Lunsumio Velo Mosunetuzumab 5 mg/.5mL Injection, 1 vial
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Other monoclonal antibodies and antibody drug conjugates class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Mosunetuzumab-axgb injection is used to treat follicular lymphoma (FL; a slow-growing blood cancer). Mosunetuzumab-axgb is in a class of medications called monoclonal antibodies. It works by killing cancer cells.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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0.2 mg / 0.5 mL
UNII Q40Q9N063P
Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
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0.8 mg / 0.5 mL
UNII 4QD397987E
An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
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0.7 mg / 0.5 mL
UNII AE28F7PNPL
Methionine is an amino acid used as a nutrient supplement and pH buffer in medicines. It helps stabilize the formulation and supports the product's overall composition.
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0.3 mg / 0.5 mL
UNII 7T1F30V5YH
A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
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41 mg / 0.5 mL
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J9350 | $674.495 / J9350 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lunsumio Velo 5 mg/.5mLthis 50242-0177-01 | Genentech, | 1 vial | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Dec 22, 2034 |
Is there a biosimilar for LUNSUMIO VELO 5 MG/0.5 ML VIAL?
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 50242-0177-01 You're viewing this | 1 VIAL, GLASS in 1 CARTON (50242-177-01) / .5 mL in 1 VIAL, GLASS | 2025-12-19 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: CYTOKINE RELEASE SYNDROME Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO VELO. Initiate treatment with the LUNSUMIO VELO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO VELO until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 and 2.4) and Warnings and Precautions (5.1) ] .
WARNING: CYTOKINE RELEASE SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO VELO. Initiate treatment with the LUNSUMIO VELO step-up dosing schedule to reduce the risk of CRS.
Withhold LUNSUMIO VELO until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.4 , 5.1 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE LUNSUMIO VELO 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). ( 1.1 )
1.1Follicular Lymphoma LUNSUMIO VELO 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 [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION LUNSUMIO VELO and LUNSUMIO have different dosage and route of administration instructions. Administer LUNSUMIO VELO only as a subcutaneous injection. ( 2.1 ) Premedicate to reduce risk of CRS.
( 2.3 , 5.1 ) Recommended dosage for LUNSUMIO VELO for subcutaneous injection ( 2.2 ): Day of Treatment Cycle length = 21 days Subcutaneous Dose of LUNSUMIO VELO Cycle 1 Day 1 5 mg Day 8 45 mg Day 15 45 mg Cycles 2+ Day 1 45 mg See Full Prescribing Information for instructions on preparation and administration. ( 2.5 )
2.1Important Dosing Information LUNSUMIO VELO and LUNSUMIO have different dosage and administration instructions [see Dosage and Administration (2.2) and Warnings and Precautions (5.7) ]. LUNSUMIO VELO is for subcutaneous use only. Check the product label to ensure that the correct formulation (LUNSUMIO VELO or LUNSUMIO) is being prescribed and administered.
Do not substitute LUNSUMIO VELO for or with LUNSUMIO. Administer LUNSUMIO VELO to well-hydrated patients. Premedicate before each dose in Cycle 1 [see Dosage and Administration (2.3) ] .
LUNSUMIO VELO 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 [see Warnings and Precautions (5.1 and 5.2) ] .
2.2Recommended Dosage The recommended dosage for LUNSUMIO VELO subcutaneous injection 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 VELO 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 VELO Subcutaneous Injection (21-Day Treatment Cycles) Day of Treatment Subcutaneous Dose of LUNSUMIO VELO Cycle 1 Day 1 5 mg Day 8 45 mg Day 15 45 mg Cycles 2+ Day 1 45 mg Table 2.
Recommendations for Restarting Therapy with LUNSUMIO VELO Subcutaneous Injection After Dose Delay Last Subcutaneous Dose Administered Time Since Last Dose Administered Action for Next Subcutaneous Dose(s) 5 mg Cycle 1 Day 1 1 week to 2 weeks Administer 45 mg (Cycle 1 Day 8) Administer premedication as per Cycle 1. , then resume the planned treatment schedule. Greater than 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.
