Brilinta®

What is ticagrelor?

Ticagrelor helps to prevent platelets in your blood from sticking together and forming a blood clot. An unwanted blood clot can occur with certain heart or blood vessel conditions.

Ticagrelor is used to lower your risk of having a stroke or serious heart problems after you have had a heart attack or severe chest pain (angina).

Ticagrelor may also be used for purposes not listed in this medication guide.

Important Information

You should not use ticagrelor if you have severe liver disease, any active bleeding (including a bleeding stomach ulcer), or a history of bleeding in the brain. Do not use this medicine just before heart bypass surgery (coronary artery bypass graft, or CABG).

You may need to stop using ticagrelor for a short time before having surgery or dental work, to prevent excessive bleeding. Do not stop taking ticagrelor without first talking to your doctor, even if you have signs of bleeding. Stopping ticagrelor may increase your risk of a heart attack or stroke.

Ticagrelor may cause you to bleed more easily, which can be severe or life-threatening. Avoid activities that may increase your risk of bleeding or injury.

Call your doctor or seek emergency medical attention if you have bleeding that will not stop. You may also have bleeding on the inside of your body, such as in your stomach or intestines. Call your doctor at once if you have black or bloody stools, red or pink urine, or if you cough up blood or vomit that looks like coffee grounds. These could be signs of bleeding in your digestive tract.

Many drugs (including some over-the-counter medicines and herbal products) can cause serious medical problems if you take them with ticagrelor. It is very important to tell your doctor about all medicines you have recently used.

Before taking this medicine

You should not use ticagrelor if you are allergic to it, or if you have:

• severe liver disease;

• any active bleeding;

• stomach ulcer or bleeding; or

• a history of bleeding in the brain (such as from a head injury).

Do not use this medicine within 5 days before heart bypass surgery (coronary artery bypass graft, or CABG).

To make sure ticagrelor is safe for you, tell your doctor if you have:

• liver disease;

• a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker);

• asthma, COPD (chronic obstructive pulmonary disorder) or other breathing problem;

• a history of stomach ulcer or colon polyps;

• a history of stroke; or

• a history of bleeding or blood clotting disorder.

Ticagrelor may cause you to bleed more easily, especially if you have:

• a recent surgery or bleeding injury;

• a disease affecting the blood vessels in your brain;

• a history of stroke;

• a history of bleeding problems;

• a history of stomach or intestinal bleeding; or

• if you are 65 or older.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ticagrelor passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take ticagrelor?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Ticagrelor should be taken together with aspirin. Follow your doctor's instructions about how much aspirin you should take.

Do not take more aspirin than your doctor has prescribed. Taking too much aspirin can make ticagrelor less effective.

Ticagrelor can be taken with or without food. Take the medicine at the same time each day.

Because ticagrelor keeps your blood from coagulating (clotting), this medicine can also make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have any bleeding that will not stop.

Any doctor, dentist, surgeon, or other medical care provider who treats you should know that you are taking ticagrelor. You may need to stop using the medicine for a short time before having surgery or dental work, to prevent excessive bleeding. Follow your doctor's instructions and start taking ticagrelor again as soon as possible.

Do not stop taking ticagrelor without first talking to your doctor, even if you have signs of bleeding. Use ticagrelor regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Stopping ticagrelor may increase your risk of a heart attack or stroke.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What should I avoid while taking ticagrelor?

While you are taking ticagrelor, do not take NSAIDs (nonsteroidal anti-inflammatory drugs) without your doctor's advice. NSAIDs include ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Avoid drinking alcohol. It may increase your risk of bleeding in your stomach or intestines.

Ask a doctor or pharmacist before using any cold, allergy, pain, or sleep medication. Aspirin (sometimes abbreviated as ASA) is contained in many combination medicines. Taking certain products together can cause you to get too much aspirin which can increase your risk of bleeding. Check the label to see if a medicine contains aspirin or ASA.

Ticagrelor side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a nosebleed or other bleeding that will not stop;

• shortness of breath or a light-headed feeling (like you might pass out), even with mild exertion or while lying down;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• red or pink urine:

• pale skin, weakness, fever, or jaundice (yellowing of the skin or eyes);

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common side effects may include:

• headache, mild dizziness;

• cough; or

• nausea, diarrhea.

This is not a complete list of side effects and others may occur.

What other drugs will affect ticagrelor?

Many drugs can interact with ticagrelor. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• imatinib;

• lovastatin (Advicor, Altoprev, Mevacor) or simvastatin (Zocor, Simcor, Vytorin, Juvisync);

• nefazodone;

• St. John's wort;

• an antibiotic--clarithromycin, telithromycin;

• antifungal medicine--itraconazole, ketoconazole, posaconazole, voriconazole;

• heart or blood pressure medicine--digoxin, nicardipine, quinidine;

• antiviral medicine to treat hepatitis or HIV/AIDS--atazanavir, boceprevir, cobicistat, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, telaprevir;

• seizure medicine--carbamazepine, phenytoin; or

• tuberculosis medicine--isoniazid, rifampin.

This list is not complete and many other drugs can interact with ticagrelor. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.