mosunetuzumab (Rx)

Brand and Other Names:Lunsumio, mosunetuzumab-axgb
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 1mg/mL (single-dose vial)
  • 30mg/30mL (single-dose vial)

Follicular Lymphoma

Indicated for relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy

Each cycle is 21 days

Cycle 1 Day 1: 1 mg IV over at least 4 hr

Cycle 1 Day 8: 2 mg IV over at least 4 hr

Cycle 1 Day 15: 60 mg IV over at least 4 hr

Cycle 2 Day 1: 60 mg IV over 2 hr if Cycle 1 infusion was well-tolerated

Cycle 3 and subsequent cycles

  • Day 1: 30 mg IV over 2 hr if Cycle 1 infusion was well-tolerated
  • Continue for 8 cycles, unless unacceptable toxicity or disease progression
  • Complete response achieved after 8 cycles: No further treatment is required
  • Partial response or stable disease after 8 cycles: Continue treatment for 9 more cycles (17 cycles total) or until unacceptable toxicity or disease progression

Restarting therapy after dose delay

Last dose administered 1 mg (Cycle 1 Day 1)

  • Time since last dose
    • 1-2 weeks: Administer 2 mg (Cycle 1 Day 8), then resume planned treatment schedule
    • >2 weeks: Repeat 1 mg (Cycle 1 Day 1), then administer 2 mg (Cycle 1 Day 8) and resume planned treatment schedule

Last dose administered 2 mg (Cycle 1 Day 8)

  • Time since last dose
    • 1-2 weeks: Administer 60 mg (Cycle 1 Day 15), then resume planned treatment schedule
    • >2 weeks to <6 weeks: Repeat 2 mg (Cycle 1 Day 8), then administer 60 mg (Cycle 1 Day 15) and resume planned treatment schedule
    • ≥6 weeks: Repeat 1 mg (Cycle 1 Day 1) and 2 mg (Cycle 1 Day 8), then administer 60 mg (Cycle 1 Day 15) and resume planned treatment schedule

Last dose administered 60 mg (Cycle 1 Day 15)

  • Time since last dose
    • 1 week to <6 weeks: Administer 60 mg (Cycle 2 Day 1), then resume planned treatment schedule
    • ≥6 weeks: Repeat 1 mg (Cycle 2 Day 1) and 2 mg (Cycle 2 Day 8), then administer 60 mg (Cycle 2 Day 15), followed by 30 mg (Cycle 3 Day 1), and then resume planned treatment schedule

Last dose administered 60 mg (Cycle 2 Day 1)

  • Time since last dose
    • 3 weeks to <6 weeks: Administer 30 mg (Cycle 3 Day 1), then resume planned treatment schedule
    • ≥6 weeks: Repeat 1 mg (Cycle 3 Day 1) and 2 mg (Cycle 3 Day 8), then administer 30 mg (Cycle 3 Day 15)*, followed by 30 mg (Cycle 4 Day 1) and then resume planned treatment schedule
    • *Premedicate for Day 1, Day 8, and Day 15 doses in next cycle

Last dose administered 30 mg (Cycle 3 and subsequent cycles)

  • Time since last dose
    • 3 weeks to <6 weeks: Administer 30 mg, then resume planned treatment schedule
    • ≥6 weeks: Repeat 1 mg on Day 1 and 2 mg on Day 8 during next cycle, then administer 30 mg on Day 15*, followed by 30 mg on Day 1 of subsequent cycles
    • *Premedicate for Day 1, Day 8, and Day 15 doses in next cycle

Dosage modifications

Refer to recommendations for restarting therapy after dose delay, as listed above

Cytokine release syndrome (CRS)

