Effient and alcohol use

Contents

Effient

SIDE EFFECTS

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

  • Bleeding
  • Thrombotic Thrombocytopenic Purpura
  • Hypersensitivity Including Angioedema

Clinical Trials Experience

Safety in patients with ACS undergoing PCI was evaluated in a clopidogrel-controlled study, TRITON-TIMI 38, in which 6741 patients were treated with Effient (60-mg loading dose and 10-mg once daily) for a median of 14.5 months (5802 patients were treated for over 6 months; 4136 patients were treated for more than 1 year). The population treated with Effient was 27 to 96 years of age, 25% female, and 92% Caucasian. All patients in the TRITON-TIMI 38 study were to receive aspirin. The dose of clopidogrel in this study was a 300-mg loading dose and 75-mg once daily.

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

Drug Discontinuation

The rate of study drug discontinuation because of adverse reactions was 7.2% for Effient and 6.3% for clopidogrel. Bleeding was the most common adverse reaction leading to study drug discontinuation for both drugs (2.5% for Effient and 1.4% for clopidogrel).

Bleeding

Bleeding Unrelated to CABG Surgery

In TRITON-TIMI 38, overall rates of TIMI Major or Minor bleeding adverse reactions unrelated to coronary artery bypass graft surgery (CABG) were significantly higher on Effient than on clopidogrel, as shown in Table 1.

Table 1: Non-CABG-Related Bleedinga (TRITON-TIMI 38)

Figure 1 demonstrates non-CABG related TIMI Major or Minor bleeding. The bleeding rate is highest initially, as shown in Figure 1 (inset: Days 0 to 7) .

Bleeding by Weight and Age

In TRITON-TIMI 38, non-CABG-related TIMI Major or Minor bleeding rates in patients with the risk factors of age ≥75 years and weight <60 kg are shown in Table 2.

Table 2: Bleeding Rates for Non-CABG-Related Bleeding by Weight and Age (TRITON-TIMI 38)

Bleeding Related to CABG

In TRITON-TIMI 38, 437 patients who received a thienopyridine underwent CABG during the course of the study. The rate of CABG-related TIMI Major or Minor bleeding was 14.1% for the Effient group and 4.5% in the clopidogrel group (see Table 3). The higher risk for bleeding adverse reactions in patients treated with Effient persisted up to 7 days from the most recent dose of study drug.

Table 3: CABG-Related Bleedinga (TRITON-TIMI 38)

Bleeding Reported as Adverse Reactions

Malignancies

During TRITON-TIMI 38, newly-diagnosed malignancies were reported in 1.6% and 1.2% of patients treated with prasugrel and clopidogrel, respectively. The sites contributing to the differences were primarily colon and lung. In another Phase 3 clinical study of ACS patients not undergoing PCI, in which data for malignancies were prospectively collected, newly-diagnosed malignancies were reported in 1.8% and 1.7% of patients treated with prasugrel and clopidogrel, respectively. The site of malignancies was balanced between treatment groups except for colorectal malignancies. The rates of colorectal malignancies were 0.3% prasugrel, 0.1% clopidogrel and most were detected during investigation of GI bleed or anemia. It is unclear if these observations are causally-related, are the result of increased detection because of bleeding, or are random occurrences.

Other Adverse Events

Table 4: Non-Hemorrhagic Treatment Emergent Adverse Events Reported by at Least 2.5% of Patients in EitherGroup

Postmarketing Experience

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

Blood and lymphatic system disorders — Thrombocytopenia, Thrombotic thrombocytopenic purpura (TTP)

Immune system disorders — Hypersensitivity reactions including anaphylaxis

Read the entire FDA prescribing information for Effient (Prasugrel Tablets)

Generic Name: prasugrel (PRA soo grel)
Brand Names: Effient

Medically reviewed by Sanjai Sinha, MD Last updated on Apr 8, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

What is Effient?

Effient (prasugrel) helps to prevent platelets in your blood from sticking together and forming a blood clot. An unwanted blood clot can occur with certain heart or blood vessel conditions.

Effient is used to prevent blood clots in people with acute coronary syndrome who are undergoing a procedure after a recent heart attack.

Effient may also be used for other purposes not listed in this medication guide.

Important Information

You should not take Effient if you have active bleeding such as a stomach ulcer or bleeding in the brain, if you have ever had a stroke or “mini-stroke”, or if you are scheduled to have surgery, especially heart bypass surgery.

Effient increases your risk of bleeding, which can be severe or life-threatening. Call your doctor or seek emergency medical attention if you have bleeding that will not stop, if you have black or bloody stools, or if you cough up blood or vomit that looks like coffee grounds.

You may need to stop using the medicine for a short time before any surgery or dental treatment. Do not stop taking Effient unless your doctor tells you to.

Before taking this medicine

You should not use Effient if you are allergic to prasugrel, or if you have:

  • any active bleeding such as a stomach ulcer or bleeding in the brain (such as from a head injury);

  • a history of stroke, including TIA (“mini-stroke”); or

  • if you are scheduled to have surgery, especially heart bypass surgery (coronary artery bypass graft, or CABG).

