Refludan

DRUG DESCRIPTION

REFLUDAN [lepirudin (rDNA) for injection] is a highly specific direct inhibitor of thrombin. Lepirudin, (chemical designation: [Leu1, Thr2]-63-desulfohirudin) is a recombinant hirudin derived from yeast cells. The polypeptide composed of 65 amino acids has a molecular weight of 6979.5 daltons. Natural hirudin is produced in trace amounts as a family of highly homologous isopolypeptides by the leech Hirudo medicinalis. The biosynthetic molecule (lepirudin) is identical to natural hirudin except for substitution of leucine for isoleucine at the N-terminal end of the molecule and the absence of a sulfate group on the tyrosine at position 63.

The activity of lepirudin is measured in a chromogenic assay. One antithrombin unit (ATU) is the amount of lepirudin that neu-tralizes one unit of World Health Organization preparation 89/588 of thrombin. The specific activity of lepirudin is approximately 16,000 ATU/mg. Its mode of action is independent of antithrombin III. Platelet factor 4 does not inhibit lepirudin. One molecule of lepirudin binds to one molecule of thrombin and thereby blocks the thrombogenic activity of thrombin. As a result, all thrombin-dependent coagulation assays are affected, eg, activated partial thromboplastin time (aPTT) and prothrom-bin time (PT /INR) values increase in a dose-dependent fashion (Roethig 1991).

REFLUDAN (lepirudin) is supplied as a sterile, white, freeze-dried powder for injection or infusion and is freely soluble in Sterile Water for Injection USP or 0.9% Sodium Chloride Injection USP.

Each vial of REFLUDAN contains 50 mg lepirudin. Other ingre-dients are 40 mg mannitol and sodium hydroxide for adjust-ment of pH to approximately 7.

What are the possible side effects of lepirudin (Refludan)?

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;
  • ...

Read All Potential Side Effects and See Pictures of Refludan

What are the precautions when taking lepirudin (Refludan)?

Consult your...

Read All Potential Precautions of Refludan


Refludan Consumer (continued)

SIDE EFFECTS: Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Consult your pharmacist.


Refludan Patient Information Including Side Effects

Brand Names: Refludan

Generic Name: lepirudin (Pronunciation: LEP i roo din)

  • What is lepirudin (Refludan)?
  • What are the possible side effects of lepirudin (Refludan)?
  • What is the most important information I should know about lepirudin (Refludan)?
  • What should I discuss with my health care provider before taking lepirudin (Refludan)?
  • How should I take lepirudin (Refludan)?
  • What happens if I miss a dose (Refludan)?
  • What happens if I overdose (Refludan)?
  • What should I avoid while taking lepirudin (Refludan)?
  • What other drugs will affect lepirudin (Refludan)?
  • Where can I get more information?

What is lepirudin (Refludan)?

Lepirudin keeps the platelets in your blood from coagulating (clotting) to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions.

Lepirudin is used to treat or prevent blood clots.

Lepirudin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of lepirudin (Refludan)?

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.

What is the most important information I should know about lepirudin (Refludan)?

Do not use this medication if you are allergic to lepirudin, or to a similar medication called bivalirudin (Angiomax).

Before using lepirudin, tell your doctor if you are allergic to any drugs, or if you have kidney or liver disease, heart disease or infection, high blood pressure, stomach ulcer, a bleeding or blood clotting disorder such as hemophilia, a history of stroke or recent biopsy, or any major bleeding from a surgery, injury, or medical trauma.

Tell your doctor if you are using or receiving blood thinners or any other medications used to prevent blood clots, such as alteplase (Activase), anistreplase (Eminase), clopidogrel (Plavix), dipyridamole (Persantine), streptokinase (Kabikinase, Streptase), ticlopidine (Ticlid), or urokinase (Abbokinase).

Because lepirudin keeps your blood from coagulating (clotting) to prevent unwanted blood clots, it can also make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop.

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