Refludan Side Effects
Generic Name: Lepirudin
Please note - some side effects for Refludan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Refludan - for the consumer
Refludan
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Refludan:
Seek medical attention right away if any of these SEVERE side effects occur when using Refludan:Redness or discomfort at the injection site.
TopSevere allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; confusion; dark urine; easy bruising or bleeding; fever; nausea or vomiting; one-sided weakness; slurred speech; vision problems; vomit that looks like coffee grounds; yellowing eyes or skin.
For the professional
Refludan
Adverse Events Reported in Clinical Trials in HIT Patients
The following safety information is based on all 198 patients treated with Refludan in the HAT-1 and HAT-2 studies. The safety profile of 113 Refludan patients from these studies who presented with TECs at baseline is compared to 91 such patients in the historical control.
Hemorrhagic EventsBleeding was the most frequent adverse event observed in patients treated with Refludan. Table 4 gives an overview of all hemorrhagic events which occurred in at least two patients.
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HAT-1 HAT-2 (All patients) (n = 198) |
Patients with TECs | ||
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Refludan (n = 113) |
Historical control (n = 91) |
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| Bleeding from puncture sites and wounds | 14.1% | 10.6% | 4.4% |
| Anemia or isolated drop in hemoglobin | 13.1% | 12.4% | 1.1% |
| Other hematoma and unclassified bleeding | 11.1% | 10.6% | 4.4% |
| Hematuria | 6.6% | 4.4% | 0 |
| Gastrointestinal and rectal bleeding | 5.1% | 5.3% | 6.6% |
| Epistaxis | 3.0% | 4.4% | 1.1% |
| Hemothorax | 3.0% | 0 | 1.1% |
| Vaginal bleeding | 1.5% | 1.8% | 0 |
| Intracranial bleeding | 0 | 0 | 2.2% |
Other hemorrhagic events (hemoperitoneum, hemoptysis, liver bleeding, lung bleeding, mouth bleeding, retroperitoneal bleeding) each occurred in one individual among all 198 patients treated with Refludan.
Nonhemorrhagic eventsTable 5 gives an overview of the most frequently observed nonhemorrhagic events.
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HAT-1 HAT-2 (All patients) (n = 198) |
Patients with TECs | ||
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Refludan (n = 113) |
Historical control (n = 91) |
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| Fever | 6.1% | 4.4% | 8.8% |
| Abnormal liver function | 6.1% | 5.3% | 0 |
| Pneumonia | 4.0% | 4.4% | 5.5% |
| Sepsis | 4.0% | 3.5% | 5.5% |
| Allergic skin reactions | 3.0% | 3.5% | 1.1% |
| Heart failure | 3.0% | 1.8% | 2.2% |
| Abnormal kidney function | 2.5% | 1.8% | 4.4% |
| Unspecified infections | 2.5% | 1.8% | 1.1% |
| Multiorgan failure | 2.0% | 3.5% | 0 |
| Pericardial effusion | 1.0% | 0 | 1.1% |
| Ventricular fibrillation | 1.0% | 0 | 0 |
Adverse Events Reported in Clinical Trials in Other Populations
The following safety information is based on a total of 2302 individuals who were treated with Refludan in clinical pharmacology studies (n = 323) or for clinical indications other than HIT (n = 1979).
Intracranial BleedingIntracranial bleeding was the most serious adverse reaction found in populations other than HIT patients. It occurred in patients with acute myocardial infarction who were started on both Refludan and thrombolytic therapy with rt-PA or streptokinase. The overall frequency of this potentially life-threatening complication among patients receiving both Refludan and thrombolytic therapy was 0.6% (7 out of 1134 patients). Although no intracranial bleeding was observed in 1168 subjects or patients who did not receive concomitant thrombolysis, there have been post marketing reports of intracranial bleeding with Refludan in the absence of concomitant thrombolytic therapy
Allergic ReactionsAllergic reactions or suspected allergic reactions in populations other than HIT patients include (in descending order of frequency*):
| Airway reactions (cough, bronchospasm, stridor, dyspnea): | common |
| Unspecified allergic reactions: | uncommon |
| Skin reactions (pruritus, urticaria, rash, flushes, chills): | uncommon |
| General reactions (anaphylactoid or anaphylactic reactions): | uncommon |
| Edema (facial edema, tongue edema, larynx edema, angioedema): | rare |
* The CIOMS (Council for International Organization of Medical Sciences) III standard categories are used for classification of frequencies:
| very common | 10% or more |
| common (frequent) | 1 to <10% |
| uncommon (infrequent) | 0.1 to<1% |
| rare | 0.01 to <0.1% |
| very rare | 0.01% or less |
About 53% (n = 46) of all allergic reactions or suspected allergic reactions occurred in patients who concomitantly received thrombolytic therapy (eg, streptokinase) for acute myocardial infarction and/or contrast media for coronary angiography.
Adverse Events from Post Marketing Reports
Serious anaphylactic reactions that have resulted in shock or death have been reported.
Intracranial bleeding has been reported in patients treated with Refludan with or without concomitant thrombolytic therapy. Although no intracranial bleeding was observed in Clinical Trials in those patients who did not receive concomitant thrombolytic therapy, there have been post marketing reports of intracranial bleeding in patients who received Refludan without concomitant thrombolytic therapy.
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