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Pfizer Prepares for Voluntary Withdrawal of U.S. New Drug Application and for Discontinuation of Commercial Availability of Mylotarg®
Date:6/21/2010

may be at increased risk for developing severe VOD.

Death from liver failure and from VOD has been reported in patients who receive 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.

Mylotarg may cause fetal harm when administered to a pregnant woman.  The reported rates of Grades 3 and 4 thrombocytopenia, neutropenia, anemia, and bleeding were 99%, 98%, 47%, and 15%, respectively. Twenty-eight percent of patients experienced severe infections, including sepsis (16%) and pneumonia (7%). The most common adverse events were fever (85%), chills (73%), nausea (70%), vomiting (63%), asthenia (44%), diarrhea (38%), abdominal pain (37%), headache (35%), stomatitis (32%), dyspnea (32%), epistaxis (31%), hypokalemia (31%), anorexia (29%), sepsis (25%), constipation (25%), local reaction (25%), nonspecific rash (22%), herpes simplex (22%), and neutropenic fever (21%).

Mylotarg can produce a postinfusion symptom complex of fever and chills and less commonly hypotension and dyspnea during the first 24 hours after administration.  Patients should receive diphenhydramine 50 mg po and acetaminophen 650-1000 mg po one hour before Mylotarg (gemtuzumab ozogamicin for Injection) administration.  Two additional doses of acetaminophen 650-1000 mg po every four hours may be given.  Vital signs should be monitored during infusion and for four hours following infusion.  

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SOURCE Pfizer Inc.
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