Lunsumio Drug Information
Generic name: MOSUNETUZUMAB
Uses of Lunsumio
Follicular Lymphoma 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Dosage & Administration of Lunsumio
Important Dosing Information LUNSUMIO and LUNSUMIO VELO have different dosage and administration instructions. LUNSUMIO is for intravenous use only. Check the product label to ensure that the correct formulation (LUNSUMIO or LUNSUMIO VELO) is being prescribed and administered.
Do not substitute LUNSUMIO for or with LUNSUMIO VELO. Administer LUNSUMIO to well-hydrated patients. Premedicate before each dose in Cycle 1 and Cycle 2.
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 CRS and neurologic toxicity, including ICANS.
Recommended Dosage
The recommended dosage for LUNSUMIO intravenous infusion is presented in Table 1. Administer for 8 cycles, unless patients experience 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 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 1. Recommended Dose and Schedule of LUNSUMIO Intravenous Infusion 21-Day Table 2.
Recommendations for Restarting Therapy with LUNSUMIO Intravenous Infusion After Dose Delay to reduce the risk of CRS and infusion-related reactions are outlined in Table 3. Table 3. Premedication to be Administered to Patients Prior to LUNSUMIO Intravenous Infusion s See Tables 4 and 5 for the recommended dosage modifications for adverse reactions of CRS and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS).
See Table 6 for the recommended dosage modifications for other adverse reactions following administration of LUNSUMIO. Dosage Modifications for Cytokine Release Syndrome Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension.
If CRS is suspected, withhold LUNSUMIO until CRS resolves, manage according to the recommendations in Table 4 and per current practice guidelines. Administer supportive therapy for CRS, which may include intensive care for severe or life-threatening CRS. Table 4.
Recommendations for Management of Cytokine Release Syndrome with LUNSUMIO Intravenous Infusion Grade Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS. Presenting Symptoms Actions If CRS is refractory to management, consider other causes including hemophagocytic lymphohistiocytosis. Grade 1 Fever ≥ 100.4°F (38°C) Premedication may mask fever, therefore if clinical presentation is consistent with CRS, follow these management guidelines.
Refer to Table 2 for information on restarting LUNSUMIO after dose delays. Modifications for Neurologic Toxicity, including ICANS Management recommendations for neurologic toxicity, including ICANS, are 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. Table 5.
Recommendations for Management of Neurologic Toxicity (including ICANS) Withhold LUNSUMIO until neurologic toxicity symptoms improve to Grade 1 or baseline for at least 72 hours. See Table 2 for recommendations on restarting LUNSUMIO after dose delays. Neutropenia To prevent medication errors, check the vial labels to ensure that the drug being prepared and administered is LUNSUMIO for intravenous infusion.
A peel-off label is provided on the LUNSUMIO Prescribing Information that should be attached to the final prepared solution. Remove the peel-off label from the Prescribing Information in the LUNSUMIO carton before discarding the carton. Affix the peel-off label to the diluted LUNSUMIO infusion bag.
Preparation 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. Dilution 1. 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 (PP). 2. 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.
Table 7. Dilution of LUNSUMIO 3. Gently mix the intravenous bag by slowly inverting the bag.
Do not shake. 4. 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.
Apply the peel-off label from the Prescribing Information to the infusion bag. 6. 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. Administration Administer LUNSUMIO as an intravenous infusion only. Do not mix LUNSUMIO with, or administer through the same infusion line, as other medicinal products.
