Leukemias, lymphomas, and other hematologic cancers:

Recent Updates:

Monograph added.

Indications for ZYNLONTA:

In adults with relapsed or refractory large B-cell lymphoma after ≥2 lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma.

Adult Dosage:

For BMI ≥35kg/m2, calculate dose based on adjusted body weight (ABW): ABW in kg = 35kg/m2 x (height in meters)2. Premedicate with dexamethasone (oral or IV) for 3 days beginning the day prior to treatment (or at least 2hrs prior to treatment). Give by IV infusion over 30mins on Day 1 of each cycle (every 3 weeks). 0.15mg/kg every 3 weeks for 2 cycles, then 0.075mg/kg every 3 weeks for subsequent cycles. Dose modifications: see full labeling. If dosing is delayed by >3 weeks due to toxicity, reduce subsequent doses by 50%. If toxicity reoccurs after dose reduction, consider discontinuation.

Children Dosage:

Not established.

ZYNLONTA Warnings/Precautions:

Monitor for edema or effusions; withhold if Grade ≥2 reaction occurs until resolved. Consider diagnostic imaging if symptoms of pleural or pericardial effusion develop. Risk of severe myelosuppression. Monitor CBCs during therapy. Monitor for infections; withhold if Grade 3 or 4 infection occurs until resolved. Monitor for cutaneous reactions (including photosensitivity); withhold if Grade 3 reaction occurs until resolved. Advise to minimize or avoid exposure to direct natural or artificial sunlight. Avoid extravasation. Mild hepatic impairment: monitor. Moderate/severe hepatic impairment, severe renal impairment, ESRD with or without dialysis: not studied. Embryo-fetal toxicity. Advise to use effective contraception during and for 9 months (females of reproductive potential) or for 6 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 months after the last dose).

ZYNLONTA Classification:

CD19-directed antibody + alkylating agent conjugate.

Adverse Reactions:

Thrombocytopenia, increased gamma-glutamyltransferase, neutropenia, anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea, musculoskeletal pain; febrile neutropenia, pneumonia, pleural effusion, sepsis, hyperpigmentation.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial—1