Tikagrelor Devatis: Uses, Dosage & Side Effects
Generic antiplatelet medication to prevent blood clots after heart attack
Quick facts about Tikagrelor Devatis
Key takeaways about Tikagrelor Devatis
- Bioequivalent generic of Brilique: Tikagrelor Devatis contains the same active substance (ticagrelor) in the same strength (60 mg) and produces the same clinical effect as the originator medicine
- Reversible P2Y12 inhibitor: Unlike clopidogrel, ticagrelor binds reversibly to platelets and does not need liver activation, providing faster onset and more consistent antiplatelet effect
- Always taken with aspirin: Tikagrelor Devatis 60 mg must be used with low-dose aspirin (75–100 mg daily) – higher aspirin doses may reduce its effectiveness
- Twice-daily dosing: Take one 60 mg tablet in the morning and one in the evening, at approximately the same times each day, to maintain stable antiplatelet protection
- Do not stop abruptly: Discontinuing ticagrelor without medical advice significantly increases the risk of another heart attack, stroke, or cardiovascular death
What Is Tikagrelor Devatis and What Is It Used For?
Tikagrelor Devatis is a generic prescription medicine containing the active substance ticagrelor, a direct-acting and reversible antiplatelet agent. The 60 mg tablets are prescribed for adults who have had a heart attack more than one year ago, in combination with low-dose aspirin, to reduce the risk of further heart attack, stroke, or cardiovascular death.
Tikagrelor Devatis is a generic version of the originator medicine Brilique, marketed by Devatis. Both products contain the same active ingredient – ticagrelor – in the same 60 mg film-coated tablet formulation. As a generic medicine, Tikagrelor Devatis has been authorised under established generic regulatory pathways after demonstrating bioequivalence to the reference product. In clinical terms, this means that the two products are expected to produce the same therapeutic effect when taken at the same dose.
Ticagrelor belongs to a group of medicines called antiplatelet agents – specifically, P2Y12 receptor antagonists. These medicines prevent the formation of dangerous blood clots by stopping platelets (small blood cells involved in clotting) from clumping together. By keeping blood flowing more freely through the arteries, Tikagrelor Devatis reduces the risk of serious cardiovascular events in patients with established heart disease.
Ticagrelor belongs to the cyclopentyltriazolopyrimidine (CPTP) chemical class, making it structurally distinct from the thienopyridine drugs clopidogrel and prasugrel. A critical pharmacological difference is that ticagrelor is a direct-acting, reversible P2Y12 antagonist. Unlike clopidogrel, which is a prodrug that requires hepatic activation by CYP2C19, ticagrelor does not need metabolic conversion to exert its antiplatelet effect. This means its activity is not affected by genetic polymorphisms in liver enzymes – a significant advantage, as up to 30% of certain populations carry reduced-function CYP2C19 alleles that diminish clopidogrel effectiveness.
Because ticagrelor binds reversibly to the P2Y12 receptor, platelet function recovers more quickly after discontinuation (typically within 3–5 days) compared to irreversible inhibitors like clopidogrel (5–7 days). The drug also has an active metabolite, AR-C124910XX, which contributes approximately equally to the overall antiplatelet effect. Steady-state plasma concentrations are achieved within 2–3 days of twice-daily dosing, with near-complete platelet inhibition occurring within 2 hours of the first dose.
How platelets form blood clots
Platelets are very small blood cells that play a crucial role in stopping bleeding. When a blood vessel is damaged, platelets aggregate (clump together) at the site of injury to form a plug that seals the wound. This is a normal, life-saving process. However, in patients with atherosclerosis – a condition where fatty deposits (plaques) build up inside artery walls – platelets can become activated at the site of a damaged or ruptured plaque, forming a blood clot (thrombus) inside the artery.
Such a clot can have devastating consequences. If it completely blocks blood flow in a coronary artery, it causes a heart attack (myocardial infarction). If it blocks blood flow in an artery supplying the brain, it causes an ischaemic stroke. Partial blockage can reduce blood flow sufficiently to cause chest pain that comes and goes (unstable angina). Tikagrelor Devatis prevents platelets from clumping together at these dangerous sites, thereby reducing the risk of clot formation and subsequent cardiovascular events.
Approved indication for Tikagrelor Devatis 60 mg
Tikagrelor Devatis 60 mg is specifically approved for long-term secondary prevention in adults who have had a myocardial infarction (heart attack) at least 12 months ago and who are at high risk of developing another atherothrombotic event. It is always prescribed in combination with low-dose acetylsalicylic acid (aspirin), typically 75–100 mg daily. This dual antiplatelet therapy (DAPT) provides broader and more effective platelet inhibition than either agent alone.
