Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.
Lunsumio must only be administered under the supervision of a healthcare professional qualified in the use of anti-cancer therapies, in a setting with appropriate medical support to manage severe reactions such as cytokine release syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) (see below and section 4.4).
It is important to check the product labels to ensure that the correct formulation (intravenous or subcutaneous fixed dose) is being administered to the patient, as prescribed. Lunsumio subcutaneous formulation is not intended for intravenous administration and should be administered via a subcutaneous injection only.
Lunsumio subcutaneous injection should be administered to well-hydrated patients.
Table 1 provides details on recommended premedication for CRS.
Table 1. Premedication to be administered to patients prior to Lunsumio subcutaneous injection:
| Patients requiring premedication | Premedication |
| Cycles 1 all patients Cycles 2+: patients who experienced any grade CRS with the previous dose | Intravenous or oral corticosteroids: dexamethasone 20 mg (preferred) or methylprednisolone 80 mg |
| Anti-histaminea: 50-100 mg diphenhydramine hydrochloride or equivalent oral or intravenous anti-histamine | |
| Anti-pyretica: 500-1000 mg paracetamol |
a Anti-histamines and anti-pyretics are optional in cycle 1 and beyond
The recommended dose of Lunsumio subcutaneous injection for each 21 day-cycle is detailed in Table 2.
Table 2. Dose of Lunsumio subcutaneous injection for patients with relapsed or refractory follicular lymphoma:
| Day of treatment | Dose of Lunsumio | |
| Cycle 1 | Day 1 | 5 mg |
| Day 8 | 45 mg | |
| Day 15 | 45 mg | |
| Cycle 2 and beyond | Day 1 | 45 mg |
Lunsumio subcutaneous injection should be administered for 8 cycles, unless a patient experiences unacceptable toxicity or disease progression.
For patients who achieve a complete response, no further treatment beyond 8 cycles is required. For patients who achieve a partial response or have stable disease in response to treatment with Lunsumio subcutaneous injection after 8 cycles, an additional 9 cycles of treatment (17 cycles total) should be administered, unless a patient experiences unacceptable toxicity or disease progression.
Table 3. Recommendations for restarting therapy with Lunsumio subcutaneous injection after dose delay:
| Last dose administered | Time since the last dose administered | Action for next dose(s) |
| 5 mg Cycle 1 Day 1 | 1 week to 2 weeks | Administer 45 mg (Cycle 1 Day 8)*, then resume the planned treatment schedule |
| >2 weeks | Repeat 5 mg (Cycle 1 Day 1)*, then administer 45 mg (Cycle 1 Day 8)* and resume the planned treatment schedule | |
| 45 mg Cycle 1 Day 8 | 1 week to less than 6 weeks | Administer 45 mg (Cycle 1 Day 15)*, then resume the planned treatment schedule |
| ≥6 weeks | Repeat 5 mg*, then administer 45 mg (Cycle 1 Day 15)* 7 days later and resume the planned treatment schedule | |
| 45 mg Cycle 1 Day 15 | 1 week to less than 6 weeks | Administer 45 mg (Cycle 2 Day 1), then resume the planned treatment schedule |
| ≥6 weeks | Repeat 5 mg (Cycle 2 Day 1)*, then administer 45 mg (Cycle 2 Day 8)* followed by 45 mg on Day 1 of subsequent cycles | |
| 45 mg Cycle 2 and beyond | 3 weeks to less than 6 weeks | Administer 45 mg, then resume the planned treatment schedule |
| ≥6 weeks | Repeat 5 mg* on Day 1 during the next cycle, then administer 45 mg* on Day 8, followed by 45 mg on Day 1 of subsequent cycles |
* Administer premedication as per Cycle 1
Note that all references to Cycle and Day are to the nominal Cycle and Day.
Patients who experience grade 3 or 4 reactions (e.g. serious infection, tumour flare, tumour lysis syndrome) should have treatment temporarily withheld until symptoms are resolved (see section 4.4).
CRS should be identified based on clinical presentation (see section 4.4). Patients should be evaluated and treated for, other causes of fever, hypoxia, and hypotension, such as infections/sepsis. If CRS is suspected, patients should be managed according to the recommendations in Table 4.
