Ticagrelor 60 mg Tablet, Film Coated, 60-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the P2Y12 Platelet Inhibitor class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Ticagrelor is used to: reduce risk of heart attack or stroke in certain high-risk patients. reduce risk of blood clots in certain high-risk patients. Ticagrelor is in a class of medications called antiplatelet medications. It works by preventing platelets (a type of blood cell) from collecting and forming clots that may cause a heart attack or stroke.
Read the full MedlinePlus article ↗- Because of how quickly your body clears ticagrelor — its half-life is only about 7 hours — twice-daily dosing is needed to keep enough of the drug in your system to protect you aro...
- Why do I have to take ticagrelor twice a day — can I just take it once?
- Shortness of breath is actually one of the more common side effects of ticagrelor — roughly 1 in 7 people experience it. The good news is it's usually mild to moderate, it doesn't...
- I've been feeling short of breath since I started ticagrelor. Should I be worried?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ticagrelor — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
UNII O7TSZ97GEP
A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
-
UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
-
UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
-
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
-
UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
11 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.303 | $18.19 / 60 tablets |
| Medicaid paysCMS SDUD · 12 mo | $4.76 | $285.82 / 60 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.9921 | $59.53 / 60 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ticagrelor 60 mgthis 00378-2214-91 | Mylan | 60 tablets | $0.303 | AB | Availability likely | — |
| Ticagrelor 60 mg 00480-2688-06 | Teva | 60 tablets | $0.303 | AB | Availability likely | — |
| Ticagrelor 60 mg 11788-0157-60 | AiPing | 60 tablets | $0.303 | AB | Availability likely | — |
| Ticagrelor 60 mg 33342-0431-09 | Macleods | 60 tablets | $0.303 | AB | Availability likely | — |
| Ticagrelor 60 mg 60505-4453-06 | Apotex | 60 tablets | $0.303 | AB | Availability likely | — |
| Ticagrelor 60 mg 60687-0935-21 | American | 30 tablets | $0.303 | AB | Availability likely | — |
| Ticagrelor 60 mg 62332-0500-60 | Alembic | 60 tablets | $0.303 | AB | Availability likely | — |
| Ticagrelor 60 mg 69452-0508-17 | BIONPHARMA | 60 tablets | $0.303 | AB | Availability likely | — |
| Ticagrelor 60 mg 72205-0406-01 | Novadoz | 60 tablets | $0.303 | AB | Availability likely | — |
| Ticagrelor 60 mg 72516-0017-06 | Oryza | 60 tablets | $0.303 | AB | Availability likely | — |
| Brilinta 60 mg 00186-0776-60 | AstraZeneca | 60 tablets | $7.421 | AB | Availability likely | +2348% |
| Ticagrelor 60 mg 43598-0629-18 | Dr. | 180 tablets | — | AB | FDA listed | — |
| Ticagrelor 60 mg 46708-0500-60 | Alembic | 60 tablets | — | AB | FDA listed | — |
| ticagrelor 60 mg 50228-0521-10 | ScieGen | 1000 tablets | — | AB | FDA listed | — |
| Ticagrelor 60 mg 55488-0544-01 | Changzhou | 60 tablets | — | AB | FDA listed | — |
| Ticagrelor 60 mg 67877-0522-05 | Ascend | 500 tablets | — | AB | FDA listed | — |
| Ticagrelor 60 mg 69097-0989-03 | Cipla | 60 tablets | — | AB | FDA listed | — |
| Ticagrelor 60 mg 70756-0047-60 | Lifestar | 60 tablets | — | AB | FDA listed | — |
| Ticagrelor 60 mg 73190-0003-60 | AvKARE | 60 tablets | — | AB | FDA listed | — |
| Ticagrelor 60 mg 76282-0584-01 | Exelan | 100 tablets | — | AB | FDA listed | — |
| ticagrelor 60 mg 77771-0521-60 | Radha | 60 tablets | — | AB | FDA listed | — |
| Ticagrelor 60 mg 72603-0940-01 | NorthStar | 60 tablets | — | AB | FDA listed | — |
| Ticagrelor 60 mg 42385-0993-01 | Laurus | 100 tablets | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00378-2214-91 You're viewing this | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2214-91) | 2025-09-25 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: BLEEDING RISK • Ticagrelor tablets, like other antiplatelet agents, can cause significant, sometimes fatal bleeding ( 5.1 , 6.1 ). • Do not use ticagrelor tablets in patients with active pathological bleeding or a history of intracranial hemorrhage ( 4.1 , 4.2 ). • Do not start ticagrelor tablets in patients undergoing urgent coronary artery bypass graft surgery (CABG) ( 5.1 , 6.1 ). • If possible, manage bleeding without discontinuing ticagrelor tablets. Stopping ticagrelor tablets increases the risk of subsequent cardiovascular events ( 5.2 ).
