Lixiana - Edoxaban uses, dose and side effects

Lixiana contains the active substance edoxaban and belongs to a group of medicines called anticoagulants (blood thinners). This medicine helps to prevent the formation of blood clots by blocking the activity of factor Xa, which is an important component in the clotting of the blood.

Lixiana is used in adults to:

prevent blood clots in the brain ( stroke ) and in other blood vessels in the body if you have a form of irregular heart rhythm called non-valvular atrial fibrillation and another at least one risk factor, e.g. heart failure , previous stroke ( stroke ) or high blood pressure
treat blood clots in the veins in the legs (deep vein thrombosis ) and in the blood vessels in the lungs ( pulmonary embolism ) and to prevent blood clots from recurring in the blood vessels in the legs and / or lungs.

What you need to know before you take Lixiana

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 have an ongoing bleeding
if you have a disease or condition that increases the risk of severe bleeding (eg stomach ulcers , injury or bleeding in the brain, or recent brain or eye surgery )
if you are taking other medicines to prevent the blood from clotting (eg warfarin , dabigatran, rivaroxaban, apixaban or heparin ), except when changing anticoagulant therapy or if you have a venous or arterial catheter flushed with heparin to keep the catheter is open
if you have a liver disease that leads to an increased risk of bleeding
if you have uncontrolled high blood pressure
if you are pregnant or breastfeeding.

Warnings and cautions

Talk to your doctor or pharmacist before taking Lixiana:

if you have an increased risk of bleeding, which may be the case if you have any of the following diseases:
- end-stage renal disease or if you receive dialysis
- severe liver disease
- bleeding disorders
- problems with the blood vessels in the fundus ( retinopathy )
- if you have recently had a brain haemorrhage ( intracranial or intracerebral haemorrhage)
- problems with the blood vessels in the brain or spine
if you have a mechanical heart valve.

Lixiana 15 mg should only be used when switching from Lixiana 30 mg to a vitamin K antagonist (eg warfarin ) (see section 3, How to take Lixiana).

Take special care with Lixiana

If you know you have a condition called antiphospholipid syndrome (a disorder of the immune system that increases the risk of getting blood clots), tell your doctor, who will decide if treatment may need to be changed.

If you need surgery

it is very important to take Lixiana before and after the operation at exactly the times that the doctor says. If possible, stop taking Lixiana at least 24 hours before surgery. Your doctor will decide when to start taking Lixiana again.In emergency situations, your doctor will decide what action to take when taking Lixiana.

Children and young people

Lixiana is not recommended for children or adolescents under 18 years of age. There is no information on 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 take any of the following:

certain medicines for fungal infections (eg ketoconazole )
drugs for the treatment of abnormal heart rhythms (eg dronedarone, quinidine , verapamil)
other drugs that reduce the ability of the blood to clot (eg heparin , clopidogrel or vitamin K antagonists such as warfarin , acenocoumarol, fenprocumon or dabigatran, rivaroxaban, apixaban)
antibiotics (eg erythromycin)
drugs that prevent organ rejection after transplantation (eg cyclosporine)
anti-inflammatory and analgesic drugs (eg naproxen or acetylsalicylic acid )
antidepressant drugs, so-called selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors.

If any of the above applies to you, tell your doctor before taking Lixiana, as these medicines may increase the effects of Lixiana and the risk of unwanted bleeding. Your doctor will then decide if you should be treated with Lixiana and if you need to be monitored.

If you take any of the following:

certain medicines to treat epilepsy (eg phenytoin , carbamazepine, phenobarbital)
St. John’s wort , an herbal medicine used to treat anxiety and mild depression
rifampicin, an antibiotic .

If any of the above applies to you, tell your doctor before taking Lixiana, as the effect of Lixiana may be reduced. Your doctor will then decide if you should be treated with Lixiana and if you need to be monitored.

Pregnancy and breastfeeding

Do not take Lixiana if you are pregnant or breastfeeding. If you are at risk of becoming pregnant, use a reliable contraceptive while you are taking Lixiana. If you become pregnant while taking Lixiana, tell your doctor immediately, who will decide how to treat you.

Driving and using machines

Lixiana has no or negligible effect on the ability to drive and use machines.

How to take Lixiana

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

How much to take

The recommended dose is one 60 mg tablet once a day.

if you have impaired kidney function , your doctor may reduce your dose to one 30 mg tablet once a day.
If your body weight is 60 kg or less , the recommended dose is one 30 mg tablet once a day.
if your doctor has prescribed medicines called P-gp inhibitors: ciclosporin, dronedarone, erythromycin or ketoconazole , the recommended dose is one 30 mg tablet once a day.

How to take the tablet

Swallow the tablet, preferably with water.

Lixiana can be taken with or without food.

If it is difficult for you to swallow the tablet whole, talk to your doctor about other ways to take Lixiana. The tablet can be crushed and mixed with water or apple puree immediately before taking it. If needed, your doctor may also give you the crushed Lixiana tablet by gavage.

