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Integrilin

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Integrilin

Integrilin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Integrilin (eptifibatide) is used to prevent blood clots or heart attack in people with severe chest pain or other conditions, and in those who are undergoing a procedure called angioplasty (to open blocked arteries). It is an antiplatelet drug. Common side effects include nausea, stomach pain, runny or stuffy nose, cough, sore throat, or mild headache or dizziness.

Dosage of Integrilin depends on the condition being treated and the patient's response. Integrilin may interact with blood thinners or any other medications used to prevent blood clots. Tell your doctor all medications you are taking. Integrilin is not expected to be harmful to a fetus. However, aspirin is sometimes given with this medication, and aspirin can cause bleeding when it is taken during the last 3 months of pregnancy. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Consult your doctor before breast-feeding.

Our Integrilin (eptifibatide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Integrilin in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • blood in your urine;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • any bleeding that will not stop;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • fever, chills, body aches, flu symptoms; or
  • feeling like you might pass out.

Less serious side effects may also occur, such as:

  • nausea;
  • upset stomach; or
  • bleeding around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Integrilin (Eptifibatide) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Integrilin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reaction is also discussed elsewhere in the labeling:

Clinical Trials Experience

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

A total of 16,782 patients were treated in the Phase III clinical trials (PURSUIT, ESPRIT, and IMPACT II) [see Clinical Trials]. These 16,782 patients had a mean age of 62 years (range: 2094 years). Eighty-nine percent of the patients were Caucasian, with the remainder being predominantly Black (5%) and Hispanic (5%). Sixty-eight percent were men. Because of the different regimens used in PURSUIT, IMPACT II, and ESPRIT, data from the 3 studies were not pooled.

Bleeding and hypotension were the most commonly reported adverse reactions (incidence ≥ 5% and greater than placebo) in the INTEGRILIN controlled clinical trial database.

Bleeding

The incidence of bleeding and transfusions in the PURSUIT and ESPRIT studies are shown in Table 2. Bleeding was classified as major or minor by the criteria of the TIMI study group. Major bleeding consisted of intracranial hemorrhage and other bleeding that led to decreases in hemoglobin greater than 5 g/dL. Minor bleeding included spontaneous gross hematuria, spontaneous hematemesis, other observed blood loss with a hemoglobin decrease of more than 3 g/dL, and other hemoglobin decreases that were greater than 4 g/dL but less than 5 g/dL. In patients who received transfusions, the corresponding loss in hemoglobin was estimated through an adaptation of the method of Landefeld et al.

Table 2: Bleeding and Transfusions in the PURSUIT and ESPRIT Studies

  PURSUIT (ACS)
Placebo
n (%)
INTEGRILIN 180/2
n (%)
Patients 4696 4679
Major bleeding* 425 (9.3%) 498 (10.8%)
Minor bleeding* 347 (7.6%) 604 (13.1%)
Requiring transfusions† 490 (10.4%) 601 (12.8%)
  ESPRIT (PCI)
Placebon
(%)
INTEGRILIN 180/2/180
n (%)
Patients 1024 1040
Major bleeding* 4 (0.4%) 13 (1.3%)
Minor bleeding* 18 (2%) 29 (3%)
Requiring transfusions† 11 (1.1%) 16 (1.5%)
Note: Denominator is based on patients for whom data are available.
* For major and minor bleeding, patients are counted only once according to the most severe classification.
† Includes transfusions of whole blood, packed red blood cells, fresh frozen plasma, cryoprecipitate, platelets, and autotransfusion during the initial hospitalization.

The majority of major bleeding reactions in the ESPRIT study occurred at the vascular access site (1 and 8 patients, or 0.1% and 0.8% in the placebo and INTEGRILIN groups, respectively). Bleeding at “other” locations occurred in 0.2% and 0.4% of patients, respectively.

In the PURSUIT study, the greatest increase in major bleeding in INTEGRILIN-treated patients compared to placebo-treated patients was also associated with bleeding at the femoral artery access site (2.8% versus 1.3%). Oropharyngeal (primarily gingival), genitourinary, gastrointestinal, and retroperitoneal bleeding were also seen more commonly in INTEGRILIN-treated patients compared to placebo-treated patients.

Among patients experiencing a major bleed in the IMPACT II study, an increase in bleeding on INTEGRILIN versus placebo was observed only for the femoral artery access site (3.2% versus 2.8%).

Table 3 displays the incidence of TIMI major bleeding according to the cardiac procedures carried out in the PURSUIT study. The most common bleeding complications were related to cardiac revascularization (CABG-related or femoral artery access site bleeding). A corresponding table for ESPRIT is not presented, as every patient underwent PCI in the ESPRIT study and only 11 patients underwent CABG.

