Prescription Drug Information: BRILINTA (Page 4 of 5)

14.2 Coronary Artery Disease but No Prior Stroke or Myocardial Infarction

THEMIS

The THEMIS study (NCT01991795) was a double-blind, parallel group, study in which 19,220 patients with CAD and Type 2 Diabetes Mellitus (T2DM) but no history of MI or stroke were randomized to twice daily BRILINTA or placebo, on a background of 75-150 mg of aspirin. The primary endpoint was the composite of first occurrence of CV death, MI, and stroke. CV death, MI, ischemic stroke, and all-cause death were assessed as secondary endpoints.

Patients were eligible to participate if they were ≥ 50 years old with CAD, defined as a history of PCI or CABG, or angiographic evidence of ≥ 50% lumen stenosis of at least 1 coronary artery and T2DM treated for at least 6 months with glucose-lowering medication. Patients with previous intracerebral hemorrhage, gastrointestinal bleeding within the past 6 months, known bleeding diathesis, and coagulation disorder were excluded. Patients taking anticoagulants or ADP receptor antagonists were excluded from participating, and patients who developed an indication for those medications during the trial were discontinued from study drug.

Patients were treated for a median of 33 months and up to 58 months.

Patients were predominantly male (69%) with a mean age of 66 years. At baseline, 80% had a history of coronary artery revascularization; 58% had undergone PCI, 29% had undergone a CABG and 7% had undergone both. The proportion of patients studied in the US was 12%. Patients in THEMIS had established CAD and other risk factors that put them at higher cardiovascular risk; see Table 10.

Table 10 — Baseline risk factors (THEMIS)

Risk factor

% Patients

Type 2 Diabetes Mellitus

100%

Hypertension

92%

Dyslipidemia

87%

Multi-vessel CAD

62%

Obesity

43%

Heart failure

16%

Current smoking

11%

Chronic kidney disease

9%

BRILINTA was superior to placebo in reducing the incidence of CV death, MI, or stroke. The effect on the composite endpoint was driven by the individual components MI and stroke; see Table 11.

Table 11 — Primary composite endpoint, primary endpoint components, and secondary endpoints (THEMIS)
*
Primary endpoint
The event rate for the components CV death, MI and stroke are calculated from the actual number of first events for each component.

BRILINTA
N=9619

Placebo
N=9601

HR (95% CI)

p -value

Events / 1000 patient years

Events / 1000 patient years

Time to first CV death, MI, or stroke *

24

27

0.90 (0.81, 0.99)

0.04

CV death

12

11

1.02 (0.88, 1.18)

Myocardial infarction

9

11

0.84 (0.71, 0.98)

Stroke

6

7

0.82 (0.67, 0.99)

Secondary endpoints

CV death

12

11

1.02 (0.88, 1.18)

Myocardial infarction

9

11

0.84 (0.71, 0.98)

Ischemic stroke

5

6

0.80 (0.64, 0.99)

All-cause death

18

19

0.98 (0.87, 1.10)

CI = Confidence interval; CV = Cardiovascular; HR = Hazard ratio; MI = Myocardial infarction.

The Kaplan-Meier curve (Figure 14) shows time to first occurrence of the primary composite endpoint of CV death, MI, or stroke.

Figure 14 — Time to First Occurrence of CV death, MI or Stroke (THEMIS)

figure_14
(click image for full-size original)

T = Ticagrelor; P = Placebo; N = Number of patients.

The treatment effect of BRILINTA appeared similar across patient subgroups, see Figure 15.

Figure 15 — Subgroup analyses of ticagrelor (THEMIS)

Figure 15
(click image for full-size original)

Note: The figure above presents effects in various subgroups all of which are baseline characteristics. The 95% confidence limits that are shown do not take into account how many comparisons were made, nor do they reflect the effect of a particular factor after adjustment for all other factors. Apparent homogeneity or heterogeneity among groups should not be over-interpreted.

16 HOW SUPPLIED/STORAGE AND HANDLING

BRILINTA (ticagrelor) 90 mg is supplied as a round, biconvex, yellow, film-coated tablet with a “90” above “T” on one side:

Bottles of 60 – NDC 0186-0777-60

100 count Hospital Unit Dose – NDC 0186-0777-39

BRILINTA (ticagrelor) 60 mg is supplied as a round, biconvex, pink, film-coated tablet with a “60” above “T” on one side:

Bottles of 60 – NDC 0186-0776-60

Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Advise patients daily doses of aspirin should not exceed 100 mg and to avoid taking any other medications that contain aspirin.

Advise patients that they:

Will bleed and bruise more easily
Will take longer than usual to stop bleeding
Should report any unanticipated, prolonged or excessive bleeding, or blood in their stool or urine.

Advise patients to contact their doctor if they experience unexpected shortness of breath, especially if severe.

Advise patients to inform physicians and dentists that they are taking BRILINTA before any surgery or dental procedure.

Advise women that breastfeeding is not recommended during treatment with BRILINTA [see Use in Specific Populations (8.2)].

BRILINTA® is a trademark of the AstraZeneca group of companies.

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

© AstraZeneca 2020

MEDICATION GUIDE

BRILINTA® (brih-LIN-tah)

(ticagrelor) Tablets

What is the most important information I should know about BRILINTA?

