Brilinta

Generic Name: ticagrelor (Oral route)

tye-KA-grel-or

Oral route(Tablet)

Ticagrelor, can cause significant, sometimes fatal, bleeding. Do not use in patients with active pathological bleeding or history of intracranial hemorrhage. Do not start in patients planned to undergo urgent CABG. When possible, discontinue at least 5 days prior to any surgery. Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention, CABG, or other surgical procedures in the setting of ticagrelor. If possible, manage bleeding without discontinuing ticagrelor. Stopping ticagrelor increases the risk of subsequent cardiovascular events. Maintenance doses of aspirin above 100 mg reduce the effectiveness of ticagrelor and should be avoided .

Commonly used brand name(s)

In the U.S.

• Brilinta

Available Dosage Forms:

• Tablet

Pharmacologic Class: ADP-Induced Aggregation Inhibitor

Uses For Brilinta

Ticagrelor is used alone or together with aspirin to lessen the chance of heart attack, stroke, or other serious problems with your heart or blood vessels. It is given to patients who have already had a heart attack or severe chest pain, stroke, or to people with other blood circulation problems that could lead to a stroke or heart attack.

A heart attack or stroke may occur when a blood vessel in the heart or brain is blocked by a blood clot. Ticagrelor reduces the chance that a harmful blood clot will form by preventing certain cells in the blood from clumping together. This effect of ticagrelor may also increase the chance of serious bleeding in some people.

This medicine is available only with your doctor's prescription.

Before Using Brilinta

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ticagrelor in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ticagrelor in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir


• Carbamazepine


• Clarithromycin


• Dexamethasone


• Indinavir


• Itraconazole


• Ketoconazole


• Nefazodone


• Nelfinavir


• Phenobarbital


• Phenytoin


• Rifampin


• Rifapentine


• Ritonavir


• Rivaroxaban


• Saquinavir


• Telithromycin


• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Digoxin


• Simvastatin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding, pathological and active (e.g., from peptic ulcers or head injury) or


• Intracranial hemorrhage (bleeding in the head), history of or


• Liver disease, severe—Should not be used in patients with these conditions.

• Bleeding problems, history of or


• Lung disease or breathing problems (e.g., asthma or COPD)—Use with caution. May make these conditions worse.

• Liver disease, moderate—Use with caution. You doctor may adjust your dose.

Proper Use of Brilinta

Take this medicine exactly as directed by your doctor. Ticagrelor will not work properly if you take less of it than directed. Taking more ticagrelor than directed may increase the chance of serious side effects without increasing the helpful effects.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

You may take this medicine with or without food.

If you are using this medicine for a condition called acute coronary syndrome, your doctor may tell you to take aspirin while you are using ticagrelor. In this case, do not change the dose or stop taking the aspirin without talking to your doctor first.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For prevention of blood clots after unstable angina (chest pain), non-ST-elevation myocardial infarction (a type of heart attack), or ST-elevation myocardial infarction or STEMI:
    
    • Adults—At first, 180 milligrams (mg) or 2 tablets taken as a single dose. Then, 90 mg two times a day. Your doctor may also give you a loading dose of aspirin 325 mg once a day, then 75 to 100 mg once a day to be taken together with this medicine.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Brilinta

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Tell all medical doctors, dentists, nurses, and pharmacists you go to that you are taking this medicine. Ticagrelor may increase the risk of serious bleeding during a surgery, other medical procedures (e.g., coronary stent procedure), or some kinds of dental work. You may need to stop using this medicine at least 5 days before a surgery, medical procedure, or dental work. Do not stop taking your medicine without your doctor's permission.

While you are using this medicine, if you have any kind of bleeding, it may take longer than usual to stop, especially if you hurt yourself. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may increase your chance of bleeding or bruising. Check with your doctor right away if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin. Avoid picking your nose. If you need to blow your nose, blow it gently.

If you have unexpected or unexplained shortness of breath, difficult or labored breathing, tightness in the chest, or wheezing, tell your doctor right away.

Do not change your dose or stop taking this medicine without checking first with your doctor. To do so may increase the chance of having a heart attack, blood clotting problems, or other serious conditions.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Brilinta Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Difficult or labored breathing


• shortness of breath


• tightness in the chest


• wheezing

Less common

• Blurred vision


• chest pain or discomfort


• confusion


• dizziness


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• fainting


• fast or irregular heartbeat


• headache


• lightheadedness, dizziness, or fainting


• loss of consciousness


• nervousness


• pounding in the ears


• slow or fast heartbeat


• sweating


• unusual tiredness or weakness

Incidence not known

• Bleeding gums


• bruising


• coughing up blood


• difficulty with breathing or swallowing


• headache, sudden and severe


• increased menstrual flow or vaginal bleeding


• nausea or vomiting


• nosebleeds


• paralysis


• prolonged bleeding from cuts


• red or black, tarry stools


• red or dark brown urine


• weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Back pain


• cough


• diarrhea

Rare

• Swelling of the breasts or breast soreness in both females and males

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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