Table 3: Major Bleeding by Procedures in the PURSUIT Study

  Placebo
n (%)
INTEGRILIN 180/2
n (%)
Patients 4577 4604
Overall incidence of major bleeding 425 (9.3%) 498 (10.8%)
Breakdown by procedure:
  CABG 375 (8.2%) 377 (8.2%)
  Angioplasty without CABG  27 (0.6%) 64 (1.4%)
  Angiography without angioplasty or CABG 11 (0.2%) 29 (0.6%)
  Medical therapy only 12 (0.3%) 28 (0.6%)
Note: Denominators are based on the total number of patients whose TIMI classification was resolved.

In the PURSUIT and ESPRIT studies, the risk of major bleeding with INTEGRILIN increased as patient weight decreased. This relationship was most apparent for patients weighing less than 70 kg.

Bleeding resulting in discontinuation of the study drug was more frequent among patients receiving INTEGRILIN than placebo (4.6% versus 0.9% in ESPRIT, 8% versus 1% in PURSUIT, 3.5% versus 1.9% in IMPACT II).

Intracranial Hemorrhage and Stroke

Intracranial hemorrhage was rare in the PURSUIT, IMPACT II, and ESPRIT clinical studies. In the PURSUIT study, 3 patients in the placebo group, 1 patient in the group treated with INTEGRILIN 180/1.3, and 5 patients in the group treated with INTEGRILIN 180/2 experienced a hemorrhagic stroke. The overall incidence of stroke was 0.5% in patients receiving INTEGRILIN 180/1.3, 0.7% in patients receiving INTEGRILIN 180/2, and 0.8% in placebo patients.

In the IMPACT II study, intracranial hemorrhage was experienced by 1 patient treated with INTEGRILIN 135/0.5, 2 patients treated with INTEGRILIN 135/0.75, and 2 patients in the placebo group. The overall incidence of stroke was 0.5% in patients receiving 135/0.5 INTEGRILIN, 0.7% in patients receiving INTEGRILIN 135/0.75, and 0.7% in the placebo group.

In the ESPRIT study, there were 3 hemorrhagic strokes, 1 in the placebo group and 2 in the INTEGRILIN group. In addition there was 1 case of cerebral infarction in the INTEGRILIN group.

Immunogenicity/Thrombocytopenia

The potential for development of antibodies to eptifibatide has been studied in 433 subjects. INTEGRILIN was nonantigenic in 412 patients receiving a single administration of INTEGRILIN (135mcg/kg bolus followed by a continuous infusion of either 0.5 mcg/kg/min or 0.75 mcg/kg/min), and in 21 subjects to whom INTEGRILIN (135-mcg/kg bolus followed by a continuous infusion of 0.75 mcg/kg/min) was administered twice, 28 days apart. In both cases, plasma for antibody detection was collected approximately 30 days after each dose. The development of antibodies to eptifibatide at higher doses has not been evaluated.

In patients with suspected INTEGRILIN-related immune-mediated thrombocytopenia, IgG antibodies that react with the GP IIb/IIIa complex were identified in the presence of eptifibatide and in INTEGRILIN-na´ve patients. These findings suggest acute thrombocytopenia after the administration of INTEGRILIN can develop as a result of naturally occurring drug-dependent antibodies or those induced by prior exposure to INTEGRILIN. Similar antibodies were identified with other GP IIb/IIIa ligand-mimetic agents. Immune-mediated thrombocytopenia with INTEGRILIN may be associated with hypotension and/or other signs of hypersensitivity.

In the PURSUIT and IMPACT II studies, the incidence of thrombocytopenia ( < 100,000/mm³ or ≥ 50% reduction from baseline) and the incidence of platelet transfusions were similar between patients treated with INTEGRILIN and placebo. In the ESPRIT study, the incidence was 0.6% in the placebo group and 1.2% in the INTEGRILIN group.

Other Adverse Reactions

In the PURSUIT and ESPRIT studies, the incidence of serious nonbleeding adverse reactions was similar in patients receiving placebo or INTEGRILIN (19% and 19%, respectively, in PURSUIT; 6% and 7%, respectively, in ESPRIT). In PURSUIT, the only serious nonbleeding adverse reaction that occurred at a rate of at least 1% and was more common with INTEGRILIN than placebo (7% versus 6%) was hypotension. Most of the serious nonbleeding adverse reactions consisted of cardiovascular reactions typical of a UA population. In the IMPACT II study, serious nonbleeding adverse reactions that occurred in greater than 1% of patients were uncommon and similar in incidence between placebo- and INTEGRILIN-treated patients.

Discontinuation of study drug due to adverse reactions other than bleeding was uncommon in the PURSUIT, IMPACT II, and ESPRIT studies, with no single reaction occurring in > 0.5% of the study population (except for “other” in the ESPRIT study).

Postmarketing Experience

Because the reactions below are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been reported in postmarketing experience, primarily with INTEGRILIN in combination with heparin and aspirin: cerebral, GI, and pulmonary hemorrhage. Fatal bleeding reactions have been reported. Acute profound thrombocytopenia, as well as immune-mediated thrombocytopenia, has been reported.

Read the entire FDA prescribing information for Integrilin (Eptifibatide) »

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