"Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Fo"...
(gemtuzumab ozogamicin for) Injection
for intravenous use only
This product's label may have been revised after this insert was used in production. For further product information and current package insert, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556.
Mylotarg (gemtuzumab ozogamicin for injection) should be administered under the supervision of physicians experienced in the treatment of acute leukemia and in facilities equipped to monitor and treat leukemia patients.
There are no controlled trials demonstrating efficacy and safety using Mylotarg (gemtuzumab ozogamicin for injection) in combination with other chemotherapeutic agents. Therefore, Mylotarg (gemtuzumab ozogamicin for injection) should only be used as single agent chemotherapy and not in combination chemotherapy regimens outside clinical trials.
Severe myelosuppression occurs when Mylotarg (gemtuzumab ozogamicin for injection) is used at recommended doses.
HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, INFUSION REACTIONS, PULMONARY EVENTS
Mylotarg (gemtuzumab ozogamicin for injection) administration can result in severe hypersensitivity reactions (including anaphylaxis), and other infusion-related reactions which may include severe pulmonary events. Infrequently, hypersensitivity reactions and pulmonary events have been fatal. In most cases, infusion-related symptoms occurred during the infusion or within 24 hours of administration of Mylotarg (gemtuzumab ozogamicin for injection) and resolved. Mylotarg (gemtuzumab ozogamicin for injection) infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension. Patients should be monitored until signs and symptoms completely resolve. Discontinuation of Mylotarg (gemtuzumab ozogamicin for injection) treatment should be strongly considered for patients who develop anaphylaxis, pulmonary edema, or acute respiratory distress syndrome. Since patients with high peripheral blast counts may be at greater risk for pulmonary events and tumor lysis syndrome, physicians should consider leukoreduction with hydroxyurea or leukapheresis to reduce the peripheral white count to below 30,000/µL prior to administration of Mylotarg. (See WARNINGS.)
Hepatotoxicity, including severe hepatic veno-occlusive disease (VOD), has been reported in association with the use of Mylotarg (gemtuzumab ozogamicin for injection) as a single agent, as part of a combination chemotherapy regimen, and in patients without a history of liver disease or hematopoietic stem cell transplant (HSCT). Patients who receive Mylotarg (gemtuzumab ozogamicin for injection) either before or after HSCT, patients with underlying hepatic disease or abnormal liver function, and patients receiving Mylotarg (gemtuzumab ozogamicin for injection) in combinations with other chemotherapy are at increased risk for developing VOD, including severe VOD. Death from liver failure and from VOD has been reported in patients who received Mylotarg (gemtuzumab ozogamicin for injection) . Physicians should monitor their patients carefully for symptoms of hepatotoxicity, particularly VOD. These symptoms can include: rapid weight gain, right upper quadrant pain, hepatomegaly, ascites, elevations in bilirubin and/or liver enzymes. However, careful monitoring may not identify all patients at risk or prevent the complications of hepatotoxicity. (See WARNINGS and ADVERSE REACTIONS sections.)
Mylotarg® (gemtuzumab ozogamicin for Injection) is a chemotherapy agent composed of a recombinant humanized IgG4, kappa antibody conjugated with a cytotoxic antitumor antibiotic, calicheamicin, isolated from fermentation of a bacterium, Micromonospora echinospora subsp. calichensis. The antibody portion of Mylotarg (gemtuzumab ozogamicin for injection) binds specifically to the CD33 antigen, a sialic acid-dependent adhesion protein found on the surface of leukemic blasts and immature normal cells of myelomonocytic lineage, but not on normal hematopoietic stem cells.
The anti-CD33 hP67.6 antibody is produced by mammalian cell suspension culture using a myeloma NS0 cell line and is purified under conditions which remove or inactivate viruses. Three separate and independent steps in the hP67.6 antibody purification process achieves retrovirus inactivation and removal. These include low pH treatment, DEAE-Sepharose chromatography, and viral filtration. Mylotarg (gemtuzumab ozogamicin for injection) contains amino acid sequences of which approximately 98.3% are of human origin. The constant region and framework regions contain human sequences while the complementarity-determining regions are derived from a murine antibody (p67.6) that binds CD33. This antibody is linked to N-acetyl-gamma calicheamicin via a bifunctional linker. Gemtuzumab ozogamicin has approximately 50% of the antibody loaded with 4-6 moles calicheamicin per mole of antibody. The remaining 50% of the antibody is not linked to the calicheamicin derivative. Gemtuzumab ozogamicin has a molecular weight of 151 to 153 kDa.
Mylotarg (gemtuzumab ozogamicin for injection) is a sterile, white, preservative-free lyophilized powder containing 5 mg of drug conjugate (protein equivalent) in an amber vial. The drug product is light sensitive and must be protected from direct and indirect sunlight and unshielded fluorescent light during the preparation and administration of the infusion. The inactive ingredients are: dextran 40; sucrose; sodium chloride; monobasic and dibasic sodium phosphate.
What are the possible side effects of gemtuzumab (Mylotarg)?
Some people receiving a gemtuzumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, or have fever, chills, or trouble breathing within 24 hours after receiving the injection.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- pain in your upper right stomach, loss...
What are the precautions when taking gemtuzumab ozogamicin for injection (Mylotarg)?
Last reviewed on RxList: 6/24/2008
This monograph has been modified to include the generic and brand name in many instances.
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