DrugsNews.net

Drugs Xagena

Xagena Mappa
Xagena Newsletter
OncologiaMedica.net
Ematobase.it

Eliquis for prevention of venous thromboembolism following a hip or knee replacement operation and stroke and blood clots in other organs in patients with atrial fibrillation


Eliquis is a medicine that contains the active substance Apixaban; it is used to prevent venous thromboembolism in adults following a hip or knee replacement operation.
Eliquis is also used to prevent stroke and blood clots in other organs in adults with atrial fibrillation. It is used in patients who have one or more risk factors, such as having had a previous stroke, high blood pressure, diabetes mellitus, heart failure or being 75 years old or over.
Eliquis is available as tablets ( 2.5 mg, 5 mg ).

For patients who have had a hip or knee replacement, treatment with Eliquis should be started 12 to 24 hours after the operation. The recommended dose is one 2.5 mg tablet taken by mouth twice a day, usually for over one month ( 32 to 38 days ) after a hip replacement or for 10 to 14 days after a knee replacement.

For patients with atrial fibrillation at risk of stroke or blood clots, the recommended dose is 5 mg taken twice a day.

Patients undergoing hip or knee replacement surgery are at a high risk of blood clots forming in the veins, which can be dangerous and even fatal if they move to another part of the body such as the lungs. Similarly, patients with atrial fibrillation are at high risk of clots forming in the heart, which can reach the brain where they can cause a stroke.
The active substance in Eliquis, Apixaban, is a factor Xa inhibitor. This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin. Thrombin is central to the process of blood clotting. By blocking factor Xa, it reduces the levels of thrombin in the blood, which reduces the risk of blood clots forming in the arteries and veins.

The effectiveness of Apixaban in preventing blood clots in veins following a hip or knee replacement was investigated in two main studies involving a total of 8,464 patients. The first study was in 5,407 patients who had undergone a hip replacement. The second study was in 3,057 patients who had undergone a knee replacement. In both studies, Apixaban was compared with Enoxaparin ( Clexane, Lovenox ). The medicine’s effectiveness was measured by looking at the number of patients who either had problems related to clotting in the veins or who died of any cause during the treatment period.
The effectiveness of Apixaban in preventing strokes and arterial blood clots in patients with atrial fibrillation was investigated in two main studies: the first ( in 18,201 patients ) compared Apixaban with Warfarin ( Coumadin ), while the second ( in 5,598 patients ) compared Eliquis with Acetylsalicylic acid ( Aspirin ). The main measures of effectiveness were based on the number of strokes or clotting events that occurred during treatment.

Apixaban was effective at preventing blood clots in the veins following a hip or knee replacement. In patients undergoing a hip replacement, 1.4% of the patients who completed treatment with Apixaban ( 27 out of 1,949 ) had a clotting event or died from any cause, compared with 3.9% ( 74 out of 1,917 ) of the patients taking Enoxaparin.
In patients undergoing a knee replacement, the corresponding numbers were 15% ( 147 out of 976 ) for Apixaban compared with 24% ( 243 out of 997 ) for Enoxaparin.
Apixaban was also shown to be effective in preventing strokes and arterial blood clots. In the study comparing Apixaban with Warfarin, 1.3% of the patients taking Apixaban had a stroke or clotting event every year compared with 1.6% of the patients taking Warfarin. The yearly rates in the second study were 1.6% for patients taking Apixaban and 3.6% for patients taking Acetylsalicylic acid.

The most frequent adverse reactions ( seen in between 1 and 10 patients in 100 ) are anaemia, haemorrhage, contusion and nausea when Apixaban is used for prevention of venous thromboembolism. When used for the prevention of stroke or systemic embolism the most common are epistaxis, contusion, haematuria and bleeding in the gut and eye.

Eliquis must not be used in patients who are hypersensitive ( allergic ) to Apixaban or any of the other ingredients. It must not be used in patients who are actively bleeding, or who have liver disease which leads to problems with blood clotting and an increased risk of bleeding. The medicine must also not be used in patients with conditions putting them at risk of major bleeding, such as an ulcer in the gut, or in patients being treated with other anticoagulant medicines except in specific circumstances. ( Xagena )

Source: European Medicines Agency ( EMA ), 2013

XagenaMedicine_2013



Indietro