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Brilinta

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Brilinta

Brilinta Side Effects Center

Medical Editor: William C. Shiel Jr., MD, FACP, FACR

Brilinta (ticagrelor) is a blood-thinning drug used to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS). Brilinta works by preventing the formation of new blood clots, thus maintaining blood flow in the body to help reduce the risk of another cardiovascular event. There is a general increase in bleeding risk with associated with the use of Brilinta. Brilinta may be taken with or without food.

Brilinta should be started with two 90 mg tablets as a loading dose, continuing treatment with 90 mg twice daily. After the initial loading dose of aspirin (usually 325 mg), use Brilinta with a daily maintenance dose of aspirin of 75-100 mg. Patients who have received a loading dose of clopidogrel may be started on Brilinta. A patient who misses a dose of Brilinta should take one 90 mg tablet (their next dose) at its scheduled time.

There are no adequate and well-controlled studies of Brilinta use in pregnant women. Brilinta should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether ticagrelor or its active metabolites are excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Brilinta, a decision should be made whether to discontinue nursing or to discontinue drug, taking into account the importance of the drug to the mother.

Patients should avoid interruption of Brilinta treatment. If Brilinta must be temporarily discontinued, restart it as soon as possible. Discontinuation of Brilinta will increase the risk of myocardial infarction, stent thrombosis, and death.

Our Brilinta Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Brilinta in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these 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 serious side effect such as:

  • feeling light-headed or short of breath, even with mild exertion or while lying down;
  • nosebleed or other bleeding that will not stop;
  • bloody or tarry stools, blood in your urine;
  • coughing up blood or vomit that looks like coffee grounds;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • pale skin, weakness, fever, or jaundice (yellowing of the skin or eyes); or
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.

Less serious side effects may include:

  • headache, mild dizziness;
  • cough; or
  • nausea, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Brilinta (Ticagrelor Tablets for Oral Administration) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Brilinta FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

The following adverse reactions are also discussed elsewhere in the labeling:

Dyspnea [see WARNINGS AND PRECAUTIONS]

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

BRILINTA has been evaluated for safety in more than 10000 patients, including more than 3000 patients treated for more than 1 year.

Bleeding

PLATO used the following bleeding severity categorization:

  • Major bleed - fatal/life-threatening. Any one of the following: fatal; intracranial; intrapericardial bleed with cardiac tamponade; hypovolemic shock or severe hypotension due to bleeding and requiring pressors or surgery; clinically overt or apparent bleeding associated with a decrease in hemoglobin (Hb) of more than 5 g/dL; transfusion of 4 or more units (whole blood or packed red blood cells (PRBCs)) for bleeding.
  • Major bleed - other. Any one of the following: significantly disabling (e.g., intraocular with permanent vision loss); clinically overt or apparent bleeding associated with a decrease in Hb of 3 g/dL; transfusion of 2-3 units (whole blood or PRBCs) for bleeding.
  • Minor bleed. Requires medical intervention to stop or treat bleeding (e.g., epistaxis requiring visit to medical facility for packing).
  • Minimal bleed. All others (e.g., bruising, bleeding gums, oozing from injection sites, etc.) not requiring intervention or treatment.

Figure 1 shows major bleeding events over time. Many events are early, at a time of coronary angiography, PCI, CABG, and other procedures, but the risk persists during later use of antiplatelet therapy.

Figure 1 : Kaplan-Meier estimate of time to first PLATO-defined 'Total Major' bleeding event

Kaplan-Meier estimate of time to first PLATO-defined ‘Total Major’ bleeding event - Illustration

Annualized rates of bleeding are summarized in Table 1 below. About half of the bleeding events were in the first 30 days.

Table 1 : Non-CABG related bleeds (KM%)

  BRILINTA
N=9235
Clopidogrel
N=9186
Total (Major + Minor) 8.7 7
  Major 4.5 3.8
    Fatal/Life-threatening 2.1 1.9
    Fatal 0.2 0.2
    Intracranial (Fatal/Life-threatening) 0.3 0.2

As shown in Table 1, BRILINTA was associated with a somewhat greater risk of non- CABG bleeding than was clopidogrel. No baseline demographic factor altered the relative risk of bleeding with BRILINTA compared to clopidogrel.

In PLATO, 1584 patients underwent CABG surgery. The percentages of those patients who bled are shown in Table 2. Rates were very high but similar for BRILINTA and clopidogrel.

