Effient

The active ingredient in Effient is prasugrel. Prasugrel belongs to a class of medications known as P2Y12 platelet inhibitors. Platelets are blood cells that our body uses to form clots when we have a bleed to stop the bleeding. However, this clot formation from platelet aggregation can become harmful in certain circumstances, as it blocks the proper flow of blood. Blocking platelets decreases our body’s ability to form clots, reducing the risk of adverse cardiovascular events. However, this also means that taking these medications will mean a higher risk for bleeding, which may or may not be life-threatening.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Effient. However, the following is a synopsis of the general guidelines for the use of Effient:

• Effient should be used exactly as prescribed at the same time every day. Depending on what you are taking Effient for, your prescriber will decide how long you will need to take it for.
• Treatment is typically started with a one-time 60 mg loading dose to attain sufficient levels in the body, after which you will take a smaller maintenance dose once a day with or without food on a daily basis. Tablets must be taken whole- do not split or crush.
• While taking Effient, you may also need to take Aspirin as instructed by your prescriber.
• Any plans for surgery or dental procedures should be relayed to your prescriber so that they can take appropriate action beforehand.
• If you miss a dose, take it as soon as you remember. However, 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.

The most common side effects of Effient include:

• High blood pressure
• Increased cholesterol
• Bleeding
• Headache
• Back pain
• Dizziness
• Shortness of breath
• Cough
• Low blood pressure
• Fatigue

Some individuals may experience serious side effects while using Effient. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of thrombotic thrombocytopenic purpura (TTP) such as purplish spots on the skin or in the mouth, pale or jaundiced complexion, unusual fatigue or weakness, fever, rapid heart rate, shortness of breath, headache, confusion, seizure, low urine output that may be pink or red in color, stomach pain, nausea, vomiting, diarrhea, or visual changes. This is a blood clotting problem that can happen after starting Effient and typically presents in a short period of time (less than 2 weeks). It causes blood clots to form in blood vessels all over the body.
• Any bleeding that you cannot stop, especially that from cuts, wounds, or nosebleeds.
• Signs of a stomach bleed such as blood in the vomit or vomit that resembles coffee grounds, streaks of blood in the stools, or dark tarry stools.
• Signs of a serious allergic reaction such as hives, swelling of the face or extremities, difficulty breathing, chest pain, dizziness, or fainting. If you have had a similar reaction while on thienopyridines such as clopidogrel or ticlopidine hydrochloride, there is a higher likelihood you will experience the same while on Effient.

These are not all of the possible side effects of Effient. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Effient, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• Bleeding problems
• A history of stroke or a transient ischemic attack (also known as a “mini-stroke”)
• An allergy to other antiplatelet agents like clopidogrel (Plavix) or ticlopidine hydrochloride
• A history of stomach ulcers, colon polyps, or diverticulosis
• Liver problems
• Kidney problems
• Recent severe injury or surgery
• Plans for surgery or a dental procedure
• Are pregnant or planning to become pregnant
• Are breastfeeding or plan to breastfeed

Boxed Warning

• Effient is associated with a significant bleeding risk that can sometimes be fatal. Risk is increased in those weighing <60 kg, who have a baseline risk for bleeding, or are using other medications that increase the risk of bleeding. Do not use Effient if you have an active bleed. In those 75 years of age or older, Effient is generally not recommended due to an increased risk for severe and fatal bleeds, unless the benefits of treatment outweigh the risks. These would be in high-risk situations where someone may have diabetes or a history of heart attack(s).
• Do not use Effient in patients with a history of TIA or stroke.
• Do not use Effient in patients going for urgent CABG (coronary artery bypass graft). Effient should be stopped at least 7 days before any surgery.
• If a patient has low blood pressure and has recently undergone coronary angiography, PCI (percutaneous coronary intervention), CABG, or any other surgery in the setting of Effient, suspect bleeding. If a bleed is suspected and the patient has had a recent heart attack, bleeding should be managed without discontinuing Effient if possible. Discontinuing Effient in this circumstance increases the risk of clot and subsequent cardiovascular events.

Do not use Effient if you have:

• An active bleed, including those from a stomach ulcer or a brain hemorrhage
• A history of TIA or stroke
• An allergy to prasugrel or any other ingredients in Effient

Effient will start to work right after the first dose and reach peak levels within the body in approximately 30 minutes.

When Effient is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Warfarin or other anticoagulants
• NSAIDs (non-steroidal anti-inflammatory drugs) like ibuprofen, naproxen, diclofenac, or ketorolac
• Opioids

Effient is available as 5 mg and 10 mg tablets.

Effient should be stored in its original container at room temperature, away from light and moisture, and out of reach of children. Keep the lid tightly closed.

Effient is manufactured by the pharmaceutical company Cosette Pharmaceuticals.

Yes, there is a generic available for the brand-name Effient.

Depending on what you are using Effient for, stopping too early or without consulting your prescriber first could cause a clot to form and increase your risk of heart attack or stroke. Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Effient.

It is unknown whether Effient is safe in pregnancy. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is unknown whether Effient passes into the breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.