Greater than or equal to 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. Greater than or equal to 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 onwards 3 weeks to less than 6 weeks Administer 45 mg, then resume the planned treatment schedule. Greater than or equal to 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.
2.3Recommended Premedication Premedications to reduce the risk of CRS are outlined in Table 3 [see Warnings and Precautions (5.1) ] . Table 3. Premedication to be Administered Prior to LUNSUMIO VELO Subcutaneous Injection Treatment Cycle Patients Requiring Premedication Premedication Dosage Cycle 1 All patients Corticosteroid Dexamethasone 20 mg (preferred) oral or intravenous or methylprednisolone 80 mg oral or intravenous Antihistamine Antihistamine and antipyretic premedications are optional in all cycles.
Diphenhydramine hydro…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS LUNSUMIO VELO is a sterile, colorless to slightly brownish-yellow solution for subcutaneous injection available as: Injection: 5 mg/0.5 mL in a single-dose vial Injection: 45 mg/mL in a single-dose vial Injection : 5 mg/0.5 mL solution in a single-dose vial. ( 3 ) 45 mg/mL solution in a single-dose vial. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Neurologic Toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome : Can cause serious and life-threatening neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). Monitor patients for signs and symptoms of neurologic toxicity during treatment; withhold or permanently discontinue based on severity. ( 5.2 ) Infections : Can cause serious or fatal infections.
Monitor patients for signs and symptoms of infection, including opportunistic infections, and treat as needed. ( 5.3 ) Hemophagocytic Lymphohistiocytosis : Can cause serious or fatal reactions. For suspected cases, interrupt LUNSUMIO VELO and evaluate and treat promptly.
( 5.4 ) Cytopenias : Monitor complete blood cell counts during treatment. ( 5.5 ) Tumor Flare : Can cause serious tumor flare reactions. Monitor patients at risk for complications of tumor flare.
( 5.6 ) Risk of Medication Errors with Incorrect Product Use : Ensure that the correct formulation is being prescribed, dispensed, and administered. ( 5.7 ) Embryo-Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.
( 5.8 , 8.1 , 8.3 )
5.1Cytokine Release Syndrome LUNSUMIO VELO can cause CRS, including serious or life-threatening reactions [see Adverse Reactions (6.1) ] . CRS occurred in 30% of patients who received LUNSUMIO VELO at the recommended dosage in the clinical trial (N = 94), with Grade 1 CRS occurring in 20%, Grade 2 in 7%, and Grade 3 in 2.1% of patients. Among 28 patients who experienced CRS, CRS recurred in 14%.
CRS occurred most commonly after the first two doses: 19% of patients experienced CRS after the Cycle 1 Day 1 dose, 13% after the Cycle 1 Day 8 dose, and 2.1% after the Cycle 1 Day 15 dose. The median time to CRS onset from the start of LUNSUMIO VELO administration was 17 hours (range: 7 to 33 hours) with the Cycle 1 Day 1 dose, and 62 hours (range: 30 to 113 hours) with the Cycle 1 Day 8 dose. CRS resolved in all patients, after a median duration of 2 days (range: 1 to 15 days).
Clinical signs and symptoms of CRS included fever, hypotension, hypoxia, chills, tachycardia, and headache. Concurrent neurologic adverse reactions occurred in 5% of patients and included but were not limited to headache, dizziness, lethargy, memory impairment, and peripheral neuropathy. Initiate therapy according to LUNSUMIO VELO 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 VELO accordingly [see Dosage and Administration (2.2 and 2.3) ] . 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 VELO 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.
5.2Neurologic Toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome LUNSUMIO VELO 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 53% of patients who received LUNSUMIO VELO at the recommended dosage in the clinical trial (N = 94), with Grade 3 neurologic toxicity occurring in 1.1% of patients. The most frequent neurologic toxicities were headache (17%), insomnia (15%), dizziness (10%), and mental status changes (7%, including confusion and lethargy).
