HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
LUNSUMIO safely and effectively. See full prescribing information for
LUNSUMIO.
LUNSUMIO™ (mosunetuzumab-axgb) injection, for intravenous use
Initial U.S. Approval: 2022
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. Initiate treatment
with the LUNSUMIO step-up dosing schedule to reduce the risk of CRS.
Withhold LUNSUMIO until CRS resolves or permanently discontinue
based on severity. (2.1, 2.4, 5.1)--------------------------- INDICATIONS AND USAGE -------------------------LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated forthe 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 verificationand description of clinical benefit in a confirmatory trial(s). (1.1)---------------------- DOSAGE AND ADMINISTRATION ---------------------•
Premedicate to reduce risk of cytokine release syndrome and infusionrelated reactions. (2.3, 5.1)•
Administer only as an intravenous infusion. (2.1)•
Recommended dosage:o
Cycle 1 Day 1 – 1 mgo
Cycle 1 Day 8 – 2 mgoCycle 1 Day 15 – 60 mg
oCycle 2 Day 1 – 60 mg
oCycle 3+ Day 1 – 30 mg
See Full Prescribing Information for instructions on preparation andadministration. (2.5)--------------------- DOSAGE FORMS AND STRENGTHS -------------------Injection:•
1 mg/mL solution in a single-dose vial. (3)•30 mg/30 mL (1 mg/mL) solution in a single-dose vial. (3)------------------------------ CONTRAINDICATIONS ----------------------------None. (4)------------------------ WARNINGS AND PRECAUTIONS --------------------•
Neurologic Toxicity: Can cause serious 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 forsigns and symptoms of infection, including opportunistic infections, andtreat as needed. (5.3)•
Cytopenias: Monitor complete blood cell counts during treatment. (5.4)•
Tumor Flare: Can cause serious tumor flare reactions. Monitor patientsat risk for complications of tumor flare. (5.5)•
Embryo-Fetal Toxicity: May cause fetal harm. Advise females ofreproductive potential of the potential risk to the fetus and to use
effective contraception. (5.6, 8.1, 8.3)------------------------------ ADVERSE REACTIONS ----------------------------The most common adverse reactions (≥ 20%) are cytokine release syndrome,
fatigue, rash, pyrexia, and headache.
The most common Grade 3 to 4 laboratory abnormalities (≥ 10%) aredecreased lymphocyte count, decreased phosphate, increased glucose,decreased neutrophil count, increased uric acid, decreased white blood cellcount, decreased hemoglobin, and decreased platelets. (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.
--------------------------USE IN SPECFIC POPULATIONS---------------------Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide.
Revised: 12/2022

FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: CYTOKINE RELEASE SYNDROME
1 INDICATIONS AND USAGE
1.1 Follicular Lymphoma
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosing Information
2.2 Recommended Dosage
2.3 Recommended Premedication and Prophylactic Medications
2.4 Dosage Modifications for Adverse Reactions
2.5 Preparation and Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Cytokine Release Syndrome
5.2 Neurologic Toxicity
5.3 Infections
5.4 Cytopenias
5.5 Tumor Flare
5.6 Embryo-Fetal Toxicity
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience

Reference ID: 5099541

7
8

11
12

13
14
16
17

DRUG INTERACTIONSUSE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
DESCRIPTION
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.6 Immunogenicity
NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
CLINICAL STUDIESHOW SUPPLIED/STORAGE AND HANDLINGPATIENT COUNSELING INFORMATION* Sections or subsections omitted from the full prescribing information are notlisted.

FULL PRESCRIBING INFORMATIONWARNING: CYTOKINE RELEASE SYNDROME
Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur
in patients receiving LUNSUMIO. Initiate treatment with the LUNSUMIO step-up dosing
schedule to reduce the risk of CRS. Withhold LUNSUMIO until CRS resolves orpermanently discontinue based on severity [see Dosage and Administration (2.1 and 2.4) andWarnings and Precautions (5.1)].
1

INDICATIONS AND USAGE

1.1

Follicular Lymphoma

LUNSUMIO is indicated for the treatment of adult patients with relapsed or refractory follicularlymphoma after two or more lines of systemic therapy.
This indication is approved under accelerated approval based on response rate [see ClinicalStudies (14.1)]. Continued approval for this indication may be contingent upon verification anddescription of clinical benefit in a confirmatory trial(s).
2DOSAGE AND ADMINISTRATION

2.1

Important Dosing Information•

Administer LUNSUMIO to well-hydrated patients.

•

Premedicate before each dose in Cycle 1 and Cycle 2 [see Dosage and Administration (2.2)].

•

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 withappropriate medical support to manage severe reactions such as cytokine release syndrome
and neurologic toxicity [see Warnings and Precautions (5.1 and 5.2)].

2.2

Recommended Dosage

The recommended dosage for LUNSUMIO 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.

Reference ID: 5099541

Table 1.

Recommended LUNSUMIO Dose and Schedule (21-Day Treatment Cycles)
Dose of
LUNSUMIO

Rate of Infusion

Day 1

1 mg

Administer over a minimum of 4 hours.

Day 8

2 mg

Day 1560 mg

Cycle 2

Day 1

60 mg

Cycles 3+

Day 1

30 mg

Day of Treatment

Cycle 1

Table 2.

Administer over 2 hours if infusions from Cycle 1 were
well-tolerated.

