Description
Drug Info: ApoThera Drug Disease Clinical Support App
IV Administration
– Administered by IV infusion
– Loading doses are infused over 90 minutes
– Maintenance doses may be infused over 30 minutes if tolerated
– Do not administer with D5W
– Do not administer IV push or by rapid bolus
– Do not mix with any other medications.
– Observe patients closely during the infusion for fever, chills, or other infusion-related symptoms
– Treatment with acetaminophen, diphenhydramine, and/or meperidine is usually effective for managing infusion-related events.
IV Reconstitution
– Reconstitute each 420 mg vial (MDV) with 20 mL of bacteriostatic sterile water for injection (sterile water for injection may be used if a patient has a known hypersensitivity to benzyl alcohol)
– Reconstitute each 150 mg vial (SDV) with 7.4 mL of sterile water for injection
Storage
Intact Vials
– Prior to reconstitution, store intact vials at 2°C to 8°C (36°F to 46°F)
Reconstituted Solutions
– Following reconstitution with bacteriostatic SWFI, the solution in the vial is stable refrigerated for 28 days from the date of reconstitution
– Do not freeze.
– Solutions reconstituted with sterile water for injection without preservatives must be used immediately.
IV Infusion Solutions
– The solution diluted in polyvinylchloride or polyethylene bags containing 250 mL NS for infusion may be stored refrigerated for up to 24 hours prior to use
– Do not freeze
Monitoring
– Assessment for HER2 overexpression and HER2 gene amplification by validated immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) methodology (pretherapy)
– Test should be specific for cancer type (breast vs gastric cancer)
– Pregnancy test (prior to treatment in women of reproductive potential)
– Monitor vital signs during infusion
– Signs and symptoms of cardiac dysfunction
– LVEF (baseline, every 3 months during treatment, upon therapy completion and if component of adjuvant therapy, every 6 months for at least 2 years; if treatment is withheld for significant LVEF dysfunction, monitor LVEF at 4-week intervals)
– Signs and symptoms of infusion reaction or pulmonary toxicity
– If pregnancy inadvertently occurs during treatment, monitor amniotic fluid volume