  • Identify CRS based on clinical presentation
  • Evaluate and treat other causes of fever, hypoxia, and hypotension
  • If CRS is suspected, withhold until CRS resolves
  • Administer supportive therapy for CRS, which may include intensive care for severe or life-threatening CRS
  • Note: Premedication may mask fever, therefore follow management guidelines below if clinical presentation is consistent with CRS
  • Grade 1 temperature ≥100.4ºF (38ºC)
    • Withhold current infusion until CRS resolves and manage per current practice guidelines
    • If symptoms resolve, restart infusion at same rate
    • Ensure CRS symptoms are resolved for ≥72 hr before next dose
    • Premedicate before next dose; monitor more frequently
  • Grade 2 temperature ≥100.4ºF (38ºC) with:
    • Hypotension responsive to fluids and not requiring vasopressors, and/or
    • Hypoxia requiring low-flow oxygen (oxygen delivered at <6 L/min) by nasal cannula or blow-by
    • Withhold current infusion and manage per current practice guidelines
    • If symptoms resolve, restart infusion at 50% rate
    • Ensure CRS symptoms are resolved for ≥72 hr before next dose
    • Premedicate before next dose and consider infusing next dose at 50% rate
    • For next dose, monitor more frequently and consider hospitalization
    • Recurrent Grade 2: Manage per Grade 3 CRS
  • Grade 3 temperature ≥100.4ºF (38ºC) with:
    • Hypotension requiring 1 vasopressor with or without vasopressin, and/or
    • Hypoxia requiring high-flow nasal cannula (high-flow nasal cannula is >6 L/min) by nasal cannula, face mask, non-rebreather mask, or Venturi mask
    • Withhold; manage per current practice guidelines and provide supportive therapy
    • Ensure CRS symptoms are resolved for ≥72 hr before next dose
    • Premedicate before next dose and infuse next dose at 50% rate
    • Hospitalize for next dose
    • Recurrent Grade 3 CRS or Grade 3 CRS lasting ≥48 hr: Permanently discontinue; provide supportive therapy
  • Grade 4 temperature ≥100.4ºF (38ºC) with
    • Hypotension requiring multiple vasopressors (excluding vasopressin), and/or
    • Hypoxia requiring positive pressure (eg, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP), intubation, and mechanical ventilation)
    • Permanently discontinue
    • Manage CRS per current practice guidelines and provide supportive therapy

Neurologic toxicity

  • First sign of neurologic toxicity
    • Including immune effector cell–associated neurotoxicity syndrome (ICANS)
    • Withhold and consider neurology evaluation; rule out other causes of neurologic symptoms
    • Provide supportive therapy, which may include intensive care, for severe or life-threatening neurologic toxicities
  • Grade 2
    • Withhold until neurologic toxicity symptoms improve to Grade 1 or baseline for ≥72 hr
    • Provide supportive therapy and consider neurology evaluation
    • ICAN confirmed: Manage per current practice guidelines
    • Recurrent Grade 2: Permanently discontinue
  • Grade 3
    • Withhold until neurologic toxicity symptoms improve to Grade 1 or baseline for ≥72 hr
    • Provide supportive therapy and consider neurology evaluation
    • Confirmed ICANS: Manage per current practice guidelines
    • Recurrent Grade 3: Permanently discontinue
  • Grade 4
    • Permanently discontinue
    • Provide supportive therapy and consider neurology evaluation
    • Confirmed ICANS: Manage per current practice guidelines

Infections

  • Grade 1-4 (active infection): Withhold infusion until infection resolves
  • Grade 4: Consider permanently discontinuing

Neutropenia

  • Absolute neutrophil count (ANC) < 0.5 x 109/L: Withhold until ANC ≥0.5 x 109/L

Other adverse reactions

  • Grade ≥3: Withhold until toxicity resolve to Grade 1 or baseline

Renal impairment

  • Mild or moderate renal impairment (CrCl 30-89 mL/min): No dosage adjustment necessary
  • Severe (CrCl 15-29 mL/min): Pharmacokinetics are unknown

Hepatic impairment

  • Mild (total bilirubin [TB] ≤ULN with AST >ULN or TB >1-1.5x ULN with any AST): No dosage adjustment necessary
  • Moderate-to-severe (TB >1.5x ULN with any AST): Pharmacokinetics are unknown

Dosing Considerations

Verify pregnancy status in females of reproductive potential

Safety and efficacy not established

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Adverse Effects

>10%

All grades

  • Lymphocyte count decreased (100%)
  • Phosphate decreased (78%)
  • Hemoglobin decreased (68%)
  • WBC decreased (60%)
  • Neutrophils decreased (58%)
  • Platelets decreased (46%)
  • CRS (44%)
  • Fatigue (42%)
  • Glucose increased (42%)
  • Rash (39%)
  • AST increased (39%)
  • Gamma-glutamyl transferase (GGT) increased (34%)
  • Magnesium decreased (34%)
  • Potassium decreased (33%)
  • Headache (32%)
  • ALT increased (32%)
  • Pyrexia (29%)
  • Musculoskeletal pain (28%)
  • Cough (22%)
  • Uric acid increased (22%)
  • Pruritus (21%)
  • Peripheral neuropathy (20%)
  • Edema (17%)
  • Diarrhea (17%)
  • Nausea (17%)
  • Dry skin (16%)
  • Upper respiratory tract infection (14%)
  • Chills (13%)
  • Dizziness (12%)
  • Abdominal (12%)
  • Insomnia (12%)
  • Arthralgia (11%)
  • Dyspnea (11%)