Recommendations for Restarting Therapy with LUNSUMIO After Dose Delay

Last Dose
AdministeredTime Since the Last Dose
Administered

Action for Next Dose(s)Administer 2 mg (Cycle 1 Day 8), then resume the planned
treatment schedule.
Repeat 1 mg (Cycle 1 Day 1), then administer 2 mg (Cycle 1
Greater than 2 weeks
Day 8) and resume the planned treatment schedule.
Administer 60 mg (Cycle 1 Day 15), then resume the planned
1 to 2 weeks
treatment schedule.
Greater than 2 weeks
Repeat 2 mg (Cycle 1 Day 8), then administer 60 mg (Cycle 1
2 mg
to less than 6 weeks
Day 15) and resume the planned treatment schedule.
Cycle 1 Day 8
Repeat 1 mg (Cycle 1 Day 1) and 2 mg (Cycle 1 Day 8), thenGreater than or equal to 6 weeks administer 60 mg (Cycle 1 Day 15) and resume the planned
treatment schedule.
Administer 60 mg (Cycle 2 Day 1), then resume the planned
1 week to less than 6 weeks
treatment schedule.
60 mg
Repeat 1 mg (Cycle 2 Day 1) and 2 mg (Cycle 2 Day 8), thenCycle 1 Day 15
administer 60 mg (Cycle 2 Day 15), followed by 30 mg
Greater than or equal to 6 weeks(Cycle 3 Day 1) and then resume the planned treatment
schedule.
Administer 30 mg (Cycle 3 Day 1), then resume the planned
3 weeks to less than 6 weeks
treatment schedule.
60 mg
Repeat 1 mg (Cycle 3 Day 1) and 2 mg (Cycle 3 Day 8), thenCycle 2 Day 1
administer 30 mg (Cycle 3 Day 15)*, followed by 30 mg
Greater than or equal to 6 weeks(Cycle 4 Day 1) and then resume the planned treatment
schedule.
Administer 30 mg, then resume the planned treatment
3 weeks to less than 6 weeks
schedule.
30 mg
Repeat 1 mg on Day 1 and 2 mg on Day 8 during the next
Cycle 3 onwards
Greater than or equal to 6 weeks cycle, then administer 30 mg on Day 15*, followed by 30 mg
on Day 1 of subsequent cycles.
*
For the Day 1, Day 8, and Day 15 doses in the next cycle, administer premedication as per Table 3 for all patients
1 mg
Cycle 1 Day 1

2.3

1 to 2 weeks

Recommended Premedication and Prophylactic Medication

Premedication to reduce the risk of cytokine release syndrome and infusion-related reactions are
outlined in Table 3 [see Warnings and Precautions (5.1)].

Reference ID: 5099541

Table 3.

Premedication to be Administered to Patients Prior to LUNSUMIO Infusion

Treatment
Cycle

Cycle 1 andCycle 2

Cycles 3+

2.4

Patients Requiring
Premedication

All patients

Patients who
experienced any
grade CRS with theprevious dose

Premedication

DosageAdministration

Corticosteroid

Dexamethasone 20 mg
intravenous or methylprednisolone
80 mg intravenous

Complete at least
1 hour prior toinfusion

Antihistamine

Diphenhydramine hydrochloride
50 mg – 100 mg or equivalent oral
or intravenous antihistamine

At least 30 minutes
prior to infusion

Antipyretic

Oral acetaminophen(500 mg – 1,000 mg)

At least 30 minutes
prior to infusion

Corticosteroid

Dexamethasone 20 mg
intravenous or methylprednisolone
80 mg intravenous

Complete at least
1 hour prior toinfusion

Antihistamine

Diphenhydramine hydrochloride
50 mg – 100 mg or equivalent oral
or intravenous antihistamine

At least 30 minutes
prior to infusion

Antipyretic

Oral acetaminophen(500 mg – 1,000 mg)

At least 30 minutes
prior to infusion

Dosage Modifications for Adverse Reactions

See Tables 4 and 5 for the recommended dosage modifications for adverse reactions of CRS andneurologic 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 cytokine release syndrome (CRS) based on clinical presentation [see Warnings andPrecautions (5.1)]. Evaluate for and treat other causes of fever, hypoxia, and hypotension.
If CRS is suspected, withhold LUNSUMIO until CRS resolves, manage according to therecommendations 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

GradeaGrade 1

Presenting Symptoms
Fever ≥ 100.4°F (38°C)c

Reference ID: 5099541

Actionsb• Withhold current infusion of LUNSUMIO andmanage per current practice guidelines.
o If symptoms resolve, restart infusion at the samerate.
• Ensure CRS symptoms are resolved for at least
72 hours prior to the next dose of LUNSUMIO.d• Administer premedicatione prior to next dose of
LUNSUMIO and monitor patient more frequently.

Gradea
Grade 2Presenting Symptoms
Fever ≥ 100.4°F (38°C)c with:
Hypotension not requiring vasopressors
and/orhypoxia requiring low-flow oxygenf by
nasal cannula or blow-by.

Grade 3Fever ≥ 100.4°F (38°C)c with:
Hypotension requiring a vasopressor(with or without vasopressin)
and/orhypoxia requiring high flow oxygenf by
nasal cannula, face mask, non-rebreathermask, or Venturi mask.

Grade 4Fever ≥ 100.4°F (38°C)c with:
Hypotension requiring multiple
vasopressors (excluding vasopressin)

Actionsb• Withhold current infusion of LUNSUMIO andmanage per current practice guidelines.
o 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.d• Administer premedicatione 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.
• Withhold LUNSUMIO, manage per current practiceguidelines 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.d• Administer premedicatione 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 andprovide supportive therapy, which may include
intensive care.
• Permanently discontinue LUNSUMIO.
• Manage CRS per current practice guidelines andprovide supportive therapy, which may include
intensive care.

and/orhypoxia requiring oxygen by positive
pressure (e.g., CPAP, BiPAP, intubationand mechanical ventilation).
aBased on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS.
b
If CRS is refractory to management, consider other causes including hemophagocytic lymphohistiocytosis.
cPremedication may mask fever, therefore if clinical presentation is consistent with CRS, follow thesemanagement guidelines.
dRefer to Table 2 for information on restarting LUNSUMIO after dose delays [see Dosage and Administration(2.2)].
e
Refer to Table 3 for additional information on premedication.
f
Low-flow oxygen defined as oxygen delivered at < 6 L/minute; high-flow oxygen defined as oxygen deliveredat ≥ 6 L/minute.