Table 4. CRS grading1 and management:
| CRS grade | CRS management2 | Next scheduled injection of Lunsumio |
| Grade 1 Fever ≥38ºC | The symptoms should be treated If CRS lasts >48 hours after symptomatic management: • Dexamethasone3 and/or tocilizumab4,5 should be considered | Ensure symptoms are resolved for at least 72 hours prior to next dose Consider administration of premedication with antihistamines, anti-pyretic medication, and monitor closely for CRS |
| Grade 2 Fever ≥38ºC and/or hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen6 by nasal cannula or blow-by | The symptoms should be treated If no improvement occurs after symptomatic management: • Dexamethasone3 and/or tocilizumab4,5 should be considered | The symptoms should be resolved for at least 72 hours prior to next injection Premedication should be maximised as appropriate7 and patients monitored more frequently |
| Grade 3 Fever ≥38ºC and/or hypotension requiring a vasopressor (with or without vasopressin) and/or hypoxia requiring high flow oxygen8 by nasal cannula, face mask, non-rebreather mask, or Venturi mask | The symptoms should be treated Dexamethasone3 and tocilizumab4,5 should be administered If CRS is refractory to dexamethasone and tocilizumab: • Alternative immunosuppressants9 and methylprednisolone 1 000 mg/day intravenously should be administered until clinical improvement | The symptoms should be resolved for at least 72 hours prior to next injection Patients should be monitored more frequently and hospitalised for the next dose Premedication should be maximised as appropriate7 If CRS occurred after 5 mg or 45 mg, the next dose should be 5 mg. The treatment schedule should be resumed after recovery. If CRS Grade 3 occurs with next doses permanently discontinue treatment. |
| Grade 4 Fever ≥38ºC and/or hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring oxygen by positive pressure (e.g., CPAP, BiPAP, intubation and mechanical ventilation) | • Treatment with Lunsumio subcutaneous injection should be permanently discontinued • The symptoms should be treated • Dexamethasone3 and tocilizumab4,5 should be administered If CRS is refractory to dexamethasone and tocilizumab: • Alternative immunosuppressants9 and methylprednisolone 1 000 mg/day intravenously should be administered until clinical improvement | |
1 ASTCT = American Society for Transplantation and Cellular Therapy. Premedication may mask fever, therefore if clinical presentation is consistent with CRS, please follow these management guidelines.
2 If CRS is refractory to management, consider other causes including haemophagocytic lymphohistiocytosis
3 Dexamethasone should be administered at 10 mg orally every 6 hours (or equivalent) until clinical improvement
4 In study GO29781, tocilizumab was administered intravenously at a dose of 8 mg/kg (not to exceed 800 mg per infusion), as needed for CRS management
5 If no clinical improvement in the signs and symptoms of CRS occurs after the first dose, a second dose of intravenous tocilizumab 8 mg/kg may be administered at least 8 hours apart (maximum 2 doses per CRS event). Within each time period of 6 weeks of Lunsumio subcutaneous injection treatment, the total amount of tocilizumab doses should not exceed 3 doses
6 Low-flow oxygen is defined as oxygen delivered at <6 L/minute
7 Refer to Table 1 for additional information
8 High-flow oxygen is defined as oxygen delivered at ≥6 L/minute
9 Riegler L et al. (2019)
ICANS should be identified based on clinical presentation (see Section 4.4). Rule out other causes of neurologic symptoms. If ICANS is suspected, it should be managed according to the recommendations in Table 5.
Table 5. Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS):
| Gradea | Actions |
| Grade 1 ICEb 7-9 or depressed level of consciousness but awakens spontaneously | Withhold Lunsumio subcutaneous injection and monitor neurologic toxicity symptoms until ICANS resolves.c,d Provide supportive therapy and consider neurologic consultation and evaluation. Consider a single dose of dexamethasone 10 mg, if not taking other corticosteroids. Consider non-sedating, anti-seizure medicinal products (e.g., levetiracetam) for seizure prophylaxis. |
| Grade 2 ICEb 3-6 or depressed level of consciousness but awakens to voice | Withhold Lunsumio subcutaneous injection and monitor neurologic toxicity symptoms until ICANS resolves.c,d Provide supportive therapy and consider neurologic consultation and evaluation. Treat with dexamethasone 10 mg intravenously every 6 hours, if not taking other corticosteroids, until improvement to Grade 1, then taper. Consider non-sedating, anti-seizure medicinal products (e.g., levetiracetam) for seizure prophylaxis. |
| Grade 3 ICEb 0-2 or depressed level of consciousness but awakens to tactile stimulus or any clinical seizure that resolves rapidly or focal/local oedema on neuroimaging | Withhold Lunsumio subcutaneous injection and monitor neurologic toxicity symptoms until ICANS resolves.d,e Provide supportive therapy, which may include intensive care, and consider neurologic consultation and evaluation. Treat with dexamethasone 10 mg intravenously every 6 hours, if not taking other corticosteroids, until improvement to Grade 1, then taper. Consider non-sedating anti-seizure medication for seizure prophylaxis until resolution of ICANS. Use anti-seizure medication for seizure management as needed. For recurrent grade 3 ICANS, consider permanently discontinuing Lunsumio subcutaneous injection. |
| Grade 4 ICEb is 0 or patient is unarousable or requires vigorous or repetitive tactile stimuli, or life-threatening prolonged seizure (>5 min) or repetitive seizures without return to baseline or deep focal motor weakness or diffuse cerebral oedema on neuroimaging | Permanently discontinue Lunsumio subcutaneous injection. Provide supportive therapy, which may include intensive care, and consider neurologic consultation and evaluation. Treat with dexamethasone 10 mg intravenously every 6 hours, if not taking other corticosteroids, until improvement to Grade 1, then taper. Alternatively, consider administration of methylprednisolone 1 000 mg per day intravenously or 3 days, if symptoms improve, then manage as above. Consider non-sedating anti-seizure medication for seizure prophylaxis until resolution of ICANS. Use anti-seizure medication for seizure management as needed. |
a American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria.
b If patient is arousable and able to perform Immune Effector Cell-Associated Encephalopathy (ICE) Assessment, assess: Orientation (oriented to year, month, city, hospital = 4 points); Naming (name 3 objects, e.g., point to clock, pen, button = 3 points); Following Commands (e.g., "show me 2 fingers" or "close your eyes and stick out your tongue" = 1 point); Writing (ability to write a standard sentence = 1 point; and Attention (count backwards from 100 by ten = 1 point). If patient is unarousable and unable to perform ICE Assessment (Grade 4 ICANS) = 0 points.
c Consider the type of neurologic toxicity before deciding to withhold Lunsumio subcutaneous injection.
d See Delayed or missed dose for guidance on restarting Lunsumio subcutaneous injection after dose delay.
e Evaluate benefit/risk before restarting Lunsumio subcutaneous injection.
No dose adjustment of Lunsumio subcutaneous injection is required in patients ≥ 65 years of age (see section 5.2).
Lunsumio subcutaneous injection has not been studied in patients with severe renal impairment. Dose adjustments are not considered necessary in patients with mild to moderate renal impairment based on pharmacokinetics (see section 5.2).
Lunsumio subcutaneous injection has not been studied in patients with hepatic impairment. Dose adjustments are not considered necessary based on pharmacokinetics (see section 5.2).
The safety and efficacy of Lunsumio subcutaneous injection in children below 18 years of age have not yet been established.
The 5 mg and 45 mg doses should be administered as subcutaneous injection only. The injection should be administered subcutaneously into the tissue of the abdomen or thigh, changing the site of injection with each dose and never into areas where the skin has tattoos, moles or scars or areas where the skin is red, bruised, tender, hard, or not intact.
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
Unopened vial:
3 years.
Prepared Syringe:
Once transferred from the vial to the syringe, Lunsumio solution for injection should be injected immediately because the medicine does not contain any antimicrobial-preservative. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless preparation has taken place in controlled and validated aseptic conditions.
If Lunsumio solution for injection is transferred from the vial to the syringe in a controlled and validated aseptic conditions, the medicine in the capped syringe can be stored in the refrigerator at 2°C to 8°C for up to 28 days protected from light and/or at 9°C to 30°C for up to 24 hours at ambient light.
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, see section 6.3.
5 mg solution for injection:
Type I glass-vial with a fluororesin-laminated rubber stopper and an aluminium seal with a plastic brown flip-off cap containing 5 mg of solution for injection.
Pack of one vial.
45 mg solution for injection:
Type I glass-vial with a fluororesin-laminated rubber stopper and an aluminium seal with a plastic lavender flip-off cap containing 45 mg of solution for injection.
Pack of one vial.
To prevent medication errors, check the vial labels to ensure that the drug being prepared and administered is Lunsumio for subcutaneous injection and not Lunsumio for intravenous infusion.
Lunsumio contains no preservative and is intended for single-dose only. Proper aseptic technique throughout the handling of this medicinal product should be followed. Do not shake.
Lunsumio subcutaneous injection should be inspected visually to ensure there is no particulate matter or discolouration prior to administration. The vial should be discarded if particulate matter is present.
Each Lunsumio vial is ready-to-use for one subcutaneous injection and should not be diluted. The Lunsumio subcutaneous injection solution should be withdrawn using an appropriately sized transfer nee (18G to 21G recommended). The transfer needle should be removed and an appropriately sized injection needle (25G to 30G recommended should be attached). The smallest syringe that can accurately deliver the injection volume should be used.
The peel-off label from the leaflet should be applied to the syringe.
The release of pharmaceuticals into the environment should be minimised. Medicinal products should not be disposed of via wastewater and disposal through household waste should be avoided.
The following points should be strictly adhered to regarding the use and disposal of syringes and other medicinal sharps:
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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