"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
Deaths from anaphylaxis have been reported following IC-GREEN® administration during cardiac catheterization.
IC-GREEN® is unstable in aque ous solution and must be use d within 6 hours. However, the dye is stable in plasma and whole blood so that samples obtained in discontinuous sampling techniques may be read hours later. Sterile techniques should be used in handling the dye solution as we ll as in the performance of the dilution curves. If a precipitate is present, discard the solution.
Drug/ Laboratory Test Interactions
Radioactive iodine uptake studies should not be performed for at least a week following the use of IC-GREEN™.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
No studies have been performed to evaluate the carcinogenicity, mutagenicity, or impairment of fertility.
Use In Specific Populations
Animal Reproduction studies have not been con - ducted with IC-GREEN™. It is also not known whether IC-GREEN™ can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. IC-GREEN™ should be given to a pregnant woman only if clearly indicated.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human m ilk, caution should be exercised when IC -GREEN ™ is administered to a nursing woman.
Safety and effectiveness in pediatric patients have been established.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/19/2015
Additional Ic-Green Information
Report Problems to the Food and Drug Administration