16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Effient (prasugrel) is available as elongated hexagonal, film-coated, non-scored tablets in the following strengths, colors, debossing, and presentations:
|Features ||Strengths |
|5 mg ||10 mg |
|Tablet color ||yellow ||beige |
|Tablet debossing ||5 ||10 |
|Tablet debossing ||5121 ||5123 |
| Presentations and NDC Codes || || |
|Bottles of 30 ||65597-601-30 ||65597-602-30 |
16.2 Storage and Handling
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature].
Keep and dispense only in original container. Keep container closed and do not remove desiccant from bottle. Do not break the tablet.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
- Advise patients not to break Effient tablets.
- Remind patients not to discontinue Effient without first discussing it with the physician who prescribed Effient [see Warnings and Precautions (5.3)].
- Inform patients to keep Effient in the container in which it comes, and keep the container closed tightly with the gray cylinder (desiccant) inside.
Inform patients that they:
- will bruise and bleed more easily.
- will take longer than usual to stop bleeding.
- should report any unanticipated, prolonged, or excessive bleeding, or blood in their stool or urine [see Warnings and Precautions (5.1)].
Thrombotic Thrombocytopenic Purpura
- Inform patients that TTP is a rare but serious condition that has been reported with Effient.
- Instruct patients to get prompt medical attention if they experience symptoms of TTP that cannot otherwise be explained [see Warnings and Precautions (5.4)].
Inform patients that they may have hypersensitivity reactions and to seek immediate medical attention if any signs and symptoms of a hypersensitivity reaction occur. Patients who have had hypersensitivity reactions to other thienopyridines may have hypersensitivity reactions to Effient.
Instruct patients to:
- inform physicians and dentists that they are taking Effient before any invasive procedure is scheduled [see Warnings and Precautions (5.1)].
- tell the doctor performing the invasive procedure to talk to the prescribing healthcare professional before stopping Effient.
Ask patients to list all prescription medications, over-the-counter medications, or dietary supplements they are taking or plan to take so the physician knows about other treatments that may affect bleeding risk (e.g., warfarin and NSAIDs) [see Drug Interactions (7.1, 7.2)].
Manufactured by Daiichi Sankyo, Inc., Basking Ridge, NJ 07920
Effient® is a registered trademark of Daiichi Sankyo Company, Ltd.Copyright © 2009, 2020 Daiichi Sankyo, Inc. All rights reserved.
|This Medication Guide has been approved by the U.S. Food and Drug Administration. ||Revised: 12/2020 |
| Medication GuideEFFIENT® (Ef´-fee-ent)(prasugrel) tablets |
|What is the most important information I should know about Effient?Effient is used to lower your chance of having a heart attack or other serious problems with your heart or blood vessels. But, Effient can cause bleeding, which can be serious, and sometimes lead to death. You should not start to take Effient if it is likely that you will have heart bypass surgery (coronary artery bypass graft surgery or CABG) right away. You have a higher risk of bleeding if you take Effient and then have heart bypass surgery. |
|What is Effient? Effient is a prescription medicine used to treat people who: |
Effient is used to lower your chance of having another serious problem with your heart or blood vessels, such as another heart attack, a stroke, blood clots in your stent, or death.Platelets are blood cells that help with normal blood clotting. Effient helps prevent platelets from sticking together and forming a clot that can block an artery or a stent.It is not known if Effient is safe and works in children.
- have had a heart attack or severe chest pain that happens when your heart does not get enough oxygen, and
- have been treated with a procedure called “angioplasty” (also called balloon angioplasty).
| Who should not take Effient? |
Your risk of bleeding while taking Effient may be higher if you also:
- Do not take Effient if you:
- currently have abnormal bleeding, such as stomach or intestinal bleeding, or bleeding in your head
- have had a stroke or “mini-stroke” (also known as transient ischemic attack or TIA)
- are allergic to prasugrel or any of the ingredients in Effient. See the end of this Medication Guide for a list of ingredients in Effient.
- Get medical help right away if you think you may be having a stroke or TIA. Symptoms that you may be having a stroke or TIA include:
- sudden slurring of speech,
- sudden weakness or numbness in one part of your body,
- sudden blurry vision, or sudden severe headache.
- If you have a stroke or TIA while taking Effient, your doctor will probably stop your Effient. Follow your doctor’s instructions about stopping Effient. Do not stop taking Effient unless your doctor tells you to.
- Before having any surgery, you should talk to your doctor about stopping Effient. If possible, Effient should be stopped at least 1 week (7 days) before any surgery, as instructed by the doctor who prescribed Effient for you.
Tell your doctor if you take any of these medicines. Ask your doctor if you are not sure if your medicine is one listed above.