Dosage Modifications for Neurologic Toxicity, including ICANSManagement recommendations for neurologic toxicity, including ICANS, is summarized inTable 5. At the first sign of neurologic toxicity, including ICANS, withhold LUNSUMIO andReference ID: 5099541

consider neurology evaluation. 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)

Adverse Reaction

Actions• Withhold LUNSUMIO until neurologic toxicity
symptoms improve to Grade 1 or baseline for at least
Grade 272 hours.3• Provide supportive therapy. If ICANS, manage percurrent practice guidelines.
• Withhold LUNSUMIO until neurologic toxicity
symptoms improve to Grade 1 or baseline for at least
72 hours.3
Neurologic Toxicity12
Grade 3
(Including ICANS )• Provide supportive therapy, which may include
intensive care, and consider neurology evaluation. If
ICANS, manage per current practice guidelines.
• If recurrence, permanently discontinue LUNSUMIO.
• Permanently discontinue LUNSUMIO.
• Provide supportive therapy, which may include
Grade 4intensive care, and consider neurology evaluation. If
ICANS, manage per current practice guidelines.
1
Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE),
version 4.0.
2
Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS.
3
See Table 2 for recommendations on restarting LUNSUMIO after dose delays [see Dosage and Administration(2.2)].

Table 6.

Severity1,2

Recommended Dosage Modification for Other Adverse Reactions

Adverse Reactions1

Severity1

Infections [see Warnings andPrecautions (5.3)]

Grades 1 – 4

Neutropenia [see Warnings andPrecautions (5.4)]

Absolute neutrophil countless than 0.5 × 109/L

Actions• Withhold LUNSUMIO in patients withactive infection until the infection resolves.2• For Grade 4, consider permanent
discontinuation of LUNSUMIO.
• Withhold LUNSUMIO until absolute
neutrophil count is 0.5 × 109/L or higher.2

Other Adverse Reactions [see• Withhold LUNSUMIO until the toxicity
Warnings and Precautions (5.5)
Grade 3 or higher
resolves to Grade 1 or baseline.2
and Adverse Reactions (6.1)]
1
Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version
4.0.
2
See Table 2 for recommendations on restarting LUNSUMIO after dose delays [see Dosage and Administration(2.2)].

2.5

Preparation and Administration

Preparation
Use aseptic technique to prepare LUNSUMIO.

Reference ID: 5099541

•Inspect the vial visually for any particulate matter, prior to administration. Do not use if thesolution 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 forthe patient’s dose and discard. Only use infusion bags made of polyvinyl chloride (PVC) or
polyolefin (PO) such as polyethylene (PE) and polypropylene.
2. Withdraw the required volume of LUNSUMIO from the vial using a sterile needle andsyringe 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 thevial.
Table 7.

Dilution of LUNSUMIO

Dose of LUNSUMIO

Volume of LUNSUMIO
in 0.9% or 0.45% Sodium Chloride Solution

Size of Infusion Bag

1 mg

1 mL

50 mL or 100 mL

2 mg

2 mL

50 mL or 100 mL

60 mg

60 mL

100 mL or 250 mL

30 mg

30 mL

50 mL, 100 mL, or 250 mL

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 opaqueparticles, discoloration, or foreign particles are observed.
5. Apply the peel-off label from the package insert 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 as an intravenous infusion only.

•

Do not use an in-line filter to administer LUNSUMIO.

•

Do not mix LUNSUMIO with, or administer through the same infusion line, as othermedicinal products.

•

No incompatibilities have been observed between LUNSUMIO and intravenous infusion
bags with product contacting materials of polyvinyl chloride (PVC), or polyolefins (PO)

Reference ID: 5099541

such as polyethylene (PE) and polypropylene (PP). In addition, no incompatibilities havebeen observed with infusion sets or infusion aids with product contacting materials of
PVC, PE, polyurethane (PUR), polybutadiene (PBD), silicone, acrylonitrile butadienestyrene (ABS), polycarbonate (PC), polyetherurethane (PEU), fluorinated ethylene
propylene (FEP), or polytetrafluorethylene (PTFE), or with drip chamber filter membranecomposed of polyamide (PA).
3

DOSAGE FORMS AND STRENGTHSLUNSUMIO is a sterile, colorless solution available as:•

Injection: 1 mg/mL mosunetuzumab-axgb of solution in a single-dose vial•

Injection: 30 mg/30 mL (1 mg/mL) mosunetuzumab-axgb of solution in a single-dosevial

