Brilionta

In this section you will find more information about ACS and why medical treatment and lifestyle changes are so critical.

Acute Coronary Syndrome (ACS):

If you’ve just had a heart attack or been diagnosed with unstable angina, your condition is known by the medical profession as ACS, or Acute Coronary Syndrome. Most people who have ACS have coronary heart disease. Coronary heart disease (CHD) is a narrowing of the small blood vessels that supply blood and oxygen to the heart. CHD is also called coronary artery disease.”

There are two main causes of ACS:

Myocardial Infarction (heart attack): This is when blood flow to the heart is blocked, usually by a blood clot that has formed over the inside of damaged arteries of the heart. With the heart muscle starved of oxygen heart tissue can be damaged (infarction). This is very serious as often this damage is permanent.^2,3

Unstable Angina: Similar to a heart attack, blood flow to the heart is drastically (although not completely) reduced causing severe chest pain. While this is still a serious, life-threatening situation, the heart muscle may be left with no permanent damage.^2,3

The first 28 days following an episode of ACS is your most risky because blood clots can form inside the previously damaged areas of your heart and can lead to another heart attack or episode of unstable angina.⁴ Your cardiologist may insist on a number of lifestyle changes (such as losing weight and avoiding certain foods) and will prescribe a number of medicines to help prevent another episode of ACS.

In addition to important lifestyle changes, your Cardiologist recommended Brilinta because it reduces the chances of you having another heart attack or a stroke or of dying from a disease related to your heart or blood vessels. In fact, compared to the most commonly used medicine (clopidogrel) Brilinta reduces your risk of having another heart attack by 16% and reduces your risk of dying from cardiovascular causes by 21%), in the 12 months following your first ACS event.⁵

Brilinta is an anti-platelet medicine meaning it affects cells called ‘platelets’. Platelets are very small blood cells that help stop bleeding by clumping together to plug tiny holes in blood vessels that are cut or damaged.

However, platelets can also form clots inside damaged blood vessels in the heart and brain.¹ This can be very dangerous because:

• the clot can cut off the blood supply completely - this can cause a heart attack (myocardial infarction) or stroke¹
• the clot can partly block the blood vessels to the heart - this reduces the blood flow to the heart and can cause chest pain which comes and goes (called ‘unstable angina’)¹

Brilinta helps stop the clumping of platelets. This reduces the chance of a blood clot forming that can reduce blood flow.¹

Anti-platelet medicines are not new, clopidogrel is a kind of anti-platelet medicine that has been available for a number of years. However, taking Brilinta instead of clopidogrel after a heart attack or episode of unstable angina reduces the chances of you having another heart attack or a stroke or of dying from a disease related to your heart or blood vessels.⁵

If you choose to take Brilinta you should expect to pay around $2400 for the full 12- month course, including GST and dispensing fees. This can be paid in monthly instalments and payment options are available.

Your first prescription will most likely be written out by your cardiologist, but all other repeat prescriptions can be issued by your GP.

Like all medicines, Brilinta can cause side effects, although not everybody gets them. One of the common side effects of Brilinta is bleeding. Around 1 in 10 people taking Brilinta will notice bruising and various kinds of bleeding such as nosebleeds, blood when they go to the toilet, or bleeding more than usual if they cut themselves.¹ This is to be expected because of the mode of action of Brilinta as an antiplatelet medicine, which stops the rapid formation of platelets clumping together.

For a full list of possible side effects see the Consumer Medicine Information at medsafe.govt.nz.

Once prescribed Brilinta you can enrol in the MyHeart programme. MyHeart is a free programme designed by clinical health psychologists to improve the lives of people who are taking Brilinta after a heart attack or episode of unstable angina. MyHeart is designed to encourage and support you as you come to terms with your diagnosis and as you recover. What’s more, all of the information you’ll receive is personalised, so you’ll always get relevant advice that’s specifically helpful to you.

It might be hard to find positives at this time, but there are plenty of reasons to look forward to a bright future. If you’ve survived an acute coronary episode such as a heart attack, you now have a chance to take charge of your health. And the first piece of good news is that more people than ever are surviving heart attacks.

• As you recover, the first 28 days after a heart attack, your risk of dying decreases and your long-term outlook improves dramatically.⁴
• A combination of new medicines and quality treatments means that the number of people who die after a heart attack is falling.^3,4
• Just sticking to a cardiac rehabilitation programme is a huge step in the right direction – attending decreases your risk of dying in the next five years by 26%.³
• Giving up smoking cuts your risk of having a heart attack in half. And what’s more, if you do have a heart attack, it reduces your risk of dying by a quarter.^3,4
• Other lifestyle changes, such as getting more active, can make all the difference, like getting more active – people who do no exercise are twice as likely to have a heart attack.^3,4
• Enrolling in the MyHeart patient support programme will help you to make – and stick to – these life-saving changes.