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).
| Day of Treatment Cycle length = 21 days | Intravenous Dose of LUNSUMIO | Rate of Infusion | |
|---|---|---|---|
| Cycle 1 | Day 1 | 1 mg | Administer over a minimum of 4 hours. |
| Day 8 | 2 mg | ||
| Day 15 | 60 mg | ||
| Cycle 2 | Day 1 | 60 mg | Administer over 2 hours if infusions from Cycle 1 were well-tolerated. |
| Cycles 3+ | Day 1 | 30 mg | |
| Day of Treatment | Intravenous Dose of LUNSUMIO | Rate of Infusion | |
|---|---|---|---|
| Cycle 1 | Day 1 | 1 mg | Administer over a minimum of 4 hours. |
| Day 8 | 2 mg | ||
| Day 15 | 60 mg | ||
| Cycle 2 | Day 1 | 60 mg | Administer over 2 hours if infusions from Cycle 1 were well-tolerated. |
| Cycles 3+ | Day 1 | 30 mg | |
| Last Intravenous Dose Administered | Time Since Last Dose Administered | Action for Next Intravenous Dose(s) |
|---|---|---|
| 1 mg Cycle 1 Day 1 | 1week to 2 weeks | Administer 2 mg (Cycle 1 Day 8), then resume the planned treatment schedule. |
| Greater than 2 weeks | Repeat 1 mg (Cycle 1 Day 1), then administer 2 mg (Cycle 1 Day 8) and resume the planned treatment schedule. | |
| 2 mg Cycle 1 Day 8 | 1 week to 2 weeks | Administer 60 mg (Cycle 1 Day 15), then resume the planned treatment schedule. |
| Greater than 2 weeks to less than 6 weeks | Repeat 2 mg (Cycle 1 Day 8), then administer 60 mg (Cycle 1 Day 15) and resume the planned treatment schedule. | |
| Greater than or equal to 6 weeks | Repeat 1 mg (Cycle 1 Day 1) and 2 mg (Cycle 1 Day 8), then administer 60 mg (Cycle 1 Day 15) and resume the planned treatment schedule. | |
| 60 mg Cycle 1 Day 15 | 1 week to less than 6 weeks | Administer 60 mg (Cycle 2 Day 1), then resume the planned treatment schedule. |
| Greater than or equal to 6 weeks | Repeat 1 mg (Cycle 2 Day 1) and 2 mg (Cycle 2 Day 8), then administer 60 mg (Cycle 2 Day 15), followed by 30 mg (Cycle 3 Day 1) and then resume the planned treatment schedule. | |
| 60 mg Cycle 2 Day 1 | 3 weeks to less than 6 weeks | Administer 30 mg (Cycle 3 Day 1), then resume the planned treatment schedule. |
| Greater than or equal to 6 weeks | Repeat 1 mg (Cycle 3 Day 1) and 2 mg (Cycle 3 Day 8), then administer 30 mg (Cycle 3 Day 15) For the Day 1, Day 8, and Day 15 doses in the next cycle, administer premedication as per Table 3 for all patients., followed by 30 mg (Cycle 4 Day 1) and then resume the planned treatment schedule. | |
| 30 mg Cycle 3 onwards | 3 weeks to less than 6 weeks | Administer 30 mg, then resume the planned treatment schedule. |
| Greater than or equal to 6 weeks | Repeat 1 mg on Day 1 and 2 mg on Day 8 during the next cycle, then administer 30 mg on Day 15, followed by 30 mg on Day 1 of subsequent cycles. |
| Treatment Cycle | Patients Requiring Premedication | Premedication | Dosage | Administration |
|---|---|---|---|---|
| Cycle 1 and Cycle 2 | All patients | Corticosteroid | Dexamethasone 20 mg (preferred) 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 (preferred) 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 |
| Grade Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS. | Presenting Symptoms | Actions If 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. | Withhold current infusion of LUNSUMIO and manage per current practice guidelines. If symptoms resolve, restart infusion at the same rate. Ensure CRS symptoms are resolved for at least 72 hours prior to the next dose of LUNSUMIO. Refer to Table 2 for information on restarting LUNSUMIO after dose delays [see Dosage and Administration (2.2) ]. Administer premedication Refer to Table 3 for additional information on premedication. prior to next dose of LUNSUMIO and monitor patient more frequently. |