Ticagrelor is available internationally in two strengths: 90 mg and 60 mg. The 90 mg formulation is used during the acute phase and the first 12 months after an acute coronary syndrome (heart attack or unstable angina). After 12 months, patients who remain at high cardiovascular risk may be switched to the 60 mg formulation for extended secondary prevention. The 60 mg dose was specifically studied in the PEGASUS-TIMI 54 trial, which demonstrated a significant reduction in the composite endpoint of cardiovascular death, heart attack, or stroke compared with aspirin alone. Tikagrelor Devatis is currently authorised at the 60 mg strength for this long-term indication.
What does “generic medicine” mean?
A generic medicine is a pharmaceutical product that contains the same active ingredient, in the same quantity and dosage form, as an originator (reference) medicine, and is used for the same therapeutic indication. Generics are only approved after the patent on the originator has expired and after demonstrating bioequivalence – meaning they deliver the same amount of active drug to the bloodstream at the same rate. Regulators such as the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and national authorities require rigorous pharmacokinetic studies to confirm bioequivalence before a generic can reach the market.
Tikagrelor Devatis has met these regulatory requirements and is therapeutically interchangeable with Brilique. The main differences are in non-active components (excipients), tablet appearance, packaging, and price. Generic ticagrelor products have substantially expanded access to this life-saving therapy at lower cost across Europe and other regions since originator patent expiry.
What Should You Know Before Taking Tikagrelor Devatis?
Before starting Tikagrelor Devatis, your doctor must evaluate your bleeding risk, current medications, and overall health. This medicine is contraindicated in patients with active bleeding, history of intracranial haemorrhage, severe liver disease, or those taking strong CYP3A4 inhibitors such as ketoconazole, clarithromycin, or ritonavir.
Like all antiplatelet medications, Tikagrelor Devatis increases the risk of bleeding. It is essential that you provide your doctor with a complete medical history and a list of all medicines you are currently taking – including prescription drugs, over-the-counter products, herbal remedies, and supplements – before starting treatment. Some conditions and medications can significantly increase the risk of dangerous bleeding or may interact with ticagrelor in ways that alter its safety or effectiveness.
Contraindications
You must not take Tikagrelor Devatis if any of the following apply:
- Allergy to ticagrelor: If you are allergic to ticagrelor or any of the other ingredients in Tikagrelor Devatis tablets
- Active bleeding: If you currently have any active pathological bleeding, including internal bleeding
- History of intracranial haemorrhage: If you have ever had a stroke caused by bleeding in the brain (haemorrhagic stroke)
- Severe liver disease: If you have severe hepatic impairment, as ticagrelor is extensively metabolised by the liver
- Strong CYP3A4 inhibitors: If you are currently taking any of the following medications: ketoconazole (antifungal), clarithromycin (antibiotic), nefazodone (antidepressant), ritonavir or atazanavir (HIV protease inhibitors). These drugs dramatically increase ticagrelor blood levels, raising the risk of bleeding and other adverse effects
Warnings and precautions
Talk to your doctor or pharmacist before taking Tikagrelor Devatis if any of the following apply to you:
- Increased bleeding risk: If you have recently had a serious injury, recent surgery (including dental procedures), a condition affecting blood clotting, or recent gastrointestinal bleeding (such as a stomach ulcer or colon polyps)
- Upcoming surgery: If you are scheduled for any surgery, including dental procedures, while taking Tikagrelor Devatis. Your doctor may advise you to stop taking ticagrelor 5 days before the procedure to reduce surgical bleeding risk
- Slow heart rate (bradycardia): If your resting heart rate is abnormally low (usually below 60 beats per minute) and you do not have a pacemaker. Ticagrelor can cause ventricular pauses and may worsen pre-existing bradycardia
- Asthma or lung problems: If you have asthma, chronic obstructive pulmonary disease (COPD), or other breathing difficulties. Ticagrelor commonly causes dyspnoea (shortness of breath), which may be more noticeable in patients with pre-existing respiratory conditions
- Abnormal breathing patterns: If you develop changes in your breathing rhythm, including faster, slower, or intermittent breathing. Your doctor may recommend further investigation, such as sleep studies, to rule out central sleep apnoea
- Liver problems: If you have a history of liver disease or any condition that may have affected your liver function. Although mild to moderate hepatic impairment does not require dose adjustment, liver function should be monitored
- Elevated uric acid: If blood tests have shown higher-than-normal levels of uric acid in your blood, as ticagrelor may further increase uric acid levels and potentially trigger gout in susceptible individuals
- Kidney disease with hyperuricaemia: If you have a history of gout or uric acid nephropathy, ticagrelor may worsen these conditions
If you are taking both Tikagrelor Devatis and heparin, and your doctor suspects heparin-induced thrombocytopenia (HIT), it is important to inform them that you are taking ticagrelor. The drug may interfere with the functional diagnostic assays used to detect HIT, potentially producing false-negative results. Your doctor may need to use alternative testing methods such as immunoassays.