To make sure Effient is safe for you, tell your doctor if you have:

  • a stomach ulcer;

  • bleeding problems;

  • surgery, an injury, or a medical emergency;

  • liver or kidney disease;

  • a severe allergic reaction to clopidogrel (Plavix) or ticlopidine (Ticlid); o

  • if you weigh less than 132 pounds; or

  • if you also use other medicines to treat or prevent blood clots.

Aspirin is usually given with Effient, and aspirin can cause bleeding when taken during the last 3 months of pregnancy. Aspirin can also cause side effects in a newborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

You should not breast-feed while using this medicine.

How should I take Effient?

Take Effient exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Effient can be taken with or without food.

If you also take aspirin, follow your doctor’s instructions about how much aspirin to take and for how long.

Because Effient keeps your blood from clotting, this medicine can also make it easier for you to bleed, even from a minor injury such as a fall or a bump on the head. Seek emergency medical attention if you have any bleeding that will not stop.

If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using Effient. You may need to stop using the medicine for a short time.

Do not stop taking Effient unless your doctor tells you to. If you stop taking this medicine too soon you could have life-threatening medical problems such as a blood clot or a heart attack.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Effient dosing information

Usual Adult Dose for Acute Coronary Syndrome:

Initial dose: 60 mg orally once
Maintenance dose: 10 mg orally once a day

-No clear benefit was observed when the loading dose of this drug was administered prior to diagnostic coronary angiography compared to at the time of percutaneous coronary intervention (PCI); however, risk of bleeding was increased with early administration in patients undergoing PCI or early coronary artery bypass graft surgery (CABG).
-Aspirin 75 to 325 mg daily should be taken with this drug.
Use: To reduce the rate of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with PCI for unstable angina (UA), non-ST segment elevation myocardial infarction (NSTEMI), or ST segment elevation myocardial infarction (STEMI).

Usual Geriatric Dose for Acute Coronary Syndrome:

65 to less than 75 years:
-Initial dose: 60 mg orally once
-Maintenance dose: 10 mg orally once a day
75 years or older: Use is generally not recommended in such patients, except in high-risk situations (e.g., diabetes or prior myocardial infarction) when benefit outweighs risk.

-No clear benefit was observed when the loading dose of this drug was administered prior to diagnostic coronary angiography compared to at the time of percutaneous coronary intervention (PCI); however, risk of bleeding was increased with early administration in patients undergoing PCI or early coronary artery bypass graft surgery (CABG).
-Aspirin 75 to 325 mg daily should be taken with this drug.
Use: To reduce the rate of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with PCI for unstable angina (UA), non-ST segment elevation myocardial infarction (NSTEMI), or ST segment elevation myocardial infarction (STEMI).

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Effient?

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and others. Using an NSAID with Effient may cause you to bruise or bleed easily.

Effient side effects

Get emergency medical help if you have signs of an allergic reaction to Effient: hives; dizziness, chest pain, difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • any bleeding that will not stop;

  • pink or brown urine;

  • signs of a serious blood-clotting problem – pale skin, purple spots under your skin or on your mouth, fever, fast heart rate, weakness, stomach pain, trouble breathing, jaundice (yellowing of the skin or eyes);

  • signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

  • signs of a stroke – sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

The risk of bleeding is higher in older adults.

Common Effient side effects may include:

  • nosebleeds; or

  • easy bruising or bleeding.

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

What other drugs will affect Effient?

Taking Effient with certain other drugs can increase your risk of bleeding. Tell your doctor about all your other medicines, especially:

  • opioid medication;

  • any other medicines to treat or prevent blood clots, including heparin or warfarin (Coumadin, Jantoven); or

  • NSAIDs (nonsteroidal anti-inflammatory drugs) – aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with prasugrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Effient only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 3.01.

Medical Disclaimer

More about Effient (prasugrel)

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prasugrel (Effient)

Brand Names: Effient

Generic Name: prasugrel

  • What is prasugrel (Effient)?
  • What are the possible side effects of prasugrel (Effient)?
  • What is the most important information I should know about prasugrel (Effient)?
  • What should I discuss with my healthcare provider before taking prasugrel (Effient)?
  • How should I take prasugrel (Effient)?
  • What happens if I miss a dose (Effient)?
  • What happens if I overdose (Effient)?
  • What should I avoid while taking prasugrel (Effient)?
  • What other drugs will affect prasugrel (Effient)?
  • Where can I get more information (Effient)?

What is prasugrel (Effient)?

Prasugrel is used to prevent blood clots in people with acute coronary syndrome who are undergoing a procedure after a recent heart attack or stroke, and in people with certain disorders of the heart or blood vessels.

Prasugrel may also be used for other purposes not listed in this medication guide.

