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Adverse Events Reported in Clinical Trials in HIT Patients
The following safety information is based on all 198 patients treated with REFLUDAN (lepirudin) in the HAT-1 and HAT-2 studies. The safety profile of 113 REFLUDAN (lepirudin) patients from these studies who presented with TECs at baseline is compared to 91 such patients in the historical control.
Hemorrhagic Events. Bleeding was the most frequent adverse event observed in patients treated with REFLUDAN (lepirudin) . Table 4 gives an overview of all hemorrhagic events which occurred in at least two patients.
Table 4: Hemorrhagic Events*
|HAT-1 HAT-2 (All patients)
|Patients with TECs|
|Bleeding from puncture sites and wounds||14.1%||10.6%||4.4%|
|Anemla or Isolated drop in hemoglobin||13.1%||12.4%||1.1%|
|Other hematoma and unclassified bleeding||11.1%||10.6%||4.4%|
|Gastrointestinal and rectal bleeding||5.1%||5.3%||6.6%|
|*Patients may have suffered more than one event|
Other hemorrhagic events (hemoperitoneum, hemoptysis, liver bleeding, lung bleeding, mouth bleeding, retroperi-toneal bleeding) each occurred in one individual among all 198 patients treated with REFLUDAN (lepirudin) .
Nonhemorrhagic events. Table 5 gives an overview of the most frequently observed nonhemorrhagic events.
Table 5: Nonhemorrhagic adverse events*
|HAT-1 HAT-2(All patients)
|Patients with TECs|
|Abnormal Ilver function||6.1%||5.3%||0|
|Allergic skin reactions||3.0%||3.5%||1.1%|
|Abnormal kidney function||2.5%||1.8%||4.4%|
|* Patients may have suffered more than one event|
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 (lepirudin) in clinical pharmacology studies (n = 323) or for clinical indications other than HIT (n = 1979).
Intracranial 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 (lepirudin) and thrombolytic therapy with rt-PA or streptokinase. The overall frequency of this potentially life-threat-ening complication among patients receiving both REFLUDAN (lepirudin) 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 (lepirudin) in the absence of concomitant thrombolytic therapy (see ADVERSE REACTIONS- Adverse Events from Post Marketing Reports and WARNINGS.)
Allergic 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|
|Ederna (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 freguencies:|
|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 aller-gic 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. (See PRECAUTIONS.)
Intracranial bleeding has been reported in patients treated with REFLUDAN (lepirudin) with or without concomitant thrombolytic therapy. (See WARNINGS.) Although no intracranial bleeding was observed in Clinical Trials in those patients who did not receive concomitant thrombolytic therapy (see Adverse Events Reported in Clinical Trials in HIT Patients and Adverse Events Reported in Clinical Trials in Other Populations below), there have been post marketing reports of intracranial bleeding in patients who received REFLUDAN (lepirudin) without concomitant throm-bolytic therapy.
Read the Refludan (lepirudin) Side Effects Center for a complete guide to possible side effects
Concomitant treatment with thrombolytics (eg, rt-PA or strep-tokinase) may
- increase the risk of bleeding complications
- considerably enhance the effect of REFLUDAN (lepirudin) on aPTT prolongation.
(See also WARNINGS: Hemorrhagic Events, ADVERSE REACTIONS: Adverse Events Reported in Other Populations; Intracranial Bleeding and DOSAGE AND ADMINISTRATION: Monitoring and Adjusting Therapy; Concomitant Use With Thrombolytic Therapy.)
Concomitant treatment with coumarin derivatives (vitamin K antagonists) and drugs that affect platelet function may also increase the risk of bleeding (see also DOSAGE AND ADMINISTRATION: Monitoring and Adjusting Therapy; Use in Patients Scheduled for a Switch to Oral Anticoagulation).This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/31/2007
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