4

CONTRAINDICATIONS

None.
5

WARNINGS AND PRECAUTIONS

5.1

Cytokine Release Syndrome

LUNSUMIO can cause cytokine release syndrome (CRS), including serious or life-threatening
reactions [see Adverse Reactions (6.1)].
Cytokine release syndrome occurred in 39% of patients who received LUNSUMIO at therecommended dose in the clinical trial, with Grade 1 CRS occurring in 28%, Grade 2 in 15%,
Grade 3 in 2%, and Grade 4 in 0.5% of patients. Recurrent CRS occurred in 11% of patients.
Most patients experienced CRS following doses of 1 mg on Cycle 1 Day 1 (15%), 2 mg on Cycle
1 Day 8 (5%), and 60 mg on Cycle 1 Day 15 (33%). Five percent of patients experienced CRS
after receiving 60 mg on Cycle 2 Day 1 with 1% of patients experiencing CRS following
subsequent dosages of LUNSUMIO.
The median time to onset of CRS from the start of administration in Cycle 1 Day 1 was 5 hours(range: 1 hour to 3 days), Cycle 1 Day 8 was 28 hours (range: 5 hours to 3 days), Cycle 1 Day 15
was 25 hours (range: 0.1 hours to 16 days), and Cycle 2 Day 1 was 46 hours (range: 12 hours to
3 days). The median duration of CRS was 3 days (range: 1 to 29 days).
Clinical signs and symptoms of CRS included, but were not limited to, fever, chills, hypotension,tachycardia, hypoxia, and headache. Concurrent neurologic adverse reactions occurred in 6% of
patients and included but were not limited to headache, confusional state, and anxiety.
Initiate therapy according to LUNSUMIO step-up dosing schedule to reduce the risk of CRS [seeDosage and Administration (2.3)]. Administer pretreatment medications to reduce the risk of
CRS, ensure adequate hydration, and monitor patients following administration of LUNSUMIO
accordingly.
At the first sign of CRS, immediately evaluate patients for hospitalization, manage per current
practice guidelines and administer supportive care; withhold or permanently discontinue
LUNSUMIO based on severity [see Dosage and Administration (2.4)].

Reference ID: 5099541

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.
5.2

Neurologic Toxicity

LUNSUMIO can cause serious neurologic toxicity, including Immune Effector Cell-Associated
Neurotoxicity Syndrome (ICANS) [see Adverse Reactions (6.1)].
Neurologic toxicity occurred in 39% of patients who received LUNSUMIO at the recommended
dose in the clinical trial, with Grade 3 neurologic toxicity occurring in 3% of patients. The mostfrequent neurologic toxicities were headache (21%), peripheral neuropathy (13%), dizziness(11%), and mental status changes (6%, including confusional state, disturbance in attention,
cognitive disorder, delirium, encephalopathy, and somnolence). ICANS was reported in 1% of
patients (Grade 1: 0.5%, Grade 2: 0.5%) who received LUNSUMIO at the recommended dose in
the clinical trial.
Coadministration of LUNSUMIO with other products that cause dizziness or mental statuschanges may increase the risk of neurologic toxicity.
Monitor patients for signs and symptoms of neurologic toxicity during treatment. At the first signof neurologic toxicity, including ICANS, immediately evaluate the patient, consider neurology
evaluation as appropriate, and provide supportive therapy based on severity; withhold or
permanently discontinue LUNSUMIO based on severity and follow management
recommendations [see Dosage and Administration (2.4)].
Patients who experience neurologic toxicity such as tremors, dizziness, insomnia, severe
neurotoxicity, or any other adverse reactions that impair consciousness should be evaluated,
including potential neurology evaluation, and patients at increased risk should be advised not todrive and to refrain from operating heavy or potentially dangerous machinery until resolution.
5.3

Infections

LUNSUMIO can cause serious or fatal infections [see Adverse Reactions (6.1)].
Among patients who received LUNSUMIO at the recommended dose in the clinical trial, serious
infections, including opportunistic infections, occurred in 17%, with Grade 3 or 4 infections in
14%, and fatal infections in 0.9% of patients. The most common Grade 3 or greater infections
were pneumonia, sepsis, and upper respiratory tract 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 ofactive 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[see Dosage and Administration (2.4)].

Reference ID: 5099541

5.4

Cytopenias

LUNSUMIO can cause serious or severe cytopenias, including neutropenia, anemia, andthrombocytopenia [see Adverse Reactions (6.1)].
Among patients who received the recommended dosage in the clinical trial, Grade 3 or 4
decreased neutrophils occurred in 38%, decreased hemoglobin in 19%, and decreased platelets in
12% of patients. Grade 4 decreased neutrophils occurred in 19% and decreased platelets in 5% of
patients. Febrile neutropenia occurred in 2%.
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 [see Dosage andAdministration (2.4)].
5.5

Tumor Flare

LUNSUMIO can cause serious or severe tumor flare [see Adverse Reactions (6.1)].
Among patients who received LUNSUMIO at the recommended dosage in the clinical trial,
tumor flare occurred in 4% of patients. 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 ofcompression or obstruction due to mass effect secondary to tumor flare. If compression or
obstruction develops, institute standard treatment of these complications.
5.6 Embryo-Fetal Toxicity
Based on its mechanism of action, LUNSUMIO may cause fetal harm when administered to apregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females ofreproductive potential to use effective contraception during treatment with LUNSUMIO and for3 months after the last dose [see Use in Specific Populations (8.1, 8.3)].
6

ADVERSE REACTIONS

The following adverse reactions are described elsewhere in the labeling:

6.1•

Cytokine Release Syndrome [see Warnings and Precautions (5.1)]•

Neurologic Toxicity [see Warnings and Precautions (5.2)]•

Infections [see Warnings and Precautions (5.3)]•

Cytopenias [see Warnings and Precautions (5.4)]•

Tumor Flare [see Warnings and Precautions (5.5)]
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 trialsof 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