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hexagonal, yellow, imprinted with 5, 5121

000025123_PB

hexagonal, beige, imprinted with 10, 5123

Effient 10 mg

hexagonal, beige, imprinted with 10 MG, 4759

Effient 5 mg

hexagonal, yellow, imprinted with 5 MG, 4760

What are the possible side effects of prasugrel (Effient)?

Get emergency medical help if you have signs of an allergic reaction: hives; dizziness, chest pain, difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • any bleeding that will not stop;
  • pink or brown urine;
  • signs of a serious blood-clotting problem–pale skin, purple spots under your skin or on your mouth, fever, fast heart rate, weakness, stomach pain, trouble breathing, jaundice (yellowing of the skin or eyes);
  • signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
  • signs of a stroke–sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

The risk of bleeding is higher in older adults.

Common side effects may include:

  • nosebleeds; or
  • easy bruising or bleeding.

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

What is the most important information I should know about prasugrel (Effient)?

You should not take prasugrel if you have active bleeding such as a stomach ulcer or bleeding in the brain, if you have ever had a stroke or “mini-stroke”, or if you are scheduled to have surgery, especially heart bypass surgery.

Prasugrel increases your risk of bleeding, which can be severe or life-threatening. Call your doctor or seek emergency medical attention if you have bleeding that will not stop, if you have black or bloody stools, or if you cough up blood or vomit that looks like coffee grounds.

You may need to stop using the medicine for a short time before any surgery or dental treatment. Do not stop taking prasugrel unless your doctor tells you to.

Effient is the brand name of the drug prasugrel, which is used along with aspirin to prevent future heart events.

The drug is prescribed to people who’ve had a heart attack, stroke, or chest pain that’s been treated with an angioplasty (a procedure to open vessels that supply blood to the heart) or placement of a stent inside one or more of their coronary arteries.

Effient (prasugrel) is in a class of drugs known as anti-platelet medications. It works by stopping platelets (a type of blood cell) from clotting.

The Food and Drug Administration (FDA) approved Effient in 2009, and the drug is manufactured by Eli Lilly and Company.

Effient Warnings

Effient may cause serious or life-threatening bleeding. You should tell your physician if you have or have ever had:

  • Any condition that causes you to bleed more easily
  • A recent surgery
  • A recent injury
  • A stomach ulcer
  • Bleeding in your stomach, intestines, or head
  • A stroke or mini-stroke
  • Any condition that causes bleeding in your intestines
  • Diverticulitis
  • Liver disease
  • Kidney disease

Your doctor might not prescribe Effient if you need heart bypass surgery, are older than age 75, or you weigh less than 132 pounds.

You will probably bleed more easily while taking Effient. However, let your doctor know right away if you experience any of the following side effects:

  • Unexplained, severe, or uncontrollable bleeding
  • Pink or brown urine
  • Red or black, tarry stools
  • Bloody vomit or vomit that looks like coffee grounds
  • Coughing up blood or blood clots
  • Unexplained bruises or bruises that get larger

You should tell your doctor you are taking Effient before having any type of surgery, including a dental procedure.

Don’t stop taking Effient without first talking to your doctor.

Effient and Treatment Time

In 2014, a clinical trial published in the New England Journal of Medicine looked at people who took aspirin with either Clopidogrel (Plavix) or Effient after receiving a coronary stent to keep narrowed arteries and the stent open.

The study compared results when either medication was given for 30 months versus 12 months. Results showed treatment for 30 months lowered the risk of heart attacks and clots but increased the risk of death when compared to treatment for 12 months.

The FDA is currently reviewing the trial results along with other available data. At this time, it’s not recommended that health care professionals change the way they prescribe these medications.

Pregnancy and Effient

Effient is a Pregnancy Category B drug, which means it’s not expected to harm an unborn baby. You should tell your doctor if you are pregnant or plan to become pregnant while taking this medication.

It’s not known whether Effient passes into breast milk or could harm a breastfeeding baby. You shouldn’t use this drug while breastfeeding a baby without first talking to your doctor.

How does this medication work? What will it do for me?

Prasugrel belongs to the class of medications called platelet aggregation inhibitors or antiplatelets. It is used in addition to acetylsalicylic acid (ASA) to help prevent heart attacks, strokes, and other circulation problems in people who have had severe chest pain or a heart attack and have been treated with a procedure called angioplasty, also called balloon angioplasty.

Normally, platelets help the blood to clot when needed, such as after an injury. When arteries become narrowed by fat deposits (plaques), platelets often clump together in the vessels. Unstable plaques can rupture, leading to more platelet clumping that can cause a larger blockage of the artery. This further narrows the arteries and increases the chances of heart attack, stroke, or other circulation problems.

Angioplasty is a common technique used to mechanically widen narrowed or obstructed blood vessels with an artificial tube, called a stent. Prasugrel helps to reduce the chances of platelets sticking together and forming clumps that can block an artery or a stent.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each 10 mg, beige, elongated hexagonal, film-coated, unscored tablet, debossed with “10 mg” on one side and “4759” on the other side, contains 10.98 mg prasugrel hydrochloride equivalent to 10 mg of prasugrel. Nonmedicinal ingredients: croscarmellose sodium, hypromellose, mannitol, microcrystalline cellulose, and vegetable magnesium stearate; color coatings: hypromellose, iron oxide red, iron oxide yellow, lactose, titanium dioxide, and triacetin.