Grade 3 or 4

  • Lymphocyte count decreased (98%)
  • Phosphate decreased (46%)
  • Glucose increased (42%)
  • Neutrophils decreased (40%)
  • Uric acid increased (22%)
  • WBC decreased (13%)
  • Hemoglobin decreased (12%)

1-10%

All grades

  • Urinary tract infection (10%)
  • Skin exfoliation (10%)

Grade 3 or 4

  • Platelets decreased (10%)
  • GGT increased (9%)
  • ALT increased (7%)
  • Potassium decreased (6%)
  • Rash (4.4%)
  • AST increased (4.4%)
  • CRS (2.2%)
  • Upper respiratory infection (2.2%)
  • Pyrexia (1.1%)
  • Edema (1.1%)
  • Chills (1.1%)
  • Peripheral neuropathy (1.1%)
  • Musculoskeletal pain (1.1%)
  • Dyspnea (1.1%)
  • Abdominal pain (1.1%)
  • Urinary tract infection (1.1%)
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Warnings

Black Box Warnings

Cytokines release syndrome

  • Cytokine release syndrome (CRS), including serious or life-threatening reactions, may occur
  • Initiate treatment with step-up dosing schedule to reduce risk of CRS
  • At first sign of CRS, immediately evaluate for hospitalization, manage per current practice guidelines and administer supportive care; withhold or permanently discontinue based on severity
  • Evaluate patients who experience CRS (or other adverse reactions that impair consciousness)
  • Advise patients to avoid driving and operating heavy or potentially dangerous machinery until resolution

Contraindications

None

Cautions

Based on its mechanism of action, fetal harm may occur when administered to pregnant females

Can promote serious or fatal infections; monitor for signs and symptoms of infection, including opportunistic infections, and treat as needed

Serious or severe cytopenias, including neutropenia, anemia, and thrombocytopenia reported; monitor complete blood cell counts during treatment

Tumor flare

  • Serious or severe tumor flare reported; may manifest as new or worsening pleural effusions, localized pain and swelling at sites of lymphoma lesions, and tumor inflammation
  • Closely monitor patients with bulky tumors or disease located near airways or a vital organ during initial therapy
  • Monitor for signs and symptoms of compression or obstruction due to mass effect secondary to tumor flare
  • If compression or obstruction develops, institute standard treatment of these complications

CRS

  • CRS reported
  • Median onset time of CRS from start of Cycle 1 Day 1 was 5 hr, Cycle 1 Day 8 was 28 hr, Cycle 1 Day 15 was 25 hr, and Cycle 2 Day 1 was 46 hr
  • Median duration of CRS was 3 days
  • Clinical signs and symptoms of CRS included fever, chills, hypotension, tachycardia, hypoxia, and headache
  • Premedicate to reduce risk of CRS, ensure adequate hydration, and monitor following administration accordingly

Neurotoxicity

  • May cause serious neurologic toxicity, including ICANS
  • Common neurologic toxicities were headache, peripheral neuropathy, dizziness, and mental status changes (including confusional state, disturbance in attention, cognitive disorder, delirium, encephalopathy, and somnolence).
  • Coadministration with drugs that can cause dizziness or mental status changes may increase the risk of neurologic toxicity.
  • Monitor for signs and symptoms of neurologic toxicity during treatment
  • Evaluate patients who experience neurologic toxicity (eg, tremors, dizziness, insomnia, severe neurotoxicity, other adverse reactions that impair consciousness)
  • Advise patients to avoid driving and operating heavy or potentially dangerous machinery until resolution
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Pregnancy & Lactation

Pregnancy

Based on mechanism of action, mosunetuzumab may cause fetal harm when administered to pregnant females

No data are available on use in pregnant females to evaluate drug-associated risk

No animal reproductive or development toxicity studies were conducted

Mosunetuzumab causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance

Human immunoglobulin G (IgG) is known to cross the placenta; therefore, mosunetuzumab may potentially transmit from mother to developing fetus

Advise females of potential risk to fetus

Verify pregnancy status of females of reproductive potential before initiating

Contraception

  • Females of reproductive potential: Use effective contraception during treatment and for 3 months after final dose

