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Kepivance

"FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. There are no"...

Kepivance

PATIENT INFORMATION

Advise patients to report the following to healthcare providers:

Inform patients

  • That the safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies [see INDICATIONS AND USAGE and WARNINGS AND PRECAUTIONS]
  • Of the evidence of tumor growth and stimulation in cell culture and in animal models of non-hematopoietic human tumors [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]

Last reviewed on RxList: 6/14/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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