How should I use this medication?

Prasugrel is normally started with a single dose of 60 mg. Thereafter, the recommended adult dose of prasugrel is 10 mg once daily for long term use.

This medication is normally taken along with aspirin to help prevent platelets from clumping together. The recommended adult dose of aspirin is 75 mg to 325 mg daily.

Prasugrel may be taken with or without food.

Do not stop taking this medication without first discussing it with your doctor. Stopping this medication too early may result in increased blood clotting and increase the risk of heart attack, stroke, or death due to other illnesses for which this is being used to prevent clotting.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature in the original packaging and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take prasugrel if you:

  • are allergic to prasugrel or any ingredients of this medication
  • have a history of stroke or a mini-stroke (also called a transient ischemic attack or TIA)
  • have an active bleeding condition, such as stomach or intestinal bleeding (e.g., a stomach ulcer) or bleeding in the brain
  • have significant liver disease

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • bleeding gums
  • bleeding or bruising from a needle puncture
  • bruising (that develops without a known cause and grows in size)
  • nose bleeds
  • skin rash

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • dizziness
  • lightheadedness
  • signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • blood in the urine
  • signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
  • bleeding from stomach, intestine, or rectum (black, tarry stools or fresh blood in the stool, spitting up of blood, vomiting blood or material that looks like coffee grounds)
  • bleeding in the eye
  • coughing up blood
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • symptoms of thrombotic thrombocytopenic purpura (purplish spots on the skin or mucous membranes, yellowish color of the skin or eyes, fever, confusion, headache, extreme tiredness)
  • speech or vision changes
  • sudden severe headache

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

January 17, 2014

Health Canada has issued new restrictions concerning the use of Effient (prasugrel). To read the full Health Canada Advisory, visit Health Canada’s web site at www.hc-sc.gc.ca.

Bleeding problems: Prasugrel increases the risk of bleeding because it reduces the ability of your blood to clot. People who weigh less than 60 kg (132 pounds) should not use prasugrel due to an increased risk of bleeding. Using other blood thinners (e.g., warfarin, NSAIDs) and blood clot dissolving drugs (e.g., alteplase) may further increase the risk of bleeding.

If you experience signs of serious or excessive bleeding (easy bruising, bleeding from the rectum, red or black stools, bloody urine, persistent abdominal pain and vomiting, coughing up blood), contact your doctor immediately.

If you have a history of bleeding disorders, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Thrombotic thrombocytopenic purpura (TTP) is a rare condition that may occur while taking prasugrel and that requires immediate medical attention. Signs include decreased number of blood cells, reduced kidney function, and fever. Your doctor will order blood tests to monitor for this condition while you are taking prasugrel.

Heart problems: There is an increased risk of bleeding if prasugrel is started in the hospital before your doctor checks the heart arteries with a procedure known as an angiogram. This risk is something that your doctor will consider before starting the medication.

If you are already taking prasugrel, this risk does not affect your situation and you should not stop taking the medication without first speaking to your doctor.

Lactose intolerance: This medication contains lactose. If you have galactose intolerance (galactosemia, glucose-galactose malabsorption, or Lapp lactase deficiency) you should not take this medication.

Liver function: If you have decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. People with severely reduced liver function should not take prasugrel.

Stomach problems: Since prasugrel can increase the risk of bleeding, it is important to remind your doctor if you have had stomach ulcers, and have the doctor or pharmacist review your medications to determine if they may cause stomach ulcers (e.g., NSAIDs such as ibuprofen, naproxen, and others). Bleeding in the digestive system is a medical emergency. If you experience signs of bleeding in the stomach, intestines, or rectum, such as black and tarry stools, vomiting blood, or blood in the stools, seek medical help immediately.

Stopping prasugrel: Do not stop taking prasugrel suddenly as this increases the risk of blood clots, heart attack, and death. If you need to stop taking prasugrel due to bleeding problems, your doctor should monitor you for any blood clots.

Surgery: Your doctor may want you to stop taking prasugrel at least 7 days prior to any planned surgery to prevent any unnecessary bleeding. However, you should not stop taking prasugrel without talking to your doctor first. It is important to tell any doctors including your dentist that you are taking prasugrel if you plan to have any surgery or dental procedure.

Pregnancy: The medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if prasugrel passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: Seniors are generally at increased risk for bleeding with or without medications. Because of the increased risk of bleeding with this medication, prasugrel is not recommended for people over 75 years of age unless the benefits outweigh the risks.

What other drugs could interact with this medication?

