GEMTUZUMAB OZOGAMICIN

GEMTUZUMAB OZOGAMICIN
(gem-tu'zu-mab)
Mylotarg
Classifications: antineoplastic agent; immunosuppressant; monoclonal antibody;
Therapeutic:antineoplastic agent
; immunosuppressant; monoclonal (igg4) antibody
Pregnancy Category: D

Availability

5 mg vial

Action

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.

Therapeutic Effect

Cytotoxic to the CD33 positive human leukemia cells in the bone marrow. CD33 antigens are found on the surface of leukemic cells.

Uses

Treatment of CD33 positive acute myeloid leukemia (AML) in first relapse in patients ≥60 y.

Contraindications

Hypersensitivity to gemtuzumab or anti-CD33 antibody therapy, murine protein hypersensitivity; systemic infections; pregnancy (category D), lactation.

Cautious Use

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

Administration

Intravenous
  • 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 25–50 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 h.

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, epistaxis, cerebral hemorrhage, hematuria, ecchymosis. Metabolic: Hyperglycemia, hyperbilirubinemia, 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.

Interactions

No clinically significant interactions established.

Pharmacokinetics

Metabolism: Hydrolyzed in liver to calicheamicin. Half-Life: 45–100 h.

Nursing Implications

Assessment & Drug Effects

  • Monitor for S&S of postinfusion syndrome: fever, chills, and rigors which occur 2–4 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.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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