WARNING: BLEEDING RISK See full prescribing information for complete boxed warning. • Ticagrelor tablets, like other antiplatelet agents, can cause significant, sometimes fatal bleeding. ( 5.1 , 6.1 ) • Do not use ticagrelor tablets in patients with active pathological bleeding or a history of intracranial hemorrhage. ( 4.1 , 4.2 ) • Do not start ticagrelor tablets in patients undergoing urgent coronary artery bypass graft surgery (CABG).
( 5.1 , 6.1 ) • If possible, manage bleeding without discontinuing ticagrelor tablets. Stopping ticagrelor tablets increases the risk of subsequent cardiovascular events. ( 5.2 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Ticagrelor tablets are a P2Y 12 platelet inhibitor indicated • to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor tablets also reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS.
( 1.1 ) • to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor tablets was established in a population with type 2 diabetes mellitus (T2DM). ( 1.2 ) • to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤ 5) or high-risk transient ischemic attack (TIA).
( 1.3 )
1.1Acute Coronary Syndrome or a History of Myocardial Infarction Ticagrelor tablets are indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor tablets also reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS [see Clinical Studies (14.1) ] .
1.2Coronary Artery Disease but No Prior Stroke or Myocardial Infarction Ticagrelor tablets are indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events [see Clinical Studies (14.2) ] . While use is not limited to this setting, the efficacy of ticagrelor tablets was established in a population with type 2 diabetes mellitus (T2DM).
1.3Acute Ischemic Stroke or Transient Ischemic Attack (TIA) Ticagrelor tablets are indicated to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤ 5) or high-risk transient ischemic attack (TIA) [see Clinical Studies (14.3) ] .
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • ACS or History of MI o Initiate treatment with 180 mg oral loading dose of ticagrelor tablets. Then administer 90 mg twice daily during the first year. After one year, administer 60 mg twice daily.
( 2.2 ) • Patients with CAD and No Prior Stroke or MI o Administer 60 mg ticagrelor tablets twice daily. ( 2.3 ) • Acute Ischemic Stroke o Initiate treatment with a 180 mg loading dose of ticagrelor tablets then continue with 90 mg twice daily for up to 30 days. ( 2.4 ) Use ticagrelor tablets with a daily maintenance dose of aspirin of 75-100 mg.
( 2 ) However, in patients who have undergone PCI, consider single antiplatelet therapy with ticagrelor tablets based on the evolving risk for thrombotic versus bleeding events. ( 2.2 )
2.1General Instructions Advise patients who miss a dose of ticagrelor tablets to take their next dose at its scheduled time. For patients who are unable to swallow tablets whole, ticagrelor tablets can be crushed, mixed with water, and drunk. The mixture can also be administered via a nasogastric tube (CH8 or greater) [see Clinical Pharmacology (12.3) ] .
Do not administer ticagrelor tablets with another oral P2Y 12 platelet inhibitor. Avoid aspirin at doses higher than recommended [see Clinical Studies (14.1) ] .
2.2Acute Coronary Syndrome or a History of Myocardial Infarction Initiate treatment with a 180 mg loading dose of ticagrelor tablets. Administer the first 90 mg maintenance dose of ticagrelor tablets, 6 to 12 hours after the loading dose. Administer 90 mg of ticagrelor tablets twice daily during the first year after an ACS event.
