Detailed Important Risk Information
TM
VONVENDI
[ von Willebrand factor ( Recombinant )] IS IN YOUR CORNER
THE FIRST AND ONLY RECOMBINANT VON WILLEBRAND FACTOR
VONVENDI TM [ von Willebrand factor ( Recombinant )] IS A PURIFIED RECOMBINANT VON WILLEBRAND FACTOR WITH AN OPTION TO DOSE INDEPENDENTLY OF RECOMBINANT FACTOR VIII ACCORDING TO PATIENT NEED . 1
For each bleeding episode , administer the first dose of VONVENDI with an approved recombinant ( non-von Willebrand factor-containing ) factor VIII ( rFVIII ) if factor VIII baseline levels are < 40 % or are unknown . VONVENDI can be administered without rFVIII in some patients if FVIII levels are ≥40 % normal activity ( 0.4 IU / mL ), if an urgent increase is not needed or if the baseline FVIII : C level is sufficient to ensure hemostasis . 1 Comprehensive dosing information can be found in the VONVENDI full Prescribing Information .
VONVENDI TM [ von Willebrand factor ( Recombinant )] Important Information
INDICATION
VONVENDI TM [ von Willebrand factor ( Recombinant )] is a recombinant von Willebrand factor indicated for on-demand treatment and control of bleeding episodes in adults ( age 18 and older ) diagnosed with von Willebrand disease .
Detailed Important Risk Information
CONTRAINDICATIONS
VONVENDI is contraindicated in patients who have had life-threatening hypersensitivity reactions to VONVENDI or constituents of the product ( tri-sodium citrate-dihydrate , glycine , mannitol , trehalose-dihydrate , polysorbate 80 , and hamster or mouse proteins ).
WARNINGS AND PRECAUTIONS Embolism and Thrombosis
Thromboembolic reactions , including disseminated intravascular coagulation ( DIC ), venous thrombosis , pulmonary embolism , myocardial infarction , and stroke , can occur , particularly in patients with known risk factors for thrombosis . Monitor for early signs and symptoms of thrombosis such as pain , swelling , discoloration , dyspnea , cough , hemoptysis , and syncope .
In patients requiring frequent doses of VONVENDI with recombinant factor VIII , monitor plasma levels for FVIII : C activity because an excessive rise in factor VIII levels can increase the risk of thromboembolic complications .
Hypersensitivity Reactions
Hypersensitivity reactions , including anaphylaxis , may occur . Symptoms can include anaphylactic shock , generalized urticaria , angioedema , chest tightness , hypotension , shock , lethargy , nausea , vomiting , paresthesia , pruritus , restlessness , wheezing and / or acute respiratory distress . If signs and symptoms of severe allergic reactions occur , immediately discontinue administration of VONVENDI and provide appropriate supportive care .
Neutralizing Antibodies
Neutralizing antibodies ( inhibitors ) to von Willebrand factor and / or factor VIII can occur . If the expected plasma levels of VWF activity ( VWF : RCo ) are not attained , perform an appropriate assay to determine if anti-VWF or anti-FVIII inhibitors are present . Consider other therapeutic options and direct the patient to a physician with experience in the care of either von Willebrand disease or hemophilia A .
In patients with high levels of inhibitors to VWF or factor VIII , VONVENDI therapy may not be effective and infusion of this protein may lead to severe hypersensitivity reactions . Since inhibitor antibodies can occur concomitantly with anaphylactic reactions , evaluate patients experiencing an anaphylactic reaction for the presence of inhibitors .
ADVERSE REACTIONS
The most common adverse reaction observed in ≥2 % of subjects in clinical trials ( n = 66 ) was generalized pruritus .
Please see VONVENDI Brief Summary on the following page .
VONVENDIPRO . COM
Reference : 1 . VONVENDI TM [ von Willebrand factor ( Recombinant )] Prescribing Information .
© 2016 Shire US Inc ., Lexington , MA 02421 . All rights reserved . 1-800-828-2088 . SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates . VONVENDI is a trademark of Baxalta Incorporated , a wholly owned , indirect subsidiary of Shire plc .
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