Pregnancy and breastfeeding
Tikagrelor Devatis is not recommended during pregnancy or in women of childbearing potential who are not using effective contraception. There is insufficient human data on the safety of ticagrelor during pregnancy, and animal studies have shown reproductive toxicity at doses higher than the human therapeutic dose. If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. Women of childbearing age should use appropriate contraception while on treatment.
It is not known whether ticagrelor or its metabolites are excreted in human breast milk, although animal studies have shown excretion in milk. A decision must be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the medicine to the mother and the potential risk to the infant. Your doctor will discuss the benefits and risks with you individually.
Driving and operating machinery
Tikagrelor Devatis is unlikely to affect your ability to drive or use machines. However, if you experience dizziness or confusion while taking this medication, you should exercise caution when driving or operating machinery until the symptoms resolve. Syncope (fainting) has also been reported and could pose a risk while driving.
Children and adolescents
Tikagrelor Devatis is not recommended for use in children and adolescents under 18 years of age, as there is insufficient evidence regarding safety and efficacy in this age group. Paediatric use of ticagrelor has been studied in conditions such as sickle cell disease but is not an approved indication for this generic product.
Elderly patients
No dose adjustment is required for elderly patients. However, older adults have an increased baseline risk of bleeding due to factors such as comorbid conditions, concomitant medications, and fragile vasculature. Regular monitoring is particularly important in this population.
Information for healthcare professionals
Inform all healthcare providers involved in your care – including dentists, surgeons, and emergency staff – that you are taking Tikagrelor Devatis. Consider wearing a medical alert identification if you are on long-term antiplatelet therapy. Before any invasive procedure, your treating physician will weigh the thrombotic risk of stopping therapy against the bleeding risk of continuing it.
How Does Tikagrelor Devatis Interact with Other Drugs?
Tikagrelor Devatis has clinically significant interactions with strong CYP3A4 inhibitors and inducers, certain statins, digoxin, cyclosporine, and opioid analgesics. Aspirin doses above 100 mg daily may reduce its effectiveness. Always inform your doctor and pharmacist about all medicines you are taking, including over-the-counter products and herbal supplements.
Ticagrelor is primarily metabolised by the liver enzyme CYP3A4 and also acts as an inhibitor of CYP3A4 and P-glycoprotein (P-gp). This means it can both be affected by and affect the blood levels of many other medications. Understanding these interactions is crucial for safe and effective treatment. The interactions described below apply equally to all ticagrelor-containing products, including Tikagrelor Devatis and originator Brilique.
