Ticagrelor
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Jesus Rosario Hernandez, M.D. [2]; Sheng Shi, M.D. [3]
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Black Box Warning
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WARNING: (A) BLEEDING RISK, and (B) ASPIRIN DOSE AND Brilinta EFFECTIVENESS
See full prescribing information for complete Boxed Warning.
BLEEDING RISK:
Brilinta, like other antiplatelet agents, can cause significant, sometimes fatal bleeding. Do not use Brilinta in patients with active pathological bleeding or a history of intracranial hemorrhage. Do not start Brilinta in patients planned to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Brilinta 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 (PCI), CABG, or other surgery. If possible, manage bleeding without discontinuing Brilinta. Stopping Brilinta increases the risk of subsequent cardiovascular events.
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Overview
Ticagrelor is a P2Y12 platelet inhibitor, Platelet aggregation inhibitor that is FDA approved for the {{{indicationType}}} of acute coronary syndromes (ACS) (unstbale angina), non-ST elevation myocardial infarction, or ST elevation myocardial infarction).. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Major and minor bleeding, headache, elevated serum creatinine, cough and dyspnea.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Acute coronary syndromes
- Dosing Information
- Initial dose: “Brilinta 180 mg PO once” with aspirin (325 mg) once.
- Maintenance dose: “Brilinta 90 mg PO bid” with aspirin 75-100 mg PO qd.
- Not recommended when aspirin maintenance dose is above 100 mg.
Percutaneous coronary intervention
- Dosing Information
- Loading dose: “Brilinta 180 mg PO” with aspirin (325 mg), once.
- Maintenance: “Brilinta 90 mg PO bid” with aspirin 75-100 mg qd.
- Use of aspirin maintenance dose above 100 mg is not recommended.
- Consider carefully the continuation of therapy beyond 12 months (for drug-eluting stents).
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information about Off-Label Use and Dosage of Ticagrelor tablet in adult patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Use and Dosage of Ticagrelor tablet in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information about ‘’FDA-Labeled Indications and Dosage” of Ticagrelor tablet in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information about Off-Label Use and Dosage of Ticagrelor tablet in pediatric patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Use and Dosage of Ticagrelor tablet in pediatric patients.
Contraindications
- History of intracranial hemorrhage
- Active pathological bleeding
- Severe hepatic impairment
- Hypersensitivity to ticagrelor or any component of the product
Warnings
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WARNING: (A) BLEEDING RISK, and (B) ASPIRIN DOSE AND Brilinta EFFECTIVENESS
See full prescribing information for complete Boxed Warning.
BLEEDING RISK:
Brilinta, like other antiplatelet agents, can cause significant, sometimes fatal bleeding. Do not use Brilinta in patients with active pathological bleeding or a history of intracranial hemorrhage. Do not start Brilinta in patients planned to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Brilinta 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 (PCI), CABG, or other surgery. If possible, manage bleeding without discontinuing Brilinta. Stopping Brilinta increases the risk of subsequent cardiovascular events.
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- Like other antiplatelet agents, Brilinta increases the risk of bleeding.
- In PLATO, use of Brilinta with maintenance doses of aspirin above 100 mg decreased the effectiveness of Brilinta.
- Moderate Hepatic Impairment: Consider the risks and benefits of treatment, noting the probable increase in exposure to ticagrelor.
- Dyspnea: Dyspnea was reported more frequently with Brilinta than with clopidogrel. Dyspnea resulting from Brilinta is self-limiting. Rule out other causes.
- Discontinuation of Brilinta: Premature discontinuation increases the risk of myocardial infarction, stent thrombosis, and death.
Adverse Reactions
Clinical Trials Experience
Clinical Trials Experience
The following adverse reactions are also discussed elsewhere in the labeling: Warnings
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
Annualized rates of bleeding are summarized in Table 1 below. About half of the bleeding events were in the first 30 days.
As shown in Table 1, Ticagrelor 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 Ticagrelor 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 Ticagrelor and Clopidogrel.
Although the platelet inhibition effect of Ticagrelor has a faster offset than Clopidogrel in in vitro tests and Ticagrelor is a reversibly binding P2Y12 inhibitor, PLATO did not show an advantage of Ticagrelor compared to Clopidogrel for CABG-related bleeding. When antiplatelet therapy was stopped 5 days before CABG, major bleeding occurred in 75% of Ticagrelor treated patients and 79% on Clopidogrel.