| Grade 2 | Fever ≥ 100.4°F (38°C) with: Hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen Low-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. | Withhold current infusion of LUNSUMIO and manage per current practice guidelines. If symptoms resolve, restart infusion at 50% rate. Ensure CRS symptoms are resolved for at least 72 hours prior to the next dose of LUNSUMIO. Administer premedication prior to next dose of LUNSUMIO and consider infusing the next dose at 50% rate. For the next dose of LUNSUMIO, monitor more frequently and consider hospitalization. |
| Recurrent Grade 2 CRS Manage per Grade 3 CRS. | ||
| Grade 3 | Fever ≥ 100.4°F (38°C) with: Hypotension requiring a vasopressor (with or without vasopressin) and/or hypoxia requiring high flow oxygen by nasal cannula, face mask, non-rebreather mask, or Venturi mask. | Withhold LUNSUMIO, manage per current practice guidelines and provide supportive therapy, which may include intensive care. Ensure CRS symptoms are resolved for at least 72 hours prior to the next dose of LUNSUMIO. Administer premedication prior to next dose of LUNSUMIO and infuse the next dose at 50% rate. Hospitalize for the next dose of LUNSUMIO. |
| Recurrent Grade 3 CRS Permanently discontinue LUNSUMIO. Manage CRS per current practice guidelines and provide supportive therapy, which may include intensive care. | ||
| 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). | Permanently discontinue LUNSUMIO. Manage CRS per current practice guidelines and provide supportive therapy, which may include intensive care. |
| Adverse Reaction | Severity Based 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 | Continue LUNSUMIO and monitor neurologic toxicity symptoms. If ICANS, manage per current practice guidelines. |
| Grade 2 | Withhold LUNSUMIO until neurologic toxicity symptoms improve to Grade 1 or baseline for at least 72 hours. See Table 2 for recommendations on restarting LUNSUMIO after dose delays [see Dosage and Administration (2.2) ]. Provide supportive therapy, and consider neurologic evaluation. If ICANS, manage per current practice guidelines. | |
| Grade 3 | Withhold LUNSUMIO until neurologic toxicity symptoms improve to Grade 1 or baseline for at least 72 hours. Provide supportive therapy, which may include intensive care, and consider neurology evaluation. If ICANS, manage per current practice guidelines. If recurrence of ICANS, permanently discontinue LUNSUMIO. | |
| Grade 4 | Permanently discontinue LUNSUMIO. Provide supportive therapy, which may include intensive care, and consider neurology evaluation. If ICANS, manage per current practice guidelines. |
| Adverse Reactions Based 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 | Withhold LUNSUMIO in patients with active infection until the infection resolves. See Table 2 for recommendations on restarting LUNSUMIO after dose delays [see Dosage and Administration (2.2) ]. For Grade 4, consider permanent discontinuation of LUNSUMIO. |
| Neutropenia [see Warnings and Precautions (5.5) ] | Absolute neutrophil count less than 0.5 × 10 9 /L | Withhold LUNSUMIO until absolute neutrophil count is 0.5 × 10 9 /L or higher. |
| Other Adverse Reactions | Grade 3 or higher | Withhold LUNSUMIO until the toxicity resolves to Grade 1 or baseline. |
| Dose of LUNSUMIO | Volume of LUNSUMIO | Size of 0.9% or 0.45% Sodium Chloride Injection 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 |
Side Effects of Lunsumio
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the WARNINGS AND PRECAUTIONS reflects exposure to LUNSUMIO as a single agent in GO29781 in 218 patients with hematologic malignancies in an open-label, multicenter, multi-cohort study. Each treatment cycle was 21 days.
Relapsed or Refractory Follicular Lymphoma The safety of LUNSUMIO was evaluated in GO29781, an open-label, multicenter, multi-cohort study which included a cohort of 90 patients with relapsed or refractory follicular lymphoma (FL). In this cohort, patients with relapsed or refractory FL were required to have received at least two prior lines of systemic therapy, including an anti-CD20 monoclonal antibody and an alkylating agent. A treatment cycle was 21 days.
