Leukemias, lymphomas, and other hematologic cancers:

Indications for: LUNSUMIO

In adults with relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy.

Adult Dosage:

Premedicate with corticosteroid, antihistamine, and antipyretic before each dose in Cycle 1 and Cycle 2 for all patients, and those who experienced any grade CRS with the previous dose in Cycles 3+. Give by IV infusion over a minimum of 4hrs for Cycle 1; if infusions are well-tolerated, give over 2hrs for Cycle 2 and thereafter. Treat for 8 cycles unless unacceptable toxicity or disease progression occurs. If complete response is achieved after 8 cycles, no further treatment is required; if partial response or stable disease is achieved after 8 cycles, give an additional 9 cycles (17 cycles total) unless unacceptable toxicity or disease progression occurs. Cycle 1: Give 1mg on Day 1, 2mg on Day 8, and 60mg on Day 15; Cycle 2: Give 60mg on Day 1; Cycle 3 and thereafter: Give 30mg on Day 1. Recommendations for restarting therapy after dose delay, dose modifications for adverse reactions: see full labeling.

Children Dosage:

Not established.

Boxed Warning:

Cytokine release syndrome (CRS).

LUNSUMIO Warnings/Precautions:

Must be administered by a qualified healthcare professional. Have appropriate medical support available. Risk for CRS. Initiate Lunsumio therapy with step-up dosing schedule and premedicate to reduce the risk for CRS. Ensure adequate hydration and monitor after administration. Monitor for neurologic toxicity (including ICANS), infections prior to and during treatment. Evaluate immediately if CRS (may need hospitalization) or neurologic toxicity (including ICANS) occurs; manage according to guidelines, and provide supportive care; withhold or discontinue based on severity (see full labeling). Active infections: do not initiate. History of recurring or chronic infections (eg, chronic, active Epstein-Barr Virus), underlying conditions that may predispose to infections or those with significant prior immunosuppressive treatment: use cautiously; give antimicrobial prophylaxis as appropriate. Obtain CBCs during treatment. If cytopenias occur, consider prophylactic granulocyte colony-stimulating factor as needed. Bulky tumors or disease (in close proximity to airways or a vital organ): monitor closely during initial therapy. Monitor for signs/symptoms of compression or obstruction due to mass effect secondary to tumor flare; treat if occurs. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 months after the last dose).

LUNSUMIO Classification:

Bispecific CD20-directed CD3 T-cell engager.

LUNSUMIO Interactions:

May potentiate CYP450 substrates (particularly after the 1st dose on Cycle 1 Day 1 and up to 14 days after the 2nd dose on Cycle 2 Day 1, and during and after CRS). Monitor for toxicity or concentrations of these CYP450 substrates; adjust dose as needed. 

Adverse Reactions:

Cytokine release syndrome, fatigue, rash, pyrexia, headache, Grade 3/4 lab abnormalities (decreased lymphocyte count, decreased phosphate, increased glucose, decreased neutrophil count, increased uric acid, decreased WBC, decreased hemoglobin, decreased platelets); infections, cytopenias, renal insufficiency, tumor flare.

Drug Elimination:

Half-life: 16.1 days.

Generic Drug Availability:


How Supplied:

Single-dose vial (1mL, 30mL)—1