Consumer Medicine Information

This leaflet answers some of the common questions people ask about Brilinta. It does not contain all the information that is known about Brilinta. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking Brilinta against the benefits they expect it will have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again.

What is Brilinta used for

Brilinta is to be used in adults only. You have been given Brilinta because you have had:

• a heart attack, or
• unstable angina (angina or chest pain that is not well controlled)

Brilinta reduces the chances of you having another heart attack or a stroke or of dying from a disease related to your heart or blood vessels.

How Brilinta works

Brilinta contains the active substance called ticagrelor. This belongs to a group of medicines called anti-platelet medicines.

Brilinta affects cells called ‘platelets’ (also called thrombocytes). These very small blood cells help stop bleeding by clumping together to plug tiny holes in blood vessels that are cut or damaged. However, platelets can also form clots inside diseased blood vessels in the heart and brain. This can be very dangerous because:

• the clot can cut off the blood supply completely - this can cause a heart attack (myocardial infarction) or stroke, or
• the clot can partly block the blood vessels to the heart - this reduces the blood flow to the heart and can cause chest pain which comes and goes (called ‘unstable angina’)

Brilinta helps stop the clumping of platelets. This reduces the chance of a blood clot forming that can reduce blood flow.

This medicine is only available with a doctor’s prescription.

Before you use Brilinta

When you must not use it
Do not take Brilinta if:

• You are allergic (hypersensitive) to ticagrelor or any of the other ingredients of Brilinta (listed in Product Description)
• You are bleeding now or have bled recently inside your body, such as bleeding in your stomach or gut from an ulcer
• You have moderate to severe liver disease
• You are taking any of the following medicines: ketoconazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV infection and AIDS)
• You have had a stroke caused by bleeding in the brain

Do not take Brilinta if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Brilinta.

Take special care with Brilinta
Check with your doctor, pharmacist or dentist before taking Brilinta if:

• You have an increased risk of bleeding because of:
  • - a recent serious injury
  • - recent surgery (including dental work)
  • - you have a condition that affects blood clotting
  • - recent bleeding from your stomach or gut (such as a stomach ulcer or colon ‘polyps’).
• You are due to have surgery (including dental work) at any time while taking Brilinta. This is because of the increased risk of bleeding. Your doctor may want you to stop taking Brilinta 7 days prior to surgery
• Your heart rate is abnormally low (usually lower than 60 beats per minute) and you do not already have in place a device that paces your heart (pacemaker)
• You have asthma or other lung problem or breathing difficulties
• You have had a blood test that showed more than the usual amount of uric acid

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or dentist before taking Brilinta.

Children
Brilinta is not recommended for children and adolescents under 18 years

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription, dietary supplements and herbal remedies. This is because Brilinta can affect the way some medicines work and some medicines can have an effect on Brilinta.

Tell your doctor or pharmacist if you are taking any of the following medicines:

• more than 40 mg daily of either simvastatin or lovastatin (medicines used to treat high cholesterol)
• rifampicin (an antibiotic), phenytoin, carbamazepine and phenobarbital (used to control seizures), dexamethasone (used to treat inflammatory and auto immune conditions), digoxin (used to treat heart failure), cyclosporin (used to lessen your body’s defences), quinidine and diltiazem (used to treat abnormal heart rhythms), beta blockers and verapamil (used to treat high blood pressure)

In particular, tell your doctor or pharmacist if you are taking any of the following medicines that increase your risk of bleeding:

• ‘oral anticoagulants’ often referred to as ’blood thinners’ which include warfarin
• non-steroidal anti-inflammatory drugs (abbreviated as NSAIDs) often taken as pain killers such as ibuprofen and naproxen
• selective serotonin reuptake inhibitors (abbreviated as SSRIs) taken as antidepressants such as paroxetine, sertraline and citalopram
• other medicines such as ketoconazole (used to treat fungal infections), clarithromycin (used totreat bacterial infections), nefazodone, (an antidepressant), ritonavir and atazanavir (used to treat HIV infection and AIDS), cisapride (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches)

Also tell your doctor that because you are taking Brilinta, you may have an increased risk of bleeding if your doctor gives you fibrinolytics, often called ‘clot dissolvers’, such as streptokinase or alteplase.

Taking Brilinta with food and drink
You can take Brilinta with or without food.

Pregnancy and breast-feeding
It is not recommended to use Brilinta if you are pregnant or may become pregnant. Women should use appropriate contraceptive measures to avoid pregnancy while taking this medicine. Talk to your doctor before taking Brilinta if you are breast-feeding. Your doctor will discuss with you the benefits and risks of taking Brilinta during this time.

Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breastfeeding.