There may be an interaction between prasugrel and any of the following:

  • acetylsalicylic acid (ASA)
  • alteplase “azole” antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • boceprevir
  • clarithromycin
  • conivaptan
  • dabigatran
  • dasatinib
  • delaviridine
  • dipyridamole
  • glucosamine
  • heparin
  • herbs with anticoagulant properties (e.g., alfalfa, chamomile, garlic, ginger, ginkgo biloba, ginseng, SAMe)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • low weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
  • multivitamins with vitamin A, E
  • nefazodone
  • nelfinavir
  • nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, diclofenac, ketorolac, naproxen)
  • omega-3-fatty acids
  • other antiplatelet medications (e.g., clopidogrel, pentoxifylline, ticlopidine)
  • ranitidine
  • rifampin
  • rivaroxaban
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • telaprevir
  • urokinase
  • vitamin E
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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Prasugrel

Editor-In-Chief: C. Michael Gibson, M.S., M.D. ; Associate Editor(s)-in-Chief: Sheng Shi, M.D. ; Adeel Jamil, M.D.

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Black Box Warning

WARNING: BLEEDING RISK See full prescribing information for complete Boxed Warning. * Effient can cause significant, sometimes fatal, bleeding (5.1, 5.2, 6.1).

  • Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke (4.1, 4.2).
  • In patients ≥75 years of age, Effient is generally not recommended, except in high-risk patients (diabetes or prior MI), where its use may be considered (8.5).
  • Do not start Effient in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Effient at least 7 days prior to any surgery (5.2).
  • Additional risk factors for bleeding include: body weight <60 kg; propensity to bleed; concomitant use of medications that increase the risk of bleeding (5.1).
  • Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of Effient (5.1).
  • If possible, manage bleeding without discontinuing Effient. Stopping Effient increases the risk of subsequent cardiovascular events (5.3).

Overview

Prasugrel is a P2Y12 platelet inhibitor, Platelet aggregation inhibitor that is FDA approved for the treatment of Acute Coronary Syndrome. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypertension, hyperlipidemia, backache, headache, epistaxis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Acute Coronary Syndrome

  • Dosing Information
  • Initial loading dosage: 60 mg PO
  • Maintaining dosage: 10 mg PO qd
  • Incombination with: aspirin 75 mg-325 mg

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Prasugrel in adult patients.

Non–Guideline-Supported Use

Prophylaxis treatment of Thrombosis of Acute coronary syndrome

  • Dosing Information
  • Recommended: 10 mg/day

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Prasugrel FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

There is limited information regarding Off-Label Guideline-Supported Use of Prasugrel in pediatric patients.

There is limited information regarding Off-Label Non–Guideline-Supported Use of Prasugrel in pediatric patients.

Contraindications

  • Active Bleeding
  • Effient is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage .
  • Prior Transient Ischemic Attack or Stroke
  • Effient is contraindicated in patients with a history of prior transient ischemic attack (TIA) or stroke. In TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel), patients with a history of TIA or ischemic stroke (>3 months prior to enrollment) had a higher rate of stroke on Effient (6.5%; of which 4.2% were thrombotic stroke and 2.3% were intracranial hemorrhage ]]) than on clopidogrel (1.2%; all thrombotic). In patients without such a history, the incidence of stroke was 0.9% (0.2% ICH) and 1.0% (0.3% ICH) with Effient and clopidogrel, respectively. Patients with a history of ischemic stroke within 3 months of screening and patients with a history of hemorrhagic stroke at any time were excluded from TRITON-TIMI 38. Patients who experience a stroke or TIA while on Effient generally should have therapy discontinued .
  • Hypersensitivity
  • Effient is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to prasugrel or any component of the product .

Warnings

WARNING: BLEEDING RISK See full prescribing information for complete Boxed Warning. * Effient can cause significant, sometimes fatal, bleeding (5.1, 5.2, 6.1).

  • Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke (4.1, 4.2).
  • In patients ≥75 years of age, Effient is generally not recommended, except in high-risk patients (diabetes or prior MI), where its use may be considered (8.5).
  • Do not start Effient in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Effient at least 7 days prior to any surgery (5.2).
  • Additional risk factors for bleeding include: body weight <60 kg; propensity to bleed; concomitant use of medications that increase the risk of bleeding (5.1).
  • Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of Effient (5.1).
  • If possible, manage bleeding without discontinuing Effient. Stopping Effient increases the risk of subsequent cardiovascular events (5.3).

General Risk of Bleeding==

clopidogrel, including Effient, increase the risk of bleeding. With the dosing regimens used in TRITON-TIMI 38, TIMI (Thrombolysis in Myocardial Infarction) Major (clinically overt bleeding associated with a fall in hemoglobin ≥5 g/dL, or intracranial hemorrhage) and TIMI Minor (overt bleeding associated with a fall in hemoglobin of ≥3 g/dL but <5 g/dL) bleeding events were more common on Effient than on clopidogrel . The bleeding risk is highest initially, as shown in Figure 1 (events through 450 days; inset shows events through 7 days).

Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, PCI, CABG, or other surgical procedures even if the patient does not have overt signs of bleeding. Do not use Effient in patients with active bleeding, prior TIA or stroke . Other risk factors for bleeding are:

  • Age ≥75 years. Because of the risk of bleeding (including fatal bleeding) and uncertain effectiveness in patients ≥75 years of age, use of Effient is generally not recommended in these patients, except in high-risk situations (patients with diabetes or history of myocardial infarction) where its effect appears to be greater and its use may be considered .
  • CABG or other surgical procedure .
  • Body weight <60 kg. Consider a lower (5-mg) maintenance dose .
  • Propensity to bleed (e.g., recent trauma, recent surgery, recent or recurrent gastrointestinal (GI) bleeding, active peptic ulcer disease, severe hepatic impairment, or moderate to severe renal impairment) .
  • Medications that increase the risk of bleeding (e.g., oral anticoagulants, chronic use of non-steroidal anti-inflammatory drugs NSAIDs, and fibrinolytic agents). Aspirin and heparin were commonly used in TRITON-TIMI 38 .

clopidogrel inhibit platelet aggregation for the lifetime of the platelet (7-10 days), so withholding a dose will not be useful in managing a bleeding event or the risk of bleeding associated with an invasive procedure. Because the half-life of prasugrel’s active metabolite is short relative to the lifetime of the platelet, it may be possible to restore hemostasis by administering exogenous platelets; however, platelet transfusions within 6 hours of the loading dose or 4 hours of the maintenance dose may be less effective.

Coronary Artery Bypass Graft Surgery-Related Bleeding

The risk of bleeding is increased in patients receiving Effient who undergo CABG. If possible, Effient should be discontinued at least 7 days prior to CABG. Of the 437 patients who underwent CABG during TRITON-TIMI 38, the rates of CABG-related TIMI Major or Minor bleeding were 14.1% in the Effient group and 4.5% in the clopidogrel group . The higher risk for bleeding events in patients treated with Effient persisted up to 7 days from the most recent dose of study drug. For patients receiving a thienopyridine within 3 days prior to CABG, the frequencies of TIMI Major or Minor bleeding were 26.7% (12 of 45 patients) in the Effient group, compared with 5.0% (3 of 60 patients) in the clopidogrel group. For patients who received their last dose of thienopyridine within 4 to 7 days prior to CABG, the frequencies decreased to 11.3% (9 of 80 patients) in the prasugrel group and 3.4% (3 of 89 patients) in the clopidogrel group. Do not start Effient in patients likely to undergo urgent CABG. CABG-related bleeding may be treated with transfusion of blood products, including packed red blood cells and platelets; however, platelet transfusions within 6 hours of the loading dose or 4 hours of the maintenance dose may be less effective.

Discontinuation of Effient

Discontinue clopidogrel, including Effient, for active bleeding, elective surgery, stroke, or TIA. The optimal duration of thienopyridine therapy is unknown. In patients who are managed with PCI and stent placement, premature discontinuation of any antiplatelet medication, including clopidogrel, conveys an increased risk of stent thrombosis, myocardial infarction, and death. Patients who require premature discontinuation of a thienopyridine will be at increased risk for cardiac events. Lapses in therapy should be avoided, and if clopidogrel must be temporarily discontinued because of an adverse event(s), they should be restarted as soon as possible .

Thrombotic Thrombocytopenic Purpura

Thrombotic thrombocytopenic purpura (TTP) has been reported with the use of Effient. TTP can occur after a brief exposure (<2 weeks). TTP is a serious condition that can be fatal and requires urgent treatment, including plasmapheresis (plasma exchange). TTP is characterized by thrombocytopenia, microangiopathic hemolytic anemia (schistocytes ]] seen on peripheral smear), neurological findings, renal dysfunction, and fever .

Hypersensitivity Including Angioedema

Hypersensitivity including angioedema has been reported in patients receiving Effient, including patients with a history of hypersensitivity reaction to other clopidogrel .

Drug Interactions

  • Warfarin
  • Coadministration of Effient and warfarin increases the risk of bleeding .
  • Non-Steroidal Anti-Inflammatory Drugs
  • Coadministration of Effient and NSAIDs (used chronically) may increase the risk of bleeding .
  • Other Concomitant Medications
  • Effient can be administered with drugs that are inducers or inhibitors of cytochrome P450 enzymes .
  • Effient can be administered with aspirin (75-mg to 325-mg per day), heparin, GPIIb/IIIa inhibitors, statins, digoxin, and drugs that elevate gastric pH, including proton pump inhibitors and H2 blockers .

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B Pregnancy Category B – There are no adequate and well-controlled studies of Effient use in pregnant women. Reproductive and developmental toxicology studies in rats and rabbits at doses of up to 30 times the recommended therapeutic exposures in humans (based on plasma exposures to the major circulating human metabolite) revealed no evidence of fetal harm; however, animal studies are not always predictive of a human response. Effient should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. In embryo fetal developmental toxicology studies, pregnant rats and rabbits received prasugrel at maternally toxic oral doses equivalent to more than 40 times the human exposure. A slight decrease in pup body weight was observed; but, there were no structural malformations in either species. In prenatal and postnatal rat studies, maternal treatment with prasugrel had no effect on the behavioral or reproductive development of the offspring at doses greater than 150 times the human exposure .
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Prasugrel in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Prasugrel during labor and delivery.

