What is Inhixa - Enoxaparin sodium used for?
Inhixa is an anticoagulant (a medicine to prevent the formation of blood clots). It is used in adults for:
- the prevention of venous thromboembolism (clots that form inside the veins obstructing blood circulation), particularly in patients undergoing surgery or who are at greater risk of developing clots because they are bedridden because of an illness;
- the treatment of conditions associated with blood clots such as deep vein thrombosis (where the clot forms in a deep vein, usually in the leg);
- the treatment of unstable angina (a type of severe chest pain caused by a problematic flow of blood to the heart);
- the treatment of certain types of myocardial infarction (heart attack);
- prevention of clot formation when blood is circulated through a hemodialysis machine to remove toxic substances.
In the treatment of unstable angina and heart attacks Inhixa is administered in combination with aspirin (acetylsalicylic acid).
The active substance in Inhixa is enoxaparin sodium.
Inhixa is a "biosimilar medicine". This means that it is very similar to a biological medicine (the "reference medicine") that is already authorized in the European Union (EU). The reference medicine for Inhixa is Clexane. For more information on biosimilar medicines, see the questions and answers by clicking here.
How is Inhixa - Enoxaparin sodium used?
Inhixa is available as a solution for injection in pre-filled syringes. It is usually given as a subcutaneous injection; however, in the treatment of a type of heart attack called acute myocardial infarction with ST segment elevation (STEMI) is first administered as an injection into a vein and, to prevent clots in hemodialysis machines, is injected directly into the tube where blood passes. The dose and duration of treatment, as well as its possible administration in combination with other medicines, depend on the condition to be prevented or treated. Dose adjustment is necessary in patients with severely reduced kidney function.
The medicine can only be obtained with a prescription. For more information, see the package leaflet
How does Inhixa - Enoxaparin sodium work?
The formation of blood clots inside the blood vessels can reduce the blood supply to the organs, including the heart. The active substance in Inhixa, enoxaparin, belongs to a group of anticoagulant medicines called "low molecular weight heparins." Enoxaparin increases the effect of antithrombin III, a natural substance that controls blood clotting factors helping to prevent blood clotting. coagulation inside the body This helps to stop the formation of new clots and to control the existing ones.
What benefit has Inhixa - Enoxaparin sodium shown during the studies?
Large-scale laboratory studies that compared Inhixa and Clexane have shown that Inhixa is very similar to Clexane in terms of structure, purity and biological activity.
Furthermore, a study of 20 healthy subjects showed that the same doses of these two drugs given by subcutaneous injection produced similar effects on blood clotting factors. The study made use of different measurement methods, corresponding to the way the medicine works in the body.
The company also presented data derived from published studies that highlight the benefits of enoxaparin in the prevention and treatment of blood clots.
What are the risks associated with Inhixa - Enoxaparin sodium?
The most common side effect of Inhixa (which may affect more than 1 in 10 people) is bleeding (bleeding): severe bleeding occurred in about 4 out of 100 people who were given Inhixa to prevent the formation of blood clots during surgery. Furthermore, it is very common (with more than 1 in 10 people) to increase the levels of liver enzymes in the blood (a sign of possible liver problems).
For the full list of all side effects reported with Inhixa, see the package leaflet.
Inhixa should not be used in patients with major prior bleeding, severe bleeding problems, or diseases that increase the risk of or resulting in bleeding, such as stomach ulcers or strokes. For the full list of limitations, see the package leaflet.
Why has Inhixa - Enoxaparin sodium been approved?
Studies have shown that Inhixa has a biological structure and activity very similar to Clexane and has the same effect on blood clotting factors. The safety profiles of the two medicines were also considered similar, based on laboratory tests.
Therefore, the Agency's Committee for Medicinal Products for Human Use (CHMP) considered that there are no clinically significant differences between Inhixa and Clexane in terms of efficacy and safety and that, as for Clexane, the benefits outweigh the identified risks. The Committee therefore recommended that Inhixa be given marketing authorization.
What measures are being taken to ensure the safe and effective use of Inhixa - Enoxaparin sodium?
Recommendations and precautions to be followed by healthcare professionals and patients for Inhixa to be used safely and effectively have been included in the summary of product characteristics and the package leaflet.
More information on Inhixa - Enoxaparin sodium
The full EPAR for Inhixa can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Inhixa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