After one year, administer 60 mg of ticagrelor tablets twice daily. Initiate ticagrelor tablets with a daily maintenance dose of aspirin of 75 mg to 100 mg. However, in patients who have undergone percutaneous coronary intervention (PCI), consider single antiplatelet therapy with ticagrelor tablets based on the evolving risk for thrombotic versus bleeding events [see Warnings and Precautions (5.1) and Clinical Studies (14) ] .
2.3Coronary Artery Disease but No Prior Stroke or Myocardial Infarction Administer 60 mg of ticagrelor tablets twice daily. Generally, use ticagrelor tablets with a daily maintenance dose of aspirin of 75 mg to 100 mg [see Clinical Studies (14) ] .
2.4Acute Ischemic Stroke or Transient Ischemic Attack (TIA) Initiate treatment with a 180 mg loading dose of ticagrelor tablets and then continue with 90 mg twice daily for up to 30 days. Administer the first maintenance dose 6 to 12 hours after the loading dose. Use ticagrelor tablets with a loading dose of aspirin (300 mg to 325 mg) and a daily maintenance dose of aspirin of 75 mg to 100 mg [see Clinical Studies (14) ] .
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Ticagrelor Tablets are available containing 60 mg or 90 mg of ticagrelor. • The 60 mg tablets are yellow, film-coated, round, unscored tablets debossed with M on one side of the tablet and TC1 on the other side. • The 90 mg tablets are yellow, film-coated, round, unscored tablets debossed with M on one side of the tablet and TC on the other side. • 60 mg and 90 mg tablets. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS • History of intracranial hemorrhage. ( 4.1 ) • Active pathological bleeding. ( 4.2 ) • Hypersensitivity to ticagrelor or any component of the product. ( 4.3 )
4.1History of Intracranial Hemorrhage Ticagrelor tablets are contraindicated in patients with a history of intracranial hemorrhage (ICH) because of a high risk of recurrent ICH in this population [see Clinical Studies (14.1 , 14.2) ] .
4.2Active Bleeding Ticagrelor tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ].
4.3Hypersensitivity Ticagrelor tablets are contraindicated in patients with hypersensitivity (e.g., angioedema) to ticagrelor or any component of the product.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Dyspnea was reported more frequently with ticagrelor tablets than with control agents in clinical trials. Dyspnea from ticagrelor tablets is self-limiting. ( 5.3 ) • Severe Hepatic Impairment: Likely increase in exposure to ticagrelor.
( 5.5 ) • Laboratory Test Interference: False negative platelet functional test results have been reported for Heparin Induced Thrombocytopenia (HIT). Ticagrelor tablets are not expected to impact PF4 antibody testing for HIT. ( 5.7 )
5.1Risk of Bleeding Drugs that inhibit platelet function including ticagrelor tablets increase the risk of bleeding [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . Patients treated for acute ischemic stroke or TIA Patients at NIHSS > 5 and patients receiving thrombolysis were excluded from THALES and use of ticagrelor tablets in such patients is not recommended.
5.2Discontinuation of Ticagrelor Tablets in Patients Treated for Coronary Artery Disease Discontinuation of ticagrelor tablets will increase the risk of myocardial infarction, stroke, and death in patients being treated for coronary artery disease. If ticagrelor tablets must be temporarily discontinued (e.g., to treat bleeding or for significant surgery), restart them as soon as possible. When possible, interrupt therapy with ticagrelor tablets for five days prior to surgery that has a major risk of bleeding.
Resume ticagrelor tablets as soon as hemostasis is achieved.
5.3Dyspnea In clinical trials, about 14% (PLATO and PEGASUS) to 21% (THEMIS) of patients treated with ticagrelor tablets developed dyspnea. Dyspnea was usually mild to moderate in intensity and often resolved during continued treatment but led to study drug discontinuation in 0.9% (PLATO), 1.0% (THALES), 4.3% (PEGASUS), and 6.9% (THEMIS) of patients. In a substudy of PLATO, 199 subjects underwent pulmonary function testing irrespective of whether they reported dyspnea.
There was no indication of an adverse effect on pulmonary function assessed after one month or after at least 6 months of chronic treatment. If a patient develops new, prolonged, or worsened dyspnea that is determined to be related to ticagrelor tablets, no specific treatment is required; continue ticagrelor tablets without interruption if possible. In the case of intolerable dyspnea requiring discontinuation of ticagrelor tablets, consider prescribing another antiplatelet agent.
