MYLOTARG (Gemtuzumab Ozogamicin)

MYLOTARG (Gemtuzumab Ozogamicin)

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prescription refrigerated

What is this medication?

MYLOTARG (Gemtuzumab Ozogamicin)
Antineoplastic Agent, Anti-CD33, Antibody Drug Conjugate, Monoclonal Antibody

MYLOTARG (Gemtuzumab Ozogamicin) is a CD33-directed antibody-drug conjugate indicated for treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults.  Gemtuzumab Ozogamicin is also indicated for  treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older.

ALERT: WARNING
Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG (Gemtuzumab Ozogamicin) as a single agent, and as part of a combination chemotherapy regimen. Monitor frequently for signs and symptoms of VOD after treatment.

How does this medication work? 

MYLOTARG (Gemtuzumab Ozogamicin) is a humanized CD-33 directed monoclonal antibody-drug conjugate, which is composed of the IgG4 kappa antibody Gemtuzumab linked to a cytotoxic calicheamicin derivative. CD33 is expressed on leukemic cells in over 80% of patients with AML. Gemtuzumab Ozogamicin binds to the CD33 antigen, resulting in internalization of the antibody-antigen complex. Following internalization, the calicheamicin derivative is released inside the myeloid cell. The calicheamicin derivative binds to DNA resulting in double strand breaks, inducing cell cycle arrest and apoptosis.

How should I take this medication? 

IV: Inject 3 mg/m2 (maximum: 4.5 mg/dose) on days 1, 4, and 7 (as monotherapy).

How to Take: Do not administer as intravenous (IV) push or bolus. Infuse over 2 hours through a 0.2-micron polyethersulfone in-line filter.

What should I watch for while using this medication? 

Before starting MYLOTARG (Gemtuzumab Ozogamicin), make sure your physician is aware of any allergies or medications you currently take. Gemtuzumab Ozogamicin use has been associated with adverse events such as bone marrow suppression, hemorrhage, hepatotoxicity, hypersensitivity/infusion reaction, QT interval prolongation, tumor lysis syndrome.  Because of the risk of infusion related reactions (including anaphylaxis), premedicate with a corticosteroid, acetaminophen, and diphenhydramine. Monitor patients during and for at least 1 hour after the end of the infusion.  Monitor platelet counts frequently because of the risk of hemorrhage.

What if I miss a dose?

If a dose of is missed, contact your healthcare provider as soon as possible for instructions.

Management of some adverse reactions may require dose interruptions or permanent discontinuation of MYLOTARG (Gemtuzumab Ozogamicin).

How should I store this medication?

Store in the refrigerator at 2°C to 8°C. Do not freeze. Store the vial in the original carton to protect from light. 

Following reconstitution and dilution, the solution should be used immediately. If the product cannot be used immediately, the diluted solution may be stored up to 18 hours in a refrigerator (2°C to 8°C) and up to 6 hours at room temperature (below 30°C).

What are the possible side effects of using this medication?

Hemorrhage, infection, fever, nausea, vomiting, constipation, headache, increased AST, increased ALT, rash, and mucositis.

Note this is not a complete list of side effects for MYLOTARG (Gemtuzumab Ozogamicin), only common ones.