Major interactions – contraindicated combinations
The following medications must not be used together with Tikagrelor Devatis, as they dramatically increase ticagrelor plasma levels and the risk of serious bleeding:
| Drug | Class | Mechanism | Clinical Effect |
|---|---|---|---|
| Ketoconazole | Antifungal | Strong CYP3A4 inhibitor | Increases ticagrelor levels by ~7-fold |
| Clarithromycin | Macrolide antibiotic | Strong CYP3A4 inhibitor | Markedly increases ticagrelor exposure |
| Nefazodone | Antidepressant | Strong CYP3A4 inhibitor | Significantly elevates ticagrelor levels |
| Ritonavir | HIV protease inhibitor | Strong CYP3A4 inhibitor | Major increase in ticagrelor exposure |
| Atazanavir | HIV protease inhibitor | Strong CYP3A4 inhibitor | Major increase in ticagrelor exposure |
Significant interactions – use with caution
The following medications may interact with Tikagrelor Devatis and require monitoring or dose adjustments:
| Drug | Effect | Recommendation |
|---|---|---|
| Simvastatin / Lovastatin | Ticagrelor increases statin levels (simvastatin by ~56%); doses above 40 mg/day increase risk of myopathy | Do not exceed 40 mg/day of simvastatin or lovastatin |
| Rosuvastatin | Ticagrelor may increase rosuvastatin exposure | Monitor for statin side effects; consider lower starting dose |
| Digoxin | Ticagrelor inhibits P-gp, increasing digoxin levels by ~28% | Monitor digoxin levels; watch for toxicity symptoms |
| Cyclosporine | Dual P-gp and CYP3A4 inhibition; may increase both drug levels | Monitor cyclosporine levels closely |
| Rifampicin | Strong CYP3A4 inducer; reduces ticagrelor levels by ~86% | Combination is discouraged; may eliminate antiplatelet effect |
| Phenytoin / Carbamazepine / Phenobarbital | CYP3A4 inducers; significantly reduce ticagrelor exposure | Combination is discouraged |
| St. John's Wort | Herbal CYP3A4 inducer; reduces ticagrelor exposure | Avoid; may compromise antiplatelet efficacy |
| Morphine / Opioids | Opioids delay gastric emptying, slowing ticagrelor absorption by ~36% | Consider IV P2Y12 inhibitor (cangrelor) in acute settings when opioids are co-administered |
| Diltiazem / Verapamil | Moderate CYP3A4 inhibitors; may increase ticagrelor levels | Monitor for increased bleeding; no dose adjustment usually needed |
| Beta-blockers | Additive bradycardic effect | Monitor heart rate, especially in patients with pre-existing bradycardia |
Bleeding risk interactions
The following medications increase the risk of bleeding when taken with Tikagrelor Devatis, and particular caution is warranted:
- Oral anticoagulants (warfarin, DOACs): Concurrent use with blood thinners such as warfarin, rivaroxaban, apixaban, edoxaban, or dabigatran significantly increases the risk of major bleeding. If combination therapy is necessary (for example, in patients with both atrial fibrillation and coronary artery disease), it should only be prescribed under specialist supervision with careful monitoring
- NSAIDs (ibuprofen, naproxen, diclofenac): Non-steroidal anti-inflammatory drugs increase the risk of gastrointestinal bleeding. Use the lowest effective dose for the shortest duration possible, and consider gastroprotective therapy such as a proton pump inhibitor
- SSRIs and SNRIs: Selective serotonin reuptake inhibitor antidepressants (paroxetine, sertraline, citalopram, escitalopram, fluoxetine) and serotonin-noradrenaline reuptake inhibitors (venlafaxine, duloxetine) impair platelet function and may increase bleeding risk when combined with antiplatelet agents
- Fibrinolytic agents (streptokinase, alteplase, tenecteplase): If you need clot-dissolving therapy, inform medical staff that you are taking Tikagrelor Devatis, as the combination substantially increases bleeding risk
- Other antiplatelet agents: Combining ticagrelor with another P2Y12 inhibitor (clopidogrel, prasugrel) or GP IIb/IIIa antagonists should be avoided except under specialist supervision
The PLATO trial found that aspirin doses above 100 mg daily were associated with reduced effectiveness of ticagrelor compared with lower doses. Current international guidelines recommend that the maintenance aspirin dose should not exceed 100 mg daily when used in combination with ticagrelor. Most guidelines suggest 75–100 mg daily for optimal benefit. This applies equally to Tikagrelor Devatis.
What Is the Correct Dosage of Tikagrelor Devatis?
The recommended dose of Tikagrelor Devatis for long-term secondary prevention is one 60 mg tablet taken twice daily (morning and evening) in combination with low-dose aspirin (75–100 mg once daily). Tablets can be taken with or without food and should be swallowed whole or crushed and mixed with water if swallowing is difficult.
Always take Tikagrelor Devatis exactly as your doctor has prescribed. Do not change the dose or stop taking the medication without consulting your physician first. Consistency in timing is important for maintaining stable antiplatelet protection throughout the day.
Adults
Standard dosing regimen
Tikagrelor Devatis 60 mg: One tablet twice daily (total daily dose: 120 mg)
Plus aspirin: 75–100 mg once daily (aspirin dose should not exceed 100 mg for optimal ticagrelor effectiveness)
Timing: Take one tablet in the morning and one in the evening, at approximately the same times each day (ideally 12 hours apart)
With food: Tikagrelor Devatis can be taken with or without food
Duration: Determined by your doctor based on individual cardiovascular risk; benefit demonstrated up to 3 years in PEGASUS-TIMI 54
Difficulty swallowing
If you have difficulty swallowing tablets, Tikagrelor Devatis can be administered as follows:
- Crush the tablet into a fine powder
- Mix the powder with half a glass of water
- Stir the mixture and drink it immediately
- Rinse the empty glass with another half glass of water and drink the rinse to ensure you receive the full dose
For hospitalised patients, crushed Tikagrelor Devatis tablets mixed with water can also be administered via a nasogastric tube directly into the stomach. This route of administration has been shown to provide equivalent bioavailability.
