No formal drug-interaction studies performed.
Potential for drug-drug  inteaction affected by cytochrome P-450 enzymes
may be not ruled out

Acute myeloid leukemia ( AML )

Acute infusion related reactions-

Cardiovascular -   hypertension   15%    hypotension     18%

CNS -           headache   35%

GI -               nausea   65%     vomiting   55%

Respiratory     dyspnea    24%    hypoxia    4%

Miscellaneous     chills   64%     fever   80%    hyperglycemia   8%

Hypersensitivity to gemtuzumab or any of its components

Special Precautions/Warnings-

Experienced heath care providers- administer gemtuzumab under the supervision of health care providers experienced to the treatment of acute leukemia and in facilites equipped to monitor and treat leukemia patients

Myelosuppression- severe myelosuppression occurs when gemtuzumab is used
in recommended dose

Hypersensitivity - gemtuzumab administration  can result in severe hypersensitivity
reactions including anaphylaxis and other infusion related reactions that may include
severe pulmonary events. Infrequently hypersensitivity reactions and pulmonary events
have been fatal.
Monitor patients until signs and symptoms completely resolve.

Hepatic function impairment - excecise extra caution when administering gemtuzumab
to patients wth hepatic impairment.

Pregnancy- advice women of child bearing potential to avoid becoming pregnant while
receiving the drug.

Lactation- decide whether to discontinue breast feeding or the drug depending upon the
importance of the drug to the mother.

Children- safety and efficacy of gemtuzumab have not been studied

Monitoring- monitor electrolytes, tests for hepatic function, complete blood counts,and
platelet counts during gemtuzumab therapy.

Monitor vital signs of during infusion period and for 4 hours following infusion.

Monitor patients carefully for symptoms of hepatotoxicity  particularly VOD eg rapid
 weight gain, right upper quardant pain, hepatomegaly, ascites, elevations in bilirubin
and/or liver enzymes
 
 

Indication-

Acute myeloid leukemia ( AML )

Dosage-
 9mg/m2 infused over 2 hour period . Consider leukoreduction with hydroxyurea or leukapheresis
to reduce the peripheral WBC count to below 30000/mcL  prior to administeration of gemtuzumab

Monitor vital signs during infusion and for 4 hours following infusion.
The recommended treatment  course is a total of 2 doses with 14 days beteween doses.
Full recovery from hemotologic toxicites is not a requirement for administration of the
second dose.

Premedication- methylpredinisolone given prior to gemtuzumab infusion may obliterate
infusion related symptoms.

1. Advice women of child bearing potential to avoid becoming pregnant while receiving treatment  with gemtuzumab.

2. Inform patients that it is necessary to take certain medications eg aminoacetophen,
    diphenhydramine, methyprednisolone , before receiving this medicine to avoid
    infusion-related symptoms.

3. Gemtuzumab may cause liver damage, use very carefully in patients who have liver
    disease , inculding cirrhosis, hepatitis or jaundice. 

Pregnancy-
Advice women of child bearing potential to avoid becoming pregnant while
receiving the drug.

Lactation-
Decide whether to discontinue breast feeding or the drug depending upon the
importance of the drug to the mother.

Children-
Safety and efficacy of gemtuzumab have not been studied