The median number of cycles was 8 (range: 1 to 17). Serious adverse reactions occurred in 47% of patients who received LUNSUMIO. Serious adverse reactions in ≥ 2% of patients included CRS, infection (including sepsis, pneumonia, urinary tract infection, EBV viremia, COVID-19, and upper respiratory tract infection), renal insufficiency, pyrexia, and tumor flare.
Permanent discontinuation of LUNSUMIO due to an adverse reaction occurred in 3% of patients. Adverse reactions resulting in permanent discontinuation of LUNSUMIO included CRS and EBV viremia. Dosage interruptions of LUNSUMIO due to an adverse reaction occurred in 37% of patients.
Adverse reactions which required dosage interruption in ≥ 5% of patients included neutropenia, infection, and CRS. Table 8 summarizes the adverse reactions in patients with relapsed or refractory FL treated with LUNSUMIO in GO29781. Table 8.
Adverse Reactions (≥ 10%) in Patients with Relapsed or Refractory FL Who Received LUNSUMIO Intravenous Infusion in GO 0 Clinically relevant adverse reactions in < 10% of patients who received LUNSUMIO included pneumonia, sepsis, COVID-19, EBV viremia, mental status changes, tumor lysis syndrome, renal insufficiency, anxiety, motor dysfunction (including ataxia, gait disturbance and tremor), tumor flare, ICANS, and Pneumocystis jirovecii pneumonia. Table 9 summarizes the laboratory abnormalities in patients with relapsed or refractory FL treated with LUNSUMIO in GO29781. Table 9.
Select Laboratory Abnormalities (≥ 20%) That Worsened from Baseline in Patients with Relapsed or Refractory FL Who Received LUNSUMIO Intravenous Infusion in GO
| Adverse Reaction Adverse reactions were graded based on CTCAE Version 4.0, with the exception of CRS, which was graded per ASTCT 2019 criteria. | LUNSUMIO (N = 90) | |
|---|---|---|
| All Grades (%) | Grade 3 or 4 (%) | |
| Immune system disorders | ||
| Cytokine release syndrome | 44 | 2.2 |
| General disorders and administration site conditions | ||
| Fatigue Fatigue includes fatigue, asthenia, and lethargy. | 42 | 0 |
| Pyrexia | 29 | 1.1 Only Grade 3 adverse reactions occurred. |
| Edema Edema includes edema, edema peripheral, peripheral swelling, face edema, swelling face, pulmonary edema, fluid overload, and fluid retention. | 17 | 1.1 |
| Chills | 13 | 1.1 |
| Skin and subcutaneous tissue disorders | ||
| Rash Rash includes rash, rash erythematous, exfoliative rash, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, erythema, palmar erythema, dermatitis, and dermatitis acneiform. | 39 | 4.4 |
| Pruritus | 21 | 0 |
| Dry skin | 16 | 0 |
| Skin exfoliation | 10 | 0 |
| Nervous system | ||
| Headache Headache includes headache and migraine. | 32 | 1.1 |
| Peripheral neuropathy Peripheral neuropathy includes peripheral neuropathy, peripheral sensory neuropathy, paresthesia, dysesthesia, hypoesthesia, burning sensation, and neuralgia. | 20 | 0 |
| Dizziness Dizziness includes dizziness and vertigo. | 12 | 0 |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal pain Musculoskeletal pain includes musculoskeletal pain, back pain, myalgia, musculoskeletal chest pain, and neck pain. | 28 | 1.1 |
| Arthralgia | 11 | 0 |
| Respiratory, thoracic, and mediastinal disorders | ||
| Cough Cough includes cough, productive cough, and upper airway cough syndrome. | 22 | 0 |
| Dyspnea Dyspnea includes dyspnea and dyspnea exertional. | 11 | 1.1 |
| Gastrointestinal disorders | ||
| Diarrhea | 17 | 0 |
| Nausea | 17 | 0 |
| Abdominal pain Abdominal pain includes abdominal pain, lower abdominal pain, and abdominal discomfort. | 12 | 1.1 |
| Infections | ||
| Upper respiratory tract infection Upper respiratory tract infection includes upper respiratory tract infection, nasopharyngitis, sinusitis, and rhinovirus infection. | 14 | 2.2 |
| Urinary tract infection Urinary tract infection includes urinary tract infection and acute pyelonephritis. | 10 | 1.1 |
| Psychiatric disorder | ||
| Insomnia | 12 | 0 |
| Laboratory Abnormality | LUNSUMIO The denominator used to calculate the rate varied from 72 to 90 based on the number of patients with a baseline value and at least one post-treatment value. | |