Children and adolescents
Tikagrelor Devatis is not recommended for children and adolescents under 18 years of age. There are no adequate data on the safety and efficacy of ticagrelor in paediatric populations for the approved indications of this product.
Elderly patients
No dose adjustment is required for elderly patients. Ticagrelor has been studied in patients up to and beyond 75 years of age, and the PEGASUS-TIMI 54 trial included a substantial proportion of elderly participants. However, elderly patients may have an increased risk of bleeding and should be monitored accordingly.
Renal impairment
No dose adjustment is necessary for patients with kidney disease, including those on haemodialysis. Ticagrelor is minimally eliminated by the kidneys, so its pharmacokinetics are not significantly altered in renal impairment. However, since clinical experience with ticagrelor in patients on dialysis is limited, caution is advised in this population.
Hepatic impairment
No dose adjustment is needed for patients with mild liver disease. Tikagrelor Devatis is contraindicated in patients with severe hepatic impairment, as ticagrelor is extensively metabolised in the liver and severe impairment would result in significantly elevated drug levels. Use in moderate hepatic impairment should be cautious, and formal studies in this subgroup are limited.
Missed dose
If you forget to take a dose of Tikagrelor Devatis, simply take your next dose at the regular scheduled time. Do not take a double dose to make up for a missed one. Maintaining a regular dosing schedule is important, so consider setting phone reminders or using a pillbox to help you track your doses.
Overdose
If you take more Tikagrelor Devatis than prescribed, contact your doctor or go to the nearest hospital emergency department immediately. Bring the medicine packaging with you. An overdose may increase the risk of bleeding. There is no specific antidote for ticagrelor, and the drug is unlikely to be removed by dialysis due to its high protein binding. Treatment is symptomatic and supportive – platelet transfusion may be considered for life-threatening bleeding but has limited efficacy due to the pharmacological properties of ticagrelor.
Overdose may also cause gastrointestinal symptoms (nausea, vomiting, diarrhoea) and ventricular pauses. Cardiac monitoring is warranted after a significant overdose.
Stopping Tikagrelor Devatis without consulting your doctor can significantly increase the risk of another heart attack, stroke, or death from cardiovascular disease – a phenomenon sometimes described as a “rebound” thrombotic risk. Take this medication regularly and for as long as your doctor continues to prescribe it. If you need to stop treatment for any reason (for example, before surgery or due to serious bleeding), your doctor will plan the safest way to do so, usually by stopping the medication 5 days before elective procedures.
What Are the Side Effects of Tikagrelor Devatis?
The most common side effects of Tikagrelor Devatis are bleeding (bruising, nosebleeds), dyspnoea (shortness of breath), and elevated uric acid levels. Most bleeding events are mild, but serious and potentially life-threatening bleeding can occur. Dyspnoea is usually mild, occurs at rest, and often resolves within the first weeks of treatment.
Like all medicines, Tikagrelor Devatis can cause side effects, although not everyone experiences them. Because ticagrelor affects blood clotting, most side effects are related to bleeding. Some bleeding is common and expected (such as bruising more easily or nosebleeds lasting longer). However, severe bleeding is uncommon but can be life-threatening and requires immediate medical attention.
The side effect profile of Tikagrelor Devatis is identical to that of the originator Brilique, as both products contain the same active substance at the same dose. The frequencies below are derived from pooled clinical trial data with ticagrelor.
Signs of stroke: Sudden numbness or weakness in the arm, leg, or face (especially on one side), sudden confusion, difficulty speaking or understanding, sudden difficulty walking, loss of balance, sudden dizziness, or sudden severe headache with no known cause.
Signs of serious bleeding: Severe or uncontrollable bleeding, unexpected bleeding or bleeding that lasts a long time, pink, red, or brown urine, vomiting red blood or vomit that looks like coffee grounds, red or black (tar-like) stools, coughing up blood.
Signs of TTP (thrombotic thrombocytopenic purpura): Fever, purple spots on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme tiredness or confusion.
Signs of severe allergic reaction: Difficulty breathing, swelling of the face, lips, tongue, or throat, severe rash or hives.
