Pronunciation:

PRA-soo-grel

Brand Names:

• Effient

Dosage Forms:

• Tablet

Warnings:

Prasugrel can cause significant and sometimes fatal bleeding. Do not use prasugrel in patients with active pathological bleeding or a history of transient ischemic attack or stroke. Risk factors for bleeding include body weight of less than 60 kg, propensity to bleed, and concomitant use of medications that increase the risk of bleeding (eg, warfarin, heparin, fibrinolytics, chronic use of NSAIDs). Prasugrel is not recommended in patients 75 years of age or older, except for high-risk situations (diabetes, history of prior myocardial infarction). Do not start prasugrel in patients likely to undergo urgent CABG, and discontinue at least 7 days prior to any surgery. If possible, manage bleeding without discontinuing prasugrel, as discontinuation in the first few weeks after acute coronary syndrome may increase risk for subsequent cardiovascular events .

Classifications:

Therapeutic—

Platelet Aggregation Inhibitor

Pharmacologic—

ADP-Induced Aggregation Inhibitor

Uses of This Medicine:

Prasugrel is used to prevent strokes, heart attacks, or other serious problems with your heart or blood vessels. It is given to patients before they have a heart procedure called percutaneous coronary intervention (PCI).

A heart attack or stroke may occur when a blood vessel in the heart or brain is blocked by a blood clot. Prasugrel reduces the chance that a harmful blood clot will form by preventing certain cells in the blood from clumping or sticking together. Prasugrel may also increase the chance for serious bleeding in some people.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of prasugrel in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of prasugrel in the elderly. Because of prasugrel's toxicity, use in elderly patients 75 years of age and older is not recommended.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Abrocitinib
• Defibrotide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Alipogene Tiparvovec
• Alteplase, Recombinant
• Amtolmetin Guacil
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Bemiparin
• Betrixaban
• Bivalirudin
• Bromfenac
• Bufexamac
• Cangrelor
• Caplacizumab-yhdp
• Celecoxib
• Certoparin
• Choline Salicylate
• Cilostazol
• Citalopram
• Clonixin
• Clopidogrel
• Curcumin
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyridamole
• Dipyrone
• Droxicam
• Duloxetine
• Edoxaban
• Enoxaparin
• Eptifibatide
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Heparin
• Ibrutinib
• Ibuprofen
• Indomethacin
• Inotersen
• Ketoprofen
• Ketorolac
• Lepirudin
• Levomilnacipran
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Melphalan
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Parnaparin
• Paroxetine
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Piracetam
• Piroxicam
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Selumetinib
• Sertraline
• Sodium Salicylate
• Sulindac
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Ticagrelor
• Tinzaparin
• Tolfenamic Acid
• Tolmetin
• Trazodone
• Turmeric
• Valdecoxib
• Vilazodone
• Vortioxetine
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ritonavir

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding (e.g., head, stomach, or bowel bleeding), active or
• Stroke, history of or
• Transient ischemic attack (TIA) or "mini-stroke", history of—Should not be used in patients with these conditions.

• Hypersensitivity reaction to clopidogrel (Plavix®) or ticlopidine (Ticlid®), history of or
• Kidney disease, moderate to severe or
• Liver disease, severe or
• Low body weight (less than 60 kilograms or 132 pounds) or
• Stomach or bowel bleeding, recurrent or
• Stomach ulcer or
• Surgery or other procedures (e.g., heart bypass surgery, coronary angiography, PCI), recent or
• Trauma, recent—Use with caution. May increase risks for more serious side effects.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

You may take this medicine with or without food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For prevention of heart attacks or strokes:
    • Adults weighing 60 kilograms (kg) or more—At first, 60 milligrams (mg) taken as a single loading dose, and then 10 mg once a day. You may take this medicine with aspirin (75 to 325 mg) once a day.
    • Adults weighing less than 60 kg—At first, 60 mg taken as a single loading dose, and then 5 mg once a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the tablets in its original container.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Tell all of your medical doctors, dentists, and nurses that you are taking this medicine. Prasugrel may increase the risk of serious bleeding during an operation or some dental procedures. Treatment may have to be stopped about 7 days before the operation or dental procedure.

Check with your doctor right away if you have the following symptoms: change in mental status, dark or bloody urine, difficulty with speaking, fever, pale color of the skin, pinpoint red spots on the skin, seizures, weakness, yellow eyes or skin. These may be symptoms of a serious condition called thrombotic thrombocytopenic purpura (TTP).

This medicine may cause serious allergic reactions, including angioedema. Angioedema can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have chest pain, a rash, itching, swelling of the face, lips, tongue, or throat, or trouble with swallowing or breathing while you are using the medicine.

Do not stop taking this medicine without checking with your doctor first. To do so may increase your risk for clots.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blurred vision

dizziness

headache

nervousness

pounding in the ears

slow or fast heartbeat

Less common

Black, tarry stools

bloating or swelling of the face, arms, hands, lower legs, or feet

chest pain or discomfort

chills

cough

difficult or labored breathing

fainting

fever

irregular heartbeat

lightheadedness, dizziness, or fainting

painful or difficult urination

rapid weight gain

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

tightness in the chest

tingling of the hands or feet

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

Incidence not known

Change in mental status

dark or bloody urine

difficulty with speaking

fever

pale color of the skin

pinpoint red spots on the skin

seizures

weakness

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Back pain

diarrhea

nausea

pain in the arms or legs

rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.