Reference ID: 5099541

malignancies in an open-label, multicenter, multi-cohort study. Patients received step-up doses of
1 mg on Cycle 1 Day 1 and 2 mg on Cycle 1 Day 8, followed by 60 mg on Cycle 1 Day 15, and60 mg on Cycle 2 Day 1, then 30 mg every 3 weeks in subsequent cycles. A treatment cycle was
21 days. Among 218 patients who received LUNSUMIO, 52% were exposed for at least 8 cycles
and 8% were exposed for 17 cycles.
In this pooled safety population, the most common (≥ 20%) adverse reactions were cytokine
release syndrome (39%), fatigue (36%), rash (34%), pyrexia (24%), and headache (21%). The
most common Grade 3 to 4 laboratory abnormalities (≥ 10%) were decreased lymphocyte count(92%), decreased phosphate (41%), increased glucose (40%), decreased neutrophil count (38%),
increased uric acid (15%), decreased white blood cell count (22%), decreased hemoglobin(19%), and decreased platelets (12%).
Relapsed or Refractory Follicular Lymphoma
GO29781
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) [see Clinical Studies (14)]. In this cohort, patients with relapsed or refractory FL wererequired to have received at least two prior lines of systemic therapy, including an anti-CD20
monoclonal antibody and an alkylating agent. Patients received step-up doses of 1 mg on Cycle 1
Day 1 and 2 mg on Cycle 1 Day 8, followed by 60 mg on Cycle 1 Day 15 and 60 mg on Cycle 2
Day 1, then 30 mg every 3 weeks in subsequent cycles. A treatment cycle was 21 days. The
median number of cycles was 8 (range: 1 – 17). In the relapsed or refractory FL cohort, 77%
were exposed for at least 8 cycles and 12% were exposed for 17 cycles.
The median age of the patients who received LUNSUMIO in the relapsed or refractory FL
cohort was 60 years (range: 29 to 90 years), 61% were male, 82% were White, 4% were Black or
African American, 9% were Asian, and 8% were Hispanic or Latino.
Serious adverse reactions occurred in 47% of patients who received LUNSUMIO. Serious
adverse reactions in ≥ 2% of patients included cytokine release syndrome, infection (including
urinary tract infection, sepsis, pneumonia, EBV viremia, and COVID-19), 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
cytokine release syndrome 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 cytokine release syndrome.
Table 8 summarizes the adverse reactions in patients with relapsed or refractory FL in GO29781.

Reference ID: 5099541

Table 8.

Adverse Reactions (≥ 10%) in Patients with Relapsed or Refractory FL Who
Received LUNSUMIO in GO29781

Adverse Reaction1
Immune system disorders
Cytokine release syndrome
General disorders and administration site conditions

LUNSUMIO(N = 90)
All Grades(%)

Grade 3 or 4
(%)

44

2.2

Fatigue2
420
Pyrexia29
1.1#
Edema317
1.1
Chills13
1.1#
Skin and subcutaneous tissue disorders
Rash4
39
4.4#
Pruritus
21
0
Dry skin
160Skin exfoliation
100
Nervous system
Headache532
1.1#
6Peripheral neuropathy
20
0
Dizziness7
120
Musculoskeletal and connective tissue disorders
Musculoskeletal pain828
1.1#
Arthralgia
110Respiratory, thoracic, and mediastinal disorders
Cough922
0
Dyspnea1011
1.1#
Gastrointestinal disorders
Diarrhea
170
Nausea170Abdominal pain11
12
1.1#
Infections
Upper respiratory tract infection12
14
2.2#
13
Urinary tract infection
10
1.1#
Psychiatric disorder
Insomnia
1201Adverse reactions were graded based on CTCAE Version 4.0, with the exception of CRS, which was graded per
ASTCT 2019 criteria
2
Fatigue includes fatigue, asthenia, and lethargy
3
Edema includes edema, edema peripheral, peripheral swelling, face edema, swelling face, pulmonary edema,
fluid overload, and fluid retention
4
Rash includes rash, rash erythematous, exfoliative rash, rash macular, rash maculo-papular, rash papular, rashpruritic, rash pustular, erythema, palmar erythema, dermatitis, and dermatitis acneiform
5
Headache includes headache and migraine
6
Peripheral neuropathy includes peripheral neuropathy, peripheral sensory neuropathy, paresthesia, dysaesthesia,
hypoaesthesia, burning sensation, and neuralgia

Reference ID: 5099541

Dizziness includes dizziness and vertigo
Musculoskeletal pain includes musculoskeletal pain, back pain, myalgia, musculoskeletal chest pain, and neckpain
9
Cough includes cough, productive cough, and upper airway cough syndrome
10
Dyspnea includes dyspnea and dyspnea exertional
11
Abdominal pain includes abdominal pain, lower abdominal pain, and abdominal discomfort
12Upper respiratory tract infection includes upper respiratory tract infection, nasopharyngitis, sinusitis, andrhinovirus infection
13
Urinary tract infection includes urinary tract infection and acute pyelonephritis#
Only Grade 3 adverse reactions occurred
7
8

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),and tumor flare.
Table 9 summarizes the laboratory abnormalities in patients with relapsed or refractory FL in
GO29781.
Table 9.

Select Laboratory Abnormalities (≥ 20%) That Worsened from Baseline inPatients with Relapsed or Refractory FL Who Received LUNSUMIO in
GO29781

Laboratory Abnormality

LUNSUMIO1All Grades(%)

Grade 3 or 4(%)

Hematology
Lymphocyte count decreased
100
98
Hemoglobin decreased
68
12White blood cells decreased60
13Neutrophils decreased
58
40
Platelets decreased
46
10
Chemistry
Phosphate decreased
78
46
Glucose increased
4242Aspartate aminotransferase increased
39
4.4
Gamma-glutamyl transferase increased
34
9Magnesium decreased
34
0
Potassium decreased
33
6
Alanine aminotransferase increased
32
7
Uric acid increased22
221
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.

