Why was refludan discontinued?

Why was refludan discontinued?

Bayer HealthCare has had a manufacturing and supply agreement in place with a third-party manufacturer that permitted the sale and distribution of Refludan® by Bayer in the U.S. The third- party manufacturer of Refludan® has permanently ceased production of the product, which has led to the product’s discontinuation in …

Is Lepirudin still used?

Lepirudin may be used as an anticoagulant when heparins (unfractionated or low-molecular-weight) are contraindicated because of heparin-induced thrombocytopenia….Lepirudin.

Clinical data
ATC code B01AE02 (WHO)
Legal status
Legal status US : ℞-only
Pharmacokinetic data

What is Lepirudin used for?

Lepirudin, a recombinant hirudin, is a direct irreversible thrombin inhibitor by binding to both free and clot-bound thrombin. It is approved for treatment of heparin-induced thrombocytopenia (HIT), which is a serious antibody-mediated drug reaction mostly associated with the use of unfractionated heparin.

Is Lepirudin a blood thinner?

Lepirudin is used to break up clots and to reduce thrombocytopenia. It binds to thrombin and prevents thrombus or clot formation. It is a highly potent, selective, and essentially irreversible inhibitor of thrombin and clot-bond thrombin. Lepirudin requires no cofactor for its anticoagulant action.

How much does Lepirudin cost?

Two vials of lepirudin are required to make a 500 mL bag with a final concentration of 0.2 mg/mL for intravenous infusion. At an associated wholesalers price (AWP) of $126 per vial, the cost of lepirudin in one bag would therefore be approximately $252.

What is the side effect of argatroban?

nausea, vomiting, diarrhea; low blood pressure; shortness of breath; headache, back pain; or.

What is the difference between aspirin and heparin?

Aspirin is an anticoagulant that prevents thrombosis by the increase prostaglandin E2. It accelerates blood to placenta, which should be started from the beginning of pregnancy. Heparin has both anticoagulative and anti-inflammatory effects. Heparin does not penetrate the placenta and is harmless for fetus.

Is heparin and Lovenox the same?

Lovenox and heparin are not the same. Lovenox is a low molecular weight heparin (LMWH), which is different from standard or unfractionated heparin (UFH). Although Lovenox and heparin are both anticoagulants, they have differences in formulation and FDA-approved uses.

What is Refludan used to treat?

REFLUDAN (lepirudin) is indicated for anticoagulation in patients with heparin-induced thrombocytopenia (HIT) and associated thromboembolic disease in order to prevent further thromboembolic complications.

Is Refludan a thrombin inhibitor?

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.

What is the difference between Refludan and lepirudin?

Refludan 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.

How often should aPTT be done after Refludan (lepirudin) infusion?

• The first aPTT determination for monitoring treatment should be done 4hours after start of the REFLUDAN (lepirudin) infusion. • Follow-up aPTT determinations are recommended at least once daily, as long as treatment with REFLUDAN (lepirudin) is ongoing.

author

Back to Top