What is NVAF?

Atrial fibrillation (AF) is a condition in which the heartbeat is irregular. Nonvalvular AF (NVAF) is the most frequently encountered AF in European countries. Scroll down to read about NVAF and its treatment with Lixiana® (edoxaban).

What is
NVAF?

What is nonvalvular atrial fibrillation (NVAF)?

Atrial fibrillation, or AF, is a condition in which the heartbeat is rapid and irregular.

Atria: the two upper chambers of the heart Fibrillation: rapid, irregular contractions

Normally the heart beats regularly between 60 and 100 times a minute. These regular contractions are driven by the heart’s in-built pacemaker. In AF, random electrical pulses are generated in the heart muscle that override the normal pacemaker and cause the atria to beat in a rapid and uncoordinated way (fibrillation).

This means that the atria only partially contract – but very rapidly, causing less blood flow into the lower two chambers of the heart (ventricles). Only some of these impulses pass through to the ventricles making them contract in an irregular way with varying force, decreasing the heart’s efficiency and output.

A. Normal sinus rhythm Coordinated activity in atria

Electrocardiogram (ECG) Normal sinus rhythm

In a normal heart rhythm, heart rate can range from 60-100 beats per minute

B. Atrial fibrillation Irregular activity in atria

Electrocardiogram (ECG) Atrial fibrillation

In AF, the heart rate can sometimes be very fast
(often between 140 and 180 beats per minute)

PREVALENCE OF AF

AF is the most common cardiac rhythm disorder,1 affecting an estimated 1.2 million people in the UK2 and 4.5 million in the EU3

Nonvalvular atrial fibrillation (NVAF) refers to AF that is not associated with rheumatic disease.3

TYPES OF AF

AF is commonly divided into the following types:

PAROXYSMAL

Episodes that come and go but usually stop within 7 days without treatment (often within 48 hours)

PERSISTENT

Lasts longer than 7 days and is likely to need treatment to get the heartbeat back to a normal rhythm

PERMANENT

AF is present long-term, sometimes called established AF

17%

of AF patients are asymptomatic4

100%

of AF patients should be assessed for their risk of stroke1

Other medical conditions that are associated with AF include:5,6

• Overactive thyroid gland • Pneumonia • Diabetes

Up to 11% of cases of AF occurs spontaneously, with no known cause, this is known as ‘lone AF’.7

About LIXIANA® (edoxaban)

The information below is taken from the Lixiana® Patient Information Leaflet. (The leaflet you will have seen inside the pack of tablets). Click here to download or print.

  1. What Lixiana® is and what it is used for [read more]
  2. Lixiana® contains the active substance edoxaban and belongs to a group of medicines called anticoagulants. This medicine helps to prevent blood clots from forming. It works by blocking factor Xa, which is an important component of blood clotting.

    Lixiana® is used in adults to:

    • Prevent blood clots in the brain (stroke) and other blood vessels in your body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor such as heart failure, previous stroke or high blood pressure.
    • Treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent blood clots from recurring in the blood vessels of your legs and/or lungs.
  3. What you need to know before you take Lixiana® [read more]
  4. Do not take Lixiana®:

    • If you are allergic to edoxaban or any of the other ingredients of this medicine (listed in section 6)
    • If you are actively bleeding
    • If you have a disease or condition that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes)
    • If you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open
    • If you have a liver disease which leads to an increased risk of bleeding
    • If you have uncontrolled high blood pressure
    • If you are pregnant or breastfeeding

    Warnings and precautions

    Talk to your doctor or pharmacist before taking Lixiana®,

    - If you have an increased risk of bleeding, as could be the case if you have any of the following conditions:

    • End-stage kidney disease or if you are on dialysis
    • Severe liver disease
    • Bleeding disorders
    • A problem with the blood vessels in the back of your eyes (retinopathy)
    • Recent bleeding in your brain (intracranial or intracerebral bleeding)
    • Problems with the blood vessels in your brain or spinal column

    - If you have a mechanical heart valve

    Lixiana® 15 mg is only to be used when changing from lixiana® 30 mg to a vitamin K antagonist (e.g. warfarin)

    Take special care with Lixiana. If you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.

    If you need to have an operation:

    It is very important to take Lixiana® before and after the operation exactly at the times you have been told by your doctor. If possible, Lixiana® should be stopped at least 24 hours before an operation. Your doctor will determine when to restart Lixiana®.

    Children and adolescents

    Lixiana® is not recommended in children and adolescents under 18 years of age. There is no information on its use in children and adolescents.

