Description
Drug Info: ApoThera Drug Disease Clinical Support App
Administration
– For oral inhalation only
– Administer at the beginning of the meal
– Remove the amount/strength of cartridges needed for a single dose from packaging; multiple cartridges may be needed to achieve the correct dose
– Allow cartridges to sit at room temperature for 10 minutes.
– Insert cartridge into the inhaler and snap to close
– Keep inhaler level with mouthpiece on top and base on the bottom.
– Loss of drug may occur if inhaler is inverted, held with mouthpiece pointing down, shaken or dropped after cartridge is inserted but prior to dose administration
– If any of these actions occur, a new cartridge must be loaded into the inhaler.
– Exhale fully.
– Close lips tightly around mouthpiece; do not exhale into inhaler.
– Tilt inhaler downward while keeping head level and inhale (rapidly, steadily and deeply).
– Hold breath for as long as comfortable at the same time removing the inhaler from the mouth.
– Exhale and continue to breathe normally.
– Throw away empty cartridge by removing it from the base; do not leave in inhaler.
– Repeat the steps for each cartridge needed for the correct total dose; use only one inhaler for multiple cartridges.
– Replace the inhaler every 15 days to maintain accurate drug delivery.
Storage
Sealed Package
– Store at 2ºC to 8ºC (36°F to 46°F)
– If foil package is not refrigerated, contents must be used within 10 days.
In Use
– Once foil package has been opened, store blister cards and strips at room temperature 25ºC ( 77ºF)
– Excursions are permitted between 15°C and 30°C (59°F and 86°F)
– Unopened blister cards and strips must be used within 10 days
– Opened strips must be used within 3 days
– Inhaler may be stored refrigerated, but should be at room temperature prior to use.
– Cartridges should also be at room temperature for 10 minutes before administration
Monitoring
– Plasma glucose
– Electrolytes
– HbA1c (at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with therapy change)
– Renal function
– Hepatic function
– Weight
– PFTs at baseline, after the first 6 months of therapy and yearly thereafter
– Frequently monitor patients with wheezing, persistent or recurring cough, bronchospasm, or breathing difficulties
– In patients at risk for DKA (acute illness or infection), increase glucose monitoring frequency.
