Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: SFL Pharmaceuticals Deutschland GmbH, Marie-Curie-Strasse 8, 79539 Loerrach, Germany
Cejemly in combination with platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small-cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations.
Therapy should be initiated and supervised by physicians experienced in the use of anticancer medicinal products.
The use of systemic corticosteroids or immunosuppressants before starting sugemalimab should be avoided (see section 4.5).
Sugemalimab 1200 mg (for individuals weighing 115 kg or less) or 1500 mg (for individuals weighing more than 115 kg) is infused intravenously over 60 minutes followed by intravenous infusion of carboplatin and paclitaxel on day 1 for up to 4 cycles every 3 weeks. Thereafter, sugemalimab 1200 mg (for individuals weighing 115 kg or less) or 1500 mg (for individuals weighing more than 115 kg) is administered every 3 weeks for the duration of therapy.
Sugemalimab 1200 mg (for individuals weighing 115 kg or less) or 1500 mg (for individuals weighing more than 115 kg) is infused intravenously over 60 minutes followed by intravenous infusion of carboplatin and pemetrexed on day 1 for up to 4 cycles every 3 weeks. Thereafter, sugemalimab 1200 mg (for individuals weighing 115 kg or less) or 1500 mg (for individuals weighing more than 115 kg) and pemetrexed are administered every 3 weeks for the duration of therapy.
Sugemalimab is administered in combination with chemotherapy. Refer to the full prescribing information for the combination products (see also section 5.1).
Treatment should be continued until disease progression, or unacceptable toxicity.
The dose of sugemalimab should not be increased or reduced. Treatment withholding or discontinuation may be required based on individual safety and tolerability. Recommended treatment modifications are provided in Table 1.
Table 1. Recommended treatment modifications of Cejemly:
| Adverse reaction | Severity* | Treatment modification |
|---|---|---|
| Immune-related pneumonitis | Grade 2 | Withhold until the adverse reaction recovers to Grade 0 to 1. |
| Grade 3 or 4, or recurrent Grade 2 | Permanently discontinue. | |
| Immune-related colitis | Grade 2 or 3 | Withhold until the adverse reaction recovers to Grade 0 to 1. |
| Grade 4 or recurrent Grade 3 | Permanently discontinue. | |
| Immune-related nephritis | Grade 2 blood creatinine increased | Withhold until the adverse reaction recovers to Grade 0 to 1. |
| Grade 3 or 4 blood creatinine increased | Permanently discontinue. | |
| Immune-related pancreatitis | Grade 2 pancreatitis† | Withhold until the adverse reaction recovers to Grade 0 to 1. |
| Grade 3 or 4 pancreatitis | Permanently discontinue. | |
| Immune-related ocular toxicities | Grade 2 ocular toxicities | Withhold until the adverse reaction recovers to Grade 0 to 1. |
| Grade 3 or 4 ocular toxicities | Permanently discontinue. | |
| Immune-related endocrine disorders | Symptomatic Grade 2 or 3 hypothyroidism Grade 2 or 3 hyperthyroidism Grade 2 or 3 symptomatic hypophysitis Grade 2 adrenal insufficiency Type-1 diabetes mellitus associated Grade 3 hyperglycaemia | Withhold until the adverse reaction recovers to Grade 0 to 1. |
| Grade 4 hypothyroidism Grade 4 hyperthyroidism Grade 4 symptomatic hypophysitis Grade 3 or 4 adrenal insufficiency Type-1 diabetes mellitus associated Grade 4 hyperglycaemia | Permanently discontinue. | |
| Immune-related hepatitis | Grade 2, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) at > 3 to 5 times the upper limit of normal (ULN) or total bilirubin (TBIL) at > 1.5 to 3 times the ULN | Withhold until the adverse reaction recovers to Grade 0 to 1. |
| Grade 3 or 4, AST or ALT > 5 times the ULN, or TBIL > 3 times the ULN | Permanently discontinue. | |
| Immune-related skin reactions | Grade 3 Suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) | Withhold until the adverse reaction recovers to Grade 0 to 1. |
| Grade 4 Confirmed SJS or TEN | Permanently discontinue. | |
| Other immune-related adverse reactions | First occurrence of other Grade 2 or Grade 3 immune-related adverse reactions depending on the reaction severity and type | Withhold until the adverse reaction recovers to Grade 0 to 1. |
| Grade 2, 3 or 4 myocarditis Grade 3 or 4 encephalitis Grade 4 myositis First occurrence of other Grade 4 immune-related adverse reactions | Permanently discontinue. | |
| Recurrent adverse reactions | Recurrent Grade 3 or 4 (except for endocrine disorders) | Permanently discontinue. |
| Infusion-related reactions | Grade 2 | Infusion should be interrupted and may be resumed at 50% of previous rate once infusion related reactions have resolved or decreased to Grade ≤1, with close observation ensured. |
| Grade 3 or 4 | Permanently discontinue. |
* Toxicity Grades are in accordance with the National Cancer Institute’s Common Terminology Criteria for Adverse Events, Version 4.03 (NCI CTCAE V4.03).
