Refludan Side Effects

Generic name: lepirudin

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

Applies to lepirudin: intravenous powder for solution.

Serious side effects of Refludan

Along with its needed effects, lepirudin (the active ingredient contained in Refludan) 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:

More common

• Bleeding from puncture sites and wounds
• blood in the urine
• bloody or black, tarry stools
• collection of blood under the skin
• constipation
• dark urine
• deep, dark purple bruise
• fever with or without chills
• itching, pain, redness, or swelling
• light-colored stools
• loss of appetite
• nausea and vomiting
• pale skin
• severe stomach pain
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• yellow eyes or skin

Less common

• Bloody nose
• chest pain or discomfort
• cloudy urine
• confusion
• cough or hoarseness
• decrease in urine output
• difficult or labored breathing
• dilated neck veins
• dizziness
• extreme fatigue
• fainting
• fast, slow, or irregular heartbeat
• headache, sudden and severe
• irregular breathing
• lightheadedness
• lower back or side pain
• noisy breathing
• painful or difficult urination
• rapid, shallow breathing
• shortness of breath
• skin rash, hives, itching, or redness
• sneezing
• sore throat
• swelling of the face, fingers, feet, or lower legs
• tightness in the chest
• troubled breathing
• vaginal bleeding
• weakness
• weight gain
• wheezing

Rare

• Difficulty swallowing
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• tightness or swelling of the neck

For Healthcare Professionals

Applies to lepirudin: intravenous powder for injection.

Hematologic

Hemorrhagic events have been the most common and potentially serious side effects associated with the use of lepirudin (the active ingredient contained in Refludan) 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]

Hypersensitivity

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

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]

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.^[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]

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).^[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 (the active ingredient contained in Refludan) ^[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]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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