BRILINTA is used to lower your chance of having a heart attack or dying from a heart attack or stroke but BRILINTA (and similar drugs) can cause bleeding that can be serious and sometimes lead to death. In cases of serious bleeding, such as internal bleeding, the bleeding may result in the need for blood transfusions or surgery. While you take BRILINTA:

you may bruise and bleed more easily
you are more likely to have nose bleeds
it will take longer than usual for any bleeding to stop

Call your doctor right away, if you have any of these signs or symptoms of bleeding while taking BRILINTA:

bleeding that is severe or that you cannot control
pink, red or brown urine
vomiting blood or your vomit looks like “coffee grounds”
red or black stools (looks like tar)
coughing up blood or blood clots

Do not stop taking BRILINTA without talking to the doctor who prescribes it for you. People who are treated with a stent, and stop taking BRILINTA too soon, have a higher risk of getting a blood clot in the stent, having a heart attack, or dying. If you stop BRILINTA because of bleeding, or for other reasons, your risk of a heart attack or stroke may increase.

Your doctor may instruct you to stop taking BRILINTA 5 days before surgery. This will help to decrease your risk of bleeding with your surgery or procedure. Your doctor should tell you when to start taking BRILINTA again, as soon as possible after surgery.

Taking BRILINTA with aspirin

BRILINTA is taken with aspirin. Talk to your doctor about the dose of aspirin that you should take with BRILINTA. You should not take a dose of aspirin higher than 100 mg daily because it can affect how well BRILINTA works. Do not take doses of aspirin higher than what your doctor tells you to take. Tell your doctor if you take other medicines that contain aspirin, and do not take new over-the-counter medicines with aspirin in them.

What is BRILINTA?

BRILINTA is a prescription medicine used to:

decrease your risk of death, heart attack, and stroke in people with a blockage of blood flow to the heart (acute coronary syndrome or ACS) or a history of a heart attack. BRILINTA can also decrease your risk of blood clots in your stent in people who have received stents for the treatment of ACS.
decrease your risk of a first heart attack or stroke in people who have a condition where the blood flow to the heart is decreased (coronary artery disease or CAD) who are at high risk for having a heart attack or stroke.

It is not known if BRILINTA is safe and effective in children.

Do not take BRILINTA if you:

have a history of bleeding in the brain
are bleeding now
are allergic to ticagrelor or any of the ingredients in BRILINTA. See the end of this Medication Guide for a complete list of ingredients in BRILINTA.

Before taking BRILINTA, tell your doctor about all of your medical conditions, if you:

have had bleeding problems in the past
have had any recent serious injury or surgery
plan to have surgery or a dental procedure
have a history of stomach ulcers or colon polyps
have lung problems, such as COPD or asthma
have liver problems
have a history of stroke
are pregnant or plan to become pregnant. It is not known if BRILINTA will harm your unborn baby. You and your doctor should decide if you will take BRILINTA.
are breastfeeding or plan to breastfeed. It is not known if BRILINTA passes into your breast milk. You and your doctor should decide if you will take BRILINTA or breastfeed. You should not do both without talking with your doctor.

Tell all of your doctors and dentists that you are taking BRILINTA. They should talk to the doctor who prescribed BRILINTA for you before you have any surgery or invasive procedure.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BRILINTA may affect the way other medicines work, and other medicines may affect how BRILINTA works.

Especially tell your doctor if you take:

an HIV-AIDS medicine
medicine for heart conditions or high blood pressure
medicine for high blood cholesterol levels
medicine used to control pain
an anti-fungal medicine by mouth
an antibiotic medicine
an anti-seizure medicine
a blood thinner medicine
rifampin

Ask your doctor or pharmacist if you are not sure if your medicine is listed above.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take BRILINTA?

Take BRILINTA exactly as prescribed by your doctor.
Your doctor will tell you how many BRILINTA tablets to take and when to take them.
Take BRILINTA with a low dose (not more than 100 mg daily) of aspirin. You may take BRILINTA with or without food.
Take your doses of BRILINTA around the same time every day.
If you forget to take your scheduled dose of BRILINTA, take your next dose at its scheduled time. Do not take 2 doses at the same time unless your doctor tells you to.
If you take too much BRILINTA or overdose, call your doctor or poison control center right away, or go to the nearest emergency room.
If you are unable to swallow the tablet(s) whole , you may crush the BRILINTA tablet(s) and mix it with water. Drink all the water right away. Refill the glass with water, stir, and drink all the water.

What are the possible side effects of BRILINTA?

BRILINTA can cause serious side effects, including:

See “What is the most important information I should know about BRILINTA?”
Shortness of breath. Call your doctor if you have new or unexpected shortness of breath when you are at rest, at night, or when you are doing any activity. Your doctor can decide what treatment is needed.

These are not all of the possible side effects of BRILINTA.

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

How should I store BRILINTA?

Store BRILINTA at room temperature between 68°F to 77°F (20°C to 25°C).

Keep BRILINTA and all medicines out of the reach of children.

General information about the safe and effective use of BRILINTA.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BRILINTA for a condition for which it was not prescribed. Do not give BRILINTA to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or doctor for information about BRILINTA that is written for health professionals.

What are the ingredients in BRILINTA?

Active ingredient: ticagrelor.

90 mg tablets:
Inactive ingredients: mannitol, dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, talc, polyethylene glycol 400, and ferric oxide yellow.

60 mg tablets:
Inactive ingredients: mannitol, dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol 400, ferric oxide black and ferric oxide red.

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

For more information call 1-800-236-9933 or go to www.Brilinta.com.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 05/2020

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