ICANS or suspected ICANS was reported in 3.1% of patients (all Grade 1). Across a broader clinical trial population, ICANS or suspected ICANS occurred in 2.2% (21/949)…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Cytokine Release Syndrome [see Warnings and Precautions (5.1) ] Neurologic Toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome [see Warnings and Precautions (5.2) ] Infections [see Warnings and Precautions (5.3) ] Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions (5.4) ] Cytopenias [see Warnings and Precautions (5.5) ] Tumor Flare [see Warnings and Precautions (5.6) ] The most common adverse reactions (≥ 20%) are injection site reactions, fatigue, rash, CRS, COVID-19 infection, musculoskeletal pain, and diarrhea.
The most common Grade 3 to 4 laboratory abnormalities (≥ 15%) are decreased lymphocyte count, decreased neutrophil count, and increased uric acid. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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. Relapsed or Refractory Follicular Lymphoma The safety of LUNSUMIO VELO was evaluated in an open-label, multicenter study which included a cohort of 94 patients with relapsed or refractory follicular lymphoma (FL) after at least two lines of systemic therapy [see Clinical Studies (14) ] .
Patients received step-up doses of 5 mg via subcutaneous injection on Cycle 1 Day 1 and 45 mg on Cycle 1 Day 8, followed by 45 mg on Cycle 1 Day 15, then 45 mg every 3 weeks in subsequent cycles. A treatment cycle was 21 days. The median number of cycles was 8 (range: 1 to 17), with 78% of patients exposed for at least 8 cycles and 6% exposed for 17 cycles.
The median age was 65 years (range: 35 to 84 years), 56% were male, 85% were White, 2.1% were Black or African American, 11% were Asian, and 2% were Hispanic or Latino. Serious adverse reactions occurred in 39% of patients. Serious adverse reactions in ≥ 10% of patients included infection (17%, including pneumonia, other respiratory tract infections, and sepsis) and CRS (15%).
Fatal adverse reactions occurred in 4.3% of patients from COVID-19 (3.2%) and HLH (1.1%). Permanent discontinuation of LUNSUMIO VELO due to an adverse reaction occurred in 7% of patients, including from COVID-19. Dosage interruptions of LUNSUMIO VELO due to an adverse reaction occurred in 40% of patients.
Adverse reactions which required dosage interruption in ≥ 5% of patients included COVID-19 and neutropenia. The most common adverse reactions (≥ 20%), excluding laboratory abnormalities, were injection site reactions, fatigue, rash, CRS, COVID-19 infection, musculoskeletal pain, and diarrhea. The most common Grade 3-4 laboratory abnormalities (≥ 15%) were decreased lymphocyte count, decreased neutrophil count, and increased uric acid.
Grade 4 laboratory abnormalities in > 5% included lymphocyte count decreased (22%) and neutrophil count decreased (9%). Table 7 summarizes the adverse reactions. Table 7.
Adverse Reactions (≥ 10%) in Patients with Relapsed or Refractory FL Who Received LUNSUMIO VELO Subcutaneous Injection in GO29781 Adverse Reaction LUNSUMIO VELO (N = 94) All Grades (%) Grade 3 or 4 (%) Immune system disorders The table includes a combination of grouped and ungrouped terms. Adverse reactions were graded based on CTCAE Version 4.0, with the exception of CRS, which was graded per ASTCT 2019 criteria. Cytokine release syndrome 30
2.1General disorders and administration site conditions Injection site reactions Injection site reactions includes injection site reaction, injection site discharge, injection site erythema, injection site edema, injection site pain, injection site pruritus and injection site rash. 69 0 Fatigue Fatigue includes fatigue, asthenia, and lethargy. 39 0 Edema Edema includes edema, ed…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Effect of LUNSUMIO VELO on CYP450 Substrates LUNSUMIO VELO causes release of cytokines [see Clinical Pharmacology (12.2) ] that may suppress activity of CYP450 enzymes, resulting in increased exposure of CYP450 substrates. Increased exposure of CYP450 substrates is more likely to occur after the first dose of LUNSUMIO VELO on Cycle 1 Day 1 and up to 14 days after the 45 mg dose on Cycle 1 Day 8 and during and after CRS [see Warnings and Precautions (5.1) ] . 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 )
8.1Pregnancy Risk Summary Based on the mechanism of action, LUNSUMIO VELO may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of LUNSUMIO VELO 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 VELO 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 2% – 4% and 15% – 20%, respectively.
