Active Substance: enoxaparin sodium
Common Name: enoxaparin sodium
ATC Code: B01AB05
Marketing Authorisation Holder: Techdow Europe AB
Active Substance: enoxaparin sodium
Authorisation Date: 2016-09-15
Therapeutic Area: Venous Thromboembolism
Pharmacotherapeutic Group: Antithrombotic agents
Inhixa is indicated for adults for:
- Prophylaxis of venous thromboembolism, particularly in patients undergoing orthopaedic, general or oncological surgery.
- Prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses including acute heart failure, acute respiratory failure, severe infections, as well as exacerbation of rheumatic diseases causing immobilisation of the patient (applies to strengths of 40 mg/0.4 mL).
- Treatment of deep vein thrombosis (DVT), complicated or uncomplicated by pulmonary embolism.
- Treatment of unstable angina and non Q wave myocardial infarction, in combination with acetylsalicylic acid (ASA).
- Treatment of acute ST segment elevation myocardial infarction (STEMI) including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL).
- Blood clot prevention in the extracorporeal circulation during haemodialysis.
What is Inhixa and what is it used for?
Inhixa is an anticoagulant medicine (a medicine to prevent blood clots). It is used in adults for the following:
- to prevent venous thromboembolism (blood clots that form inside the veins, obstructing blood flow), especially in patients who are having surgery or who are at greater risk of clots because they are bedridden due to illness;
- to treat conditions associated with blood clots such as deep vein thrombosis (where the clot develops in a deep vein, usually in the leg);
- to treat unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart);
- to treat certain types of myocardial infarction (heart attack);
- to prevent clots forming when blood is circulated through a haemodialysis machine to remove toxic substances.
In the treatment of unstable angina and heart attack Inhixa is given with aspirin (acetylsalicylic acid).
The active substance in Inhixa is enoxaparin sodium.
Inhixa is a ‘biosimilar medicine’. This means that Inhixa is highly similar to a biological medicine (also known as the ‘reference medicine’) that is already authorised in the European Union (EU). The reference medicine for Inhixa is Clexane.
How is Inhixa used?
Inhixa is available as a solution for injection in pre-filled syringes. It is usually given as an injection under the skin although in the treatment of a type of heart attack called acute ST-segment elevation myocardial infarction (STEMI) it is first given as an injection into a vein, and to prevent clots in haemodialysis machines it is injected directly into the tube carrying the blood. The dose and how long the medicine is given for, as well as whether it is given with other medicines, depend on the condition to be prevented or treated. Doses must be adjusted in patients with severely reduced kidney function.
The medicine can only be obtained with a prescription. For further information, see the package leaflet.
How does Inhixa work?
When blood clots develop inside blood vessels they may restrict the blood flow to the organs, including the heart. The active substance in Inhixa, enoxaparin, is one of a group of anticoagulant medicines called ‘low-molecular weight heparins’. Enoxaparin increases the effect of antithrombin III, a natural substance that controls the blood’s clotting factors and helps prevent blood from clotting inside the body. This helps to stop the formation of new blood clots and control existing ones.
What benefits of Inhixa have been shown in studies?
Extensive laboratory studies comparing Inhixa with Clexane have shown that Inhixa is highly similar to Clexane in terms of structure, purity and biological activity.
In addition, a study in 20 healthy subjects has shown the same doses of the two products given by injection under the skin produced similar effects on blood clotting factors, using various measures that reflect the way the medicine works in the body.
The company also provided information from published studies showing the benefits of enoxaparin in preventing and treating blood clots.
What are the risks associated with Inhixa?
The most common side effect with Inhixa (which may affect more than 1 in 10 people) is haemorrhage (bleeding); serious bleeding occurred in around 4 people in 100 given Inhixa to prevent blood clots during surgery. In addition, increased levels of liver enzymes in the blood (a sign of possible liver problems) are very common (may affect more than 1 in 10 people).
For the full list of all side effects reported with Inhixa, see the package leaflet.
Inhixa must not be used in patients with existing major bleeding, severe disorders of blood clotting, or with conditions that increase the risk of, or from, bleeding, such as stomach ulcers or stroke. For the full list of restrictions, see the package leaflet.
Why is Inhixa approved?
Studies have shown that Inhixa has a highly similar structure and biological activity 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 testing.
Therefore, the Agency’s Committee for Medicinal Products for Human Use (CHMP) considered that there are no clinically meaningful differences between Inhixa and Clexane in terms of effectiveness and safety and took the view that, as for Clexane, the benefit outweighs the identified risk. The Committee recommended that Inhixa be given marketing authorisation.
What measures are being taken to ensure the safe and effective use of Inhixa?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Inhixa have been included in the summary of product characteristics and the package leaflet.
Other information about Inhixa
The European Commission granted a marketing authorisation valid throughout the European Union for Inhixa on 15 September 2016.
For more information about treatment with Inhixa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Source: European Medicines Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.