Effient

Effient (Prasugrel) is normally started with a single dose of 60 mg. Thereafter, the recommended adult dose of Effient (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.

Effient (Prasugrel) may be taken with or without food.

Do not stop taking Effient (Prasugrel) without first discussing it with your doctor. Stopping Effient (Prasugrel) 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 Effient (Prasugrel) 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 Effient (Prasugrel) 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.

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 Effient (Prasugrel) hydrochloride equivalent to 10 mg of Effient (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.

Do not take Effient (Prasugrel) if you:

• are allergic to Effient (Prasugrel) or any ingredients of Effient (Prasugrel)
• 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

There may be an interaction between Effient (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 Effient (Prasugrel). 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.

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 Effient (Prasugrel).

HEALTH CANADA ADVISORY

January 17, 2014

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

Bleeding problems: Effient (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 Effient (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 Effient (Prasugrel), and whether any special monitoring is needed.

Thrombotic thrombocytopenic purpura (TTP) is a rare condition that may occur while taking Effient (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 Effient (Prasugrel).

Heart problems: There is an increased risk of bleeding if Effient (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 Effient (Prasugrel), this risk does not affect your situation and you should not stop taking the medication without first speaking to your doctor.

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

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

Stomach problems: Since Effient (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 Effient (Prasugrel): Do not stop taking Effient (Prasugrel) suddenly as this increases the risk of Blood Clots, heart attack, and death. If you need to stop taking Effient (Prasugrel) due to bleeding problems, your doctor should monitor you for any blood clots.

Surgery: Your doctor may want you to stop taking Effient (Prasugrel) at least 7 days prior to any planned surgery to prevent any unnecessary bleeding. However, you should not stop taking Effient (Prasugrel) without talking to your doctor first. It is important to tell any doctors including your dentist that you are taking Effient (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 Effient (Prasugrel), contact your doctor immediately.

Breast-feeding: It is not known if Effient (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 Effient (Prasugrel) 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 Effient (Prasugrel), Effient (Prasugrel) is not recommended for people over 75 years of age unless the benefits outweigh the risks.