Lepirudin Side Effects

Applies to lepirudin: intravenous powder for solution.

Serious side effects of lepirudin

Along with its needed effects, lepirudin 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 or nurse immediately if any of the following side effects occur while taking lepirudin:

Precautions

This medicine will only be given to you while you are in the hospital. Before you leave the hospital, you may be switched to an oral medicine that works in a similar way. If you have any concerns about this, talk to your doctor.

It is very important that your doctor check you at regular visits after you leave the hospital for any problems or unwanted effects that may be caused by this medicine. Be sure to keep all appointments.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you get the injection.

This medicine may increase your chance of bleeding. Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin. Avoid picking your nose. If you need to blow your nose, blow it gently.

For healthcare professionals

Applies to lepirudin: intravenous powder for injection.

General adverse events

General side effects have included fever (4% to 6% of patients) and unspecified allergic reactions (less than 1% of patients).

The prevalence of sepsis, unspecified infections, and multiorgan failure has been similar among treated versus control patients (4.0% versus 5.5%, 2.5% versus 1.1%, and 2.0% versus 0%, respectively).^[Ref]

Hypersensitivity

Hypersensitivity reactions have occurred in up to 10% of patients and have included skin rashes, pruritus, urticaria, flushing, or chills (less than 1.0% to 3.5%) and airway reactions, such as cough, bronchospasm, stridor, dyspnea (up to 10%). Anaphylaxis or anaphylactoid reactions have been observed in less than 1% of patients. Approximately 53% of allergic or suspected allergic reactions occurred in patients also receiving thrombolytic therapy for acute myocardial infarction and/or contrast media for coronary angiography.^[Ref]

Serious anaphylactic reactions resulting in shock or death have been reported.^[Ref]

Immunologic

Antihirudin antibodies have been reported in approximately 40% of heparin-induced thrombocytopenia patients receiving lepirudin. Complexation of lepirudin to these antibodies may increase the anticoagulant effect due to delayed renal elimination of active complexes. Lepirudin neutralization and allergic reactions have not been reported despite positive antibody tests. Adverse reactions following reexposure have been limited to mild skin reactions.^[Ref]

Respiratory

Respiratory effects as a result of hypersensitivity reactions have been reported in up to 10% of patients. Symptoms included cough, bronchospasm, stridor, and dyspnea. Pneumonia has occurred in up to 4.4% of patients compared with 5.5% in control patients.^[Ref]

Hepatic

Abnormal elevations of liver transaminases and other measurements of liver function have been reported in approximately 6% of patients.^[Ref]

Hematologic

Hemorrhagic events have been the most common and potentially serious side effects associated with the use of lepirudin. The following were reported during controlled trials: bleeding from puncture sites and wounds (10.6% to 14.1%); anemia or isolated drop in hemoglobin concentration (12.4% to 13.1%); hematoma or unclassified hemorrhage (10.6% to 11.1%); gastrointestinal or rectal bleeding (5.1% to 5.3%); epistaxis (3.0% to 4.4%); hemothorax (0% to 3.0%); vaginal bleeding (1.5% to 1.8%); intracranial bleeding (0%). Intracranial hemorrhage (ICH) has been observed in patients with acute myocardial infarction who were started on both thrombolytic therapy and lepirudin. The overall prevalence of ICH in this population was 0.6% (7 of 1134 patients). ICH was not observed among 1168 patients who did not receive concomitant thrombolytic therapy. There has been at least one case report of thrombocytopenia.^[Ref]

Other hemorrhagic events (hemoperitoneum, hemoptysis, liver bleeding, lung bleeding, mouth bleeding, retroperitoneal bleeding) each occurred in one individual among 198 patients treated with lepirudin in controlled trials.^[Ref]

Cardiovascular

Cardiovascular side effects have included new or worsened heart failure in up to 3% of patients. Pericardial effusion and ventricular fibrillation each have been reported in 1% of patients. Edema (facial, tongue, laryngeal, or angioedema) has been associated rarely with use of lepirudin.^[Ref]

Renal

New or worsened renal insufficiency has been observed in 1.8% to 2.5% of patients versus 4.4% among control patients.^[Ref]

See also:

Further information

Lepirudin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer