Dosage & Administration
See Full Prescribing Information for instructions on preparation and administration. (
Use aseptic technique to prepare LUNSUMIO.
| Dose of LUNSUMIO | Volume of LUNSUMIO in 0.9% or 0.45% Sodium Chloride Solution | Size of Infusion Bag |
|---|---|---|
| 1 mg | 1 mL | 50 mL or 100 mL |
| 2 mg | 2 mL | 50 mL or 100 mL |
| 60 mg | 60 mL | 100 mL or 250 mL |
| 30 mg | 30 mL | 50 mL, 100 mL, or 250 mL |
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Lunsumio Prescribing Information
- Administer LUNSUMIO to well-hydrated patients.
- Premedicate before each dose in Cycle 1 and Cycle 2[see Dosage and Administration (2.3)].
- Administer only as an intravenous infusion through a dedicated infusion line.Do not use an in-line filter to administer LUNSUMIO. Drip chamber filters can be used to administer LUNSUMIO.
- LUNSUMIO should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as cytokine release syndrome and neurologic toxicity, including ICANS[see Warnings and Precautions (5.1and 5.2)].
See Tables 4and 5for the recommended dosage modifications for adverse reactions of CRS and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS). See Table 6for the recommended dosage modifications for other adverse reactions following administration of LUNSUMIO.
Identify cytokine release syndrome (CRS) based on clinical presentation
If CRS is suspected, withhold LUNSUMIO until CRS resolves, manage according to the recommendations in Table 4and per current practice guidelines. Administer supportive therapy for CRS, which may include intensive care for severe or life-threatening CRS.
| GradeBased on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS. | Presenting Symptoms | ActionsIf CRS is refractory to management, consider other causes including hemophagocytic lymphohistiocytosis [see Warnings and Precautions (5.4)] . |
|---|---|---|
| Grade 1 | Fever ≥ 100.4°F (38°C)Premedication may mask fever, therefore if clinical presentation is consistent with CRS, follow these management guidelines. |
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| Grade 2 | Fever ≥ 100.4°F (38°C)with: Hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygenLow-flow oxygen defined as oxygen delivered at < 6 L/minute; high-flow oxygen defined as oxygen delivered at ≥ 6 L/minute.by nasal cannula or blow-by. |
|
Recurrent Grade 2 CRS
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| Grade 3 | Fever ≥ 100.4°F (38°C)with: Hypotension requiring a vasopressor (with or without vasopressin) and/or hypoxia requiring high flow oxygenby nasal cannula, face mask, non-rebreather mask, or Venturi mask. |
|
Recurrent Grade 3 CRS
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| Grade 4 | Fever ≥ 100.4°F (38°C)with: Hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring oxygen by positive pressure (e.g., CPAP, BiPAP, intubation and mechanical ventilation). |
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Management recommendations for neurologic toxicity, including ICANS, is summarized in Table 5. At the first sign of neurologic toxicity, including ICANS, consider neurology evaluation and withholding of LUNSUMIO based on the type and severity of neurotoxicity. Rule out other causes of neurologic symptoms. Provide supportive therapy, which may include intensive care.
| Adverse Reaction | SeverityBased on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.,Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS. | Actions |
|---|---|---|
| Neurologic Toxicity (including ICANS) | Grade 1 |
|
| Grade 2 |
| |
| Grade 3 |
| |
| Grade 4 |
|
| Adverse ReactionsBased on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. | Severity | Actions |
|---|---|---|
| Infections [see Warnings and Precautions (5.3)] | Grades 1 – 4 |
|
| Neutropenia [see Warnings and Precautions (5.4)] | Absolute neutrophil count less than 0.5 × 109/L |
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| Other Adverse Reactions [see Warnings and Precautions (5.5)and Adverse Reactions (6.1)] | Grade 3 or higher |
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LUNSUMIO can cause cytokine release syndrome (CRS), including serious or life-threatening reactions
Cytokine release syndrome occurred in 39% of patients who received LUNSUMIO at the recommended dose in the clinical trial, with Grade 1 CRS occurring in 28%, Grade 2 in 15%, Grade 3 in 2%, and Grade 4 in 0.5% of patients. Recurrent CRS occurred in 11% of patients. Most patients experienced CRS following doses of 1 mg on Cycle 1 Day 1 (15%), 2 mg on Cycle 1 Day 8 (5%), and 60 mg on Cycle 1 Day 15 (33%). Five percent of patients experienced CRS after receiving 60 mg on Cycle 2 Day 1 with 1% of patients experiencing CRS following subsequent dosages of LUNSUMIO.
The median time to onset of CRS from the start of administration in Cycle 1 Day 1 was 5 hours (range: 1 hour to 3 days), Cycle 1 Day 8 was 28 hours (range: 5 hours to 3 days), Cycle 1 Day 15 was 25 hours (range: 0.1 hours to 16 days), and Cycle 2 Day 1 was 46 hours (range: 12 hours to 3 days). The median duration of CRS was 3 days (range: 1 to 29 days).
Clinical signs and symptoms of CRS included, but were not limited to, fever, chills, hypotension, tachycardia, hypoxia, and headache. Concurrent neurologic adverse reactions occurred in 6% of patients and included but were not limited to headache, confusional state, and anxiety.
Initiate therapy according to LUNSUMIO step-up dosing schedule to reduce the risk of CRS
At the first sign of CRS, immediately evaluate patients for hospitalization, manage per current practice guidelines and administer supportive care; withhold or permanently discontinue LUNSUMIO based on severity
Patients who experience CRS (or other adverse reactions that impair consciousness) should be evaluated and advised not to drive and to refrain from operating heavy or potentially dangerous machinery until resolution.
Warnings and Precautions (LUNSUMIO can cause serious and life-threatening neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS) [see Adverse Reactions (6.1)] .Neurologic toxicity occurred in 39% of patients who received LUNSUMIO at the recommended dose in the clinical trial, with Grade 3 neurologic toxicity occurring in 3% of patients. The most frequent neurologic toxicities were headache (21%), peripheral neuropathy (13%), dizziness (11%), and mental status changes (6%, including confusional state, disturbance in attention, cognitive disorder, delirium, encephalopathy, and somnolence). ICANS was reported in 1% of patients (Grade 1: 0.5%, Grade 2: 0.5%) who received LUNSUMIO at the recommended dose in the clinical trial. Across a broader clinical trial population, ICANS or suspected ICANS occurred in 2.1% (20/949) of patients who received LUNSUMIO. The most frequent manifestations included confusional state and lethargy. Nineteen patients had Grade 1-2 events and 1 patient had a Grade 3 event. The majority of cases (75%) occurred during the first cycle of treatment. The median time to onset was 17 days (range: 1 to 48 days). In total, 87% of cases resolved after a median duration of 3 days (range: 1-20 days). Coadministration of LUNSUMIO with other products that cause dizziness or mental status changes may increase the risk of neurologic toxicity. Monitor patients for signs and symptoms of neurologic toxicity during treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate the patient, consider neurology evaluation as appropriate, and provide supportive therapy based on severity; withhold or permanently discontinue LUNSUMIO based on severity and follow management recommendations [see Dosage and Administration (2.4)] .Patients who experience neurologic toxicity such as tremors, dizziness, insomnia, severe neurotoxicity, or any other adverse reactions that impair consciousness should be evaluated, including potential neurology evaluation, and patients at increased risk should be advised not to drive and to refrain from operating heavy or potentially dangerous machinery until resolution. | 11/2024 |
Warnings and Precautions (LUNSUMIO can cause fatal or serious hemophagocytic lymphohistiocytosis (HLH). HLH is a potentially life-threatening, hyperinflammatory syndrome that is independent of CRS. Common manifestations include fever, elevated ferritin, hemophagocytosis, cytopenias, coagulopathy, hepatitis, and splenomegaly. Across a broader clinical trial population, HLH occurred in 0.5% (7/1536) of patients. Most cases (5/7) were identified within the first 28 days following initiation of LUNSUMIO, with 3 cases preceded by diagnosed or suspected CRS. Of the 7 cases of HLH, 6 had fatal outcomes, with 2 deaths from HLH alone and 4 deaths with concurrent unresolved HLH. Of the 7 cases of HLH, 4 occurred in the context of concurrent EBV and/or CMV infection. Monitor for clinical signs and symptoms of HLH. Consider HLH when the presentation of CRS is atypical or prolonged, or when there are features of macrophage activation. For suspected HLH, interrupt LUNSUMIO and evaluate and treat promptly for HLH per current practice guidelines. | 11/2024 |
LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (
LUNSUMIO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
This indication is approved under accelerated approval based on response rate
- Premedicate to reduce risk of cytokine release syndrome and infusion-related reactions. (,
2.3 Recommended Premedication and Prophylactic MedicationPremedication to reduce the risk of cytokine release syndrome and infusion-related reactions are outlined in Table 3
[see Warnings and Precautions (5.1)].Table 3. Premedication to be Administered to Patients Prior to LUNSUMIO Infusion Treatment Cycle Patients Requiring Premedication Premedication Dosage Administration Cycle 1 and Cycle 2 All patients Corticosteroid Dexamethasone 20 mg intravenous or methylprednisolone 80 mg intravenous Complete at least 1 hour prior to infusion Antihistamine Diphenhydramine hydrochloride 50 mg to 100 mg or equivalent oral or intravenous antihistamine At least 30 minutes prior to infusion Antipyretic Oral acetaminophen (500 mg to 1,000 mg) At least 30 minutes prior to infusion Cycles 3+ Patients who experienced any grade CRS with the previous dose Corticosteroid Dexamethasone 20 mg intravenous or methylprednisolone 80 mg intravenous Complete at least 1 hour prior to infusion Antihistamine Diphenhydramine hydrochloride 50 mg to 100 mg or equivalent oral or intravenous antihistamine At least 30 minutes prior to infusion Antipyretic Oral acetaminophen (500 mg to 1,000 mg) At least 30 minutes prior to infusion )5.1 Cytokine Release SyndromeLUNSUMIO can cause cytokine release syndrome (CRS), including serious or life-threatening reactions
[see Adverse Reactions (6.1)].Cytokine release syndrome occurred in 39% of patients who received LUNSUMIO at the recommended dose in the clinical trial, with Grade 1 CRS occurring in 28%, Grade 2 in 15%, Grade 3 in 2%, and Grade 4 in 0.5% of patients. Recurrent CRS occurred in 11% of patients. Most patients experienced CRS following doses of 1 mg on Cycle 1 Day 1 (15%), 2 mg on Cycle 1 Day 8 (5%), and 60 mg on Cycle 1 Day 15 (33%). Five percent of patients experienced CRS after receiving 60 mg on Cycle 2 Day 1 with 1% of patients experiencing CRS following subsequent dosages of LUNSUMIO.
The median time to onset of CRS from the start of administration in Cycle 1 Day 1 was 5 hours (range: 1 hour to 3 days), Cycle 1 Day 8 was 28 hours (range: 5 hours to 3 days), Cycle 1 Day 15 was 25 hours (range: 0.1 hours to 16 days), and Cycle 2 Day 1 was 46 hours (range: 12 hours to 3 days). The median duration of CRS was 3 days (range: 1 to 29 days).
Clinical signs and symptoms of CRS included, but were not limited to, fever, chills, hypotension, tachycardia, hypoxia, and headache. Concurrent neurologic adverse reactions occurred in 6% of patients and included but were not limited to headache, confusional state, and anxiety.
Initiate therapy according to LUNSUMIO step-up dosing schedule to reduce the risk of CRS
[see Dosage and Administration (2.3)]. Administer pretreatment medications to reduce the risk of CRS, ensure adequate hydration, and monitor patients following administration of LUNSUMIO accordingly.At the first sign of CRS, immediately evaluate patients for hospitalization, manage per current practice guidelines and administer supportive care; withhold or permanently discontinue LUNSUMIO based on severity
[see Dosage and Administration (2.4)].Patients who experience CRS (or other adverse reactions that impair consciousness) should be evaluated and advised not to drive and to refrain from operating heavy or potentially dangerous machinery until resolution.
- Administer only as an intravenous infusion. ()
2.1 Important Dosing Information- Administer LUNSUMIO to well-hydrated patients.
- Premedicate before each dose in Cycle 1 and Cycle 2[see Dosage and Administration (2.3)].
