glofitamab

High Alert

Relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma, after ≥2 lines of systemic therapy.

Contraindicated in:

Active infection;
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children;
Geri: ↑risk of fatal adverse reactions in older adults.

CV: edema

Derm: abdominal pain, rash

F and E: hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia

GI: ↑liver enzymes, constipation, diarrhea, nausea, vomiting

Hemat: ↓fibrinogen, anemia, lymphopenia, neutropenia, thrombocytopenia

Metab: hyperuricemia

MS: pain

Neuro: fatigue, headache, cognitive changes, confusion, delirium, disorientation, dizziness, IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME (ICANS), myelitis, peripheral neuropathy, sedation, tremor

Misc: cytokine release syndrome (CRS), fever, infection, tumor flare, infusion reactions, tumor lysis syndrome

Drug-drug:

May suppress activity of CYP450 drug-metabolizing enzymes (especially after the first dose on Cycle 1, Day 8; up to 14 days after the first 30 mg dose on Cycle 2, Day 1; and then during/after onset of cytokine release syndrome); careful monitoring of CYP450 substrates is recommended.

Solution for injection: 1 mg/mL

To be administered during 21-day treatment cycles.

IV (Adults ): Cycle 1, Day 1: Administer obinutuzumab 1000 mg as single dose; Cycle 1, Day 8: Administer glofitamab 2.5 mg as single dose (step-up dose 1); Cycle 1, Day 15: Administer glofitamab 10 mg as single dose (step-up dose 2); Cycle 2–12, Day 1: Administer glofitamab 30 mg as single dose. Continue glofitamab for a maximum of 12 cycles or until disease progression or unacceptable toxicity, whichever occurs first.

Acts as a T-cell engager, binding to CD20 expressed on the surface of B cells and to the CD3 receptor on the surface of T cells, resulting in facilitated lysis of malignant cells.

Therapeutic effects:

Slowed progression of diffuse large B-cell lymphoma.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: T-cell engagers

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Metabolized into small peptides by catabolic pathways.

Half-Life: 7.6 days.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	unknown	unknown

Explain purpose and side effects of glofitamab to patient. Do not stop receiving drug without consulting health care professional. If an appointment is missed, contact health care professional as soon as possible to reschedule. Advise patient to read Patient Information before starting therapy.
Explain need for continued medical follow-up to assess effectiveness and possible side effects of medication. Periodic lab tests and exams may be needed.
Teach the patient how to recognize and respond to signs and symptoms of neurologic toxicities, including CRS and ICANS. Advise patient to wear medical ID describing disease process and medication regimen at all times in case of emergencies.
Advise patient to report signs and symptoms of tumor flare, including painful or swollen lymph nodes, upper abdominal swelling, swollen spleen, fever, bone pain, rash, and difficulty urinating, to health care professional.
May cause dizziness and drowsiness. Advise patient to avoid driving or operating heavy or potentially dangerous machinery during and for 48 hr after step-up dosing and with new onset of any neurologic toxicity. Otherwise, caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Instruct patient to notify health care professional or call 911 immediately to seek medical care if swelling of face, eyes, lips, or tongue or if difficulty swallowing or breathing occur.
Advise patient to notify health care professional if signs and symptoms of infusion reactions (fever, chills or shivering, muscle or joint pain, nausea, vomiting, diarrhea, tiredness, dizziness, sweating, hives, itching, shortness of breath, wheezing) occur.
Advise patient to report symptoms of infection and neutropenia (fever, chills, cough, headache, fatigue, weakness, flu-like symptoms, painful or bloody urination, rash, nonhealing wound).
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: May cause fetal harm. Advise patient to notify health care professional if pregnancy is planned, or suspected or if breastfeeding. Women of reproductive potential should be advised to use effective contraception during treatment and for 1 mo after the last dose. Advise patients not to breastfeed during glofitamab treatment and for 1 mo after the last dose.

NDC Code

50242- Genentech, Inc.
- 50242-125- Columvi
  - 50242-125-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-125-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE

50242- Genentech, Inc.
- 50242-127- Columvi
  - 50242-127-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-127-01) / 10 mL in 1 VIAL, SINGLE-DOSE

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