obinutuzumab

High Alert

Previously untreated chronic lymphocytic leukemia (in combination with chlorambucil).
Follicular lymphoma in patients who have relapsed after, or are refractory to, a rituximab-containing regimen (in combination with bendamustine, followed by obinutuzumab monotherapy).
Previously untreated stage II bulky, III, or IV follicular lymphoma (in combination with chemotherapy, followed by obinutuzumab monotherapy in patients achieving at least a partial remission).

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Active infection;
Lactation: Lactation.

Use Cautiously in:

Hepatitis B virus (HBV) infection (may reactivate);
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypotension

GI: HBV reactivation, hypocalcemia, hypokalemia, hyponatremia

Hemat: anemia, BLEEDING, DISSEMINATED INTRAVASCULAR COAGULATION (DIC), NEUTROPENIA, THROMBOCYTOPENIA

Neuro: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)

Resp: cough

Misc: infusion reactions, fever, HYPERSENSITIVITY REACTIONS (INCLUDING BRONCHOSPASM, URTICARIA, AND SERUM SICKNESS), INFECTION (INCLUDING BACTERIAL, FUNGAL, AND VIRAL), TUMOR LYSIS SYNDROME

Interactions ⬆ ⬇

Drug-drug:

↑risk of immunosuppression/neutropenia with other antineoplastics, immunosuppressants or radiation therapy.
May ↓ antibody response to and ↑ risk of adverse reactions from live-virus vaccines (do not administer prior to or during treatment).
Concurrent use of anticoagulants or antiplatelet agents, especially during the first cycle, may ↑ risk of bleeding.

Availability ⬆ ⬇

Solution for injection: 25 mg/mL

Route/Dosage ⬆ ⬇

Chronic Lymphocytic Leukemia

Cycles 1–6 (each cycle = 28 days) should also include chlorambucil.
IV (Adults ): Day 1 of Cycle 1: 100 mg; Day 2 of Cycle 1: 900 mg; Days 8 and 15 of Cycle 1: 1000 mg; Day 1 of Cycles 2–61000 mg.

Relapsed or Refractory Follicular Lymphoma

Cycles 1–6 should also include bendamustine.
IV (Adults ): Days 1, 8, and 15 of Cycle 1: 1000 mg, Day 1 of Cycles 2–6: 1000 mg. If patient achieves disease stability, complete response, or partial response after 6 cycles, continue obinutuzumab as monotherapy as 1000 mg every 2 mo for up to 2 yr.

Previously Untreated Follicular Lymphoma

May be administered for cycles 1–6 (each cycle = 28 days) with bendamustine; cycles 1–6 (each cycle = 21 days) with CHOP, followed by 2 additional cycles (each cycle = 21 days) of obinutuzumab monotherapy; or cycles 1–8 (each cycle = 21 days) with CVP).
IV (Adults ): Days 1, 8, and 15 of Cycle 1: 1000 mg, Day 1 of Cycles 2–6 or Cycles 2–8: 1000 mg. If patient achieves disease stability, complete response, or partial response after 6–8 cycles, continue obinutuzumab as monotherapy as 1000 mg every 2 mo for up to 2 yr.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Humanized anti-CD20 monoclonal IgG1 antibody, targeting an antigen found on the surface of pre and mature B- lymphocytes. Result is B-cell lysis and depletion.

Therapeutic effects:

Improved progression-free survival.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 28.4 days.

Time/Action Profile ⬆ ⬇

(improvement progression-free survival)

ROUTE	ONSET	PEAK	DURATION
IV	within 3 mo	12 mo	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose of obinutuzumab to patient.
Advise patient to avoid live viral vaccines during therapy
Instruct patient to notify health care professional immediately if signs and symptoms of infusion reaction (dizziness, nausea, chills, fever, vomiting, diarrhea, breathing problems, chest pain), tumor lysis syndrome (nausea, vomiting, diarrhea, lethargy), infection (fever, cough), hepatitis (worsening fatigue, yellow discoloration of skin or eyes) or new changes in neurological symptoms (confusion, dizziness, loss of balance, difficulty talking or walking, vision problems) occur.
Rep: May cause fetal harm. Caution females of reproductive potential to use effective contraception and avoid breastfeeding during and for 6 mo after last dose of therapy. Advise patient to notify health care professional immediately if pregnancy is suspected. May cause fetal B-cell depletion; avoid administering live vaccines to neonates and infants exposed to obinutuzumab in utero until B-cell recovery occurs.
Emphasize importance of regular lab test to monitor for adverse reactions.

Pronunciation ⬆ ⬇

oh-bi-nue-TOOZ-ue mab

Code ⬆

NDC Code

50242- Genentech, Inc.
- 50242-070- Gazyva
  - 50242-070-01- 1 VIAL, SINGLE-USE in 1 CARTON (50242-070-01) / 40 mL in 1 VIAL, SINGLE-USE

50242- Genentech, Inc.
- 50242-070- Gazyva
  - 50242-070-86- 1 VIAL, SINGLE-USE in 1 CARTON (50242-070-86) / 40 mL in 1 VIAL, SINGLE-USE

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Indications ⬇