What is Fiasp - Insulin Aspart used for?
Fiasp is a medicine used to treat diabetes in adults. It contains the active substance insulin aspart, a fast-acting insulin.
How is Fiasp - Insulin Aspart used?
Fiasp is a solution for injection available in vials, cartridges or pre-filled pens and can only be obtained with a prescription. It is usually injected subcutaneously, immediately before a meal although, if necessary, it can be administered up to 20 minutes after the start of the same. The dose depends on the patient's blood sugar level, which must be checked regularly to find the minimum effective dose. When administered by subcutaneous injection, Fiasp should be used in combination with an intermediate or prolonged insulin that is administered at least once a day. Normally Fiasp is injected under the skin of the abdomen or upper arm.
Fiasp can also be used with a pump system for continuous infusion of insulin by subcutaneous route or, alternatively, it can be administered into a vein, but only by medical or nursing staff.
For more information, see the package leaflet.
How does Fiasp - Insulin Aspart work?
Diabetes is a disease in which blood sugar is high, because the body cannot produce insulin (type 1 diabetes) or because it does not produce enough insulin or is unable to use it effectively (type 2 diabetes). Fiasp replacement insulin acts like the insulin naturally produced by the body and promotes the penetration of glucose into the cells from the blood. By controlling the level of blood sugar, the symptoms and complications of diabetes are reduced. After the injection, insulin aspart enters the bloodstream faster than human insulin and therefore acts more quickly.
What benefit has Fiasp - Insulin Aspart shown during the studies?
In three main studies the benefits of Fiasp in reducing blood glucose as part of diabetes treatment have been demonstrated.
In two studies, Fiasp was shown to be at least as effective as another insulin, NovoRapid. Both Fiasp and NovoRapid contain insulin aspart but Fiasp contains some different components intended to favor its rapid absorption. The main measure of effectiveness was the ability of the medicine to reduce the level in the blood of a substance called glycosylated hemoglobin (HbA1c), which gives an indication of the effectiveness of glycemic control over time. A study of 1, 143 patients with type 1 diabetes, whose initial HbA1c was about 7.6%, found that after 6 months of treatment HbA1c had decreased by 0.32 percentage points with a prandial dose of Fiasp, compared to 0.17 points with the other insulin. In the second study of 689 patients with type 2 diabetes, the decrease after 6 months of treatment (from an initial value of 7.96% and 7.89% respectively) was 1.38 points with Fiasp and 1, 36 points with the comparison product.
A third study of 236 patients with type 2 diabetes and an initial HbA1c of about 7.9% found that the addition of prandial Fiasp to treatment with long-acting insulin and the metformin antidiabetic medicine improved control of glycaemia (in this study there was no direct comparison between Fiasp and another prandial insulin). In patients treated with Fiasp the decrease in HbA1c after 18 weeks was 1.16 percentage points, compared to 0.22 points of those treated only with long-acting insulin and metformin.
What are the risks associated with Fiasp - Insulin Aspart?
The most common side effect with Fiasp (which may affect more than 1 in 10 people) is hypoglycaemia (excessively low blood sugar levels). Hypoglycaemia may occur more rapidly with Fiasp than with other prandial insulins. For the full list of all side effects reported with Fiasp and its limitations, see the package leaflet.
Why has Fiasp - Insulin Aspart been approved?
A clinically relevant benefit in reducing blood glucose has been demonstrated in the Fiasp studies.
Compared to NovoRapid, an already approved insulin aspart medicine, lowering blood sugar occurs first with Fiasp, although the total magnitude of the reduction effect is similar. However, it is not clear whether this translates into a difference in the risk of diabetic complications. In terms of safety, the overall rate and severity of undesirable effects was comparable to NovoRapid, although hypoglycaemia occurred more often in the first 2 hours after a dose of Fiasp.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Fiasp's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Fiasp - Insulin Aspart?
Recommendations and precautions to be followed by healthcare professionals and patients for Fiasp to be used safely and effectively have been included in the summary of product characteristics and the package leaflet.
More information on Fiasp - Insulin Aspart
For the full version of EPAR and the summary of the Fiasp risk management plan, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Fiasp therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