5.4Bradyarrhythmias Ticagrelor tablets can cause ventricular pauses [see Adverse Reactions (6.1) ] . Bradyarrhythmias including AV block have been reported in the postmarketing setting. Patients with a history of sick sinus syndrome, 2 nd or 3 rd degree AV block or bradycardia-related syncope not protected by a pacemaker were excluded from clinical studies and may be at increased risk of developing bradyarrhythmias with ticagrelor.
5.5Severe Hepatic Impairment Avoid use of ticagrelor tablets in patients with severe hepatic impairment. Severe hepatic impairment is likely to increase serum concentration of ticagrelor. There are no studies of ticagrelor tablets patients with severe hepatic impairment [see Clinical Pharmacology (12.3) ].
5.6Central Sleep Apnea Central sleep apnea (CSA) including Cheyne-Stokes respiration (CSR) has been reported in the post-marketing setting in patients taking ticagrelor, including recurrence or worsening of CSA/CSR following rechallenge. If central sleep apnea is suspected, consider further clinical assessment.
5.7Laboratory Test Interferences False negative functional tests for Heparin Induced Thrombocytopenia (HIT) Ticagrelor tablets have been reported to cause false negative results in platelet functional tests (including the heparin-induced platelet aggregation (HIPA) assay) for patients with Heparin Induced Thrombocytopenia (HIT). This is related to inhibition of the P2Y 12 -receptor on the healthy donor platelets in the test by ticagrelor in the affected patient’s serum/plasma. Information on concomitant treatme…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: • Bleeding [see Warnings and Precautions (5.1) ] • Dyspnea [see Warnings and Precautions (5.3) ] Most common adverse reactions (˃ 5%) are bleeding and dyspnea. ( 5.1 , 5.3 , 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience 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. Ticagrelor tablets have been evaluated for safety in more than 58,000 patients. Bleeding in PLATO (Reduction in risk of thrombotic events in ACS) Figure 1 is a plot of time to the first non-CABG major bleeding event.
Figure 1: Kaplan-Meier estimate of time to first non-CABG PLATO-defined major bleeding event (PLATO) Frequency of bleeding in PLATO is summarized in Tables 1 and 2. About half of the non-CABG major bleeding events were in the first 30 days. Table 1: Non-CABG related bleeds (PLATO) PLATO Minor bleed: requires medical intervention to stop or treat bleeding.
PLATO Major bleed: any one of the following: fatal; intracranial; intrapericardial with cardiac tamponade; hypovolemic shock or severe hypotension requiring intervention; significantly disabling (e.g., intraocular with permanent vision loss); associated with a decrease in Hb of at least 3 g/dL (or a fall in hematocrit (Hct) of at least 9%); transfusion of 2 or more units. PLATO Major bleed, fatal/life-threatening: any major bleed as described above and associated with a decrease in Hb of more than 5 g/dL (or a fall in hematocrit (Hct) of at least 15%); transfusion of 4 or more units.
Fatal: A bleeding event that directly led to death within 7 days. Ticagrelor Tablets 90 mg BID N = 9235 Clopidogrel N = 9186 n (%) patients with event n (%) patients with event PLATO Major + Minor 713 (7.7) 567 (6.2) Major 362 (3.9) 306 (3.3) Fatal/Life-threatening 171 (1.9) 151 (1.6) Fatal 15 (0.2) 16 (0.2) Intracranial hemorrhage (Fatal/Life-threatening) 26 (0.3) 15 (0.2) No baseline demographic factor altered the relative risk of bleeding with ticagrelor tablets compared to clopidogrel. In PLATO, 1584 patients underwent CABG surgery.
The percentages of those patients who bled are shown in Figure 2 and Table 2. Figure 2: ‘Major fatal/life-threatening’ CABG-related bleeding by days from last dose of study drug to CABG procedure (PLATO) X-axis is days from last dose of study drug prior to CABG. The PLATO protocol recommended a procedure for withholding study drug prior to CABG or other major surgery without unblinding.