    Other medicines and Lixiana®

    Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

    If you are taking any of the following:

    • Some medicines for fungal infections (e.g. ketoconazole)
    • Medicines to treat abnormal heart beat (e.g. dronedareone, quinidine and verapamil)
    • Other medicines to reduce blood clotting (e.g. heparin, clopidogrel or vitamin K antagonists such as warfarin, acenocoumarol, phenprocoumon or dabigatran, rivaroxaban, apixaban)
    • Antibiotic medicine (e.g. erythromycin)
    • Medicines to prevent organ rejection after transplantation (e.g. ciclosporin)
    • Anti-inflammatory and pain relieving medicines (e.g. naproxen or aspirin)
    • Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors

    Tell your doctor before taking Lixiana®, because these medicines may increase the effects of Lixiana® and the chance of unwanted bleeding. Your doctor will decide, if you should be treated with Lixiana® and if you should be kept under observation.

    If you are taking any of the following:

    • Some medicines for treatment of epilepsy (e.g. phenytoin, carbamazepine, phenobarbital)
    • St John’s Wort, a herbal product used for anxiety and mild depression
    • Rifampicin, an antibiotic

    If any of the above apply to you, tell your doctor before taking Lixiana®, because the effect of Lixiana® may be reduced. Your doctor will decide, if you should be treated with Lixiana® and if you should be kept under observation.

    Pregnancy and breastfeeding

    Do not take Lixiana® if you are pregnant or breastfeeding. If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Lixiana®. If you become pregnant while you are taking Lixiana®, immediately tell your doctor, who will decide how you should be treated.

    Driving and using machines

    Lixiana® has no or negligible effects on your ability to drive or use machines.

  5. How to take Lixiana® [read more]
  6. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

    How much to take

    The recommended dose is one 60 mg tablet once daily.

    • If you have impaired kidney function, the dose may be reduced to one 30 mg tablet once daily by your doctor.
    • If your body weight is 60 kg or lower, the recommended dose is one 30 mg tablet once daily.
    • If your doctor has prescribed drugs known as P-gp inhibitors: ciclosporin, dronedarone, erythromycin, or ketoconazole, the recommended dose is one 30 mg tablet once daily.

    How to take the tablet

    Swallow the tablet preferably with water.
    Lixiana® can be taken with or without food.

    Your doctor may change your anticoagulant treatment as follows:

    Changing from vitamin K antagonists (e.g. warfarin) to Lixiana

    Stop taking the vitamin K antagonist (e.g. warfarin). Your doctor will need to do blood measurements and will instruct you when to start taking Lixiana.

    Changing from non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) to Lixiana

    Stop taking the previous medicines (e.g. dabigatran, rivaroxaban, or apixaban) and start Lixiana at the time of the next scheduled dose.

    Changing from parenteral anticoagulants (e.g. heparin) to Lixiana

    Stop taking the anticoagulant (e.g. heparin) and start Lixiana at the time of the next scheduled anticoagulant dose.

    Changing from Lixiana to vitamin K antagonists (e.g. warfarin)

    If you currently take 60 mg Lixiana: Your doctor will tell you to reduce your dose of Lixiana to a 30 mg tablet once daily and to take it together with a vitamin K antagonist (e.g. warfarin). Your doctor will need to do blood measurements and will instruct you when to stop taking Lixiana.

    If you currently take 30 mg (dose reduced) Lixiana: Your doctor will tell you to reduce your dose of Lixiana to a 15 mg tablet once daily and to take it together with a vitamin K antagonist (e.g. warfarin). Your doctor will need to do blood measurements and will instruct you when to stop taking Lixiana.

    Changing from Lixiana to non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban)

    Stop taking Lixiana and start the non-VKA anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) at the time of the next scheduled dose of Lixiana.

    Changing from Lixiana to parenteral anticoagulants (e.g. heparin)

    Stop taking Lixiana and start the parenteral anticoagulant (e.g. heparin) at the time of the next scheduled dose of Lixiana.

    Patients undergoing cardioversion:

    If your abnormal heartbeat needs to be restored to normal by a procedure called cardioversion, take Lixiana at the times your doctor tells you to prevent blood clots in the brain and other blood vessels in your body.

    If you take more Lixiana® than you should

    Tell your doctor immediately if you have taken too many Lixiana® tablets. If you take more Lixiana® than recommended, you may have an increased risk of bleeding.

    If you forget to take Lixiana®

    You should take the tablet immediately and then continue the following day with the once daily tablet intake as usual. Do not take a double dose on the same day to make up for a forgotten dose.

    If you stop taking Lixiana®

    Do not stop taking Lixiana® without talking to your doctor first, because Lixiana® treats and prevents serious conditions.

