Classifications: antineoplastic agent; immunosuppressant; monoclonal antibody; Therapeutic:antineoplastic agent; immunosuppressant; monoclonal (igg4) antibody
Pregnancy Category: D
5 mg vial
Chemotherapeutic agent composed of recombinant IgG4 antibodies which bind specifically to CD33 antigens that are expressed on the surface of leukemic myeloblasts and immature
normal cells of myelomonocytic origin.
Cytotoxic to the CD33 positive human leukemia cells in the bone marrow. CD33 antigens are found on the surface of leukemic
Treatment of CD33 positive acute myeloid leukemia (AML) in first relapse in patients ≥60
Hypersensitivity to gemtuzumab or anti-CD33 antibody therapy, murine protein hypersensitivity; systemic infections; pregnancy
(category D), lactation.
Hepatic impairment including jaundice; renal dysfunction; pulmonary disease; moderate or severe thrombocytopenia or neutropenia.
History of asthma or allergies; concurrent administration with antiplatelet agents or anticoagulants.
Route & Dosage
|Acute Myeloid Leukemia (AML)
Adult: IV 9 mg/m2 infused over 2 h, repeat in 14 d
- Protect gemtuzumab from sunlight and unshielded fluorescent light during preparation and administration.
- Allow vials to come to room temperature before reconstitution.
- Acetaminophen 650 mg orally and diphenhydramine 2550 mg IV are normally given prior to infusion to control adverse effects.
PREPARE: Continuous: Reconstitute each vial with 5 mL of sterile water for injection to yield 1 mg/mL. Gently swirl to dissolve. Dilute the reconstituted
drug further just prior to administration by withdrawing the required amount of drug and adding it to 100 mL of NS. Cover
the IV bag with a UV protectant cover.
ADMINISTER: Continuous: Infuse over 2 h through a separate IV line with a nonpyrogenic low-protein-binding 1.2 micron filter. Do not give push as
a bolus dose.
INCOMPATIBILITIES Solution/additive &: Y-site: Do not mix with other drugs.
- Store unopened vials refrigerated at 2°8° C (36°46° F). Store reconstituted drug refrigerated
at 2°8° C (36°46° F) and protected for light for ≤8
Adverse Effects (≥1%)Body as a Whole:
Severe hypersensitivity anaphylaxis, chills, fever, asthenia, infection, sepsis
. CV: Hypotension,
hypertension, tachycardia. GI: Nausea, vomiting, mucositis, abdominal pain, anorexia, constipation, diarrhea, stomatitis. Hematologic: Neutropenia, thrombocytopenia, anemia, bleeding,
hemorrhage, hematuria, ecchymosis. Metabolic:
abnormal AST, ALT, hypokalemia, hypomagnesemia, increased lactic dehydrogenase. Musculoskeletal: Arthralgia
. CNS: Headache, depression
, dizziness, insomnia. Respiratory: Hypoxia
, dyspnea, cough,
pharyngitis, rhinitis, pneumonia
, fatal pulmonary events. Skin: Rash, herpes simplex, local reactions from infusion, peripheral edema, petechiae.
No clinically significant interactions established.
Hydrolyzed in liver to calicheamicin. Half-Life:
Assessment & Drug Effects
- Monitor for S&S of postinfusion syndrome: fever, chills, and rigors which occur 24 h after initiation of infusion; hypotension
and dyspnea which may occur during first 24 h after infusion.
- Monitor vital signs during and for at least 2 h after infusion.
- Lab tests: Monitor CBC with differential, platelet count, lymphoblast smears at least weekly. Periodically monitor liver functions
and routine blood chemistry.
Patient & Family Education
- Report S&S of infection immediately to physician (e.g., chills, fever, sore throat, lower back or side pain).
- Report unusual bleeding or bruising, black tarry stools, or pinpoint red spots on skin to physician immediately.
- Avoid exposure to infections.
- Avoid immunizations unless approved by physician; avoid contact with anyone who has received oral polio virus vaccine.
- Avoid situations that could result in injury during periods of bone marrow suppression.