Mosunetuzumab: Drug information

(For additional information see "Mosunetuzumab: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)

ALERT: US Boxed Warning

Cytokine release syndrome:

Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving mosunetuzumab. Initiate treatment with the mosunetuzumab step-up dosing schedule to reduce the risk of CRS. Withhold mosunetuzumab until CRS resolves or permanently discontinue based on severity.

Brand Names: US

Lunsumio

Pharmacologic Category

Antineoplastic Agent, Anti-CD20;
Antineoplastic Agent, Anti-CD3;
Antineoplastic Agent, Bispecific T Cell Engager;
Antineoplastic Agent, Monoclonal Antibody

Dosing: Adult

Note: Ensure patients are well hydrated prior to mosunetuzumab initiation. Do not administer to patients with active infection.

Premedication: Premedicate prior to each dose in cycle 1 and cycle 2; administer in cycle 3 and beyond if patient experienced cytokine release syndrome (any grade) with the previous dose.

Premedication should include a corticosteroid (dexamethasone 20 mg IV or methylprednisolone 80 mg IV) completed at least 1 hour prior to mosunetuzumab infusion, an antihistamine (diphenhydramine 50 to 100 mg [or equivalent] orally or IV) at least 30 minutes prior to mosunetuzumab infusion, and an antipyretic (acetaminophen 500 to 1,000 mg orally) at least 30 minutes prior to mosunetuzumab infusion.

Prophylaxis: Administer prophylactic antimicrobials according to local practice guidelines. Consider prophylactic granulocyte colony-stimulating factor administration, as appropriate.

Follicular lymphoma, relapsed or refractory

Follicular lymphoma, relapsed or refractory: IV:

**Mosunetuzumab Dosing Schedule^{a, b}(21-Day Treatment Cycles)**
Cycle number	Day of treatment	Mosunetuzumab dose	Infusion duration
^a Administer for 8 cycles (in the absence of disease progression or unacceptable toxicity); no further treatment is required after 8 cycles if complete response is achieved. For patients achieving a partial response or with stable disease in response to treatment after 8 cycles, an additional 9 cycles (for a total of 17 cycles) should be administered (in the absence of disease progression or unacceptable toxicity).
^b Manufacturer’s labeling; Budde 2022.
Cycle 1	Day 1	1 mg IV	At least 4 hours
	Day 8	2 mg IV	At least 4 hours
	Day 15	60 mg IV	At least 4 hours
Cycle 2	Day 1	60 mg IV	Infuse over 2 hours if cycle 1 infusions were well-tolerated
Cycle 3 and beyond^a	Day1	30 mg IV

**Recommendations for Restarting Mosunetuzumab After a Dosing Delay**
Last dose administered	Time since last dose	Action for next mosunetuzumab dose
^a For the day 1, day 8, and day 15 doses in the next cycle, administer premedications for all patients as per the premedication instructions above.
Cycle 1, day 1 (1 mg)	1 to 2 weeks	Administer 2 mg (cycle 1, day 8), then resume the planned treatment schedule.
Cycle 1, day 1 (1 mg)	>2 weeks	Repeat 1 mg (cycle 1, day 1), then administer 2 mg (cycle 1, day 8) and resume the planned treatment schedule.
Cycle 1, day 8 (2 mg)	1 to 2 weeks	Administer 60 mg (cycle 1, day 15), then resume the planned treatment schedule.
	>2 weeks to <6 weeks	Repeat 2 mg (cycle 1, day 8), then administer 60 mg (cycle 1, day 15) and resume the planned treatment schedule.
	≥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.
Cycle 1, day 15 (60 mg)	1 week to <6 weeks	Administer 60 mg (cycle 2, day 1), then resume the planned treatment schedule.
Cycle 1, day 15 (60 mg)	≥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.
Cycle 2, day 1 (60 mg)	3 weeks to <6 weeks	Administer 30 mg (cycle 3, day 1), then resume the planned treatment schedule.
Cycle 2, day 1 (60 mg)	≥6 weeks	Repeat 1 mg (cycle 3, day 1) and 2 mg (cycle 3, day 8), then administer 30 mg (cycle 3, day 15)^a, followed by 30 mg (cycle 4, day 1), and then resume the planned treatment schedule.
Cycle 3 and beyond (30 mg)	3 weeks to <6 weeks	Administer 30 mg, then resume the planned treatment schedule.
Cycle 3 and beyond (30 mg)	≥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^a, followed by 30 mg on day 1 of subsequent cycles.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Note: Kidney function estimated using the Cockcroft-Gault equation.