- have had trauma, such as an accident or surgery
- have stomach or intestine bleeding that is recent or keeps coming back, or you have a stomach ulcer
- have severe liver problems
- have moderate to severe kidney problems
- weigh less than 132 pounds
- take other medicines that increase your risk of bleeding, including:
- warfarin sodium (Coumadin , Jantoven *)
- a medicine that contains heparin
- other medicines to prevent or treat blood clots
- regular daily use of nonsteroidal anti-inflammatory drugs (NSAIDs)
- Effient increases your risk of bleeding because it lessens the ability of your blood to clot. While you take Effient:
- you will bruise and bleed more easily
- you are more likely to have nose bleeds
- it will take longer for any bleeding to stop
- Call your doctor right away if you have any of these signs or symptoms of bleeding:
- unexpected bleeding or bleeding that lasts a long time
- bleeding that is severe or you cannot control
- pink or brown urine
- red or black stool (looks like tar)
- bruises that happen without a known cause or get larger
- cough up blood or blood clots
- vomit blood or your vomit looks like “coffee grounds”
- Do not stop taking Effient without talking to the doctor who prescribes it for you. People who are treated with angioplasty and have a stent, and stop taking Effient too soon, have a higher risk of a blood clot in the stent, having a heart attack, or dying. If you must stop Effient because of bleeding, your risk of a heart attack may be higher. See “What are the possible side effects of Effient?” for more information about side effects.
|What should I tell my doctor before taking Effient?Before you take Effient, tell your doctor about all of your medical conditions, including if you: |
Tell all of your doctors and dentists that you are taking Effient. They should talk to the doctor who prescribed Effient for you, before you have any surgery or invasive procedure.Tell your doctor about all the medicines you take , including prescription and nonprescription medicines, vitamins, and herbal supplements. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about Effient?“Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
- have any bleeding problems.
- have had a stroke or “mini-stroke” (also known as transient ischemic attack or TIA).
- are allergic to any medicines, including clopidogrel (Plavix *) or ticlopidine hydrochloride.
- have a history of stomach ulcers, colon polyps, diverticulosis.
- have liver problems.
- have kidney problems.
- have had any recent severe injury or surgery.
- plan to have surgery or a dental procedure. See “What is the most important information I should know about Effient?“
- are pregnant, or are planning to get pregnant. It is not known if Effient will harm your baby.
- are breastfeeding. It is not known if Effient passes into your breast milk. You and your doctor should decide if you will take Effient or breastfeed. You should not do both without talking with your doctor.
| How should I take Effient? |
- Take Effient exactly as prescribed by your doctor.
- Take Effient one time each day.
- You can take Effient with or without food.
- Do not split Effient tablets.
- Take Effient with aspirin as instructed by your doctor.
- Your doctor will decide how long you should take Effient. Do not stop taking Effient without first talking to the doctor who prescribed it for you. See “What is the most important information I should know about Effient?“
- If you miss a dose, take Effient as soon as you remember. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time. Do not take two doses at the same time unless your doctor tells you to.
- If you take too much Effient, call your local emergency room or poison control center right away.
- Call your doctor or healthcare provider right away if you fall or injure yourself, especially if you hit your head. Your doctor or healthcare provider may need to check you.
|What are the possible side effects of Effient?Effient can cause serious side effects, including: |
Tell your doctor if you have any side effect that bothers you or that does not go away.These are not all of the possible side effects of Effient. For more information, ask your doctor or pharmacist.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
- See “What is the most important information I should know about Effient?“
- A blood clotting problem called thrombotic thrombocytopenic purpura (TTP). TTP can happen with Effient, sometimes after a short time (less than 2 weeks). TTP is a blood clotting problem where blood clots form in blood vessels and can happen all over the body. TTP needs to be treated in a hospital right away, because you may die. Get medical help right away if you have any of these symptoms and they cannot be explained by another medical condition:
- purplish spots called purpura on the skin or mucous membranes (such as on the mouth) due to bleeding under the skin
- paleness or jaundice (a yellowish color of the skin or eyes)
- feeling tired or weak
- fast heart rate or feeling short of breath
- headache, speech changes, confusion, coma, stroke, or seizure
- low amount of urine or urine that is pink-tinged or has blood in it
- stomach area (abdominal) pain, nausea, vomiting, or diarrhea
- visual changes
- Serious allergic reactions. Serious allergic reactions can happen with Effient, or if you have had a serious allergic reaction to medicines called thienopyridines, for example clopidogrel (Plavix *) or ticlopidine hydrochloride. Get medical help right away if you get any of these symptoms of a severe allergic reaction while taking Effient.
- swelling or hives of your face, lips, in or around your mouth, or throat
- trouble breathing or swallowing
- chest pain or pressure
- dizziness or fainting
|How should I store Effient? |
Keep Effient and all medicines out of the reach of children.
- Keep Effient at room temperature between 59°F to 86°F (15°C to 30°C).
- Keep and dispense only in original container.
- Keep the container closed tightly with the gray cylinder inside.
- Protect Effient from moisture.
|General information about the safe and effective use of Effient Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Effient for a condition for which it was not prescribed. Do not give your Effient to other people, even if they have the same symptoms you have. It may harm them.This Medication Guide summarizes the most important information about Effient. If you would like more information about Effient, talk with your doctor or pharmacist. |
|What are the ingredients in Effient?Active ingredient: prasugrelInactive ingredients: 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).Manufactured by Daiichi Sankyo, Inc., Basking Ridge, NJ 07920Effient® is a registered trademark of Daiichi Sankyo Company, Ltd.Copyright © 2009, 2020 Daiichi Sankyo, Inc. All rights reserved.USMG-EFF-1220-r100For more information, call 1-877-437-7763 or go to www.effient.com. |
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