    If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  7. Possible side effects [read more]
  8. Like all medicines, this medicine can cause side effects, although not everybody gets them.

    Like other similar medicines (medicines to reduce blood clotting), Lixiana® may cause bleeding which may potentially be life threatening. In some cases the bleeding may not be obvious.

    If you experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately. Your doctor may decide to keep you under closer observation or change your medicine.

    Overall list of possible side effects:

    Common (may affect up to 1 in 10 people):

    • Stomach ache
    • Abnormal liver blood tests
    • Bleeding from the skin or under the skin
    • Anaemia (low levels of red blood cells)
    • Bleeding from the nose
    • Bleeding from the vagina
    • Rash
    • Bleeding in the bowel
    • Bleeding from the mouth and/or throat
    • Blood found in your urine
    • Bleeding following an injury (puncture)
    • Bleeding in the stomach
    • Dizziness
    • Feeling sick
    • Headache
    • Itching

    Uncommon (may affect up to 1 in 100 people):

    • Other types of bleeding
    • Bleeding in the eyes
    • Bleeding from a surgical wound following an operation
    • Blood in the spit when coughing
    • Bleeding in the brain
    • Allergic reaction
    • Hives

    Rare (may affect up to 1 in 1,000 people):

    • Bleeding in the muscles
    • Bleeding in joints
    • Bleeding in the abdomen
    • Bleeding in the heart
    • Bleeding inside the skull
    • Bleeding following a surgical procedure
    • Allergic shock
    • Swelling of any part of the body due to allergic reaction

    If you get any side effects, talk to your doctor or pharmacist.

    Reporting of side effects

    If you get any side effects, talk to your doctor or pharmacist. This also includes any possible side effects not listed above.

    In addition to reporting any side effects to your doctor or pharmacist, you can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

  9. How to store Lixiana® [read more]
  10. Keep this medicine out of the sight and reach of children.

    Do not use this medicine after the expiry date which is stated on the carton and on each blister after EXP. The expiry date refers to the last day of that month.

    This medicine does not require any special storage conditions.

    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  11. Contents of the pack and other information [read more]
  12. What Lixiana® contains

    • The active substance is edoxaban tosilate.

      Lixiana® 15 mg: Each tablet contains 15 mg edoxaban (as tosilate).

      Lixiana® 30 mg: Each tablet contains 30 mg edoxaban (as tosilate).

      Lixiana® 60 mg: Each tablet contains 60 mg edoxaban (as tosilate).

    • The other ingredients are:

      Lixiana® 15 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).

      Lixiana® 30 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).

      Lixiana® 60 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).

    • Film coat:

      Lixiana® 15 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172), iron oxide yellow (E172).

      Lixiana® 30 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172).

      Lixiana® 60 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide yellow (E172).

    What Lixiana® looks like and contents of the pack

    Lixiana® 15 mg film-coated tablets are orange, round-shaped (6.7 mm diameter) and debossed with “DSC L15” on one side.

    They come in blisters in cartons of 10 film-coated tablets or unit dose blisters in cartons of 10 x 1 film-coated tablets.

    Lixiana® 30 mg film-coated tablets are pink, round-shaped (8.5 mm diameter) and debossed with “DSC L30” on one side.

    They come in blisters in cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets or unit dose blisters in cartons of 10 x 1, 50 x 1, or 100 x 1 film-coated tablets.

    Lixiana® 60 mg film-coated tablets are yellow, round-shaped (10.5 mm diameter) and debossed with “DSC L60” on one side.

    They come in blisters in cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets or unit dose blisters in cartons of 10 x 1, 50 x 1, or 100 x 1 film-coated tablets.

    Not all pack sizes may be marketed.

    Marketing Authorisation Holder
    Daiichi Sankyo Europe GmbH
    Zielstattstrasse 48
    81379 Munich
    Germany

    Manufacturer
    Daiichi Sankyo Europe GmbH
    Luitpoldstrasse 1
    85276 Pfaffenhofen
    Germany

References

  1. Lixiana®, Package Information Leaflet 2020.

REFERENCES

LIXIANA
Q&As

You have been prescribed Lixiana® (edoxaban), which thins your blood and helps to prevent you from suffering dangerous clots. It is important that you take your medication exactly as instructed by your doctor.

References

  1. Lixiana®, Package Information Leaflet 2020.
  2. NHS, England. Atrial Fibrillation. Available at: http://www.nhs.uk/conditions/atrial-fibrillation/Pages/Introduction.aspx Last accessed: April 2020.

REFERENCES