Very Common
- Dyspnoea (shortness of breath) – usually mild, occurs at rest, may resolve within weeks
- Elevated uric acid levels in the blood (detected on blood tests)
- Bleeding due to blood disorders
Common
- Bruising (ecchymosis)
- Headache
- Dizziness or vertigo (spinning sensation)
- Diarrhoea or indigestion (dyspepsia)
- Nausea
- Constipation
- Skin rash
- Itching (pruritus)
- Severe joint pain and swelling – signs of gout (hyperuricaemia)
- Dizziness, light-headedness, or blurred vision – signs of low blood pressure
- Nosebleed (epistaxis)
- Heavier-than-normal bleeding after surgery or from wounds (e.g. while shaving)
- Gastrointestinal bleeding (stomach lining bleeding)
- Bleeding gums
- Syncope (fainting) – temporary loss of consciousness due to reduced blood flow to the brain
Uncommon
- Allergic reaction – skin rash, itching, or swelling of the face, lips, or tongue
- Confusion
- Visual disturbances due to bleeding in the eye
- Vaginal bleeding heavier than or at different times from normal menstruation
- Bleeding into joints and muscles causing painful swelling
- Bleeding from the ear
- Internal bleeding that may cause dizziness or light-headedness
- Elevated serum creatinine (kidney function marker)
Rare
- Thrombotic thrombocytopenic purpura (TTP) – a rare but serious blood disorder
- Haemorrhagic stroke (bleeding in the brain)
- Liver enzyme elevations
Not Known
- Abnormally slow heart rate (bradycardia, usually below 60 beats per minute)
- Central sleep apnoea – abnormal breathing patterns during sleep
Dyspnoea (shortness of breath) explained
Dyspnoea is one of the most distinctive side effects of ticagrelor and deserves special attention. It occurs in approximately 14% of patients and is more common with the 90 mg dose than the 60 mg dose used in Tikagrelor Devatis. The breathlessness associated with ticagrelor is typically described as a sudden, unexpected need for air. It usually occurs at rest rather than during exertion and tends to be mild in severity.
Research suggests that ticagrelor-induced dyspnoea is related to the drug's inhibition of adenosine reuptake through the equilibrative nucleoside transporter 1 (ENT1). By blocking adenosine reuptake, ticagrelor increases local adenosine concentrations, which can stimulate pulmonary C-fibres and cause a sensation of breathlessness. Importantly, this is not caused by impaired lung function or worsening heart disease.
In most patients, the dyspnoea appears within the first weeks of starting treatment and resolves spontaneously as the body adapts. If your shortness of breath becomes more severe, occurs with exertion, or is accompanied by chest pain, wheezing, or swelling, contact your doctor promptly, as these symptoms could indicate a different underlying cause that requires evaluation.
Bleeding risk in clinical context
The PEGASUS-TIMI 54 trial – which evaluated the 60 mg twice-daily dose used in Tikagrelor Devatis for long-term secondary prevention – reported that TIMI major bleeding occurred in approximately 2.3% of patients on ticagrelor compared with 1.1% on placebo over three years. Importantly, rates of fatal bleeding and intracranial haemorrhage were similar to placebo, suggesting that the bleeding excess was largely driven by less serious events. This balance of benefit and bleeding risk is the basis for the prescribing recommendations applied to all generic ticagrelor products, including Tikagrelor Devatis.
Reporting suspected side effects
If you experience any side effects, speak to your doctor or pharmacist. This includes side effects not listed in the patient leaflet. You can also help by reporting side effects directly to your national pharmacovigilance authority – for example, the MHRA Yellow Card Scheme in the UK, the EMA EudraVigilance system in the EU, or the FDA MedWatch programme in the US. Reporting side effects helps regulators and healthcare providers monitor the safety of Tikagrelor Devatis over time.
How Should You Store Tikagrelor Devatis?
Store Tikagrelor Devatis at room temperature (below 25 °C or as specified on the carton) in the original blister pack. No special temperature storage conditions are generally required. Keep out of the sight and reach of children and do not use after the expiry date printed on the pack.
Tikagrelor Devatis tablets should be stored at room temperature, away from excessive heat, moisture, and direct sunlight. Keep the tablets in their original blister pack until you are ready to take a dose, as this helps protect them from environmental factors that could affect their stability. Refer to the specific storage statement on the outer carton, as exact temperature limits may vary slightly between generic manufacturers.