CrCl 30 to 89 mL/minute: There are no dosage adjustments provided in the manufacturer’s labeling; however, no clinically significant difference in mosunetuzumab pharmacokinetics was observed based on CrCl 30 to 89 mL/minute.

CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer’s labeling (effects on mosunetuzumab pharmacokinetics are unknown).

Dosing: Hepatic Impairment: Adult

Mild impairment (total bilirubin ≤ ULN with AST > ULN or total bilirubin >1 to 1.5 times ULN with any AST): There are no dosage adjustments provided in the manufacturer’s labeling; however, no clinically significant difference in mosunetuzumab pharmacokinetics was observed based on mild hepatic impairment.

Moderate or severe impairment (total bilirubin >1.5 times ULN with any AST): There are no dosage adjustments provided in the manufacturer’s labeling (effects on mosunetuzumab pharmacokinetics are unknown).

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m²: The dosing in the FDA-approved prescribing information should be followed in all patients, regardless of obesity status. If a patient with a BMI ≥30 kg/m² experiences high-grade toxicity from systemic anticancer therapy, the same dosage modification recommendations should be followed for all patients, regardless of obesity status (Ref).

Dosing: Adjustment for Toxicity: Adult

Refer to "Dosing: Adult" for recommendations on restarting mosunetuzumab after dose delays.

Cytokine release syndrome: If cytokine release syndrome (CRS) is suspected, interrupt mosunetuzumab until resolved; manage according to the table below and per clinical practice guidelines. Supportive therapy for CRS may include intensive care for severe or life-threatening CRS. If CRS is refractory to management, consider other causes, including hemophagocytic lymphohistiocytosis.

**Mosunetuzumab-Related CRS Management**
CRS grade	Symptoms	Actions
^aFever may be masked by antipyretics or anticytokine therapy; if clinical presentation is consistent with CRS, follow CRS management recommendations.
^bRefer to "Dosing: Adult" for recommended premedications.
Grade 1	Temperature ≥38°C (≥100.4°F)^a, attributed to CRS	Withhold current mosunetuzumab infusion and manage per 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 mosunetuzumab dose. Administer premedication^b prior to the next mosunetuzumab dose and monitor more frequently.
Grade 2	Temperature ≥38°C (≥100.4°F)^awith: hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen (<6 L/minute) via nasal cannula or blow-by	Withhold current mosunetuzumab infusion and manage per practice guidelines. If symptoms resolve, restart infusion at the 50% rate. Ensure CRS symptoms are resolved for at least 72 hours prior to the next mosunetuzumab dose. Administer premedication^b prior to the next mosunetuzumab dose and consider infusing the next dose at 50% rate. For the next dose, monitor more frequently and consider hospitalization.
Grade 2, recurrent		Manage per grade 3 CRS
Grade 3	Temperature ≥38°C (≥100.4°F)^a with: hypotension requiring a vasopressor (with or without vasopressin) and/or hypoxia requiring high-flow oxygen (≥6 L/minute) via nasal cannula, face mask, non-rebreather mask, or Venturi mask	Withhold mosunetuzumab and manage per 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 mosunetuzumab dose. Administer premedication^b prior to the next mosunetuzumab dose and infuse the next dose at 50% rate. Hospitalize for the next mosunetuzumab dose.
Grade 3, recurrent		Permanently discontinue mosunetuzumab. Manage CRS per practice guidelines and provide supportive therapy, which may include intensive care.
Grade 4	Temperature ≥38°C (≥100.4°F)^a with: hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring oxygen via positive pressure (eg, continuous positive airway pressure [CPAP], bilevel positive airway pressure [BiPAP], intubation, and mechanical ventilation)	Permanently discontinue mosunetuzumab. Manage CRS per practice guidelines and provide supportive therapy, which may include intensive care.

Neurologic toxicity: Interrupt mosunetuzumab at the first sign of neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and consider neurology evaluation. Provide supportive therapy, which may include intensive care.

**Mosunetuzumab-Related Neurologic Toxicity Management (Including ICANS)**
Adverse reaction	Severity	Actions
Neurologic toxicity (including ICANS)	Grade 2	Withhold mosunetuzumab until neurologic toxicities/symptoms improve to grade 1 or baseline for at least 72 hours. Provide supportive therapy. If ICANS, manage per practice guidelines.
	Grade 3	Withhold mosunetuzumab until neurologic toxicities/symptoms improve to grade 1 or baseline for at least 72 hours. Provide supportive therapy, which may include intensive care; consider neurology evaluation. If ICANS, manage per practice guidelines. If grade 3 neurologic toxicity recurs, permanently discontinue mosunetuzumab.
	Grade 4	Permanently discontinue mosunetuzumab. Provide supportive therapy, which may include intensive care; consider neurology evaluation. If ICANS, manage per practice guidelines.

