PRASUGREL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PRASUGREL HYDROCHLORIDE (UNII: G89JQ59I13) (PRASUGREL - UNII:34K66TBT99)

Available from:

Aurobindo Pharma Limited

INN (International Name):

PRASUGREL HYDROCHLORIDE

Composition:

PRASUGREL 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Prasugrel tablets are indicated to reduce the rate of thrombotic CV events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows: - Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI). - Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI. Prasugrel tablets have been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke compared to clopidogrel. The difference between treatments was driven predominantly by MI, with no difference on strokes and little difference on CV death [see Clinical Studies (14) ] . Prasugrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage (ICH) [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)] . Prasugrel tablets are contraindicated in patients with a history of prior transient ischemic attack (TIA) or stroke. In TRITON-TIMI 38 (TR ial to Assess I mprovement in T herapeutic Outcomes by O ptimizing 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 prasugrel tablets (6.5%; of which 4.2% were thrombotic stroke and 2.3% were intracranial hemorrhage [ICH]) 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 prasugrel tablets 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 prasugrel tablets generally should have therapy discontinued [see Adverse Reactions (6.1) and Clinical Studies (14)] . Prasugrel tablets are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to prasugrel or any component of the product [see Adverse Reactions (6.2)] . Risk Summary There are no data with prasugrel use in pregnant women to inform a drug-associated risk. No structural malformations were observed in animal reproductive and developmental toxicology studies when rats and rabbits were administered prasugrel during organogenesis at doses of up to 30 times the recommended therapeutic exposures in humans [see Data] . Due to the mechanism of action of prasugrel, and the associated identified risk of bleeding, consider the benefits and risks of prasugrel and possible risks to the fetus when prescribing prasugrel to a pregnant woman [see Boxed Warning and Warnings and Precautions (5.1, 5.3)]. The background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. Data Animal Data 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 fetal 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. Risk Summary There is no information regarding the presence of prasugrel in human milk, the effects on the breastfed infant, or the effects on milk production. Metabolites of prasugrel were found in rat milk [see Data] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for prasugrel and any potential adverse effects on the breastfed child from prasugrel or from the underlying maternal condition. Data Animal Data Following a 5 mg/kg oral dose of [14 C]-prasugrel to lactating rats, metabolites of prasugrel were detected in the maternal milk and blood. Safety and effectiveness in pediatric patients have not been established. In a randomized, placebo-controlled trial, the primary objective of reducing the rate of vaso-occlusive crisis (painful crisis or acute chest syndrome) in pediatric patients, aged 2 to less than 18 years, with sickle cell anemia was not met. 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 (prasugrel compared with clopidogrel) was similar across age groups. Patients ≥75 years of age who received prasugrel 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 prasugrel 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 [see Clinical Studies (14)] , use of prasugrel 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 [see Warnings and Precautions (5.1), Clinical Pharmacology (12.3), and Clinical Studies (14)] . In TRITON-TIMI 38, 4.6% of patients treated with prasugrel 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 [see Dosage and Administration (2), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3)] . 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 [see Dosage and Administration (2) and Clinical Pharmacology (12.3)] . 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 [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)] . 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 [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)] . In healthy subjects, patients with stable atherosclerosis, and patients with ACS receiving prasugrel, there was no relevant effect of genetic variation in CYP2B6, CYP2C9, CYP2C19, or CYP3A5 on the pharmacokinetics of prasugrel’s active metabolite or its inhibition of platelet aggregation.

Product summary:

Prasugrel Tablets USP, 5 mg are yellow, elongated hexagonal, film-coated, non-scored tablets debossed with ‘I’ on one side and ‘23’ on the other side.              Bottles of 30                                                              NDC 65862-829-30             Cartons of 30 (3 x 10) Unit-dose Tablets                  NDC 65862-829-03 Prasugrel Tablets USP, 10 mg are beige, elongated hexagonal, film-coated, non-scored tablets debossed with ‘I’ on one side and ‘24’ on the other side.             Bottles of 30                                                              NDC 65862-830-30             Cartons of 30 (3 x 10) Unit-dose Tablets                  NDC 65862-830-03 Store at 20° to 25°C (68° to 77°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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Aurobindo Pharma Limited
----------
Medication Guide
Prasugrel Tablets, USP
(PRA-soo-grel)
What
is
the
most
important
information
I
should
know
about
prasugrel
tablets?
Prasugrel tablets are used to lower your chance of having a heart
attack or other serious problems
with your heart or blood vessels. But, prasugrel tablets can cause
bleeding, which can be serious, and
sometimes lead to death. You should not start to take prasugrel
tablets 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 prasugrel tablets and then have heart
bypass surgery.
What
are
prasugrel
tablets?
Prasugrel
tablets
are
a
prescription
medicine
used
to
treat
people
who:
•
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).
Prasugrel tablets are 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.
Prasugrel tablets help prevent platelets
from
sticking
together
and
forming
a
clot
that
can
block
an
artery
or
a
stent.
It is not known if prasugrel tablets are safe and work in children.
Who
should
not
take
prasugrel
tablets
?
•
Do not take prasugrel tablets 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 prasugrel
tablets. See the end of
this Medication Guide for a list of ingredients in prasugrel tablets.
•
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 numb

Summary of Product characteristics

PRASUGREL - PRASUGREL TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRASUGREL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PRASUGREL
TABLETS.
PRASUGREL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
WARNING: BLEEDING RISK
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
PRASUGREL CAN CAUSE SIGNIFICANT, SOMETIMES FATAL, BLEEDING (5.1, 5.2,
6.1).
DO NOT USE PRASUGREL 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, PRASUGREL IS GENERALLY NOT
RECOMMENDED, EXCEPT IN
HIGH-RISK PATIENTS (DIABETES OR PRIOR MYOCARDIAL INFARCTION [MI]),
WHERE ITS USE MAY
BE CONSIDERED (8.5).
DO NOT START PRASUGREL IN PATIENTS LIKELY TO UNDERGO URGENT CORONARY
ARTERY BYPASS
GRAFT SURGERY (CABG). WHEN POSSIBLE, DISCONTINUE PRASUGREL 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
INVASIVE OR SURGICAL PROCEDURES (5.1).
IF POSSIBLE, MANAGE BLEEDING WITHOUT DISCONTINUING PRASUGREL. STOPPING
PRASUGREL
INCREASES THE RISK OF SUBSEQUENT CARDIOVASCULAR EVENTS (5.3).
INDICATIONS AND USAGE
Prasugrel tablets are a P2Y
platelet inhibitor indicated for the reduction of thrombotic
cardiovascular
events (including stent thrombosis) in patients with acute coronary
syndrome who are to be managed
with percutaneous coronary intervention (PCI) as follows:
Patients with unstable angina or non-ST-elevation myocardial
infarction (NSTEMI) (1.1).
Patients with ST-elevation myocardial infarction (STEMI) when managed
with either primary or delayed
PCI (1.1).
DOSAGE AND ADMINISTRATION
Initiate treatment with a single 60 mg oral loading dose (2).
Continue at 10 mg once daily with or without food.