Always check the expiry date (marked “EXP”) on the blister pack and outer carton before taking a tablet. The expiry date refers to the last day of the stated month. Do not use Tikagrelor Devatis after this date, as the medication may have degraded and could be less effective or potentially harmful.
Keep all medicines out of the sight and reach of children. Do not dispose of unused medicines via household waste or through the plumbing system. Return any unused or expired tablets to your pharmacist for safe disposal, which helps protect the environment from pharmaceutical contamination.
Travel considerations
If you are travelling with Tikagrelor Devatis, keep the tablets in your hand luggage to avoid loss of medication and to protect them from extreme temperatures in checked baggage. Carry the original packaging and, ideally, a copy of your prescription. When travelling across time zones, continue taking your tablets approximately 12 hours apart and discuss any schedule adjustments with your pharmacist if the trip is very long.
What Does Tikagrelor Devatis Contain?
Each Tikagrelor Devatis 60 mg film-coated tablet contains 60 mg of the active substance ticagrelor. The tablets are film-coated and contain standard pharmaceutical excipients. Specific inactive ingredients vary slightly between generic manufacturers and are listed in full on the product package leaflet.
The active substance in Tikagrelor Devatis is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor, identical to the dose in the originator product Brilique. The bioequivalence of Tikagrelor Devatis to the reference product has been demonstrated in regulatory pharmacokinetic studies.
Inactive ingredients (excipients)
The other ingredients typically include:
- Tablet core: Mannitol, calcium hydrogen phosphate, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate
- Film coating: Hypromellose, titanium dioxide, macrogol, iron oxides (as colourants)
The exact excipients and their grades may vary between generic ticagrelor products and should be checked against the package leaflet supplied with your specific carton of Tikagrelor Devatis. If you have known allergies to any excipient (for example, specific colourants or sugars), confirm the full ingredient list before starting treatment.
Appearance and packaging
Tikagrelor Devatis 60 mg tablets are film-coated and typically round or oval. Exact tablet appearance, colour, and embossing differs from the originator Brilique (pink tablets marked “60” above “T”) and between different generic manufacturers, but this does not affect clinical efficacy. The tablets are available in blister packs; common pack sizes are 56 tablets (for monthly dispensing), 60 tablets, and 168 tablets (for longer-term supply). Not all pack sizes may be marketed in every country.
Sodium content
Tikagrelor Devatis tablets contain less than 1 mmol (23 mg) of sodium per tablet, meaning they are essentially sodium-free. This is relevant for patients on sodium-restricted diets, such as those with heart failure or severe hypertension.
Manufacturer and regulatory status
Tikagrelor Devatis is marketed by Devatis, a pharmaceutical company that supplies generic medicines for the European market. The product has been authorised through national or decentralised regulatory procedures after demonstrating bioequivalence to Brilique (AstraZeneca). It joined the expanding market of generic ticagrelor products that became available after the originator patents expired, helping to improve affordability and access to this important cardiovascular therapy. Availability varies by country; not all markets may stock every generic manufacturer.
Frequently Asked Questions About Tikagrelor Devatis
Tikagrelor Devatis 60 mg is a generic antiplatelet medicine used in combination with low-dose aspirin to prevent further heart attacks, strokes, or death from cardiovascular disease in adults who have had a heart attack more than one year ago. It works by preventing platelets from clumping together to form dangerous blood clots inside arteries. It contains the same active substance (ticagrelor) as the originator medicine Brilique and is always prescribed as part of dual antiplatelet therapy alongside aspirin.
Tikagrelor Devatis contains the same active ingredient (ticagrelor) in the same strength (60 mg) and dosage form (film-coated tablet) as Brilique. As a generic medicine, it has been approved by regulators after demonstrating bioequivalence to Brilique – meaning it delivers the same amount of active drug to the bloodstream at the same rate and is expected to produce the same clinical effect. Differences between the two products are limited to inactive ingredients, tablet appearance, packaging, and price. Your doctor or pharmacist can switch you between these bioequivalent products without affecting your treatment.
Ticagrelor (the active ingredient in Tikagrelor Devatis) is a direct-acting, reversible P2Y12 receptor antagonist, while clopidogrel is an irreversible prodrug that requires liver enzyme activation by CYP2C19. This means ticagrelor provides faster onset and offset of action, more consistent platelet inhibition regardless of genetic variations, and does not depend on liver metabolism for activation. The landmark PLATO trial showed that ticagrelor reduced the rate of cardiovascular death, heart attack, and stroke compared with clopidogrel in patients with acute coronary syndrome, though at the cost of slightly higher rates of non-procedure-related bleeding and dyspnoea.