If surgery was elective or non-urgent, study drug was interrupted temporarily, as follows: If local practice was to allow antiplatelet effects to dissipate before surgery, capsules (blinded clopidogrel) were withheld 5 days before surgery and tablets (blinded ticagrelor) were withheld for a minimum of 24 hours and a maximum of 72 hours before surgery. If local practice was to perform surgery without waiting for dissipation of antiplatelet effects capsules and tablets were withheld 24 hours prior to surgery and use of aprotinin or other hemostatic agents was allowed.
If local practice was to use IPA monitoring to determine when surgery could be performed both the capsules and tablets were withheld at the same time and the usual monitoring procedures followed. T Ticagrelor; C Clopidogrel. Table 2: CABG-related bleeding (PLATO) PLATO Major bleed: any one of the following: fatal; intracranial; intrapericardial with cardiac tamponade; hypovolemic shock or severe hypotension requiring intervention; significantly disabling (e.g., intraocular with permanent vision loss); associated with a decrease in Hb of at least 3 g/dL (or a fall in hematocrit (Hct) of at least 9%); transfusi…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Avoid use with strong CYP3A inhibitors or CYP3A inducers. ( 7.1 , 7.2 ) • Opioids: Decreased exposure to ticagrelor. Consider use of parenteral anti-platelet agent.
( 7.3 ) • Patients receiving more than 40 mg per day of simvastatin or lovastatin may be at increased risk of statin-related adverse effects. ( 7.4 ) • Rosuvastatin plasma concentrations may increase. Monitor for statin-related adverse effects.
( 7.4 ) • Monitor digoxin levels with initiation of or any change in ticagrelor tablets. ( 7.5 )
7.1Strong CYP3A Inhibitors Strong CYP3A inhibitors substantially increase ticagrelor exposure and so increase the risk of dyspnea, bleeding, and other adverse events. Avoid use of strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromycin) [see Clinical Pharmacology (12.3) ].
7.2Strong CYP3A Inducers Strong CYP3A inducers substantially reduce ticagrelor exposure and so decrease the efficacy of ticagrelor. Avoid use with strong inducers of CYP3A (e.g., rifampin, phenytoin, carbamazepine and phenobarbital) [see Clinical Pharmacology (12.3) ].
7.3Opioids As with other oral P2Y 12 inhibitors, co-administration of opioid agonists delay and reduce the absorption of ticagrelor and its active metabolite presumably because of slowed gastric emptying [see Clinical Pharmacology (12.3) ] . Consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring co-administration of morphine or other opioid agonists.
7.4Simvastatin, Lovastatin, Rosuvastatin Ticagrelor tablets increase serum concentrations of simvastatin and lovastatin because these drugs are metabolized by CYP3A4. Avoid simvastatin and lovastatin doses greater than 40 mg [see Clinical Pharmacology (12.3) ]. Ticagrelor tablets increase serum concentration of rosuvastatin because rosuvastatin is a BCRP substrate [see Clinical Pharmacology (12.3) ] .
7.5Digoxin Ticagrelor tablets inhibit the P-glycoprotein transporter; monitor digoxin levels with initiation of or change in ticagrelor tablets therapy [see Clinical Pharmacology (12.3) ].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Lactation: Breastfeeding not recommended. ( 8.2 )
8.1Pregnancy Risk Summary Available data from case reports with ticagrelor tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Ticagrelor given to pregnant rats and pregnant rabbits during organogenesis caused structural abnormalities in the offspring at maternal doses about 5 to 7 times the maximum recommended human dose (MRHD) based on body surface area. When ticagrelor was given to rats during late gestation and lactation, pup death and effects on pup growth were seen at approximately 10 times the MRHD (see Data ) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data In reproductive toxicology studies, pregnant rats received ticagrelor during organogenesis at doses from 20 to 300 mg/kg/day. 20 mg/kg/day is approximately the same as the MRHD of 90 mg twice daily for a 60 kg human on a mg/m 2 basis. Adverse outcomes in offspring occurred at doses of 300 mg/kg/day (16.5 times the MRHD on a mg/m 2 basis) and included supernumerary liver lobe and ribs, incomplete ossification of sternebrae, displaced articulation of pelvis, and misshapen/misaligned sternebrae.