- Administer only as an intravenous infusion through a dedicated infusion line.Do not use an in-line filter to administer LUNSUMIO. Drip chamber filters can be used to administer LUNSUMIO.
- LUNSUMIO should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as cytokine release syndrome and neurologic toxicity, including ICANS[see Warnings and Precautions (5.1and 5.2)].
- Recommended dosage:
- Cycle 1 Day 1 – 1 mg
- Cycle 1 Day 8 – 2 mg
- Cycle 1 Day 15 – 60 mg
- Cycle 2 Day 1 – 60 mg
- Cycle 3+ Day 1 – 30 mg
See Full Prescribing Information for instructions on preparation and administration. (
Use aseptic technique to prepare LUNSUMIO.
- Inspect the vial visually for any particulate matter, prior to administration. Do not use if the solution is discolored, or cloudy, or if foreign particles are present.
- Determine the dose, the total volume of LUNSUMIO solution required, and the number of LUNSUMIO vials needed.
1.000000000000000e+00 Withdraw the volume from an infusion bag of 0.9% Sodium Chloride Injection, USP or 0.45% Sodium Chloride Injection, USP equal to the volume of the LUNSUMIO required for the patient's dose and discard. Only use infusion bags made of polyvinyl chloride (PVC) or polyolefin (PO) such as polyethylene (PE) and polypropylene.2.000000000000000e+00 Withdraw the required volume of LUNSUMIO from the vial using a sterile needle and syringe and dilute into the infusion bag of 0.9% Sodium Chloride Injection, USP or 0.45% Sodium Chloride Injection, USP according to Table 7. Discard any unused portion left in the vial.
| Dose of LUNSUMIO | Volume of LUNSUMIO in 0.9% or 0.45% Sodium Chloride Solution | Size of Infusion Bag |
|---|---|---|
| 1 mg | 1 mL | 50 mL or 100 mL |
| 2 mg | 2 mL | 50 mL or 100 mL |
| 60 mg | 60 mL | 100 mL or 250 mL |
| 30 mg | 30 mL | 50 mL, 100 mL, or 250 mL |
3.000000000000000e+00 Gently mix the intravenous bag by slowly inverting the bag.Do not shake.4.000000000000000e+00 Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if visibly opaque particles, discoloration, or foreign particles are observed.5.000000000000000e+00 Apply the peel-off label from the package insert to the infusion bag.6.000000000000000e+00 Immediately use diluted LUNSUMIO infusion solution. If not used immediately, the diluted solution can be stored refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours and at ambient temperature 9°C to 30°C (48°F to 86°F) for up to 16 hours. Prior to administration, ensure the infusion solution comes to reach room temperature.
- Administer as an intravenous infusion only.
- Do not use an in-line filter to administer LUNSUMIO.
- Do not mix LUNSUMIO with, or administer through the same infusion line, as other medicinal products.
- No incompatibilities have been observed between LUNSUMIO and intravenous infusion bags with product contacting materials of polyvinyl chloride (PVC), or polyolefins (PO) such as polyethylene (PE) and polypropylene (PP). In addition, no incompatibilities have been observed with infusion sets or infusion aids with product contacting materials of PVC, PE, polyurethane (PUR), polybutadiene (PBD), silicone, acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polyetherurethane (PEU), fluorinated ethylene propylene (FEP), or polytetrafluorethylene (PTFE), or with drip chamber filter membrane composed of polyamide (PA).
LUNSUMIO is a sterile, colorless solution available as:
- Injection: 1 mg/mL mosunetuzumab-axgb of solution in a single-dose vial
- Injection: 30 mg/30 mL (1 mg/mL) mosunetuzumab-axgb of solution in a single-dose vial
Lactation: Advise not to breastfeed. (
There is no information regarding the presence of mosunetuzumab-axgb in human milk, the effect on the breastfed child, or milk production. Because human IgG is present in human milk, and there is potential for mosunetuzumab-axgb absorption leading to B-cell depletion, advise women not to breastfeed during treatment with LUNSUMIO and for 3 months after the last dose.