8.2Lactation Risk Summary 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 VELO and for 3 months after the last dose.
8.3Females and Males of Reproductive Potential LUNSUMIO VELO may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ]. Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating LUNSUMIO VELO. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with LUNSUMIO VELO and for 3 months after the last dose.
8.4Pediatric Use The safety and efficacy of LUNSUMIO VELO have not been established in pediatric patients.
8.5Geriatric Use Among the 94 patients treated with LUNSUMIO VELO, 51% were 65 years of age or older. There is an insufficient number of patients 65 years of age or older to assess whether there are differences in safety or effectiveness by age group.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on the mechanism of action, LUNSUMIO VELO may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of LUNSUMIO VELO 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 VELO 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 2% – 4% and 15% – 20%, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of LUNSUMIO VELO have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use Among the 94 patients treated with LUNSUMIO VELO, 51% were 65 years of age or older. There is an insufficient number of patients 65 years of age or older to assess whether there are differences in safety or effectiveness by age group.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Mosunetuzumab-axgb is a T-cell engaging bispecific 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. In vitro, mosunetuzumab-axgb activated T-cells, caused the release of proinflammatory cytokines, and induced lysis of B-cells.
12.2Pharmacodynamics After subcutaneous administration of the recommended dosage of LUNSUMIO VELO, peripheral B-cell counts decreased to undetectable levels (< 5 cells/microliter) in most patients (94%) by Cycle 2 Day 1 and the depletion was sustained at later cycles including at Cycle 4 and Cycle 8. LUNSUMIO VELO caused hypogammaglobulinemia (defined as IgG levels < 500 mg/dL). Among 49 patients with baseline IgG levels ≥ 500 mg/dL, 39% experienced a decrease in their IgG levels to < 500 mg/dL after receiving LUNSUMIO VELO.
Plasma concentrations of cytokines (IL-2, IL-6, IL-10, TNF-α and IFN-γ) were measured with subcutaneous administration of LUNSUMIO VELO, and transient elevation of cytokines were observed at doses of 1.6 mg and above. After administration of the recommended dosage of LUNSUMIO VELO, the highest elevation of cytokines was generally observed within 48 hours after the first dose on Cycle 1 Day 8 and generally returned to baseline prior to the third 45 mg full dose on Cycle 2 Day 1. The observed pattern of cytokine release appeared slower and reduced relative to intravenous administration.
12.3Pharmacokinetics Mosunetuzumab-axgb subcutaneously administered PK exposure increased proportionally over a dose range from 1.6 mg to 45 mg (0.04 to 1 times the recommended treatment dosage). When comparing mosunetuzumab exposures following the recommended LUNSUMIO VELO subcutaneous dosing regimen to the recommended LUNSUMIO intravenous dosing regimen in patients with relapsed or refractory follicular lymphoma in Study GO29781 [see Clinical Studies (14) ] , the geometric mean ratios (GMRs) (90% CI) for observed Cycle 3 C trough was 1.39 (1.20 to 1.61) and AUC over 0-84 days was 1.06 (0.92 to 1.21).
PK exposures for the recommended dosage of LUNSUMIO VELO via subcutaneous injection are summarized in Table 9 and Figure 1 . Table 9. Exposure Parameters of Mosunetuzumab-axgb Subcutaneous Injection AUC (day∙µg/mL) Values are geometric mean with geometric CV%.
C max (µg/mL) C trough (µg/mL) All values reported are model-predicted exposure metrics. Cycle 1 (0 – 21 days) 36.7 (57.0) 3.8 (53.9) 3.5 (54.1) Cycle 2 (21 – 42 days) 82.3 (50.9) 5.2 (50.3) 2.5 (55.7) Cycle 3 (42 – 63 days) 72.9 (42.8) 4.5 (44.0) 2.4 (52.3) Steady state Steady state values are approximated at Cycle 4 (63 – 84 days). 72.8 (34.5) 4.4 (36.7) 2.4 (34.2) Figure 1.