At the mid-dose of 100 mg/kg/day (5.5 times the MRHD on a mg/m 2 basis), delayed development of liver and skeleton was seen. 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/m 2 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/m 2 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/m 2 basis).
8.2Lactation Risk Summary There are no data on the presence of ticagrelor or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Ticagrelor and its metabolites were present in rat milk at higher concentrations than in maternal plasma. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Breastfeeding is not recommended during treatment with ticagrelor tablets.
8.4Pediatric Use The safety and effectiveness of ticagrelor tablets have not been established in pediatric patients. Effectiveness was not demonstrated in an adequate and well-controlled study conducted in 101 ticagrelor tablets-treated pediatric patients, aged 2 to < 18 for reducing the rate of vaso-occlusive crises in sickle cell disease.
8.5Geriatric Use About half of the patients in PLATO, PEGASUS, THEMIS, and THALES were ≥ 65 years of age and at least 15% were ≥ 75 years of age. No overall differences in safety or effectiveness were observed between elderly and younger patients.
8.6Hepatic Impairment Ticagrelor is metabolized by the liver and impaired hepatic function can increase risks for bleeding and other adverse events. Avoid use of ticagrelor tablets in patients with severe hepatic impairment. There is limited experience with ticagrelor tablets in patients with moderate hepatic impairment; consider the risks and benefits of treatment, noting the probable increase in exposure to ticagrelor.
No dosage adjustment is needed in patients with mild hepatic…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from case reports with ticagrelor tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Ticagrelor given to pregnant rats and pregnant rabbits during organogenesis caused structural abnormalities in the offspring at maternal doses about 5 to 7 times the maximum recommended human dose (MRHD) based on body surface area. When ticagrelor was given to rats during late gestation and lactation, pup death and effects on pup growth were seen at approximately 10 times the MRHD (see Data ) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data In reproductive toxicology studies, pregnant rats received ticagrelor during organogenesis at doses from 20 to 300 mg/kg/day. 20 mg/kg/day is approximately the same as the MRHD of 90 mg twice daily for a 60 kg human on a mg/m 2 basis. Adverse outcomes in offspring occurred at doses of 300 mg/kg/day (16.5 times the MRHD on a mg/m 2 basis) and included supernumerary liver lobe and ribs, incomplete ossification of sternebrae, displaced articulation of pelvis, and misshapen/misaligned sternebrae.
At the mid-dose of 100 mg/kg/day (5.5 times the MRHD on a mg/m 2 basis), delayed development of liver and skeleton was seen. 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/m 2 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/m 2 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/m 2 basis).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of ticagrelor tablets have not been established in pediatric patients. Effectiveness was not demonstrated in an adequate and well-controlled study conducted in 101 ticagrelor tablets-treated pediatric patients, aged 2 to < 18 for reducing the rate of vaso-occlusive crises in sickle cell disease.
🧓 Geriatric Use ▾
8.5Geriatric Use About half of the patients in PLATO, PEGASUS, THEMIS, and THALES were ≥ 65 years of age and at least 15% were ≥ 75 years of age. No overall differences in safety or effectiveness were observed between elderly and younger patients.
🆘 Overdosage ▾
10 OVERDOSAGE There is currently no known treatment to reverse the effects of ticagrelor tablets, and ticagrelor is not dialyzable. Treatment of overdose should follow local standard medical practice. Bleeding is the expected pharmacologic effect of overdosing.
If bleeding occurs, appropriate supportive measures should be taken. Platelet transfusion did not reverse the antiplatelet effect of ticagrelor tablets in healthy volunteers and is unlikely to be of clinical benefit in patients with bleeding. Other effects of overdose may include gastrointestinal effects (nausea, vomiting, diarrhea) or ventricular pauses.
Monitor the ECG.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Ticagrelor and its major metabolite reversibly interact with the platelet P2Y 12 ADP-receptor to prevent signal transduction and platelet activation. Ticagrelor and its active metabolite are approximately equipotent.