Driving and using machines
Brilinta is not likely to affect your ability to drive or use machines.

How to take Brilinta

Always take Brilinta exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much to take

• The starting dose is two tablets at the same time (loading dose of 180 mg). This dose will usually be given to you in the hospital
• After this starting dose, the usual dose is one tablet of 90 mg twice a day for up to 12 months unless your doctor tells you differently. Take Brilinta around the same time every day (for example, one tablet in the morning and one in the evening)

Your doctor will usually also tell you to take aspirin. This is a substance present in many medicines used to prevent blood clotting. Your doctor will tell you how much to take (usually between 75-150 mg daily).

How to take Brilinta

• You can take the tablet with or without food
• You can check when you last took a tablet of Brilinta by looking on the blister. There is a sun (for the morning) and a moon (for the evening). This will tell you whether you have taken the dose.

If you take more Brilinta than you should
If you take more Brilinta than you should, talk to a doctor or go to hospital straight away. Take the medicine pack with you. You may be at increased risk of bleeding.

If you forget to take Brilinta

• If you forget to take a dose, just take your next dose as normal
• Do not take a double dose (two doses at the same time) to make up for the forgotten dose.

If you stop taking Brilinta
Do not stop taking Brilinta without talking to your doctor. Take Brilinta on a regular basis and for as long as your doctor keeps prescribing it. If you stop taking Brilinta, it may increase your chances of having another heart attack or stroke or dying from a disease related to your heart or blood vessels. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Side Effects

Like all medicines, Brilinta can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

The frequency of possible side effects listed below is defined using the following convention: common (affects 1 to 10 users in 100); uncommon (affects 1 to 10 users in 1,000); rare (affects 1 to 10 users in 10,000)

See a doctor straight away if you notice any of the following – you may need urgent medical treatment:

• Signs of a stroke such as:
  • - sudden numbness or weakness of your arm, leg or face, especially if only on one side of the body
  • - sudden confusion, difficulty speaking or understanding others
  • - sudden difficulty in walking or loss of balance or co-ordination
  • - suddenly feeling dizzy or sudden severe headache with no known cause

These are signs of a kind of stroke caused by bleeding into the brain. This is uncommon.

• Bleeding – some bleeding is common. However, severe bleeding is uncommon, but can be life threatening. Bleeding of many different kinds can be increased, for example:
  • - nose bleed (common)
  • - blood in your urine (uncommon)
  • - black stools or blood in your stools (common)
  • - blood in your eye (uncommon)
  • - coughing up or bringing up blood (uncommon)
  • - vaginal bleeding that is heavier, or happens at different times, to your normal period (menstrual) bleeding (uncommon)
  • - bleeding after surgery or from cuts and wounds that is more than normal (common) - bleeding from your stomach lining (ulcer) (uncommon)
  • - bleeding gums (uncommon)
  • - blood in your ear (rare)
  • - internal bleeding (rare)
  • - bleeding into joints causing painful swelling (rare)

Discuss with your doctor if you notice any of the following:

• Feeling short of breath - this is common. It might be due to your heart disease or another cause, or it might be a side effect of Brilinta. If your feeling of shortness of breath gets worse or lasts a long time, tell your doctor. Your doctor will decide if it needs treatment or further investigations.

Other possible side effects

Common (affects 1 to 10 users in 100)

• Bruising

Uncommon, rare or very rare (affects 1 to 10 users in 1,000)

• Headache
• Feeling dizzy or like the room is spinning
• Abdominal pain
• Diarrhoea or indigestion
• Feeling or being sick
• Rash
• Itching
• Inflamed stomach (gastritis)

Rare (affects 1 to 10 users in 10,000)

• Constipation
• A tingling feeling
• Confusion

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist, but do not stop taking Brilinta until you have spoken to them.

How to store Brilinta

Keep out of the reach and sight of children.

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

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.

Product Description

What Brilinta contains

• The active substance is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
• The other ingredients are:
  

  Tablet core: mannitol (E421), dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl-cellulose (E463), magnesium stearate (E470b)

  Tablet film coating: hypromellose (E464), titanium dioxide (E171), talc, polyethylene glycol 400, and ferric oxide yellow (E172).

What Brilinta looks like and contents of the pack
Film-coated tablet (tablet): The tablets are round, biconvex, yellow, film-coated marked with a “90” above “T” on one side.

Brilinta is available in calendar blisters (with sun/moon symbols) in cartons of 14 and 56 tablets.

Marketed by

AstraZeneca Limited
P299 Private Bag 92175, Auckland 1142.
Telephone: (09) 306 5650.

Trademarks herein are the property of the AstraZeneca Group.

© This CMI is copyrighted to AstraZeneca Limited and may be reproduced but not altered in any way. 26 September 2011