Nursing Mothers

It is not known whether Effient is excreted in human milk; however, metabolites of Effient were found in rat milk. Because many drugs are excreted in human milk, prasugrel should be used during nursing only if the potential benefit to the mother justifies the potential risk to the nursing infant.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established .

Geriatic Use

In TRITON-TIMI 38, 38.5% of patients were ≥65 years of age and 13.2% were ≥75 years of age. The risk of bleeding increased with advancing age in both treatment groups, although the relative risk of bleeding (Effient compared with clopidogrel) was similar across age groups. Patients ≥75 years of age who received Effient 10-mg had an increased risk of fatal bleeding events (1.0%) compared to patients who received clopidogrel (0.1%). In patients ≥75 years of age, symptomatic intracranial hemorrhage occurred in 7 patients (0.8%) who received Effient and in 3 patients (0.3%) who received clopidogrel. Because of the risk of bleeding, and because effectiveness is uncertain in patients ≥75 years of age , use of Effient is generally not recommended in these patients, except in high-risk situations (diabetes and past history of myocardial infarction) where its effect appears to be greater and its use may be considered .

Gender

There is no FDA guidance on the use of Prasugrel with respect to specific gender populations.

Race

There is no FDA guidance on the use of Prasugrel with respect to specific racial populations.

Renal Impairment

No dosage adjustment is necessary for patients with renal impairment. There is limited experience in patients with end-stage renal disease, but such patients are generally at higher risk of bleeding .

Hepatic Impairment

No dosage adjustment is necessary in patients with mild to moderate hepatic impairment (Child-Pugh Class A and B). The pharmacokinetics and pharmacodynamics of prasugrel in patients with severe hepatic disease have not been studied, but such patients are generally at higher risk of bleeding .

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Prasugrel in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Prasugrel in patients who are immunocompromised.

Low Body Weight

In TRITON-TIMI 38, 4.6% of patients treated with Effient had body weight <60 kg. Individuals with body weight <60 kg had an increased risk of bleeding and an increased exposure to the active metabolite of prasugrel . Consider lowering the maintenance dose to 5-mg in patients <60 kg. The effectiveness and safety of the 5-mg dose have not been prospectively studied .

Administration and Monitoring

Administration

Initiate Effient treatment as a single 60-mg oral loading dose and then continue at 10-mg orally once daily. Patients taking Effient should also take aspirin (75-mg to 325-mg) daily . Effient may be administered with or without food .

Dosing in Low Weight Patients

Compared to patients weighing ≥60 kg, patients weighing <60 kg have an increased exposure to the active metabolite of prasugrel and an increased risk of bleeding on a 10-mg once daily maintenance dose. Consider lowering the maintenance dose to 5-mg in patients <60 kg. The effectiveness and safety of the 5-mg dose have not been prospectively studied .

Monitoring

There is limited information regarding Prasugrel Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Prasugrel and IV administrations.

Overdosage

  • Signs and Symptoms
  • Platelet inhibition by prasugrel is rapid and irreversible, lasting for the life of the platelet, and is unlikely to be increased in the event of an overdose. In rats, lethality was observed after administration of 2000 mg/kg. Symptoms of acute toxicity in dogs included emesis, increased serum alkaline phosphatase, and hepatocellular atrophy. Symptoms of acute toxicity in rats included mydriasis, irregular respiration, decreased locomotor activity, ptosis, staggering gait, and lacrimation.
  • Recommendations about Specific Treatment
  • Platelet transfusion may restore clotting ability. The prasugrel active metabolite is not likely to be removed by dialysis.

Pharmacology

Mechanism of Action

Prasugrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets.

Structure

Effient contains prasugrel, a thienopyridine class inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP receptor. Effient is formulated as the hydrochloride salt, a racemate, which is chemically designated as 5–4,5,6,7-tetrahydrothienopyridin-2-yl acetate hydrochloride. Prasugrel hydrochloride has the empirical formula C20H20FNO3S•HCl representing a molecular weight of 409.90. The chemical structure of prasugrel hydrochloride is:

Prasugrel hydrochloride is a white to practically white solid. It is soluble at pH 2, slightly soluble at pH 3 to 4, and practically insoluble at pH 6 to 7.5. It also dissolves freely in methanol and is slightly soluble in 1- and 2-propanol and acetone. It is practically insoluble in diethyl ether and ethyl acetate. Effient is available for oral administration as 5-mg or 10-mg elongated hexagonal, film-coated, non-scored tablets, debossed on each side. Each yellow 5-mg tablet is manufactured with 5.49 mg prasugrel hydrochloride, equivalent to 5-mg prasugrel and each beige 10-mg tablet with 10.98 mg prasugrel hydrochloride, equivalent to 10-mg of prasugrel.

