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Effient

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Effient

Effient

SIDE EFFECTS

Clinical Trials Experience

The following serious adverse reactions are also discussed elsewhere in the labeling:

Safety in patients with ACS undergoing PCI was evaluated in a clopidogrel-controlled study, TRITON-TIMI 38, in which 6741 patients were treated with Effient (60-mg loading dose and 10 mg once daily) for a median of 14.5 months (5802 patients were treated for over 6 months; 4136 patients were treated for more than 1 year). The population treated with Effient was 27 to 96 years of age, 25% female, and 92% Caucasian. All patients in the TRITON-TIMI 38 study were to receive aspirin. The dose of clopidogrel in this study was a 300-mg loading dose and 75 mg once daily.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials cannot be directly compared with the rates observed in other clinical trials of another drug and may not reflect the rates observed in practice.

Drug Discontinuation

The rate of study drug discontinuation because of adverse reactions was 7.2% for Effient and 6.3% for clopidogrel. Bleeding was the most common adverse reaction leading to study drug discontinuation for both drugs (2.5% for Effient and 1.4% for clopidogrel).

Bleeding

Bleeding Unrelated to CABG Surgery - In TRITON-TIMI 38, overall rates of TIMI Major or Minor bleeding adverse reactions unrelated to coronary artery bypass graft surgery (CABG) were significantly higher on Effient than on clopidogrel, as shown in Table 1.

Table 1: Non-CABG-Related Bleedinga (TRITON-TIMI 38)

  Effient (%) (N=6741) Clopidogrel (%) (N=6716) p-value
TIMI Major or Minor bleeding 4.5 3.4 p=0.002
TIMI Major bleedingb 2.2 1.7 p=0.029
  Life-threatening 1.3 0.8 p=0.015
    Fatal 0.3 0.1  
    Symptomatic intracranial hemorrhage (ICH) 0.3 0.3  
    Requiring inotropes 0.3 0.1  
    Requiring surgical intervention 0.3 0.3  
    Requiring transfusion ( ≥ 4 units) 0.7 0.5  
TIMI Minor bleedingb 2.4 1.9 p=0.022
aPatients may be counted in more than one row.
bSee PRECAUTIONS for definition.

Figure 1 demonstrates non-CABG related TIMI Major or Minor bleeding. The bleeding rate is highest initially, as shown in Figure 1 (inset: Days 0 to 7) [see WARNINGS AND PRECAUTIONS].

Bleeding rates in patients with the risk factors of age 75 years and weight < 60 kg are shown in Table 2.

Table 2: Bleeding Rates for Non-CABG-Related Bleeding by Weight and Age (TRITON-TIMI 38)

  Major/Minor Fatal
Effient (%) Clopidogrel (%) Effient (%) Clopidogrel (%)
Weight < 60 kg (N=308 Effient, N=356 clopidogrel) 10.1 6.5 0 0.3
Weight ≥ 60 kg (N=6373 Effient, N=6299 clopidogrel) 4.2 3.3 0.3 0.1
Age < 75 years (N=5850 Effient, N=5822 clopidogrel) 3.8 2.9 0.2 0.1
Age ≥ 75 years (N=891 Effient, N=894 clopidogrel) 9 6.9 1 0.1

Bleeding Related to CABG - In TRITON-TIMI 38, 437 patients who received a thienopyridine underwent CABG during the course of the study. The rate of CABG-related TIMI Major or Minor bleeding was 14.1% for the Effient group and 4.5% in the clopidogrel group (see Table 3). The higher risk for bleeding adverse reactions in patients treated with Effient persisted up to 7 days from the most recent dose of study drug.

Table 3: CABG-Related Bleedinga (TRITON-TIMI 38)

  Effient (%)
(N=213)
Clopidogrel (%)
(N=224)
TIMI Major or Minor bleeding 14.1 4.5
TIMI Major bleeding 11.3 3.6
   Fatal 0.9 0
   Reoperation 3.8 0.5
   Transfusion of ≥ 5 units 6.6 2.2
   Intracranial hemorrhage 0 0
TIMI Minor bleeding 2.8 0.9
aPatients may be counted in more than one row.

Bleeding Reported as Adverse Reactions - Hemorrhagic events reported as adverse reactions in TRITON-TIMI 38 were, for Effient and clopidogrel, respectively: epistaxis (6.2%, 3.3%), gastrointestinal hemorrhage (1.5%, 1.0%), hemoptysis (0.6%, 0.5%), subcutaneous hematoma (0.5%, 0.2%), post-procedural hemorrhage (0.5%, 0.2%), retroperitoneal hemorrhage (0.3%, 0.2%), pericardial effusion/hemorrhage/tamponade (0.3%, 0.2%), and retinal hemorrhage (0.0%, 0.1%).

Malignancies

During TRITON-TIMI 38, newly-diagnosed malignancies were reported in 1.6% and 1.2% of patients treated with prasugrel and clopidogrel, respectively. The sites contributing to the differences were primarily colon and lung. It is unclear if these observations are causally-related or are random occurrences.

Other Adverse Events

In TRITON-TIMI 38, common and other important non-hemorrhagic adverse events were, for Effient and clopidogrel, respectively: severe thrombocytopenia (0.06%, 0.04%), anemia (2.2%, 2.0%), abnormal hepatic function (0.22%, 0.27%), allergic reactions (0.36%, 0.36%), and angioedema (0.06%, 0.04%). Table 4 summarizes the adverse events reported by at least 2.5% of patients.

Table 4: Non-Hemorrhagic Treatment Emergent Adverse Events Reported by at Least 2.5% of Patients in Either Group

  Effient (%)
(N=6741)
Clopidogrel (%)
(N=6716)
Hypertension 7.5 7.1
Hypercholesterolemia/Hyperlipidemia 7 7.4
Headache 5.5 5.3
Back pain 5 4.5
Dyspnea 4.9 4.5
Nausea 4.6 4.3
Dizziness 4.1 4.6
Cough 3.9 4.1
Hypotension 3.9 3.8
Fatigue 3.7 4.8
Non-cardiac chest pain 3.1 3.5
Atrial fibrillation 2.9 3.1
Bradycardia 2.9 2.4
Leukopenia ( < 4 x 109 WBC/L) 2.8 3.5
Rash 2.8 2.4
Pyrexia 2.7 2.2
Peripheral edema 2.7 3
Pain in extremity 2.6 2.6
Diarrhea 2.3 2.6

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Effient. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders — Thrombocytopenia, Thrombotic thrombocytopenic purpura (TTP) [see WARNINGS AND PRECAUTIONS and Patient Counseling Information]

Immune system disorders — Hypersensitivity reactions including anaphylaxis [see CONTRAINDICATIONS]

Read the Effient (prasugrel tablets) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Warfarin

Coadministration of Effient and warfarin increases the risk of bleeding [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Non-Steroidal Anti-Inflammatory Drugs

Coadministration of Effient and NSAIDs (used chronically) may increase the risk of bleeding [see WARNINGS AND PRECAUTIONS].

Other Concomitant Medications

Effient can be administered with drugs that are inducers or inhibitors of cytochrome P450 enzymes [see CLINICAL PHARMACOLOGY].

Effient can be administered with aspirin (75 mg to 325 mg per day), heparin, GPIIb/IIIa inhibitors, statins, digoxin, and drugs that elevate gastric pH, including proton pump inhibitors and H2 blockers [see CLINICAL PHARMACOLOGY].

Read the Effient Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 12/14/2012
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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