Model-Predicted Mosunetuzumab-axgb Subcutaneous Injection Concentration Time Profile Pharmacokinetic parameters ( Table 10 ) were evaluated at the recommended dosage and are presented as geometric mean (CV%) unless otherwise specified. Table 10. Mosunetuzumab-axgb Pharmacokinetic Parameters in Patients with Relapsed or Refractory Follicular Lymphoma Parameter LUNSUMIO VELO via Subcutaneous Injection T max = time to peak concentration Bioavailability 89.8% T max median (range), days Steady-state 4.2 (2.5 – 7.1) Volume of distribution a (L) 5.5 (31%) Half-life a (days) 17.0 (15%) Systemic clearance (L/day) 1.1 (63%) at baseline 0.58 (18%) at steady state Specific Populations There were no clinically significant differences in the pharmacokinetics of mosunetuzumab-axgb based on age (18 to 96 years), sex, race (Asian and Non-Asian), ethnicity (Hispanic/Latino and not Hispanic/Latino), mild or moderate renal impairment (estimated creatinine clearance [CrCL] by Cockcroft-Gault formula: 30 to 89 mL/min), or mild hepatic impairment (total bilirubin less than or equal to upper limit of normal [ULN] with AST greater than ULN or total bilirubin greater than 1 to 1.5 times ULN with any AST).
The effects of severe renal impairm…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Mosunetuzumab-axgb is a T-cell engaging bispecific 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. In vitro, mosunetuzumab-axgb activated T-cells, caused the release of proinflammatory cytokines, and induced lysis of B-cells.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING LUNSUMIO VELO (mosunetuzumab-axgb) injection is a sterile, colorless to slightly brownish-yellow, preservative-free solution for subcutaneous injection supplied as follows: One 5 mg/0.5 mL single-dose vial in a carton (NDC 50242-177-01) One 45 mg/mL single-dose vial in a carton (NDC 50242-201-01). Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.
📦 Storage and Handling ▾
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.
📋 Description ▾
11 DESCRIPTION Mosunetuzumab-axgb is a bispecific CD20-directed CD3 T-cell engager. It is a humanized monoclonal anti-CD20xCD3 T-cell-dependent bispecific antibody of the immunoglobulin G1 (IgG1) isotype. Mosunetuzumab-axgb is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
The approximate molecular weight is 146 kDa. LUNSUMIO VELO (mosunetuzumab-axgb) injection is a sterile, preservative-free, colorless to slightly brownish-yellow solution for subcutaneous use. Each single-dose vial contains a 0.5 mL solution of mosunetuzumab-axgb (5 mg), acetic acid (0.2 mg), histidine (0.8 mg), methionine (0.7 mg), polysorbate 20 (0.3 mg), sucrose (41 mg), and Water for Injection, USP.
The pH is 5.8. Each single-dose vial contains a 1 mL solution of mosunetuzumab-axgb (45 mg), acetic acid (0.4 mg), histidine (1.6 mg), methionine (1.5 mg), polysorbate 20 (0.6 mg), sucrose (82.1 mg), and Water for Injection, USP. The pH is 5.8.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Cytokine Release Syndrome (CRS) – Discuss the signs and symptoms associated with CRS, including fever, chills, hypotension, tachycardia, hypoxia, and headache. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.
Advise patients who experience symptoms that impair consciousness not to drive and refrain from operating heavy or potentially dangerous machinery until events resolve [see Warnings and Precautions (5.1) ] . Neurologic Toxicity, including ICANS – Discuss the signs and symptoms associated with neurologic toxicity, including ICANS, headache, peripheral neuropathy, dizziness, or mental status changes. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of neurologic toxicity.