**Recom** **mended Mosunetuzumab Dosage Modifications for Other Adverse Reactions**
Adverse reaction	Severity	Actions
Hematologic toxicity	ANC <500/mm³	Withhold mosunetuzumab until ANC is ≥500/mm³. Consider prophylactic granulocyte colony-stimulating factor administration as appropriate.
Hematologic toxicity	Other cytopenias	Temporarily withhold or permanently discontinue mosunetuzumab based on the severity.
Infections	Grades 1 to 4	Withhold mosunetuzumab or consider permanently discontinuing based on severity. Manage infection appropriately and as clinically indicated. Withhold mosunetuzumab in patients with active infection until infection resolves. For grade 4 infection, consider permanently discontinuing mosunetuzumab.
Compression or obstruction due to tumor flare	Any	Institute standard treatment as clinically indicated.
Other adverse reactions	Grade 3 or higher	Withhold mosunetuzumab until adverse reaction resolves to grade 1 or baseline.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

>10%:

Cardiovascular: Edema (17%)

Dermatologic: Pruritus (21%), skin rash (39%), xeroderma (16%)

Endocrine & metabolic: Decreased serum magnesium (34%), decreased serum phosphate (78%), decreased serum potassium (33%), increased serum glucose (42%), increased uric acid (22%)

Gastrointestinal: Abdominal pain (12%), diarrhea (17%), nausea (17%)

Hematologic & oncologic: Decreased hemoglobin (68%; grades 3/4: 12%), decreased neutrophils (58%; grades 3/4: 40%), decreased white blood cell count (60%; grades 3/4: 13%), lymphocytopenia (100%; grades 3/4: 98%), thrombocytopenia (46%; grades 3/4: 10%)

Hepatic: Increased gamma-glutamyl transferase (34%), increased serum alanine aminotransferase (32%), increased serum aspartate aminotransferase (39%)

Hypersensitivity: Cytokine release syndrome (44%)

Nervous system: Chills (13%), dizziness (12%), fatigue (42%), headache (32%), insomnia (12%), peripheral neuropathy (20%)

Neuromuscular & skeletal: Arthralgia (11%), musculoskeletal pain (28%)

Respiratory: Cough (22%), dyspnea (11%), upper respiratory tract infection (14%)

Miscellaneous: Fever (29%)

1% to 10%:

Dermatologic: Desquamation (10%)

Genitourinary: Urinary tract infection (10%)

Hematologic & oncologic: Tumor flare (<10%), tumor lysis syndrome (<10%)

Infection: Epstein-Barr infection (<10%), sepsis (<10%)

Nervous system: Anxiety (<10%), mental status changes (<10%; including cognitive dysfunction, confusion, delirium, disturbance in attention, drowsiness, encephalopathy), motor dysfunction (<10%; including abnormal gait, ataxia, tremor)

Renal: Renal insufficiency (<10%)

Respiratory: Pneumonia (<10%)

Frequency not defined:

Hematologic & oncologic: Febrile neutropenia

Infection: Serious infection (including opportunistic infection)

Nervous system: Neurotoxicity (including immune effector cell-associated neurotoxicity syndrome)

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Cytokine release syndrome: Mosunetuzumab may cause cytokine release syndrome (CRS), including serious or life-threatening reactions. In the clinical trial, CRS occurred in over one-third of patients who received mosunetuzumab; grade 1 occurred in 28%, grade 2 in 15%, grade 3 in 2%, and grade 4 in <1% of patients. Recurrent CRS has been reported. Most patients experienced CRS following the initial dose on day 1 of cycle 1, day 8 of cycle 1, and day 15 of cycle 1; CRS has also been observed with subsequent doses. The median time to onset of CRS from the start of administration on day 1 of cycle 1 was 5 hours (range: 1 hour to 3 days); the onset with subsequent doses was 25 to 46 hours (range: up to 16 days). The median duration of CRS was 3 days (range: 1 to 29 days). Clinical signs/symptoms of CRS included (but were not limited to) fever, chills, hypotension, tachycardia, hypoxia, and headache. Concurrent neurologic adverse reactions occurred in some patients and included (but were not limited to) headache, confusion, and anxiety. 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/potentially dangerous machinery until resolution.

