Does INJEXION cause injuries of tissues and blood vessels?
Injuries of vessels are unlikely.Pre-clinical studies were carried out in which acute damage of the injected area was determined by histologic examination after jet injection with different devices. It was demonstrated that jet injected fluids will follow the path of least resistance and did not pass into the substance of bone, into the media of blood vessels, or into the fiber substance of nerve trunks. To our knowledge injuries of this kind are not reported in the current literature.
Which Preparations can be applied ?
Injector and ampules are designed for subcutaneously administering U-100 insulins (regular and NPH) only. The ampule scale is calibrated in ml and units and reads from 5 I.U. to 30 I.U. (0.05 to 0.3 ml). U-40 and U-80 insulins cannot be administered with this system. Use of lente and ultralente insulins is not presently recommended at this point in time.
The current design of the ampule, allows accurate application of closes > 5 units only. A special ampule for precise injection of very small doses (<10 I.U.) is under development.
Does INJEXION cause changes in the bioavailability of insulins?
Publications of the last two decades generally demonstrate equivalent absorption of insulin (regular and/or NPH preparations) resulting in similar peak plasma concentrations either with jet injection or conventional needle syringe. The pharmacokinetic data obtained, indicate that jet injection does not modify the physical composition of NPH and regular insulin. Some investigators, however, point out that administration of regular insulin or mixed regular/NPH insulin with use of a jet injector produces more rapid and less prolonged increases in plasma free insulin concentrations than does conventional subcutaneous injection. These findings suggest, that when switching from a syringe to a jet injector, insulin dose adjustment may become necessary. Own pharmacokinetic data with INJEX and a fast acting insulin analogue didn’t show any differences compared to needle administration, neither in time to peak free plasma concentrations nor in total amount of free insulin.
Does INJEXION cause specific adverse events?
Specific problems and side effects in comparison with the injection of insulin via conventional needle syringe have not been reported.
Minor bleeding and bruising at the injection site do not occur more frequent than with conventional needle-syringes. They are mostly due to regular application of anticoagulants (e.g. Marcumar, Aspirin) for treatment of patients with coronary heart disease or with a history of myocardial infarction. Bruising and blistering of the skin or appearance of blood or fluid often indicate too shallow a depth of injection as a result of not spreading the skin taught, not applying the right amount of pressure or not holding the INJEX at a 90° angle to the skin.
Does INJEXION cause tissue trauma and scar formation?
Since INJEX was only recently launched, no studies are available regarding tissue injuries after longterm use of the system. As the diameter of the medication jet is tiny in comparison with single-use syringe needles, it is unlikely that tissue lacerations and scarring will occur more frequently. Some publications report reduced frequency of insulin induced swellings of subcutaneous adipose tissue resp. insulin induced fat atrophy when the medication was delivered via jet-injection rather than with a needle syringe.
Does INJEX allow the mixing of different types of insulin ?
Regular and NPH-insulins can be applied with one single ampule, provided mixing is recommended by the manufacturer.
Drug adjustments are they necessary ?
Change of the injection device resp. of the insulin preparation should be principally performed under the supervision of a physician. Most often necessary drug adjustments may be performed ambulatory.