Original Formulation. During manufacture and storage, partial conversion from prasugrel hydrochloride to prasugrel free base may occur. Other ingredients include mannitol, hypromellose, croscarmellose sodium, microcrystalline cellulose, and vegetable magnesium stearate. The color coatings contain lactose, hypromellose, titanium dioxide, triacetin, iron oxide yellow, and iron oxide red (only in Effient 10-mg tablet).

Revised Formulation Other ingredients include mannitol, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, sucrose stearate, and glyceryl behenate. The color coatings contain lactose, hypromellose, titanium dioxide, triacetin, iron oxide yellow, and iron oxide red (only in Effient 10-mg tablet).

Pharmacodynamics

Prasugrel produces inhibition of platelet aggregation to 20 μM or 5 μM ADP, as measured by light transmission aggregometry. Following a 60-mg loading dose of Effient, approximately 90% of patients had at least 50% inhibition of platelet aggregation by 1 hour. Maximum platelet inhibition was about 80% (see Figure 2). Mean steady-state inhibition of platelet aggregation was about 70% following 3 to 5 days of dosing at 10-mg daily after a 60-mg loading dose of Effient.

Platelet aggregation gradually returns to baseline values over 5-9 days after discontinuation of prasugrel, this time course being a reflection of new platelet production rather than pharmacokinetics of prasugrel. Discontinuing clopidogrel 75-mg and initiating a prasugrel 10-mg maintenance dose with or without a prasugrel 60-mg loading dose results in a decrease of 14 percentage points in maximum platelet aggregation (MPA) by Day 7. This decrease in MPA is not greater than that typically produced by a 10-mg maintenance dose of prasugrel alone. The relationship between inhibition of platelet aggregation and clinical activity has not been established. 5-mg in Low Body Weight Patients – In patients with stable coronary artery disease, mean platelet inhibition in subjects <60 kg taking 5-mg prasugrel was similar to that of subjects ≥60 kg taking 10-mg prasugrel. The relationship between inhibition of platelet aggregation and clinical activity has not been established.

Pharmacokinetics

Prasugrel is a prodrug and is rapidly metabolized to a pharmacologically active metabolite and inactive metabolites. The active metabolite has an elimination half-life of about 7 hours (range 2-15 hours). Healthy subjects, patients with stable atherosclerosis, and patients undergoing PCI show similar pharmacokinetics.

Absorption and Binding – Following oral administration, ≥79% of the dose is absorbed. The absorption and metabolism are rapid, with peak plasma concentrations (Cmax) of the active metabolite occurring approximately 30 minutes after dosing. The active metabolite’s exposure (AUC) increases slightly more than proportionally over the dose range of 5 to 60-mg. Repeated daily doses of 10-mg do not lead to accumulation of the active metabolite. In a study of healthy subjects given a single 15-mg dose, the AUC of the active metabolite was unaffected by a high fat, high calorie meal, but Cmax was decreased by 49% and Tmax was increased from 0.5 to 1.5 hours. Effient can be administered without regard to food. The active metabolite is bound about 98% to human serum albumin.

Metabolism and Elimination – Prasugrel is not detected in plasma following oral administration. It is rapidly hydrolyzed in the intestine to a thiolactone, which is then converted to the active metabolite by a single step, primarily by CYP3A4 and CYP2B6 and to a lesser extent by CYP2C9 and CYP2C19. The estimates of apparent volume of distribution of prasugrel’s active metabolite ranged from 44 to 68 L and the estimates of apparent clearance ranged from 112 to 166 L/hr in healthy subjects and patients with stable atherosclerosis. The active metabolite is metabolized to two inactive compounds by S-methylation or conjugation with cysteine. The major inactive metabolites are highly bound to human plasma proteins. Approximately 68% of the prasugrel dose is excreted in the urine and 27% in the feces as inactive metabolites.

Nonclinical Toxicology

Carcinogenesis – No compound-related tumors were observed in a 2-year rat study with prasugrel at oral doses up to 100 mg/kg/day (>100 times the recommended therapeutic exposures in humans (based on plasma exposures to the major circulating human metabolite). There was an increased incidence of tumors (Hepatocellular adenoma

Clinical Studies

There is limited information regarding Prasugrel Clinical Studies in the drug label.

How Supplied

There is limited information regarding Prasugrel How Supplied in the drug label.

Storage

There is limited information regarding Prasugrel Storage in the drug label.

Images

Package and Label Display Panel

Patient Counseling Information

There is limited information regarding Prasugrel Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Prasugrel 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 Prasugrel Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Prasugrel Look-Alike Drug Names in the drug label.

Drug Shortage Status

The contents of this FDA label are provided by the National Library of Medicine.

  1. Roe MT, Armstrong PW, Fox KA, White HD, Prabhakaran D, Goodman SG et al. (2012) Prasugrel versus clopidogrel for acute coronary syndromes without revascularization. N Engl J Med 367 (14):1297-309. DOI:10.1056/NEJMoa1205512 PMID: 22920930

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