Eravacycline dihydrochloride is available as a lyophilized powder in single-dose (preservative-free) vials containing the equivalent of 50 mg of eravacycline and 150 mg of mannitol in each vial.3434 Each vial also may contain sodium hydroxide and hydrochloric acid for pH adjustment.3434
Each 50-mg vial should be reconstituted with 5 mL of sterile water for injection or sodium chloride 0.9% to yield a reconstituted solution with an eravacycline concentration of 10 mg/mL.3434 During reconstitution, vials should be swirled gently to completely dissolve the vial contents; shaking or rapid movement should be avoided as it may cause foaming.3434 If any particles are present or if cloudiness is observed, the reconstituted solution should not be used.3434 The reconstituted solution must be further diluted prior to administration.3434 The appropriate volume of the reconstituted solution should be withdrawn from the vial(s) and diluted in an infusion bag containing sodium chloride 0.9% for a target eravacycline concentration of 0.3 mg/mL (within the range of 0.2 to 0.6 mg/mL).3434 The infusion bag should not be shaken.3434 The diluted solution for infusion also should be visually inspected for particulate matter and discoloration prior to administration.3434 Unused portions of reconstituted or diluted solutions should be discarded.3434
pH
The pH is adjusted to the range of 5.5 to 7.3434
Equivalency
Eravacycline dihydrochloride 63.5 mg is equivalent to 50 mg of eravacycline.3434
Trade Name(s)
Xerava
Eravacycline dihydrochloride is administered by intravenous infusion over 60 minutes after reconstitution and further dilution.3434 The reconstituted solution is not for direct injection.3434
Eravacycline dihydrochloride may be administered intravenously through a dedicated line or through a Y-site.3434 If the intravenous line is used to administer other drugs, it should be flushed with sodium chloride injection 0.9% prior to and following eravacycline dihydrochloride administration.3434
Eravacycline dihydrochloride lyophilized powder is a yellow to orange powder that forms a clear, pale yellow to orange solution upon reconstitution and a clear, light yellow to orange solution upon dilution.3434 Intact vials of eravacycline dihydrochloride should be stored at 2 to 8°C in the original carton until time of use.3434
The manufacturer states that the drug should not be mixed with any other drugs or solutions.3434
The reconstituted solution may be stored for up to 1 hour after reconstitution at room temperature up to 25°C, but should be diluted in an infusion bag within 1 hour after reconstitution.3434 Admixtures prepared as directed from the lyophilized powder should be infused within 7 days if stored at 2 to 8°C or 24 hours if stored at room temperature up to 25°C.3434
Freezing Solutions
The manufacturer states that neither the reconstituted nor diluted solutions should be frozen.3434
For a list of references cited in the text of this monograph, search the monograph titled References.