Reference ID: 5099541

7

DRUG INTERACTIONS

Effect of LUNSUMIO on CYP450 Substrates
LUNSUMIO 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 on
Cycle 1 Day 1 and up to 14 days after the second 60 mg dose on Cycle 2 Day 1 and during andafter 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 forrecommended dosage modification.
8

USE IN SPECIFIC POPULATIONS

8.1

Pregnancy

Risk Summary
Based on the mechanism of action, LUNSUMIO may cause fetal harm when administered to apregnant woman [see Clinical Pharmacology (12.1)]. 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 andthe 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 betransmitted from the mother to the developing fetus. Advise women of the potential risk to thefetus.
In the U.S. general population, the estimated background risk of major birth defects andmiscarriage in clinically recognized pregnancies is 2% – 4% and 15% – 20%, respectively.
8.2

Lactation

Risk Summary
There is no information regarding the presence of mosunetuzumab-axgb in human milk, theeffect on the breastfed child, or milk production. Because human IgG is present in human milk,
and there is potential for mosunetuzumab-axgb absorption leading to B-cell depletion, advise
women not to breastfeed during treatment with LUNSUMIO and for 3 months after the last dose.
8.3

Females and Males of Reproductive Potential

LUNSUMIO 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.

Reference ID: 5099541

Contraception
Females
Advise females of reproductive potential to use effective contraception during treatment with
LUNSUMIO and for 3 months after the last dose.
8.4

Pediatric Use

The safety and efficacy of LUNSUMIO have not been established in pediatric patients.
8.5

Geriatric UseAmong the 90 patients with relapsed or refractory follicular lymphoma treated with
LUNSUMIO, 33% were 65 years of age or older, and 8% were 75 years of age or older. There isan insufficient number of patients 65 years of age or older and 75 years of age or older to assess
whether there are differences in safety or effectiveness in patients 65 years of age and older
compared to younger adult patients.
11

DESCRIPTION

Mosunetuzumab-axgb is a bispecific CD20-directed CD3 T-cell engager. It is a humanizedmonoclonal anti-CD20xCD3 T-cell-dependent bispecific antibody of the immunoglobulin G1(IgG1) isotype. Mosunetuzumab-axgb is produced in Chinese Hamster Ovary (CHO) cells byrecombinant DNA technology. The approximate molecular weight is 146 kDa.
LUNSUMIO (mosunetuzumab-axgb) injection is a sterile, preservative-free, colorless solution
for intravenous use.
Each single-dose vial contains a 1 mL solution of mosunetuzumab-axgb (1 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.
Each single-dose vial contains a 30 mL solution of mosunetuzumab-axgb (30 mg), acetic acid(12.8 mg), histidine (46.6 mg), methionine (44.8 mg), polysorbate 20 (18 mg), sucrose(2,462.4 mg), and Water for Injection, USP. The pH is 5.8.
12

CLINICAL PHARMACOLOGY

12.1 Mechanism 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 andsome healthy B-lineage cells.
In vitro, mosunetuzumab-axgb activated T-cells, caused the release of proinflammatory
cytokines, and induced lysis of B-cells.
12.2 Pharmacodynamics
After administration of the recommended dosage of LUNSUMIO, peripheral B-cell counts
decreased to undetectable levels (< 5 cells/microliter) in most patients (92%) by Cycle 2 Day 1
and the depletion was sustained at later cycles including at Cycle 4 and Cycle 8.
LUNSUMIO caused hypogammaglobulinemia (defined as IgG levels < 500 mg/dL). Among 67
patients with baseline IgG levels ≥ 500 mg/dL, 40% had their IgG level decreased to< 500 mg/dL after administration of the recommended dosage of LUNSUMIO.

Reference ID: 5099541

Plasma concentrations of cytokines (IL-2, IL-6, IL-10, TNF-α, and IFN-γ) were measured, andtransient elevation of cytokines were observed at doses of 0.4 mg and above. Afteradministration of the recommended dosage of LUNSUMIO, the highest elevation of cytokines
was observed within 24 hours after first dose on Cycle 1 Day 1 and after the first 60 mg dose on
Cycle 1 Day 15. The elevated cytokine levels generally returned to baseline prior to the next
infusion on Cycle 1 Day 8 and on Cycle 2 Day 1. Limited data is available in subsequent
treatment cycles.
12.3 Pharmacokinetics
Mosunetuzumab-axgb PK exposure increased proportionally over a dose range from 0.2 mg to60 mg (0.007 to 2 times the recommended treatment dosage). PK exposures are summarized forthe recommended dosage of LUNSUMIO in Table 10 and Figure 1.
Table 10. Exposure Parameters of Mosunetuzumab-axgb
AUC (day•μg/mL)1
Cycle 1 (0 ‒ 21 days)
35.2 (36.6)
Cycle 2 (21 ‒ 42 days)
90.3 (48.5)
2
Steady state
52.9 (40.7)
1
Values are geometric mean with geometric CV%
2
Steady state values are approximated at Cycle 4 (63 ‒ 84 days)

Cmax (μg/mL)1
11.1 (36.7)
13.6 (37.7)
7.02 (37.9)

Ctrough (μg/mL)1
2.57 (54.0)
1.97 (83.1)
1.29 (59.9)

Figure 1. Model-Predicted Mosunetuzumab Concentration Time Profile

Geometric mean
90th percentile prediction interval

Distribution
The mean (CV%) volume of distribution of mosunetuzumab-axgb was 5.49 L (31%).