• Cytopenias: Mosunetuzumab may cause serious or severe cytopenias (including neutropenia, anemia, and thrombocytopenia). Grade 3 and 4 events have been commonly reported; neutropenic fever occurred in a small percentage of patients.

• Infections: Mosunetuzumab may cause serious or fatal infections, including opportunistic infections. The most common grade 3 or higher infections were pneumonia, sepsis, and upper respiratory tract infection. Mosunetuzumab should not be administered in the presence of active infection; use caution if considering mosunetuzumab in patients with a history of recurring or chronic infections (eg, chronic, active Epstein-Barr virus), with underlying conditions that may predispose to infections, or who have had significant prior immunosuppressive treatment.

• Neurologic toxicity: Mosunetuzumab may cause serious neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). Neurologic toxicity occurred in over one-third of patients who received mosunetuzumab; grade 3 neurologic toxicity was observed in a small percentage of patients. The most frequent neurologic toxicities were headache, peripheral neuropathy, dizziness, and mental status changes (including confusion, attention disturbance, cognitive disorder, delirium, encephalopathy, and somnolence). ICANS was reported rarely, with case reports of grade 1 and 2 events. Coadministration of mosunetuzumab with other products that cause dizziness or mental status changes may increase the risk of neurologic toxicity. Patients who experience neurologic toxicity (eg, 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/potentially dangerous machinery until resolution.

• Tumor flare: Mosunetuzumab may cause serious or severe tumor flare in a small percentage of patients. Tumor flare manifestations include new or worsening pleural effusions, localized pain/swelling at lymphoma lesion sites, and tumor inflammation. Patients with bulky tumors or disease located in close proximity to airways or a vital organ may be at risk for complications.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous [preservative free]:

Lunsumio: Mosunetuzumab-axgb 1 mg/mL (1 mL); Mosunetuzumab-axgb 30 mg/30 mL (30 mL)

Generic Equivalent Available: US

Pricing: US

Solution (Lunsumio Intravenous)

1 mg/mL (per mL): $723.56

30 mg/30 mL (per mL): $723.56

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Prescribing and Access Restrictions

Mosunetuzumab is available through authorized specialty distributors. Distribution information is available at https://www.genentech-access.com/hcp/brands/lunsumio/learn-about-our-services/product-distribution.html.

Administration: Adult

IV: Infuse over at least 4 hours in cycle 1; if cycle 1 infusions are tolerated, infuse over 2 hours in cycle 2 and beyond. Do not infuse through an inline filter, although drip chamber filters may be used to administer mosunetuzumab. For IV infusion only. Do not infuse other medications through the same IV line. Administer in a facility with appropriate support to manage severe reactions, such as cytokine release syndrome and neurotoxicity.

No incompatibilities have been observed with infusion sets or infusion aids with products containing materials of polyvinyl chloride (PVC), polyolefin, polyurethane, polybutadiene, silicone, acrylonitrile butadiene styrene, polycarbonate, polyetherurethane, fluorinated ethylene propylene, polytetrafluorethylene, or with drip chamber filter membrane composed of polyamide.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Lunsumio: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761263s000lbl.pdf#page=21

Use: Labeled Indications

Follicular lymphoma, relapsed or refractory: Treatment of relapsed or refractory follicular lymphoma in adults after ≥2 lines of systemic therapy.

Medication Safety Issues

Sound-alike/look-alike issues:

Mosunetuzumab may be confused with margetuximab, mirvetuximab soravtansine, mogamulizumab, moxetumomab pasudotox.

High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy

Antithymocyte Globulin (Equine): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of anti-CD20 B-cell depleting therapy is reduced. Anti-CD20 B-Cell Depleting Therapies may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy

Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Products: Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid combination

Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination

Chikungunya Vaccine (Live): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination

Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification

COVID-19 Vaccines: Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of COVID-19 Vaccines. Management: Administer COVID-19 vaccine 2 to 4 weeks prior to the next scheduled dose of anti-CD20 therapy, if used chronically for the treatment of autoimmune disease. Revaccinate 6 months after completion of anti-CD20 therapy if used over a limited period. Risk D: Consider therapy modification

CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors): Mosunetuzumab may increase the serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification

Dengue Tetravalent Vaccine (Live): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification

Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines 2 weeks prior to starting anti-CD20 B-cell depleting therapies. Vaccination of patients treated with these agents in the past 6 months is not recommended. Risk D: Consider therapy modification

Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification

Mumps- Rubella- or Varicella-Containing Live Vaccines: Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination

Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy

Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Poliovirus Vaccine (Live/Trivalent/Oral): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Rabies Vaccine: Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination

Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor therapy

Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination

Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination

Typhoid Vaccine: Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Inactivated/Non-Replicating): Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider therapy modification

Vaccines (Live): Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Yellow Fever Vaccine: Anti-CD20 B-Cell Depleting Therapies may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Reproductive Considerations

Verify pregnancy status prior to treatment initiation.