Table 2 : CABG bleeds (KM%)

  Patients with CABG
BRILINTA N=770 Clopidogrel N=814
Total Major 85.8 86.9
  Fatal/Life-threatening 48.1 47.9
    Fatal 0.9 1.1

Although the platelet inhibition effect of BRILINTA has a faster offset than clopidogrel in in vitro tests and BRILINTA is a reversibly binding P2Y12 inhibitor, PLATO did not show an advantage of BRILINTA compared to clopidogrel for CABG-related bleeding. When antiplatelet therapy was stopped 5 days before CABG, major bleeding occurred in 75% of BRILINTA treated patients and 79% on clopidogrel.

No data exist with BRILINTA regarding a hemostatic benefit of platelet transfusions.

Drug Discontinuation

In PLATO, the rate of study drug discontinuation attributed to adverse reactions was 7.4% for BRILINTA and 5.4% for clopidogrel. Bleeding caused permanent discontinuation of study drug in 2.3% of BRILINTA patients and 1.0% of clopidogrel patients. Dyspnea led to study drug discontinuation in 0.9% of BRILINTA and 0.1% of clopidogrel patients.

Common Adverse Events

A variety of non-hemorrhagic adverse events occurred in PLATO at rates of 3% or more. These are shown in Table 3. In the absence of a placebo control, whether these are drug related cannot be determined in most cases, except where they are more common on BRILINTA or clearly related to the drug's pharmacologic effect (dyspnea).

Table 3 : Percentage of patients reporting non-hemorrhagic adverse events at least 3% or more in either group

  BRILINTA N=9235 Clopidogrel N=9186
Dyspnea1 13.8 7.8
Headache 6.5 5.8
Cough 4.9 4.6
Dizziness 4.5 3.9
Nausea 4.3 3.8
Atrial fibrillation 4.2 4.6
Hypertension 3.8 4
Non-cardiac chest pain 3.7 3.3
Diarrhea 3.7 3.3
Back pain 3.6 3.3
Hypotension 3.2 3.3
Fatigue 3.2 3.2
Chest pain 3.1 3.5
1 Includes: dyspnea, dyspnea exertional, dyspnea at rest, nocturnal dyspnea, dyspnea paroxysmal nocturnal

Bradycardia

In clinical studies BRILINTA has been shown to increase the occurrence of Holter-detected bradyarrhythmias (including ventricular pauses). PLATO excluded patients at increased risk of bradycardic events (e.g., patients who have sick sinus syndrome, 2nd or 3rd degree AV block, or bradycardic-related syncope and not protected with a pacemaker). In PLATO, syncope, pre-syncope and loss of consciousness were reported by 1.7% and 1.5% of BRILINTA and clopidogrel patients, respectively.

In a Holter substudy of about 3000 patients in PLATO, more patients had ventricular pauses with BRILINTA (6.0%) than with clopidogrel (3.5%) in the acute phase; rates were 2.2% and 1.6% respectively after 1 month.

Gynecomastia

In PLATO, gynecomastia was reported by 0.23% of men on BRILINTA and 0.05% on clopidogrel.

Other sex-hormonal adverse reactions, including sex organ malignancies, did not differ between the two treatment groups in PLATO.

Lab abnormalities

Serum Uric Acid

Serum uric acid levels increased approximately 0.6 mg/dL from baseline on BRILINTA and approximately 0.2 mg/dL on clopidogrel in PLATO. The difference disappeared within 30 days of discontinuing treatment. Reports of gout did not differ between treatment groups in PLATO (0.6% in each group).

Serum Creatinine

In PLATO, a > 50% increase in serum creatinine levels was observed in 7.4% of patients receiving BRILINTA compared to 5.9% of patients receiving clopidogrel. The increases typically did not progress with ongoing treatment and often decreased with continued therapy. Evidence of reversibility upon discontinuation was observed even in those with the greatest on treatment increases. Treatment groups in PLATO did not differ for renal-related serious adverse events such as acute renal failure, chronic renal failure, toxic nephropathy, or oliguria.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of BRILINTA. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune system disorders - Hypersensitivity reactions including angioedema [see CONTRAINDICATIONS].

Read the entire FDA prescribing information for Brilinta (Ticagrelor Tablets for Oral Administration) »

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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