Active Ingredient: Serplulimab
Serplulimab in combination with carboplatin and etoposide is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 4.5 milligrams serplulimab per kilogram of body weight, once every 3 weeks.
The recommended dose is 4.5 mg/kg serplulimab every 3 weeks until disease progression or unacceptable toxicity.
Dose escalation or reduction of serplulimab is not recommended. Dose withholding or discontinuation may be required based on individual safety and tolerability. Dose withholding for up to 12 weeks for tolerability is acceptable.
Serplulimab should be withheld or discontinued to manage adverse reactions as described in the following table.
Recommended treatment modifications:
| Immune-related adverse reactions | Severity | Treatment modification# |
|---|---|---|
| Immune-related lung disease | Grade 2 | Withhold until adverse reactions recover or improve to Grade 1 |
| Grade 3 or 4 or recurrent Grade 2 | Permanently discontinue | |
| Colitis | Grade 2 or 3 | Withhold until adverse reactions recover or improve to Grade 1 |
| Grade 4 or recurrent Grade 3 | Permanently discontinue | |
| Hepatitis | Grade 2 with AST or ALT > 3 to 5 times ULN, or total bilirubin > 1.5 to 3 times ULN | Withhold until adverse reactions recover or improve to Grade 1 |
| Grade 3 or 4 with AST or ALT > 5 times ULN, or total bilirubin > 3 times ULN | Permanently discontinue | |
| Nephritis and renal dysfunction | Grade 2 elevation of serum creatinine | Withhold until adverse reactions recover or improve to Grade 1 |
| Grade 3 or 4 elevation of serum creatinine | Permanently discontinue | |
| Endocrinopathies | Symptomatic Grade 2 or 3 hypothyroidism, Grade 2 or 3 hyperthyroidism, Grade 2 or 3 hypophysitis, Grade 2 adrenal insufficiency, Grade 3 hyperglycaemia or type 1 diabetes mellitus | Withhold until symptoms resolve and management with corticosteroids is complete. Treatment should be continued in the presence of hormone replacement therapy as long as no symptoms are present |
| Grade 4 hypothyroidism Grade 4 hyperthyroidism Grade 4 hypophysitis Grade 3 or 4 adrenal insufficiency Grade 4 hyperglycaemia | Permanently discontinue | |
| Skin adverse reactions | Grade 3 | Withhold until adverse reactions recover or improve to Grade 1 |
| Grade 4 Stevens Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN) | Permanently discontinue | |
| Other immune-related adverse reactions | Grade 3 or 4 elevation of serum amylase or lipase Grade 2 or 3 pancreatitis Grade 2 myocarditis* Grade 2 or 3 other immune-mediated adverse reactions occurred for the first time Grade 3 decreased platelet count (thrombocytopenia) or white blood cell count | Withhold until adverse reactions recover or improve to Grade 1 |
| Grade 4 pancreatitis or recurrent pancreatitis of any grade Grade 3 or 4 myocarditis Grade 3 or 4 encephalitis Grade 4 other immune-related adverse reactions occurred for the first time Grade 4 or recurrent Grade 3 decreased platelet count (thrombocytopenia) or white blood cell count | Permanently discontinue | |
| Infusion-related reactions | Grade 2 | Reduce infusion rate to half rate or interrupt. Treatment may be resumed when the event is resolved |
| Grade 3 or 4 | Permanently discontinue |
Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).
ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal.
# Serplulimab must be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for any Grade 4 immune-mediated adverse reactions, except for endocrinopathies that are controlled with replacement hormones.
* The safety of retreatment with serplulimab in patients who experienced immune-related myocarditis is not clear.
No dose adjustment is needed for elderly patients (≥65 years).
The initial infusion rate should be set up to 100 ml per hour. If the first infusion is well tolerated, all subsequent infusions may be shortened to 30 minutes (± 10 minutes).
When administered in combination with chemotherapy, serplulimab should be given first followed by chemotherapy on the same day. Use separate infusion bags for each infusion.
Serplulimab must not be administered as an intravenous push or bolus injection.
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