No data exist with Ticagrelor 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 Ticagrelor and 5.4% for clopidogrel. Bleeding caused permanent discontinuation of study drug in 2.3% of Ticagrelor patients and 1.0% of clopidogrel patients. Dyspnea led to study drug discontinuation in 0.9% of Ticagrelor 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 Ticagrelor or clearly related to the drug’s pharmacologic effect (dyspnea).
Bradycardia
In clinical studies Ticagrelor 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 Ticagrelor (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 Ticagrelor 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 Ticagrelor 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.
Drug Interactions
Effects of other drugs
Ticagrelor is predominantly metabolized by CYP3A4 and to a lesser extent by CYP3A5. Ticagrelor is also a p-glycoprotein (P-gp) substrate.
CYP3A inhibitors
Avoid use of strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromycin). See Warnings and Pharmacology.
CYP3A inducers
Avoid use with potent inducers of CYP3A (e.g., rifampin, dexamethasone, phenytoin, carbamazepine and phenobarbital) See #Contraindications⎪Contraindications, Pharmacology and Warnings.
Aspirin
See Pharmacology and Warnings.
Effect of ticagrelor on other drugs.
Ticagrelor is an inhibitor of CYP3A4/5 and the P-glycoprotein transporter.
Simvastatin, lovastatin
Brilinta will result in higher serum concentrations of simvastatin and lovastatin because these drugs are metabolized by CYP3A4. Avoid simvastatin and lovastatin doses greater than 40 mg. See Pharmacology.
Digoxin
Digoxin: Because of inhibition of the P-glycoprotein transporter, monitor digoxin levels with initiation of or any change in ticagrelor therapy. See Pharmacology
Other Concomitant Therapy
BRILINTA can be administered with unfractionated or low-molecular-weight heparin, GPIIb/IIIa inhibitors, proton pump inhibitors, beta-blockers, angiotensin converting enzyme inhibitors, and angiotensin receptor blockers.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): C There are no adequate and well-controlled studies of BRILINTA use in pregnant women. In animal studies, ticagrelor caused structural abnormalities at maternal doses about 5 to 7 times the maximum recommended human dose (MRHD) based on body surface area. BRILINTA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
In reproductive toxicology studies, pregnant rats received ticagrelor during organogenesis at doses from 20 to 300 mg/kg/day. The lowest dose was approximately the same as the MRHD of 90 mg twice daily for a 60 kg human on a mg/m2 basis. Adverse outcomes in offspring occurred at doses of 300 mg/kg/day (16.5 times the MRHD on a mg/m2 basis) and included supernumerary liver lobe and ribs, incomplete ossification of sternebrae, displaced articulation of pelvis, and misshapen/misaligned sternebrae. When pregnant rabbits received ticagrelor during organogenesis at doses from 21 to 63 mg/kg/day, fetuses exposed to the highest maternal dose of 63 mg/kg/day (6.8 times the MRHD on a mg/m2 basis) had delayed gall bladder development and incomplete ossification of the hyoid, pubis and sternebrae occurred.
In a prenatal/postnatal study, pregnant rats received ticagrelor at doses of 10 to 180 mg/kg/day during late gestation and lactation. Pup death and effects on pup growth were observed at 180 mg/kg/day (approximately 10 times the MRHD on a mg/m2 basis). Relatively minor effects such as delays in pinna unfolding and eye opening occurred at doses of 10 and 60 mg/kg (approximately one-half and 3.2 times the MRHD on a mg/m2 basis).
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ticagrelor in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ticagrelor during labor and delivery.
Nursing Mothers
It is not known whether ticagrelor or its active metabolites are excreted in human milk. Ticagrelor is excreted in rat 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.
Pediatric Use
The safety and effectiveness of BRILINTA in pediatric patients have not been established.
Geriatic Use
In PLATO, 43% of patients were ≥65 years of age and 15% were ≥75 years of age. The relative risk of bleeding was similar in both treatment and age groups.
No overall differences in safety or effectiveness were observed between these patients and younger patients. While this clinical experience has not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.
Gender
There is no FDA guidance on the use of Ticagrelor with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ticagrelor with respect to specific racial populations.
Renal Impairment
No dosage adjustment is needed in patients with renal impairment. Patients receiving dialysis have not been studied [see Clinical Pharmacology (12.3)].
