mosunetuzumab

moe-SUN-e-TOOZ-ue-mab

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies, T-cell engagers

High Alert

Relapsed or refractory follicular lymphoma in patients who previously received ≥2 lines of systemic therapy.

Acts as a T-cell engager, binding to the CD3 receptor on T cells and CD20 on lymphoma cells and some B cells. It activates T cells, releasing proinflammatory cytokines and causing lysis of B cells.

Therapeutic effects:

Decreased progression of follicular lymphoma.

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Unknown.

Half-Life: 16.1 days.

(depletion of B cells)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	22 days	persists through completion of 8 cycles

Contraindicated in:

Active infection;
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

History of recurrent or chronic infection, with underlying conditions that may predispose to infections or previously received immunosuppressive treatment;
Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children.

CV: edema

Derm: dry skin, pruritus, rash, skin exfoliation

Endo: hyperglycemia

F and E: hypokalemia, hypomagnesemia, hypophosphatemia

GI: abdominal pain, diarrhea, ↑liver enzymes, nausea

GU: renal impairment

Hemat: anemia, leukopenia, lymphocytopenia, neutropenia, thrombocytopenia, HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH)

Metab: hyperuricemia

MS: arthralgia, pain

Neuro: dizziness, fatigue, headache, insomnia, peripheral neuropathy, anxiety, ataxia, attention disturbance, cognitive disorder, confusion, delirium, encephalopathy, gait disturbance, IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME (ICANS), sedation, tremor

Resp: cough, dyspnea

Misc: chills, fever, cytokine release syndrome (crs), infection , TUMOR LYSIS SYNDROME, tumor flare

Drug-drug:

Use with CNS depressants, including opioids, benzodiazepines, nonbenzodiazepine sedative/hypnotics, anxiolytics, general anesthetics, muscle relaxants, antipsychotics, and alcohol, may ↑ risk of neurologic toxicity.
May suppress activity of CYP450 drug-metabolizing enzymes (starting after receiving first dose and continuing up to 14 days after the dose on Day 1 of Cycle 2; may also occur during and after experiencing cytokine release syndrome); closely monitor drugs that are CYP450 substrates.

Duration of each cycle = 21 days.
IV (Adults ): Day 1 of Cycle 1: 1 mg; Day 8 of Cycle 1: 2 mg; Day 15 of Cycle 1: 60 mg; Day 1 of Cycle 2: 60 mg; Day 1 of Cycle 3 and beyond: 30 mg. Continue for a total of 8 cycles unless patient experiences disease progression or unacceptable toxicity. No further treatment required after 8 cycles if complete response achieved. For patients achieving partial response or with stable disease after 8 cycles, an additional 9 cycles (total of 17 cycles) should be administered (unless patient experiences disease progression or unacceptable toxicity).

Solution for injection: 1 mg/mL

Monitor for signs and symptoms of CRS (fever, chills, hypotension, tachycardia, hypoxia, headache). If Grade 1 CRS (fever ≥100.4°F) occurs: Hold infusion; restart at same infusion rate if resolves. Ensure fever resolved for ≥72 hr before next dose. If Grade 2 CRS (fever ≥100.4°F with hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen) occurs: Hold infusion; restart at 50% of the infusion rate if resolves. Ensure symptoms resolved for ≥72 hr before next dose and consider infusing at 50% of the infusion rate in hospital. For recurrent Grade 2 or Grade 3 CRS (fever ≥100.4°F with hypotension requiring a vasopressor and/or hypoxia requiring high-flow oxygen) occurs: Hold infusion; ensure symptoms resolved for ≥72 hr before next dose. Infuse at 50% of the infusion rate in hospital. For recurrent Grade 3 or Grade 4 CRS (fever ≥100.4°F with hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring oxygen by positive pressure) occurs: Permanently discontinue mosunetuzumab. Treat per current guidelines for all CRS grades.
Monitor for signs/symptoms of ICANS (headache, peripheral neuropathy, dizziness, delirium, encephalopathy, lethargy). If Grade 1 neurotoxicity occurs: Monitor for symptom progression. If Grade 2–3 neurotoxicity occurs: Hold infusion until improved to Grade ≤1 for ≥72 hr. If Grade 3 ICANS recurs or Grade 4 neurotoxicity occurs: Permanently discontinue mosunetuzumab. Manage per current guidelines and consider neurologic evaluation if neurotoxicity, including ICANS, occurs at any grade.
Monitor for signs/symptoms of infection (pneumonia, sepsis, upper respiratory tract), including opportunistic, prior to and during therapy. If Grade 1–4 active infection occurs: Hold therapy until resolves and consider permanent discontinuation for Grade 4.
Monitor for signs/symptoms of HLH (fever, ↑ ferritin, hemophagocytosis, cytopenias, coagulopathy, hepatitis, splenomegaly). For suspected HLH: Hold therapy and treat promptly.
Monitor for signs/symptoms of tumor flare (new or ↑ pleural effusion, pain and swelling of lymphoma lesions, tumor inflammation). If compression or obstruction due to mass effect occurs: Institute standard treatment.

Lab Test Considerations:

Confirm negative pregnancy status prior to initiating therapy.
Monitor CBC throughout therapy; may cause neutropenia, anemia, and thrombocytopenia. For ANC <0.5 × 10⁹/L: Hold until ANC ≥0.5 × 10⁹; consider prophylactic granulocyte colony-stimulating factor administration as indicated.
May cause hypophosphatemia, hyperglycemia and hyperuricemia.

Premedications: Administer dexamethasone 20 mg IV (or methylprednisolone 80 mg IV), diphenhydramine 50–100 mg PO/IV, and acetaminophen 500–1000 mg PO before each dose in Cycles 1–2 and before each dose in Cycles 3+ in patients who experience any grade CRS with previous dose.
Ensure adequate hydration prior to each dose.
See package insert for recommendations for restarting therapy after dose delay.

IV Administration:

Administer only through dedicated infusion line, without in-line filter and with infusion bag made only from polyvinyl chloride or polyolefin.
Intermittent Infusion: Diluent: Withdraw from 0.9% NaCl or 0.45% NaCl infusion bag a volume equal to the volume of dose and discard. For 1–2-mg dose, use 50- or 100-mL bag; for 30-mg dose, use 50-, 100-, or 250-mL bag; for 60-mg dose, use 100- or 250-mL bag. Withdraw required volume of drug from vial(s) and dilute in prepared infusion bag. Gently mix by slowly inverting bag. Do not shake. Do not use if discolored or contains particulates. Use infusion immediately or may keep at room temperature for 16 hr or refrigerate for 24 hr. Bring solution back to room temperature prior to infusion. Concentration: 0.01–0.6 mg/mL. Rate: Infuse Cycle 1 over 4 hr; may infuse subsequent cycles over 2 hr, if well tolerated.
Y-Site Incompatibility: Do not administer other drugs through same IV line.

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other medications.
Teach the patient how to recognize and respond to signs/symptoms of neurologic toxicities, including CRS. Advise patient to wear medical ID describing disease process and medication regimen at all times in case of emergencies.
Advise patient to notify health care provider immediately if signs/symptoms of ICANS, opportunistic infections, HLH or cytopenias occur.
Inform patient to notify a health care provider if signs/symptoms of a tumor flare occur.
Rep: May cause fetal harm. Advise women of reproductive potential to use effective contraception and to avoid breastfeeding during therapy and for 3 mo after last dose.

Decreased progression of follicular lymphoma.

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Assessment ⬆ ⬇

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US Brand Names ⬆