gemtuzumab ozogamicin

Contraindicated in:

Hypersensitivity;
OB: Pregnancy (may cause fetal harm);
Lactation: Lactation.

Use Cautiously in:

Moderate-severe hepatic impairment, patients treated after hematopoietic stem cell transplantation (HSCT), and patients undergoing HSCT after treatment (↑ risk of veno-occlusive liver disease);
QT interval prolongation at baseline, taking QT-interval prolonging medications, or electrolyte disturbances (↑ risk of QT interval prolongation);
Rep: Women of reproductive potential and men with female partners of reproductive potential;
Pedi: Children <1 mo (safety and efficacy not established).

Adv. Reactions/Side Effects ⬆ ⬇

CV: QT INTERVAL PROLONGATION, tachycardia

Derm: rash

F and E: hypokalemia, hyponatremia, hypophosphatemia

GI: constipation, mucositis, nausea, vomiting, ↑bilirubin, diarrhea, HEPATOTOXICITY(INCLUDING VENO-OCCLUSIVE LIVER DISEASE)

GU: ↓fertility

Hemat: anemia, BLEEDING, neutropenia, thrombocytopenia

Neuro: headache

Resp: pulmonary edema

Misc: chills, fever, ANAPHYLAXIS, INFECTION, INFUSION REACTIONS, tumor lysis syndrome

Interactions ⬆ ⬇

Drug-drug:

None reported to date.

Availability ⬆ ⬇

Lyophilized powder for injection: 4.5 mg/vial

Route/Dosage ⬆ ⬇

Newly Diagnosed CD33–Positive AML (in combination with chemotherapy)

IV (Adults ): Induction cycle 1: 3 mg/m²(up to one 4.5–mg vial) on Days 1, 4, and 7 (in combination with daunorubicin and cytarabine). Consolidation cycles: 3 mg/m² (up to one 4.5–mg vial) on Day 1 (in combination with daunorubicin and cytarabine).
IV (Children ≥1 mo and body surface area [BSA] ≥0.6 m²): Induction cycle 1: 3 mg/m²once (in combination with standard chemotherapy). Intensification course 2: 3 mg/m²once (in combination with standard chemotherapy).
IV (Children ≥1 mo and BSA <0.6 m²): Induction cycle 1: 0.1 mg/kg once (in combination with standard chemotherapy). Intensification course 2: 0.1 mg/kg once (in combination with standard chemotherapy).

Newly Diagnosed CD33–Positive AML (as monotherapy)

IV (Adults ): Induction cycle: 6 mg/m²on Day 1 and 3 mg/m²on Day 8. Continuation therapy: 2 mg/m² on Day 1 every 4 wk.

Relapsed or Refractory CD33–Positive AML (as monotherapy)

IV (Adults and Children ≥2 yr): 3 mg/m²(up to one 4.5-mg vial) on Days 1, 4, and 7.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

The antibody portion (gemtuzumab) attaches to the CD33 antigen on the surface of acute myeloid leukemic cells. Binding produces a complex that is internalized by the leukemic cells. Once internalized the antitumor antibiotic portion of the drug (ozogamicin, also know as calicheamicin) is released and binds to DNA resulting in breaks in double strand DNA and cell death.

Therapeutic effects:

Induction of remission.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies, antitumor antibiotics

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Binds to CD33 receptor sites, is then internalized by leukemic cells, releasing ozogamicin.

Metabolism/Excretion: Ozogamicin is probably metabolized by the liver.

Half-Life: 62 hr (↑ with second dose).

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
IV	rapid	following infusion	2 wk

Patient/Family Teaching ⬆ ⬇

Explain purpose of medication to patient.
Advise patient to notify health care professional immediately if signs and symptoms of liver toxicity (rapid weight gain, right upper quadrant pain and tenderness, hepatomegaly, ascites), bleeding, or infusion reactions occur.
Instruct patient to notify healthcare professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult healthcare professional before taking other Rx, OTC, or herbal products.
Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during and for at least 6 mos after last dose and to avoid breastfeeding during and for at least 1 mo after last dose. Advise males with female partners of reproductive potential to use effective contraception during and for at least 3 mos after last dose. Inform patient may impair female and male fertility.

Pronunciation ⬆ ⬇

gem-TU-zoo-mab o-zo-ga-MY-sin

Code ⬆

NDC Code

0008- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- 0008-4510- Mylotarg
  - 0008-4510-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (0008-4510-01) > 5 mL in 1 VIAL, SINGLE-DOSE

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