Drug Interaction:
No formal drug-interaction studies performed.
Potential for drug-drug inteaction affected by cytochrome P-450 enzymes
may be not ruled out
Indication:
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
Gemtuzumab For Myeloid leukemia 12-09-2002
Acute myeloid leukemia ( AML )
Adverse Reaction:
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%
Contra-Indications:
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
Dosages/ Overdosage Etc:
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.
Patient Information:
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 and lactation:
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
Manufacturer Details