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of cemiplimab (see “Description of selected adverse reactions” below).

Cemiplimab as monotherapy The safety of cemiplimab as monotherapy has been evaluated in 1281 patients with advanced solid malignancies who received cemiplimab monotherapy in 5 clinical studies. The median duration of exposure to cemiplimab was 28 weeks (range: 2 days to 144 weeks).

2%). 6% of patients. 2). 4% of patients. 4% of patients. 4). Cemiplimab in the adjuvant CSCC setting The safety of cemiplimab as monotherapy in the adjuvant treatment of patients with CSCC at high risk of recurrence was evaluated in 205 patients in the C-POST study.

9 weeks (range: 3 weeks to 52 weeks) in the cemiplimab group. The safety profile of cemiplimab in the adjuvant setting in the C-POST study is consistent with the known safety profile for cemiplimab monotherapy in advanced cancers. 8% in the monotherapy population with advanced solid malignancies.

6% of patients. 8% of patients. Cemiplimab in combination with platinum‐based chemotherapy 12 The safety of cemiplimab in combination with platinum‐based chemotherapy has been evaluated in a clinical study of 465 patients with locally advanced or metastatic NSCLC.

3 weeks (4 days to 95 weeks) in the chemotherapy group. 4%). 0% of patients. 2). 3% of patients. 1% of patients. Tabulated list of adverse reactions Table 2 lists the incidence of adverse reactions in the monotherapy safety dataset and in patients treated with cemiplimab in combination with chemotherapy.

Adverse reactions are presented by system organ class and by frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 8). These immune-mediated reactions may involve any organ system.

Immune-mediated reactions can manifest at any time during treatment with cemiplimab; however, immune-mediated adverse reactions can occur after discontinuation of cemiplimab. The guidance for immune-mediated adverse reactions applies to cemiplimab whether administered as monotherapy or in combination with chemotherapy.

Immune-mediated adverse reactions affecting more than one body system can occur simultaneously, such as myositis and myocarditis or myasthenia gravis, in patients treated with cemiplimab or other PD-1/PD-L1 inhibitors. 8 Monitor patients for signs and symptoms of immune-mediated adverse reactions.

Immune-mediated adverse reactions should be managed with cemiplimab treatment modifications, hormone replacement therapy (if clinically indicated), and corticosteroids. For suspected immune-mediated adverse reactions, patients should be evaluated to confirm an immune-mediated adverse reaction and to exclude other possible causes, including infection.

2). In patients with pre-existing autoimmune disease (AID), data from observational studies suggest that the risk of immune-mediated adverse reactions following immune checkpoint inhibitor therapy may be increased as compared with the risk in patients without pre-existing AID.

In addition, flares of the underlying AID were frequent, but the majority were mild and manageable. 8). Patients should be monitored for signs and symptoms of pneumonitis and causes other than immune-mediated pneumonitis should be ruled out.

2). 8). 2). 8). 2). 8). Thyroid disorders (Hypothyroidism/Hyperthyroidism/Thyroiditis) Immune-mediated thyroid disorders have been observed in patients receiving cemiplimab. Thyroiditis can present with or without an alteration in thyroid function tests.

1.