Innovation Pharmaceuticals Inc (IPIX)

[thefamilyman]

Important Safety Information

*The safety and efficacy of Kepivance® have not been proven in patients with cancers other than bone marrow cancers. Tumor growth of cancers other than bone marrow cancers in cell culture and animal models has been seen.
*The most common adverse reactions are rash, fever, increase of the enzyme amylase in the blood, itching, redness of the skin and fluid retention.
*Please tell your healthcare professional if you experience rashes and reddening of the skin, itchiness, swelling of the tongue, changes in mouth and tongue sensation, or an alteration in taste while taking Kepivance®.
*Kepivance® has been shown to interact with heparin. If heparin is used to maintain your IV line, your IV line must be rinsed with saline prior to and after Kepivance® administration.
*Kepivance® should not be administered during the 24 hours before receiving chemotherapy and/or radiotherapy.
*In clinical studies, bone marrow recovery was similar between people who received Kepivance® or placebo and there were no differences seen in cancer progression or patient survival.
*Information on the dosing and safety of Kepivance® in the pediatric population is limited. Use in children and adolescents 1-16 years of age is supported by evidence from adult studies and a study of 27 children with acute lukemia undergoing stem cell transplant.
*Adequate and well-controlled studies of Kepivance® in pregnant women or nursing mothers do not exist. Kepivance® should only be used during pregnancy or nursing if the potential benefit to the mother justifies the potential risk to the fetus or the child.