inotuzumab ozogamicin

Contraindicated in:

OB: May cause fetal harm in pregnancy
Lactation: Avoid breast feeding.

Use Cautiously in:

Hematopoietic stem cell transplant (HSCT) after inotuzumab ozogamicin treatment, use of HSCT conditioning regimens containing two alkylating agents, last total bilirubin level the upper limit of normal prior to HSCT, hepatic impairment, prior HSCT, increased age, later salvage lines, and greater number of inotuzumab ozogamicin cycles (↑ risk of hepatic veno-occlusive disease [VOD])
History of QT interval prolongation, receiving QT-interval prolonging medications, or electrolyte abnormalities
Rep: Women of reproductive potential and men with female partners of reproductive potential
Pedi: Safety and effectiveness not established.

Adv. Reactions/Side Effects ⬆ ⬇

CV: QTc interval prolongation.

Endo: hyperuricemia.

GI: hepatotoxicity(including hepatic VOD), abdominal pain, constipation, ↓ appetite, diarrhea, ↑liver enzymes, nausea, stomatitis, vomiting, ascites, ↑ amylase, ↑ lipase.

GU: ↓fertility.

Hemat: hemorrhage, neutropenia, thrombocytopenia, anemia, lymphopenia.

Misc: DEATH (POST-HSCT), INFECTION, fatigue, fever, infusion-related reactions, tumor lysis syndrome.

Interactions ⬆ ⬇

Drug-Drug:

QT interval prolonging medications may ↑ risk of QT interval prolongation.

Availability ⬆ ⬇

Lyophilized powder for injection (must be reconstituted and diluted further): 0.9 mg/vial;

Route/Dosage ⬆ ⬇

IV (Adults): Cycle 1 (duration = 3–4 wk) — 0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8, and 0.5 mg/m² on Day 15. Subsequent cycles for patients who achieve complete remission or complete remission with incomplete hematologic recovery (duration = 4 wk) — 0.5 mg/m² on Day 1, 0.5 mg/m² on Day 8, and 0.5 mg/m² on Day 15. Subsequent cycles for patients who do not achieve complete remission or complete remission with incomplete hematologic recovery (duration = 4 wk) — 0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8, and 0.5 mg/m² on Day 15; patients who do not achieve a complete remission or complete remission with incomplete hematologic recovery within a total of 3 cycles should discontinue treatment.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

The antibody portion (inotuzumab) attaches to the CD22 antigen on the surface of tumor cells. A cytotoxic agent (N-acetyl-gamma-calicheamicin) is linked to the antibody portion. Binding of the antibody-drug conjugate to the CD22 antigen allows internalization of the complex into the leukemic cells. Once internalized, the N-acetyl-gamma-calicheamicin is released and binds to DNA resulting in breaks in double strand DNA and cell death.

Therapeutic Effects:

Achievement of complete remission.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: drug-antibody conjugates

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Distributed to tissues.

Protein Binding: 97%.

Metabolism/Excretion: N-acetyl-gamma-calicheamicin primarily metabolized via non-enzymatic reduction.

Half-life: 12.3 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose of medication to patient.
Inform patient of potential for adverse reactions including increased risk of post-HSCT non-relapse mortality.
Instruct patient to notify health care professional immediately if signs and symptoms of hepatotoxicity (rapid weight gain, potentially painful abdominal swelling), infection, bleeding (fatigue, dyspnea, blood in stools or urine), or infusion related reactions (fever, chills, rash, breathing problems) occur.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Rep: Advise patient that this medication may have teratogenic effects. Advise females to use effective contraception during and for at least 8 mo after therapy is concluded and to avoid breast feeding for at least 2 mo after last dose. Advise males with female partner of reproductive potential to use effective contraception during and for at least 5 mo after last dose. Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding. Inform female and male patients that inotuzumab ozogamicin may impair fertility.

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Indications ⬇

Contraind./Precautions ⬆ ⬇