+ Use in children under 12
+ Perioperative management
CLINICAL NEWS
Choosing Between Strategies for Managing Fetal or Neonatal Alloimmune Thrombocytopenia
For women diagnosed with fetal and neonatal alloimmune thrombocytopenia ( FNAIT ), a noninvasive strategy of weekly intravenous immunoglobulin infusion ( IVIg ) and corticosteroids could help prevent the development of FNAIT in subsequent pregnancies , according to the results of a systematic review published in Blood . More invasive strategies , such as serial fetal blood sampling ( FBS ) and intrauterine platelet transfusions ( IUPTs ), resulted in higher complication rates than noninvasive techniques .
FNAIT can lead to severe bleeding complications in the fetus and newborn babies , and as a result of the lack of population-based screening programs , it is typically identified only after an incidental finding of neonatal thrombocytopenia , wrote the authors , led by Dian Winkelhorst , from the Department of Obstetrics at the Leiden University Medical Center in The Netherlands .
“ No international consensus on the optimal antenatal management of FNAIT exists , and numerous strategies – non-invasive as well as invasive – are applied in different centers that specialize in antenatal therapy ,” the authors explained .
The researchers searched Medline , EMBASE , and the Cochrane Library for English-language studies published between 1946 and December 2015 that met the following criteria :
• included ≥5 pregnant women with pregnancies at risk for FNAIT or fetuses / neonates diagnosed with FNAIT
• included patients treated with either IVIg , steroids , or IUPT
• IUPT alone ( n = 5 )
• IUPT and IVIg ( n = 3 )
Though pooling of results was not possible due to the “ considerable heterogeneity ” of the study sample , the authors reported
For patients with Hemophilia A , the FDA has now approved ADYNOVATE ® for
+ Use in children under 12
+ Perioperative management
PROVEN PROPHYLAXIS + SIMPLE ,* TWICE-WEEKLY
DOSING SCHEDULE = moments that “ most studies found comparable outcomes regarding the occurrence of ICH , regardless of antenatal management strategy applied ( FBS , IUPT , or IVIg with or without corticosteroids ).”
All but one study included information on ICH . In a total of 839 pregnancies , 24
THEIR WAY
* ADYNOVATE allows patients to infuse on the same 2 days every week .
The pediatric study ( N = 73 ) evaluated the efficacy , PK , and safety of ADYNOVATE twice-weekly prophylaxis and determined hemostatic efficacy in the treatment of bleeding episodes for 6 months . 1 , 2
+ Sixty-six patients ( 32 patients aged < 6 years and 34 patients aged 6 to < 12 years ) received 40-60 IU / kg of ADYNOVATE prophylactically , twice weekly 2
ICHs were observed ( 3 %); seven occurred before treatment started , and one developed in a patient who received no treatment . IVIg had a 98.7 percent success rate in preventing ICH ( 4 ICHs in 315 pregnancies ).
Twenty-four studies ( totaling 821 pregnancies ) assessed mortality , reporting an overall mortality rate of 4 percent ( 30 deaths ). Seventeen deaths were related to FBS / IUPT treatment ( 53 %), and seven were due to ICH ( 22 %).
+ Children experienced a median overall ABR of 2.0 ( IQR : 3.9 ) and a median ABR of zero for both joint ( IQR : 1.9 ) and spontaneous ( IQR : 1.9 ) bleeds 1 , 3
+ 38 % ( n = 25 ) of children experienced zero total bleeding episodes ; 73 % ( n = 48 ) experienced zero joint bleeding episodes ; and 67 % ( n = 44 ) experienced zero spontaneous bleeding episodes 1
For more information , talk to a Shire representative or visit ADYNOVATEPRO . com
• included outcomes of intracranial hemorrhage ( ICH ) and fetal / neonatal platelet count
The final cohort consisted of 26 studies : four randomized , controlled trials ; five prospective studies ; and 17 retrospective studies . The studies investigated the following antenatal FNAIT management strategies :
• IVIg alone ( n = 17 studies )
• corticosteroids alone ( n = 3 )
• IVIg and corticosteroids ( n = 11 )
• FBS ( n = 24 )
• FBS with IUPT ( n = 16 )
ASHClinicalNews . org
ADYNOVATE [ Antihemophilic Factor ( Recombinant ), PEGylated ] Important Information
Indications
ADYNOVATE , Antihemophilic Factor ( Recombinant ), PEGylated , is a human antihemophilic factor indicated in children and adults with hemophilia A ( congenital factor VIII deficiency ) for :
• On-demand treatment and control of bleeding episodes
• Perioperative management
• Routine prophylaxis to reduce the frequency of bleeding episodes Limitation of Use ADYNOVATE is not indicated for the treatment of von Willebrand disease .
DETAILED IMPORTANT RISK INFORMATION
CONTRAINDICATIONS
ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE , to the parent molecule ( ADVATE [ Antihemophilic Factor ( Recombinant )]), mouse or hamster protein , or excipients of ADYNOVATE ( e . g . Tris , mannitol , trehalose , glutathione , and / or polysorbate 80 ).
WARNINGS & PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions are possible with ADYNOVATE . Allergic-type hypersensitivity reactions , including anaphylaxis , have been reported with other recombinant antihemophilic factor VIII products , including the parent molecule , ADVATE . Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema , chest tightness , dyspnea , wheezing , urticaria , and pruritus . Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur .
Neutralizing Antibodies
Formation of neutralizing antibodies ( inhibitors ) to factor VIII can occur following administration of ADYNOVATE . Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests . Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected , or if bleeding is not controlled with expected dose .
ADVERSE REACTIONS
The most common adverse reactions ( ≥1 % of subjects ) reported in the clinical studies were headache and nausea .
Please see the following page for the Brief Summary of the ADYNOVATE full Prescribing Information .
For full Prescribing Information , visit www . ADYNOVATEPRO . com .
References : 1 . ADYNOVATE Prescribing Information . Westlake Village , CA : Baxalta US Inc . 2 . Mullins ES , Stasyshyn O , Alvarez-Román MT , et al . Extended half-life pegylated , full-length recombinant factor VIII for prophylaxis in children with severe haemophilia A . Haemophilia . 2016 Nov 27 . doi : 10.1111 / hae . 13119 [ Epub ahead of print ]. 3 . Data on file ; Shire US Inc .
© 2017 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 . ADVATE and ADYNOVATE are trademarks or registered trademarks of Baxalta Incorporated , a wholly owned , indirect subsidiary of Shire plc . S17616 01 / 17