"Bivalirudin has become a foundation anti-thrombin for patients undergoing PCI under The Medicines Company’s fifteen-year leadership in the cath lab," said Glenn Sblendorio, President and Chief Financial Officer, The Medicines Company.
"This agreement with Sandoz, itself a leader in the generics market, helps to ensure that bivalirudin remains a high quality product in this market. With the imminent launch of Kengreal (cangrelor), our intravenous P2Y12 inhibitor, we look forward to advancing patient care in the cath lab for years to come."
Angiomax is indicated in patients undergoing percutaneous coronary intervention (PCI) with provisional use of GPI and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI.
In addition, Angiomax is also indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA.
An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax should be used with caution in patients with disease states associated with an increased risk of bleeding.
In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components.
In clinical trials comparing Angiomax and heparin, the most common adverse reaction for Angiomax was bleeding (28%). Other common adverse reactions were headache, thrombocytopenia and fever.