|---|---|---|
| All Grades (%) | Grade 3 or 4 (%) | |
| Hematology | ||
| Lymphocyte count decreased | 100 | 98 |
| Hemoglobin decreased | 68 | 12 |
| Neutrophils decreased | 58 | 40 |
| Platelets decreased | 46 | 10 |
| Chemistry | ||
| Phosphate decreased | 78 | 46 |
| Glucose increased | 42 | 42 |
| Aspartate aminotransferase increased | 39 | 4.4 |
| Gamma-glutamyl transferase increased | 34 | 9 |
| Magnesium decreased | 34 | 0 |
| Potassium decreased | 33 | 6 |
| Alanine aminotransferase increased | 32 | 7 |
| Uric acid increased | 22 | 22 |
Warnings & Cautions for Lunsumio
Cytokine Release Syndrome LUNSUMIO can cause
CRS, including serious or life-threatening reactions. Among 86 patients who experienced CRS, CRS recurred in 28%. 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.
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. 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.
Neurologic
Toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome LUNSUMIO can cause serious and life-threatening neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). Neurologic toxicity occurred in 39% of patients who received LUNSUMIO at the recommended dosage in the clinical trial, with Grade 3 neurologic toxicity occurring in 3% of patients. Across a broader clinical trial population, ICANS or suspected ICANS occurred in 2.2% (21/949) of patients who received LUNSUMIO or LUNSUMIO VELO.
The most frequent manifestations included confusional state and lethargy. Twenty 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). 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.
Infections LUNSUMIO can cause serious or fatal infections
The most common Grade 3 or greater infections were pneumonia, sepsis, and upper respiratory infection. Monitor patients for signs and symptoms of infection prior to and during treatment with LUNSUMIO and treat appropriately. LUNSUMIO should not be administered in the presence of active infection.
Caution should be exercised when considering the use of LUNSUMIO in patients with a history of recurring or chronic infections (e.g., chronic, active Epstein-Barr Virus), with underlying conditions that may predispose to infections or who have had significant prior immunosuppressive treatment. Administer prophylactic antimicrobials according to guidelines. Withhold LUNSUMIO or consider permanent discontinuation of LUNSUMIO based on severity.
Hemophagocytic Lymphohistiocytosis 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 or LUNSUMIO VELO, with 3 cases preceded by diagnosed or suspected CRS. 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.
Cytopenias LUNSUMIO can cause serious or severe cytopenias, including lymphopenia, neutropenia, anemia, and thrombocytopenia. Febrile neutropenia occurred in 2% of patients. Monitor complete blood counts throughout treatment.
Based on the severity of cytopenias, temporarily withhold, or permanently discontinue LUNSUMIO. Consider prophylactic granulocyte colony-stimulating factor administration as applicable.
Tumor Flare LUNSUMIO can cause serious or severe tumor flare. Among patients who received LUNSUMIO at the recommended dosage in the clinical trial, tumor flare occurred in 4%. Manifestations included new or worsening pleural effusions, localized pain and swelling at the sites of lymphoma lesions, and tumor inflammation.
Patients with bulky tumors or disease located in close proximity to airways or a vital organ should be monitored closely during initial therapy. Monitor for signs and symptoms of compression or obstruction due to mass effect secondary to tumor flare. If compression or obstruction develops, institute standard treatment of these complications.
Risk of Medication Errors with Incorrect Product Use Mosunetuzumab-axgb is available in two formulations: as an injection for intravenous use (LUNSUMIO) and as an injection for subcutaneous use (LUNSUMIO VELO). Check the product labels to ensure that the correct formulation is being prescribed, dispensed, and administered to the patient. Do not substitute LUNSUMIO for or with LUNSUMIO VELO.
