Refludan Side Effects

Generic name: lepirudin

Note: This document contains side effect information about lepirudin. Some of the dosage forms listed on this page may not apply to the brand name Refludan.

Some side effects of Refludan 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 lepirudin: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking lepirudin (the active ingredient contained in Refludan) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• pain or swelling in one or both legs;

• any bleeding that will not stop;

• black, bloody, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

• decreased blood pressure (feeling light-headed or fainting); or

• urinating less than usual or not at all.

Less serious side effects are more likely to occur, such as:

• pain in your back or pelvis;

• nausea, vomiting, stomach pain or upset;

• feeling restless or nervous;

• headache;

• fever;

• sleep problems (insomnia); or

• pain, bleeding, or irritation where the injection was given.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to lepirudin: intravenous powder for injection

Hematologic

Other hemorrhagic events (hemoperitoneum, hemoptysis, liver bleeding, lung bleeding, mouth bleeding, retroperitoneal bleeding) each occurred in one individual among 198 patients treated with lepirudin (the active ingredient contained in Refludan) in controlled trials.

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.

Hypersensitivity

Serious anaphylactic reactions resulting in shock or death have been reported.

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.

Immunologic

Antihirudin antibodies have been reported in approximately 40% of heparin-induced thrombocytopenia patients receiving lepirudin (the active ingredient contained in Refludan) 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.

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.

Hepatic

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

General

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).

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 (the active ingredient contained in Refludan)

Renal

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

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