Hepatic Impairment
BRILINTA has not been studied in the patients with moderate or severe hepatic impairment. Ticagrelor is metabolized by the liver and impaired hepatic function can increase risks for bleeding and other adverse events. Hence, BRILINTA is contraindicated for use in patients with severe hepatic impairment and its use should be considered carefully in patients with moderate hepatic impairment. No dosage adjustment is needed in patients with mild hepatic impairment [see Contraindications (4), Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ticagrelor in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Ticagrelor in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Ticagrelor Administration in the drug label.
Monitoring
There is limited information regarding Ticagrelor Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Ticagrelor and IV administrations.
Overdosage
There is limited information regarding Ticagrelor overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Ticagrelor Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Ticagrelor Mechanism of Action in the drug label.
Structure
There is limited information regarding Ticagrelor Structure in the drug label.
Pharmacodynamics
There is limited information regarding Ticagrelor Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Ticagrelor Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Ticagrelor Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Ticagrelor Clinical Studies in the drug label.
How Supplied
There is limited information regarding Ticagrelor How Supplied in the drug label.
Storage
There is limited information regarding Ticagrelor Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
See FDA-approved patient labeling (Medication Guide)
Benefits and Risks
- Tell patients to take BRILINTA exactly as prescribed.
- Inform patients not to discontinue BRILINTA without discussing it with the prescribing physician.
- Tell patients daily doses of aspirin should not exceed 100 mg and to avoid taking any other medications that contain aspirin.
- Tell patients to read the Medication Guide.
Bleeding
- Inform 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.
Other Signs and Symptoms Requiring Medical Attention
- Inform patients that BRILINTA can cause shortness of breath. Tell them to contact their doctor if they experience unexpected shortness of breath, especially if severe.
Invasive Procedures
Instruct patients to:
- Inform physicians and dentists that they are taking BRILINTA before any surgery or dental procedure.
- Tell the doctor performing any surgery or dental procedure to talk to the prescribing physician before stopping BRILINTA.
Concomitant Medications
Tell patients to list all prescription medications, over-the-counter medications or dietary supplements they are taking or plan to take so the physician knows about other treatments that may affect bleeding risk (e.g. warfarin, heparin).
Issued: 12/2013
BRILINTA® is a trademark of the AstraZeneca group of companies.
Distributed by: AstraZeneca LP, Wilmington, DE 19850 © AstraZeneca 2011, 2013 MEDICATION GUIDE BRILINTA® (brih-LIN-tah) (ticagrelor)
Tablets
Read this Medication Guide before you start taking BRILINTA and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
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. When instructed by your doctor, you should stop taking BRILINTA 5 days before you have elective 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 treat people who:
- have had a recent heart attack or severe chest pain that happened because their heart was not getting enough oxygen.
- have had a heart attack or chest pain and are being treated with medicines or with a procedure to open blocked arteries in the heart.
BRILINTA is used with aspirin to lower your chance of having another serious problem with your heart or blood vessels, such as heart attack, stroke, or blood clots in your stent. These can be fatal. Platelets are blood cells that help with normal blood clotting. BRILINTA helps prevent platelets from sticking together and forming a clot that can block an artery. It is not known if BRILINTA is safe and effective in children.
Who should not take BRILINTA?
Do not take BRILINTA if you:
- are bleeding now
- have a history of bleeding in the brain
- have bleeding from your stomach or intestine now (an ulcer)
- have severe liver problems
- 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.
What should I tell my doctor before taking BRILINTA?
Before you take BRILINTA, tell your doctor 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 non-prescription 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
- an anti-fungal medicine by mouth
- an anti-seizure medicine
- a blood thinner medicine
- rifampin (Rifater, Rifamate, Rimactane, Rifadin)
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 two 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.
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.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of BRILINTA. For more information, ask your doctor or pharmacist. 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 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. This Medication Guide summarizes the most important information about BRILINTA. If you would like more information about BRILINTA, talk with your doctor. You can ask your pharmacist or doctor for information about BRILINTA that is written for health professionals. For more information call 1-800-236-9933 or go to www.Brilinta.com.
What are the ingredients in BRILINTA?
Active ingredient: ticagrelor 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.
Precautions with Alcohol
Alcohol-Ticagrelor interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Ticagrelor Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Ticagrelor Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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