Lactation

There are no data on presence of mosunetuzumab in human milk, effects on breastfed children, or effects on milk production

Maternal IgG is known to be present in human milk

Advise patients not to breastfeed during treatment and for 3 months after final dose

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Bispecific T-cell engaging antibody binds to the CD3 receptor expressed on the surface of T-cells and CD20 expressed on surface of lymphoma cells and some healthy B-lineage cells

Absorption

Peak plasma concentration

  • Cycle 1 (0-21 days): 11 mcg/mL
  • Cycle 2 (21-42 days): 13.6 mcg/mL
  • Steady-state: 7.02 mcg/mL

Trough plasma concentration

  • Cycle 1 (0-21 days): 2.54 mcg/mL
  • Cycle 2 (21-42 days): 1.97 mcg/mL
  • Steady-state: 1.29 mcg/mL

AUC

  • Cycle 1 (0-21 days): 35.2 mcg⋅hr/mL
  • Cycle 2 (21-42 days): 90.3mcg⋅hr/mL
  • Steady-state: 52.9 mcg⋅hr/mL

Distribution

Vd: 5.49 L

Elimination

Clearance (steady-state): 0.584 L/day

Half-life (steady-state): 16.1 days

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Administration

IV Compatibilities

0.9% NaCl

0.45% NaCl

IV infusion bags containing polyvinyl chloride (PVC), or polyolefins (PO) such as polyethylene (PE) and polypropylene (PP)

Infusion sets or infusion aids containing PVC, PE, polyurethane (PUR), polybutadiene (PBD), silicone, acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polyetherurethane (PEU), fluorinated ethylene propylene (FEP), or polytetrafluorethylene (PTFE), or with drip chamber filter membrane composed of polyamide (PA)

IV Preparation

Withdraw volume from 0.9% NaCl or 0.45% NaCl infusion bag equal to drug volume required for patient’s dose and discard

Only use infusion bags made of PVC or PO (eg, PE, PP)

Withdraw required drug volume from vial using sterile needle and syringe and inject into 0.9% NaCl or 0.45% infusion bag for dilution

Dilution

  • 1-mg dose: Inject 1 mL of drug into 50-mL or 100-mL infusion bag
  • 2-mg dose: Inject 2 mL of drug into 50-mL or 100-mL infusion bag
  • 60-mg dose: Inject 60 mL of drug into 100-mL or 250-mL infusion bag
  • 30-mg dose: Inject 30 mL of drug into 50-mL, 100-mL, or 250-mL infusion bag
  • Gently mix solution by slowly inverting infusion bag; do not shake
  • Visually inspect diluted solution in infusion bag for particulate matter and discoloration before administering, whenever solution and container permit; discard if visibly opaque particles, discoloration, or foreign particles are observed
  • Apply peel-off label from package insert to infusion bag
  • If not used immediately, refrigerate at 2-8ºC (36-46ºF) for up to 24 hr and at ambient temperature 9-30ºC (48-86ºF) for up to 16 hr
  • Before administration, ensure infusion solution comes to room temperature

Premedication

Cycle 1 and 2 (all patients)

  • Dexamethasone 20 mg IV or methylprednisolone 80 mg IV; complete at least 1 hr before infusion
  • Diphenhydramine 50 mg - 100 mg or equivalent PO/IV antihistamine at least 30 min before infusion
  • Acetaminophen 500 - 1,000 mg PO at least 30 min before infusion

Cycle 3 and thereafter (patients who experienced any grade CRS with previous dose)

  • Dexamethasone 20 mg IV or methylprednisolone 80 mg IV; complete at least 1 hr before infusion
  • Diphenhydramine 50 mg - 100 mg or equivalent PO/IV antihistamine at least 30 min before infusion
  • Acetaminophen 500 - 1,000 mg PO at least 30 min before infusion

IV Administration

Administer to well-hydrated patients

Premedicate before each dose in Cycle 1 and Cycle 2

Administer only as IV infusion through dedicated line; may use drip chamber filters for infusion

Do NOT use an in-line filter

Storage

Unopened vials

  • Refrigerate at 2-8ºC (36-46ºF) in original carton to protect from light
  • Do NOT freeze
  • Do NOT shake

Diluted infusion

  • Use immediately
  • If not used immediately, refrigerate at 2-8ºC (36-46ºF) for up to 24 hr and at ambient temperature 9-30ºC (48-86ºF) for up to 16 hr
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Images

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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.