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Refludan

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Refludan

Refludan Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Refludan (lepirudin) is used to treat or prevent blood clots. It is a direct inhibitor of thrombin, which works by keeping the platelets in the blood from coagulating (clotting) to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions. Common side effects include pain in the back or pelvis, nausea, vomiting, stomach pain or upset, feeling restless or nervous, headache, fever, insomnia, or pain, bleeding, or irritation where the injection was given.

The dose of Refludan is 0.4 mg/kg body weight (up to 110kg) administered slowly intravenously (e.g., over 15 to 20 seconds), followed by 0.15 mg/kg body weight (up to 110kg)/hour as a continuous intravenous infusion for 2 to 10 days or longer if clinically needed. Refludan may interact with blood thinners, or other medications used to prevent blood clots. Tell your doctor all medications and supplements you use. Refludan is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Refludan (lepirudin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Refludan in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Refludan (Lepirudin) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Refludan FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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)
(n=198)
Patients with TECs
REFLUDAN
(n=113)
Historical control
(n=91)
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%
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%
*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)
(n=198)
Patients with TECs
REFLUDAN
(n=113)
Historical control
(n=91)
Fever 6.1% 4.4% 8.8%
Abnormal Ilver function 6.1% 5.3% 0
Pneumonla 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 fallure 2.0% 3.5% 0
Pericardlal effusion 1.0% 0 1.1%
Ventricular fibrillation 1.0% 0 0
* 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

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

(See PRECAUTIONS.)

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 entire FDA prescribing information for Refludan (Lepirudin) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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