Your doctor may change your blood-thinning treatment as follows:

Switching from vitamin K antagonists (eg warfarin ) to Lixiana

Stop taking the vitamin K antagonist (eg warfarin ). Your doctor will need to take blood samples and inform you when to start taking Lixiana.

Switching from oral (oral) non-vitamin D antagonists (dabigatran, rivaroxaban or apixaban) to Lixiana

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

Change from parenteral (injected) blood thinner (eg heparin ) to Lixiana

Stop taking the blood thinner (eg heparin ) and start taking Lixiana at the time of the next scheduled dose of the blood thinner.

Switching from Lixiana to Vitamin K Antagonists (eg warfarin )

If you are currently taking 60 mg Lixiana:

Your doctor will tell you to reduce the dose of Lixiana to a 30 mg tablet once a day and to take it with a vitamin K antagonist (eg warfarin ). Your doctor will need to take blood samples and inform you when to stop taking Lixiana.

If you are currently taking 30 mg (reduced dose ) Lixiana:

Your doctor will tell you to reduce the dose of one of Lixiana to a 15 mg tablet once a day and to take it with a vitamin K antagonist (eg warfarin ). Your doctor will need to take blood samples and inform you when to stop taking Lixiana.

Switching from Lixiana to blood thinners other than vitamin K antagonists (dabigatran, rivaroxaban, or apixaban)

Stop taking Lixiana and start with the blood thinner that is not a vitamin K antagonist (eg dabigatran, rivaroxaban, or apixaban) at the time of the next scheduled dose of Lixiana.

Switching from Lixiana to parenteral (injected) blood thinners (eg heparin )

Stop taking Lixiana and start with the parenteral (injected) blood thinner (eg heparin ) at the time of your next scheduled dose of Lixiana.

Patients undergoing electrical conversion:

If your irregular heartbeat needs to be restored to a normal rhythm, through a procedure called electrical conversion, you should take Lixiana at the times prescribed by your doctor to prevent blood clots in the brain and other blood vessels in the 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, the risk of bleeding may increase.

If you forget to take Lixiana

You should take the tablet immediately and then continue the next day with one tablet daily 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 a doctor first, as Lixiana treats and prevents serious conditions.

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

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Like other similar medicines (medicines that reduce the risk of blood clots), Lixiana can cause life-threatening bleeding. In some cases, the bleeding may not be visible.

If you experience bleeding that does not stop on its own or if you experience signs of heavy bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), you should contact a doctor immediately. Your doctor may decide that you should be monitored more closely or change your medicine.

The overall list of possible side effects:

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

magont
abnormal liver values (shown in blood tests)
bleeding in the skin or under the skin
anemia (low red blood cell count )
nosebleeds
vaginal bleeding
rash
bleeding in the intestine
bleeding from the mouth and / or throat
blood in the urine
bleeding after an injury (puncture)
bleeding in the stomach
dizziness
nausea
headache
itching .

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

bleeding in the eyes
bleeding from a surgical wound after surgery
bloody vomiting
bleeding in the brain
other types of bleeding
low platelet count (which can affect coagulation )
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 after a surgical procedure.
severe allergic reaction (allergic shock )
swelling in any part of the body due to allergic reaction .

How to store Lixiana

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 any blister or jar after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is edoxaban (as tosilate).Lixiana 15 mg film-coated tabletsEach tablet contains 15 mg of edoxaban (as tosilate).
Lixiana 30 mg film-coated tabletsEach tablet contains 30 mg of edoxaban (as tosilate).
Lixiana 60 mg film-coated tabletsEach tablet contains 60 mg of edoxaban (as tosilate).
Other ingredients are:Lixiana 15 mg g film-coated tabletsTablet core: mannitol (E421), pregelatinized starch , crospovidone (E1202), hydroxypropylcellulose (E463), magnesium stearate (E470b).Film coating; hypromellose (E464), macrogol (8000), titanium dioxide (E171), talc (E553b), carnauba wax, red iron oxide (E172), yellow iron oxide (E172).
Lixiana 30 mg film-coated tabletsTablet core: mannitol (E421), pregelatinized starch , crospovidone (E1202), hydroxypropylcellulose (E463), magnesium stearate (E470b).Film coating: hypromellose (E464), macrogol (8000), titanium dioxide (E171), talc (E553b), carnauba wax, red iron oxide (E172).
Lixiana 60 mg film-coated tabletsTablet core: mannitol (E421), pregelatinized starch , crospovidone (E1202), hydroxypropylcellulose (E463), magnesium stearate (E470b).Film coating: hypromellose (E464), macrogol (8000), titanium dioxide (E171), talc (E553b), carnauba wax, yellow iron oxide (E172).

What the medicine looks like and contents of the pack

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

They are supplied in blisters in cartons of 10 film-coated tablets or single-dose blisters in cartons of 10 x 1 film-coated tablets.

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

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

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Daiichi Sankyo Europe GmbH

Zielstattstrasse 48

81379 Munich

Germany

Manufacturer