12.2Pharmacodynamics The inhibition of platelet aggregation (IPA) by ticagrelor and clopidogrel was compared in a 6-week study examining both acute and chronic platelet inhibition effects in response to 20 μM ADP as the platelet aggregation agonist. The onset of IPA was evaluated on Day 1 of the study following loading doses of 180 mg ticagrelor or 600 mg clopidogrel. As shown in Figure 5, IPA was higher in the ticagrelor group at all time points.
The maximum IPA effect of ticagrelor was reached at around 2 hours, and was maintained for at least 8 hours. The offset of IPA was examined after 6 weeks on ticagrelor 90 mg twice daily or clopidogrel 75 mg daily, again in response to 20 μM ADP. As shown in Figure 6, mean maximum IPA following the last dose of ticagrelor was 88% and 62% for clopidogrel.
The insert in Figure 6 shows that after 24 hours, IPA in the ticagrelor group (58%) was similar to IPA in clopidogrel group (52%), indicating that patients who miss a dose of ticagrelor would still maintain IPA similar to the trough IPA of patients treated with clopidogrel. After 5 days, IPA in the ticagrelor group was similar to IPA in the placebo group. It is not known how either bleeding risk or thrombotic risk track with IPA, for either ticagrelor or clopidogrel.
Figure 5: Mean inhibition of platelet aggregation (± SE) following single oral doses of placebo, 180 mg ticagrelor or 600 mg clopidogrel Figure 6: Mean inhibition of platelet aggregation (IPA) following 6 weeks on placebo, ticagrelor 90 mg twice daily, or clopidogrel 75 mg daily Transitioning from clopidogrel to ticagrelor tablets resulted in an absolute IPA increase of 26.4% and from ticagrelor tablets to clopidogrel resulted in an absolute IPA decrease of 24.5%. Patients can be transitioned from clopidogrel to ticagrelor tablets without interruption of antiplatelet effect [see Dosage and Administration (2) ].
Figure 5: Mean Inhibition of Platelet Aggregation (± SE) Following Single Oral Doses of Placebo, 180 mg Ticagrelor or 600 mg Clopidogrel Figure 6: Mean Inhibition of Platelet Aggregation (IPA) Following 6 Weeks on Placebo, Ticagrelor 90 mg Twice Daily, or Clopidogrel 75 mg Daily
12.3Pharmacokinetics Ticagrelor demonstrates dose proportional pharmacokinetics, which are similar in patients and healthy volunteers. Absorption Ticagrelor tablets can be taken with or without food. Absorption of ticagrelor occurs with a median t max of 1.5 h (range 1.0-4.0).
The formation of the major circulating metabolite AR-C124910XX (active) from ticagrelor occurs with a median t max of 2.5 h (range 1.5-5.0). The mean absolute bioavailability of ticagrelor is about 36% (range 30%-42%). Ingestion of a high-fat meal had no effect on ticagrelor C max , but resulted in a 21% increase in AUC.
The C max of its major metabolite was decreased by 22% with no change in AUC. Ticagrelor as crushed tablets mixed in water, given orally or administered through a nasogastric tube into the stomach, is bioequivalent to whole tablets (AUC and C max within 80-125% for ticagrelor and AR-C124910XX) with a median t max of 1.0 hour (range 1.0-4.0) for ticagrelor and 2.0 hours (range 1.0-8.0) for AR-C124910XX. Distribution The steady state volume of distribution of ticagrelor is 88 L.
Ticagrelor and the active metabolite are extensively bound to human plasma proteins (> 99%). Metabolism CYP3A4 is the major enzyme responsible for ticagrelor metabolism and the formation of its major active metabolite. Ticagrelor and its major active metabolite are weak P-glycoprotein substrates and inhibitors.
The systemic exposure to the active metabolite is approximately 30-40% of the exposure of ticagrelor. Ticagrelor is a BCRP inhibitor. Excretion The primary…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Ticagrelor and its major metabolite reversibly interact with the platelet P2Y 12 ADP-receptor to prevent signal transduction and platelet activation. Ticagrelor and its active metabolite are approximately equipotent.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Ticagrelor Tablets are available containing 60 mg or 90 mg of ticagrelor. The 60 mg tablets are yellow, film-coated, round, unscored tablets debossed with M on one side of the tablet and TC1 on the other side. They are available as follows: NDC 0378-2214-91 bottles of 60 tablets NDC 0378-2214-80 bottles of 180 tablets NDC 0378-2214-05 bottles of 500 tablets The 90 mg tablets are yellow, film-coated, round, unscored tablets debossed with M one one side of the tablet and TC on the other side.