† Continued clinical monitoring is recommended for asymptomatic pancreatitis or increase in pancreatic enzyme/lipase, but no temporary medicinal products discontinuation is required.
No treatment modification of sugemalimab is required for elderly patients (≥65 years of age) (see section 5.1).
No treatment modification of sugemalimab is required in patients with mild or moderate renal impairment (see section 5.2). Sugemalimab has not been studied in patients with severe renal impairment. Sugemalimab must be administered with caution in patients with severe renal impairments.
No treatment modification of sugemalimab is recommended for patients with mild hepatic impairment (see section 5.2). Sugemalimab has not been studied in patients with moderate or severe hepatic impairment. Sugemalimab must be administered with caution in patients with moderate or severe hepatic impairment.
The safety and efficacy of sugemalimab in children below the age of 18 years have not been established. No data are available.
Cejemly is for intravenous use only.
Sugemalimab after dilution is administered as an intravenous infusion over 60 minutes.
Sugemalimab must not be administered as an intravenous push or bolus injection. For the management of infusion-related reactions, see Table 1.
The diluted sugemalimab solution is administered first, followed by chemotherapy. Chemotherapy may be started 30 minutes after completion of sugemalimab administration.
For instructions on dilution of the medicinal product before administration, see section 6.6.
No events of sugemalimab overdose have been reported in clinical studies. In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment should be initiated as dictated by patient’s clinical status.
Unopened vial:
30 months.
Diluted medicinal product prepared for infusion:
Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2°C to 8°C and for up to 4 hours at room temperature (up to 25°C) from the time of preparation. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.
20 mL of concentrate for solution for infusion in Type 1 glass vial with an elastomeric stopper and a blue flip-off aluminum seal containing 600 mg sugemalimab.
Pack size of 2 vials.
Cejemly is supplied as a single-use vial and does not contain any preservatives. Aseptic technique must be used for preparation and administration.
See SmPCs of platinum-based chemotherapy medicinal products and pemetrexed or paclitaxel for preparation.
Preparation and administration of Cejemly concentrate for solution for infusion:
a. Do not shake the vial.
b. 1200 mg dose
Withdraw 20 mL from each of the 2 vials (total 40 mL) of Cejemly using sterile syringe and transfer into a 250 ml intravenous bag containing sodium chloride 9 mg/mL (0.9%) solution for injection for a total 1200 mg dose. Mix diluted solution by gentle inversion. Do not freeze or shake the solution.
1500 mg dose
Withdraw 20 mL from each of 2 vials and 10 ml from 1 vial (total 50 mL) of Cejemly using sterile syringe and transfer into a 250 ml intravenous bag containing sodium chloride 9 mg/mL (0.9%) solution for injection for a total 1500 mg dose. Mix diluted solution by gentle inversion. Do not freeze or shake the solution.
c. Do not co-administer other medicinal products through the same infusion line. The infusion solution should be administered through an intravenous line containing a sterile, low-protein binding in-line or add-on polyether sulfone (PES) filter with a 0.22-micron pore size.
d. Allow the diluted solution to come to room temperature prior to administration.
e. Discard any unused portion left in the vial.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements
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