Eptifibatide Side Effects

Some side effects of eptifibatide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to eptifibatide: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking eptifibatide: 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.

For Healthcare Professionals

Applies to eptifibatide: intravenous solution

General

Prior to approval by the FDA, the efficacy and safety of eptifibatide was evaluated in 8,737 patients. The average age of these patients was 62 years (range 20 to 94). Eighty nine percent were Caucasian, 5% were Black, and 5% were Hispanic. Sixty seven percent were male. The most common side effect was bleeding. Discontinuation of eptifibatide due to adverse events other than bleeding has been uncommon; no single event occurred in greater than 0.5% of the study population.

Hematologic

The overall incidence of intracranial hemorrhage or stroke in large clinical trials has ranged from 0.5% to 0.7% of patients, depending on dose. The incidences of thrombocytopenia and the need for platelet transfusions were similar between patients who received eptifibatide and those who received placebo, suggesting a stronger relationship between these problems and the use of heparin than with the use of the study drug. However, bleeding times and activated clotting times have been significantly higher among treated patients compared with placebo, in some cases despite receiving less heparin.

The incidence of thrombocytopenia (less than 100,000 cells/mcL) associated with eptifibatide is 1.2% to 6.8%, while severe thrombocytopenia (less than 50,000 cells/mcL) has been reported in 0.2% of patients. Platelet transfusions have been reported in 1.3% to 1.5% of patients.

The results of one study (PROTECT-TIMI-30 trial) indicate that in high-risk non ST segment elevation acute coronary syndrome patients undergoing percutaneous coronary intervention (PCI) and treated with eptifibatide, increased age significantly correlated with bleeding events. Patients with reduced CrCl (less than or equal to 50 mL/min), given a full-dose eptifibatide infusion, were associated with a greater incidence of bleeding events. No bleeding events occurred in patients with reduced CrCl who received a reduced dose infusion. In addition, the majority of bleeding events occurred more than 6 hours after initiation of the eptifibatide infusion.

Risk factors for bleeding events in patients treated with glycoprotein (GP) IIb/IIIa inhibitors undergoing percutaneous coronary intervention have been identified and include advanced age, renal dysfunction, female gender, peripheral vascular disease, lower body weight, duration of GP IIb/IIIa inhibitor infusion, baseline platelet count, lower baseline hemoglobin, diabetes, and elevated peak activated clotting time. According to one study (CRUSADE trial) involving patients with non ST segment elevation acute coronary syndrome treated with a GPIIb/IIIa inhibitor, women are at a greater risk of bleeding than men, primarily because of excessive dosing.

Hematologic side effects have been the most common and potentially serious. The incidences of major (intracranial hemorrhage or decreases in hemoglobin of 5 mg/dL or more) and minor bleeding (spontaneous gross hematuria or hematemesis, decreases in hemoglobin of less than 5 mg/dL) were 10.8% and 13.1% (PURSUIT study) and 4.7% and 14.2% (IMPACT II study), respectively. The incidences of the transfusion requirements in these two studies were 12.8% and 5.8%, respectively. The overall incidence of major bleeding was strongly associated with the incidence of coronary artery bypass graft surgery, and occurred mainly at arterial puncture sites. The next most common sites of bleeding--occurring in 0% to 6% of patients--were oropharyngeal (primarily gingival), gastrointestinal (incidences of upper and lower GI bleeding similar), genitourinary, then retroperitoneal. In the PURSUIT study, the risk of major bleeding was inversely related to body weight; patients less than 70 kg showed the highest correlation. Bleeding was cited as the reason to discontinue therapy in 3.5% to 8.0% of patients.

Fatal bleeding, thrombocytopenia, as well as cerebral, gastrointestinal and pulmonary hemorrhage (when used in combination with aspirin and heparin) have been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity reactions have been rare, and have included anaphylaxis in approximately 0.05% of patients.

Cardiovascular

Cardiovascular side effects have included hypotension (7% versus 6% among placebo patients). Other cardiovascular side effects may have been related to underlying disease as they were typical of side effects among patients with unstable angina.

Nervous system

Nervous system side effects have been limited to non hemorrhagic stroke in approximately 0.5% of treated and placebo patients in controlled trials.

Musculoskeletal

Musculoskeletal discomfort--basically back pain--was reported in significantly more patients who received eptifibatide compared with placebo patients in the IMPACT II trial (50% versus 47%).

Local

Local intravenous site reactions have been reported in significantly more treated patients compared with placebo patients in controlled trials. Arterial access sites are the most common sites of bleeding.

Immunologic

Immunologic side effects have included postmarketing reports of IgG antibodies related to immune-mediated thrombocytopenia.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.