Dyspnoea (shortness of breath) occurs in up to 14% of patients taking ticagrelor. It is believed to be related to ticagrelor's inhibition of adenosine reuptake through the equilibrative nucleoside transporter 1 (ENT1), which increases local adenosine concentrations in the lungs and stimulates sensory nerve fibres. The breathlessness is usually mild, occurs at rest rather than during exercise, and often resolves within the first few weeks of treatment. Lung function tests in affected patients show no change in respiratory function, confirming that this is a benign drug effect rather than a sign of worsening heart or lung disease.
Yes – Tikagrelor Devatis is specifically designed to be taken together with low-dose aspirin (75–100 mg daily) as dual antiplatelet therapy (DAPT). However, it is important that the aspirin dose does not exceed 100 mg daily, as higher maintenance doses have been associated with reduced effectiveness of ticagrelor. This was an important finding from the PLATO trial. Your doctor will advise you on the correct aspirin dose to use alongside Tikagrelor Devatis.
If you miss a dose of Tikagrelor Devatis, simply take your next dose at the regular scheduled time. Do not take a double dose to compensate for the forgotten tablet. To help remember your doses, take one tablet in the morning and one in the evening at approximately the same times each day, ideally 12 hours apart. Setting phone reminders or using a pillbox with morning/evening compartments can help you stay on track. If you regularly miss doses, speak to your doctor or pharmacist.
For elective (planned) surgery where antiplatelet therapy would increase bleeding risk unacceptably, ticagrelor is usually stopped 5 days before the procedure to allow platelet function to recover. However, never stop Tikagrelor Devatis on your own – your cardiologist, surgeon, and anaesthetist must coordinate this decision, weighing the risk of bleeding during surgery against the risk of a new cardiovascular event from stopping the drug. For minor procedures (such as some dental work or cataract surgery), it may not be necessary to stop the medication at all.
Tikagrelor Devatis 60 mg is prescribed for long-term secondary prevention in patients who have had a heart attack more than one year ago. Treatment duration is determined by your doctor based on your individual cardiovascular risk profile. The PEGASUS-TIMI 54 trial demonstrated continued benefit with treatment lasting up to 3 years or longer. Never stop taking Tikagrelor Devatis without consulting your doctor first, as abruptly discontinuing antiplatelet therapy significantly increases the risk of another heart attack, stroke, or cardiovascular death.
References
- Wallentin L, Becker RC, Budaj A, et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes (PLATO trial). N Engl J Med. 2009;361(11):1045–1057. doi:10.1056/NEJMoa0904327
- Bonaca MP, Bhatt DL, Cohen M, et al. Long-term use of ticagrelor in patients with prior myocardial infarction (PEGASUS-TIMI 54). N Engl J Med. 2015;372(19):1791–1800. doi:10.1056/NEJMoa1500857
- European Medicines Agency (EMA). Brilique (ticagrelor) – Summary of Product Characteristics. Updated 2024. Available at: EMA – Brilique
- European Medicines Agency (EMA). Guideline on the Investigation of Bioequivalence. CPMP/EWP/QWP/1401/98 Rev. 1. 2010.
- Byrne RA, Rossello X, Coughlan JJ, et al. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023;44(38):3720–3826. doi:10.1093/eurheartj/ehad191
- Virani SS, Newby LK, Arnold SV, et al. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease. Circulation. 2023;148(6):e149–e227.
- Joint Formulary Committee. British National Formulary (BNF). Ticagrelor. London: BMJ Group and Pharmaceutical Press; 2024.
- Storey RF, Becker RC, Harrington RA, et al. Characterization of dyspnoea in PLATO study patients treated with ticagrelor or clopidogrel and its association with clinical outcomes. Eur Heart J. 2011;32(23):2945–2953.
- Cattaneo M, Schulz R, Nylander S. Adenosine-mediated effects of ticagrelor: evidence and potential clinical relevance. J Am Coll Cardiol. 2014;63(23):2503–2509.
- World Health Organization. WHO Model List of Essential Medicines – 23rd list, 2023. Geneva: World Health Organization; 2023.
- Gurbel PA, Bliden KP, Butler K, et al. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease. Circulation. 2009;120(25):2577–2585.
- Teng R. Ticagrelor: Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Profile. Clin Pharmacokinet. 2015;54(11):1125–1138.
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