Advise patients who experience neurologic toxicity that impairs consciousness to refrain from driving or operating heavy or potentially dangerous machinery until neurologic toxicity resolves [see Warnings and Precautions (5.2) ] . Infections – Discuss the signs or symptoms associated with infection [see Warnings and Precautions (5.3) ]. Hemophagocytic Lymphohistiocytosis (HLH) – Discuss the signs and symptoms associated with HLH, including fever, coagulopathy, cytopenias, and splenomegaly [see Warnings and Precautions (5.4) ] .
Cytopenias – Discuss the signs and symptoms associated with cytopenias, including neutropenia and febrile neutropenia, anemia, and thrombocytopenia [see Warnings and Precautions (5.5) ] . Tumor Flare – Inform patients of the potential risk of tumor flare reaction and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions (5.6) ]. Injection-Site Reactions – Inform patients that injection site reactions may occur and to report any severe reactions [see Adverse Reactions (6.1) ].
Embryo-Fetal Toxicity – Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider if they are pregnant or become pregnant [see Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during treatment with LUNSUMIO VELO and for 3 months after the last dose [see Use in Specific Populations (8.3) ] .
Lactation – Advise women not to breastfeed during treatment with LUNSUMIO VELO and for 3 months after the last dose [see Use in Specific Populations (8.2) ] .
💬 Medication Guide ▾
MEDICATION GUIDE LUNSUMIO VELO™ (lun-SUM-mee-oh VEH-low) (mosunetuzumab-axgb) injection, for subcutaneous use This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: June 2026 What is the most important information I should know about LUNSUMIO VELO?
LUNSUMIO VELO can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with LUNSUMIO VELO, and can also be severe or life-threatening. Get medical help right away if you develop any signs or symptoms of CRS at any time, including: fever of 100.4°F (38°C) or higher chills low blood pressure fast or irregular heartbeat tiredness or weakness difficulty breathing headache confusion feeling anxious dizziness or light-headedness nausea vomiting Due to the risk of CRS, you will receive LUNSUMIO VELO on a "step-up dosing schedule".
The step-up dosing schedule is when you receive smaller "step-up" doses before receiving higher doses of LUNSUMIO VELO during your first cycle of treatment. If your dose of LUNSUMIO VELO is delayed for any reason, you may need to repeat the "step-up dosing schedule." You may receive medicines to help reduce your risk of CRS before your dose. See " How will I receive LUNSUMIO VELO? " for more information about how you will receive LUNSUMIO VELO.
Your healthcare provider will check you for CRS during treatment with LUNSUMIO VELO and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with LUNSUMIO VELO if you have severe side effects. See " What are the possible side effects of LUNSUMIO VELO? " for more information about side effects.
What is LUNSUMIO VELO? LUNSUMIO VELO is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments. It is not known if LUNSUMIO VELO is safe and effective in children.
Before receiving LUNSUMIO VELO, tell your healthcare provider about all of your medical conditions, including if you: have an infection or have had an infection in the past which lasted a long time or keeps coming back. have or had Epstein-Barr Virus. are pregnant or plan to become pregnant. LUNSUMIO VELO may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LUNSUMIO VELO.
Females who are able to become pregnant: your healthcare provider should do a pregnancy test before you start treatment with LUNSUMIO VELO. use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of LUNSUMIO VELO. are breastfeeding or plan to breastfeed. It is not known if LUNSUMIO VELO passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of LUNSUMIO VELO.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive LUNSUMIO VELO? LUNSUMIO VELO will be given to you by your healthcare provider as an injection under your skin (subcutaneous) in your stomach area (abdomen) or thigh.
After you complete the weekly "step-up dosing schedule" in Cycle 1, LUNSUMIO VELO is given every 21 days. After Cycle 1, your healthcare provider will decide if you need to continue to take other medicines to help reduce side effects from LUNSUMIO VELO during future cycles. Your healthcare provider will decide how many treatment cycles you will receive of LUNSUMIO VELO.
See " What is the most important information I should know about LUNSUMIO VELO? " for more information about how you will receive LUNSUMIO VELO. What should I avoid while receiving LUNSUMIO VELO? Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair c…