Reference ID: 5099541

Elimination
The steady-state geometric mean (CV%) terminal elimination half-life of mosunetuzumab-axgb
was 16.1 (17.3%) days. The geometric mean (CV%) clearance at baseline and at steady state are
1.08 L/day (63%) and 0.584 L/day (18%), respectively.
Specific Populations
There were no clinically significant differences in the pharmacokinetics of mosunetuzumab-axgb
based on age (19 to 96 years), sex, race (Asian and Non-Asian), ethnicity (Hispanic/Latino andnot 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 lessthan 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 impairment (CrCL 15 to 29 mL/min) or moderate to severe hepatic
impairment (total bilirubin greater than 1.5 times ULN with any AST) on the pharmacokinetics
of mosunetuzumab-axgb are unknown.
Drug Interaction Studies
No clinical studies evaluating the drug interaction potential of mosunetuzumab-axgb have been
conducted.
12.6 Immunogenicity
The observed incidence of anti-drug antibodies is highly dependent on the sensitivity andspecificity of the assay. Differences in assay methods preclude meaningful comparisons of theincidence of anti-drug antibodies in the study described below with the incidence of anti-drug
antibodies in other studies, including those of mosunetuzumab-axgb.
During treatment in Study GO29781 (up to 12 months) [see Clinical Studies (14)], using an
enzyme-linked immunosorbent assay (ELISA), no patients (N = 418) treated with LUNSUMIO
developed anti-mosunetuzumab-axgb antibodies. Based on these data, the clinical relevance ofanti-mosunetuzumab-axgb antibodies could not be assessed.
13

NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenicity or genotoxicity studies have been conducted with mosunetuzumab-axgb.
No dedicated studies have been conducted to evaluate the effects of mosunetuzumab-axgb on
fertility. No adverse effects on either male or female reproductive organs were identified in a 26week repeat dose chronic toxicity study in sexually mature cynomolgus monkeys.
14

CLINICAL STUDIESThe 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 analkylating agent. The study excluded patients with active infections, history of autoimmune
disease, prior allogeneic transplant, or any history of CNS lymphoma or CNS disorders.

Reference ID: 5099541

Patients received step-up doses of 1 mg on Cycle 1 Day 1 and 2 mg on Cycle 1 Day 8, followedby 60 mg on Cycle 1 Day 15, and 60 mg on Cycle 2 Day 1, then 30 mg every 3 weeks insubsequent cycles. A treatment cycle was 21 days. LUNSUMIO was administered for 8 cycles
unless patients experienced progressive disease or unacceptable toxicity. After 8 cycles, patientswith 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.
Among the 90 patients with relapsed or refractory FL, the median age was 60 years (range:
29 to 90 years), 33% were 65 years of age or older, 61% were male, 82% were White, 9% were
Asian, 4% were Black or African American, and 8% were Hispanic or Latino. A total of 77% of
patients had Stage III-IV disease, 34% had bulky disease, and all patients had an Eastern
Cooperative Oncology Group (ECOG) performance status of 0 or 1. The median number of priortherapies was 3 (range: 2 to 10), with 38% receiving 2 prior therapies, 31% receiving 3 priortherapies, and 31% receiving more than 3 prior therapies.
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 celltransplant, and 3% received prior CAR T therapy. Fifty-two percent of patients had progressionof 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 11.
Table 11. Efficacy Results in Patients with Relapsed or Refractory FL
Response
Objective response rate (ORR), n (%)(95% CI)
Complete response rate (CR), n (%)(95% CI)
Partial response rate (PR), n (%)(95% CI)
Duration of Response (DOR)
Median DOR1,2, months (95% CI)
Rate of Continued Response2
At 12 months, %(95% CI)At 18 months, %(95% CI)LUNSUMIO
N = 9072 (80)(70, 88)
54 (60)(49, 70)
18 (20)(12, 30)
N = 7222.8 (10, NR)
62(50, 74)57(44, 70)

CI = confidence interval; NR = not reached
1 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, whichever occurs first), among patients who achieved a PR orCR.
2 Kaplan-Meier estimate.

Reference ID: 5099541

The median time to first response was 1.4 months (range: 1.1 to 8.9).
16

HOW SUPPLIED/STORAGE AND HANDLINGLUNSUMIO (mosunetuzumab-axgb) injection is a sterile, colorless, preservative-free solution
supplied as follows:••

One 1 mg/mL single-dose vial in a carton (NDC 50242-159-01)
One 30 mg/30 mL (1 mg/mL) single-dose vial in a carton (NDC 50242-142-01).

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.
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 toseek 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 fromoperating heavy or potentially dangerous machinery until events resolve [see Warnings andPrecautions (5.1)].
Neurologic Toxicity – 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 andPrecautions (5.3)].
Cytopenias – Discuss the signs and symptoms associated with cytopenias, including neutropenia
and febrile neutropenia, anemia, and thrombocytopenia [see Warnings and Precautions (5.4)].
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 [seeWarnings and Precautions (5.5)].
Embryo-Fetal Toxicity – Advise pregnant women of the potential risk to a fetus. Advise femalesof 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 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 and for 3
months after the last dose [see Use in Specific Populations (8.2)].

Reference ID: 5099541

Manufactured by:
Genentech, Inc.
A Member of the Roche Group
1 DNA WaySouth San Francisco, CA 94080-4990
U.S. License No.: 1048

Reference ID: 5099541

LUNSUMIO is a trademark of Genentech, Inc.
©
2022 Genentech, Inc.