They are available as follows: NDC 0378-2215-91 bottles of 60 tablets NDC 0378-2215-80 bottles of 180 tablets NDC 0378-2215-05 bottles of 500 tablets Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
📋 Description ▾
11 DESCRIPTION Ticagrelor tablets contain ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y 12 ADP-receptor. Chemically it is (1 S ,2 S ,3 R ,5 S )-3-[7-{[(1 R ,2 S )-2-(3,4-Difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3 H -[1,2,3]triazolo [4,5- d ] pyrimidin-3-yl]-5-(2-hydroxyethoxy) cyclopentane -1,2-diol. The molecular formula of ticagrelor is C 23 H 28 F 2 N 6 O 4 S and its molecular weight is 522.57.
The chemical structure of ticagrelor is: Ticagrelor is a white or off white to pale pink powder with an aqueous solubility of approximately 10 µg/mL at room temperature. Ticagrelor 60 mg tablets and 90 mg tablets for oral administration contain 60 mg or 90 mg of ticagrelor, respectively, and the following ingredients: black iron oxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, titanium dioxide, triacetin and yellow iron oxide.
The 60 mg and 90 mg ticagrelor tablets each contain 5 mg of phosphorus. Ticagrelor Structural Formula
💬 Information for Patients ▾
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 ticagrelor tablets before any surgery or dental procedure. Advise women that breastfeeding is not recommended during treatment with ticagrelor tablets [see Use in Specific Populations (8.2) ] .
Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
💬 Medication Guide ▾
Medication Guide Ticagrelor Tablets (tye kaʹ grel or) What is the most important information I should know about ticagrelor tablets? Ticagrelor tablets are used to lower your chance of having, or dying from, a heart attack or stroke. Ticagrelor tablets (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 ticagrelor tablets: • 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 healthcare provider right away, if you have any of these signs or symptoms of bleeding while taking ticagrelor tablets: • 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 ticagrelor tablets without talking to the healthcare provider who prescribes them for you.
People who are treated with a stent, and stop taking ticagrelor tablets too soon, have a higher risk of getting a blood clot in the stent, having a heart attack, or dying. If you stop ticagrelor tablets because of bleeding, or for other reasons, your risk of a heart attack or stroke may increase. Your healthcare provider may instruct you to stop taking ticagrelor tablets 5 days before surgery.
This will help to decrease your risk of bleeding with your surgery or procedure. Your healthcare provider should tell you when to start taking ticagrelor tablets again, as soon as possible after surgery. Taking ticagrelor tablets with aspirin Ticagrelor tablets are taken with aspirin, unless your healthcare provider specifically tells you otherwise.
Talk to your healthcare provider about the dose of aspirin that you should take with ticagrelor tablets. In most cases, you should not take a dose of aspirin higher than 100 mg daily. Do not take doses of aspirin higher than what your healthcare provider tells you to take.
Tell your healthcare provider if you take other medicines that contain aspirin, and do not take new over-the-counter medicines with aspirin in them. What are ticagrelor tablets? Ticagrelor tablets are 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.
Ticagrelor tablets 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. • decrease your risk of stroke in people who are having a stroke (acute ischemic stroke) or mini-stroke (transient ischemic attack or TIA). It is not known if ticagrelor tablets are safe and effective in children.
Do not take ticagrelor tablets if you: • have a history of bleeding in the brain • are bleeding now • are allergic to ticagrelor or any of the ingredients in ticagrelor tablets. See the end of this Medication Guide for a complete list of ingredients in ticagrelor tablets. Before taking ticagrelor tablets, tell your healthcare provider 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.
See “What is the most important information I should know about ticagrelor tablets?” • have a history of stomach ulcers or colon polyps • have lung or breathing 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 ticagrelor will harm your unborn baby. You and your healthcare provider sho…