"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
- Patient Information:
Details with Side Effects
Advise patients to report the following to healthcare providers:
- Rashes and reddening of skin [see ADVERSE REACTIONS]
- Itchiness [see ADVERSE REACTIONS]
- Swelling of tongue [see ADVERSE REACTIONS]
- Changes in mouth and tongue sensation [see ADVERSE REACTIONS]
- Alteration in taste [see ADVERSE REACTIONS]
- 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.
Additional Kepivance Information
Report Problems to the Food and Drug Administration
Find out what women really need.