Patients who could become pregnant should use effective contraception during therapy and for 3 months after the last mosunetuzumab dose.

Pregnancy Considerations

Mosunetuzumab is a humanized monoclonal antibody (IgG₁). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).

Animal reproduction studies have not been conducted. Based on the mechanism of action, in utero exposure to mosunetuzumab may cause B-cell lymphocytopenia in exposed infants and compromise pregnancy maintenance.

A long-term observational research study is collecting information about the diagnosis and treatment of cancer during pregnancy. For additional information about the pregnancy and cancer registry or to become a participant, contact Cooper Health (1-877-635-4499).

Breastfeeding Considerations

It is not known if mosunetuzumab is present in breast milk.

Mosunetuzumab is a humanized monoclonal antibody (IgG₁). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).

Due to the potential for B-cell depletion in the breastfed infant, breastfeeding is not recommended by the manufacturer during treatment and for 3 months after the last mosunetuzumab dose.

Monitoring Parameters

CBC with differential (monitor throughout treatment). Verify pregnancy status prior to treatment initiation (in patients who could become pregnant). Monitor for signs/symptoms of cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). At the first sign of CRS, immediately evaluate patients for hospitalization; if CRS occurs, monitor more frequently during subsequent doses. At the first sign of neurologic toxicity (including ICANS), immediately evaluate and consider neurology evaluation, as appropriate. Monitor hydration status. Monitor for signs/symptoms of infection (including opportunistic infections) prior to and during treatment and for signs/symptoms of tumor flare, including compression or obstruction due to mass effect secondary to tumor flare; patients with bulky tumors or disease located in close proximity to airways or a vital organ should be monitored closely during initial therapy.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Mosunetuzumab is a T-cell engaging bispecific humanized monoclonal antibody that binds to the CD3 receptor expressed on the surface of T-cells and CD20 expressed on the surface of lymphoma cells and some healthy B-lineage cells. Mosunetuzumab activates T-cells, releasing proinflammatory cytokines, and inducing B-cell lysis.

Pharmacokinetics (Adult Data Unless Noted)

Onset: Peripheral B-cell counts decreased to undetectable levels (<5 cells/microliter) in a majority of patients by day 1 of cycle 2; B-cell depletion was sustained at later cycles, including at cycles 4 and 8.

Distribution: V_d: 5.49 L.

Half-life elimination: ~16 days.

Excretion: Clearance: Baseline: 1.08 L/day; Steady state: 0.584 L/day.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(QA) Qatar: Lunsumio

Anderson PO. Monoclonal antibodies during breastfeeding. Breastfeed Med. 2021;16(8):591-593. doi:10.1089/bfm.2021.0110 [PubMed 33956488]
Budde LE, Sehn LH, Matasar M, et al. Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study. Lancet Oncol. 2022;23(8):1055-1065. doi:10.1016/S1470-2045(22)00335-7 [PubMed 35803286]
Clements T, Rice TF, Vamvakas G, et al. Update on transplacental transfer of IgG subclasses: impact of maternal and fetal factors. Front Immunol. 2020;11:1920. doi:10.3389/fimmu.2020.01920 [PubMed 33013843]
Griggs JJ, Bohlke K, Balaban EP, et al. Appropriate systemic therapy dosing for obese adult patients with cancer: ASCO guideline update. J Clin Oncol. 2021:JCO2100471. doi:10.1200/JCO.21.00471 [PubMed 33939491]
Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
Lunsumio (mosunetuzumab) [prescribing information]. South San Francisco, CA: Genentech, Inc; December 2022.
Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. doi:10.1155/2012/985646 [PubMed 22235228]
Pentsuk N, van der Laan JW. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol. 2009;86(4):328-344. doi:10.1002/bdrb.20201 [PubMed 19626656]

Topic 140391 Version 26.0

خرید پکیج

Mosunetuzumab: Drug information