MEDICATION GUIDELUNSUMIO™ (lun-SUM-mee-oh)(mosunetuzumab-axgb)
injection, for intravenous infusion
What is the most important information I should know about LUNSUMIO?
LUNSUMIO may cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment
with LUNSUMIO, 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• headache•chills•confusion•

low blood pressure•

feeling anxious•

fast or irregular heartbeat•

dizziness or light-headedness•

tiredness or weakness•

nausea•difficulty breathing•

vomiting

Due to the risk of CRS, you will receive LUNSUMIO on a “step-up dosing schedule”.
•

The step-up dosing schedule is when you receive smaller “step-up” doses of LUNSUMIO on Day 1 and Day 8 ofyour first cycle of treatment.

•

You will receive a higher dose of LUNSUMIO on Day 15 of your first cycle of treatment.

•

If your dose of LUNSUMIO is delayed for any reason, you may need to repeat the “step-up dosing schedule.”•

Before each dose in Cycle 1 and Cycle 2, you will receive medicines to help reduce your risk of CRS.

•

See “How will I receive LUNSUMIO?” for more information about how you will receive LUNSUMIO.

Your healthcare provider will check you for CRS during treatment with LUNSUMIO and may treat you in a hospital if
you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop yourtreatment with LUNSUMIO, if you have severe side effects.
See “What are the possible side effects of LUNSUMIO?” for more information about side effects.
What is LUNSUMIO?
LUNSUMIO 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 for their cancer.
It is not known if LUNSUMIO is safe and effective in children.
Before receiving LUNSUMIO, tell your healthcare provider about all of your medical conditions, including ifyou:•have ever had an infusion reaction after receiving LUNSUMIO.

•

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 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.
Females who are able to become pregnant:o your healthcare provider should do a pregnancy test before you start treatment with LUNSUMIO.
o you should use an effective method of birth control during your treatment and for 3 months after the last doseof LUNSUMIO.

•

are breastfeeding or plan to breastfeed. It is not known if LUNSUMIO passes into your breast milk. Do notbreastfeed during treatment and for 3 months after the last dose of LUNSUMIO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.

Reference ID: 5099541

How will I receive LUNSUMIO?
•LUNSUMIO will be given to you by your healthcare provider by infusion through a needle placed in a vein
(intravenous infusion).

•

After you complete the weekly “step-up dosing schedule” in Cycle 1, LUNSUMIO is given every 21 days.

•

After Cycle 1 and Cycle 2, your healthcare provider will decide if you need to continue to take other medicines tohelp reduce side effects from LUNSUMIO during future cycles.

•Your healthcare provider will decide how many treatment cycles you will receive of LUNSUMIO.

See “What is the most important information I should know about LUNSUMIO?” for more information about how
you will receive LUNSUMIO.
What should I avoid while receiving LUNSUMIO?
Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors,
sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may besigns and symptoms of CRS or neurologic problems.
See “What is the most important information I should know about LUNSUMIO?” and “What are the possible
side effects of LUNSUMIO?” for more information about signs and symptoms of CRS and neurologic problems.
What are the possible side effects of LUNSUMIO?
LUNSUMIO may cause serious side effects, including:See “What is the most important information I should know about LUNSUMIO?”•••

Neurologic problems. Your healthcare provider will check you for neurologic problems during treatment with
LUNSUMIO. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic
problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems
during or after treatment with LUNSUMIO, including:
o
o
o
o
o
o
o

headachenumbness and tingling of the arms, legs, hands, or feetdizziness
confusion and disorientationdifficulty paying attention or understanding things
forgetting things or forgetting who or where you aretrouble speaking, reading, or writing

o
o
o
o
o

fever of 100.4°F (38°C) or higher
coughchest pain
tiredness
shortness of breath

o
o
o
o
o
o

sleepiness or trouble sleeping
tremors
loss of consciousness
seizuresmuscle problems or muscle weakness
loss of balance or trouble walking

Serious infections. LUNSUMIO can cause serious infections that may lead to death. Your healthcare provider will
check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider rightaway if you develop any signs or symptoms of infection during treatment with LUNSUMIO, including:oooopainful rashsore throat
pain during urination
feeling weak or generally unwell

Low blood cell counts. Low blood cell counts are common during treatment with LUNSUMIO and can also be
severe.
Your healthcare provider will check your blood cell counts during treatment with LUNSUMIO. LUNSUMIO may
cause the following low blood cell counts:olow white blood cell counts (neutropenia). Low white blood cells can increase your risk for infection.

o

low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath.

olow platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems.

Reference ID: 5099541

•

Growth in your tumor or worsening of tumor related problems (Tumor flare). LUNSUMIO may cause serious
or severe worsening of your tumor.
Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment
with LUNSUMIO: tender or swollen lymph nodes, chest pain, cough, trouble breathing, and pain or swelling at thesite of the tumor.

Your healthcare provider may temporarily stop or permanently stop treatment with LUNSUMIO if you develop
severe side effects.
The most common side effects of LUNSUMIO include: tiredness, rash, fever, and headache.
The most common severe abnormal lab test results with LUNSUMIO include: decreased phosphate, increased
glucose, and increased uric acid levels.
These are not all the possible side effects of LUNSUMIO.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of LUNSUMIO.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask yourpharmacist or healthcare provider for information about LUNSUMIO that is written for health professionals.
What are the ingredients in LUNSUMIO?
Active ingredient: mosunetuzumab-axgb
Inactive ingredients: acetic acid, histidine, methionine, polysorbate 20, sucrose, and Water for Injection
Manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990
U.S. License No.: 1048
LUNSUMIO is a trademark of Genentech, Inc.
For more information, call 1-844-832-3687 or go to www.LUNSUMIO.com.
This Medication Guide has been approved by the U.S. Food and Drug Administration.

Reference ID: 5099541

Issued: 12/2022