Embryo-Fetal Toxicity Based on its mechanism of action, LUNSUMIO may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with LUNSUMIO and for 3 months after the last dose.
Drug Interactions with Lunsumio
Effect of LUNSUMIO on CYP450 Substrates LUNSUMIO causes release of cytokines that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP450 substrates. Monitor for toxicity or concentrations of drugs that are CYP450 substrates where minimal concentration changes may lead to serious adverse reactions. Consult the concomitant CYP450 substrate drug prescribing information for recommended dosage modification.
Pregnancy Safety for Lunsumio
Pregnancy Risk Summary Based on the mechanism of action, LUNSUMIO may cause fetal harm when administered to a pregnant woman. There are no available data on the use of LUNSUMIO in pregnant women to evaluate for a drug-associated risk. No animal reproductive or developmental toxicity studies have been conducted with mosunetuzumab-axgb.
Mosunetuzumab-axgb causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. In addition, based on expression of CD20 on B-cells and the finding of B-cell depletion in non-pregnant animals, mosunetuzumab-axgb can cause B-cell lymphocytopenia in infants exposed to mosunetuzumab-axgb in-utero. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, LUNSUMIO has the potential to be transmitted from the mother to the developing fetus.
Advise women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is respectively.
Pediatric Use of Lunsumio
Pediatric Use The safety and efficacy of LUNSUMIO have not been established in pediatric patients.
Clinical Studies of Lunsumio
The efficacy of LUNSUMIO was evaluated in an open-label, multicenter, multi-cohort study (GO29781, NCT02500407) in patients with relapsed or refractory follicular lymphoma (FL) who had received at least two prior therapies, including an anti-CD20 monoclonal antibody and an alkylating agent. The study excluded patients with active infections, history of autoimmune disease, prior allogeneic transplant, or any history of CNS lymphoma or CNS disorders. A treatment cycle was 21 days.
LUNSUMIO was administered for 8 cycles unless patients experienced progressive disease or unacceptable toxicity. After 8 cycles, patients with a complete response discontinued therapy; patients with a partial response or stable disease continued treatment up to 17 cycles, unless patients experienced progressive disease or unacceptable toxicity. Seventy-nine percent of patients were refractory to prior anti-CD20 monoclonal antibody therapy, 53% were refractory to both anti-CD20 monoclonal antibody and alkylator therapy, 9% received prior rituximab plus lenalidomide therapy, 21% received prior autologous stem cell transplant, and 3% received prior CAR-T therapy.
Fifty-two percent of patients had progression of disease within 24 months of first systemic therapy. Efficacy was established on the basis of objective response rate (ORR) and duration of response (DOR) as assessed by an independent review facility according to standard criteria for NHL (Cheson 2007). The median follow-up for DOR was 14.9 months.
The efficacy results are summarized in Table 12. Table 12. Efficacy Results in Patients with Relapsed or Refractory FL Who Received LUNSUMIO Intravenous Infusion The median time to first response was 1.4 months (range: 1.1 to 8.9).
| Response | LUNSUMIO N = 90 |
|---|---|
| CI = confidence interval; NR = not reached | |
| Objective response rate (ORR), n (%) | 72 (80) |
| (95% CI) | (70, 88) |
| Complete response (CR), n (%) | 54 (60) |
| (95% CI) | (49, 70) |
| Partial response (PR), n (%) | 18 (20) |
| (95% CI) | (12, 30) |
| Duration of response (DOR) | N = 72 |
| Median DOR DOR is defined as the time from the initial occurrence of a documented PR or CR until the patient experienced an event (documented disease progression or death due to any cause)., Kaplan-Meier estimate., months (95% CI) | 22.8 (10, NR) |
| Rate of continued response | |
| At 12 months, % | 62 |
| (95% CI) | (50, 74) |
| At 18 months, % | 57 |
| (95% CI) | (44, 70) |
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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