Aikening Dosage/Direction for Use

Dosage regimen: For adults 18 years old and above, AIKENING is administered by intravenous infusion at a dose of 320 mg once a day on Day 1, 2, 3, and 8, and thereafter once a week.
Children: The safety and efficacy of AIKENING have not been established in children under 18 years old.
Geriatric: No adequate human data are available in geriatric patients aged over 60 years; it is unknown whether their response to AIKENING is different from young people.
Preparation of AIKENING: (See Table 2.)

Click on icon to see table/diagram/image

Step 1: Determine number of AIKENING vial(s) needed for infusion based on assigned dosage (see table previously mentioned). For 320 mg dose, two vials are needed.
Have all the materials ready before starting the dose preparation to minimize the overall preparation time. Use aseptic technique when preparing and administering the dose.
From a 100 mL infusion bag (bottle) of 0.9% sodium chloride solution withdraw 12 mL to discard. The remaining 88 mL of 0.9% sodium chloride solution will be used for the AIKENING reconstitution.
Step 2: Inject 1.2 mL of 5% sodium bicarbonate solution into each vial, shake or vortex the vial thoroughly to form solution.
When preparing for two vials of AIKENING, do not withdraw 2.4 mL of sodium bicarbonate solution in one syringe and attempt to split the volume into two vials.
Note: It will be difficult to control the volume of sodium bicarbonate solution injected into the vial as the vials are sealed under vacuum (negative air pressure) which will likely create a suction.
Upon addition of sodium bicarbonate, immediately vibrate the vial (within 30 seconds) using a vortex mixer at a setting of 2500 rpm to dissolve AIKENING powder into the sodium bicarbonate solution.
The complete dissolution is normally achieved within 5 min; if undissolved solid is observed after 5 min of mixing, continue using a vortex mixer or manually shaking till a complete dissolution. Discard the vial if a complete dissolution was not achieved in 20 min of mixing; re-prepare the dose with a fresh vial.
Step 3: Withdraw 6 mL of sodium chloride solution from remaining 88 mL of 0.9% sodium chloride solution in Step 1 and inject into each AIKENING vial to mix thoroughly.
Gently mix AIKENING solution in sodium bicarbonate with sodium chloride solution in the vial to avoid excessive bubbling. The resulted solution should be clear, transparent, and free of visible particulate.
Step 4: Withdraw entire contents of vial(s) and inject back into the original bag (bottle) of the remaining 0.9% sodium chloride solution in Step 3 to get a final total of infusion volume of ~90 mL AIKENING solution.
The prepared dose should be administered as soon as possible (or within 30 minutes after end of reconstitution). Discard the dose if the infusion is not started within 30 min after the end of dose preparation and re-prepare the dose with a fresh vial.
The storage of reconstituted drug product in refrigerator or freezer is not allowed.
Administration: Administer AIKENING solution by intravenous infusion via a peripheral vein in one of the upper extremities for 45 ± 8 minutes at speed of about 2 ml/minute.