Calendar
ASH Consultative Hematology Course
September 7, 2017
Chicago, IL
(prior to the 2017 ASH Meeting on
Hematologic Malignancies)
December 11, 2017
Atlanta, GA (during the 2017 ASH Annual Meeting)
An interactive, half-day program in which participants
engage in case-based presentations and discussions
focusing on non-malignant hematology topics such
as thrombosis, thrombocytopenia, and bleeding.
International Society of Experimental
Hematology 46th Annual Scientific Meeting
Peer Review Week
September 11 – 17, 2017
Peer Review Week is an annual global event celebrating
the essential role that peer review plays in maintaining
scientific quality. The theme “Transparency in Review” will
be explored in virtual events, such as webinars and social
media activities, and in-person panel discussions that
coincide with the Peer Review Congress in Chicago, Illinois.
August 24 – 27, 2017
Frankfurt, Germany
The ISEH 46th Annual Scientific Meeting features presenta-
tions on cutting-edge, unpublished hematologic research.
ASH Meeting on Hematologic Malignancies
September 8 – 9, 2017
Chicago, IL
Top experts in hematologic malignancies discuss
the latest developments in clinical care and answer
challenging patient care questions.
Advanced Practice Providers Oncology Summit
Chicago, IL
The goal of this summit is to foster collaboration, share
best practices, and provide a forum for peer-to-peer
interaction among advanced practice providers who are
actively engaged in caring for oncology patients.
Upcoming Dates and Locations:
September 15 – 16, 2017
Denver, CO
ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated]
Lyophilized Powder for Solution For Intravenous Injection
Brief Summary of Prescribing Information: Please see package insert for full Prescribing Information.
®
INDICATIONS AND USAGE
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.
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 AND 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.
Monitoring Laboratory Tests
• Monitor plasma factor VIII activity by performing a validated one-stage
clotting assay to confirm the adequate factor VIII levels have been
achieved and maintained.
• Monitor for the development of factor VIII inhibitors. Perform the
Bethesda inhibitor assay to determine if factor VIII inhibitor is present.
If expected factor VIII activity plasma levels are not attained, or if
bleeding is not controlled with the expected dose of ADYNOVATE,
use Bethesda Units (BU) to determine inhibitor levels.
ADVERSE REACTIONS
The most common adverse reactions (≥1% of subjects) reported in the
clinical studies were headache and nausea.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions,
adverse reaction rates observed in the clinical trials of a drug cannot be
directly compared to rates in clinical trials of another drug and may
not reflect the rates observed in practice.
The safety of ADYNOVATE was evaluated in 237 previously treated patients
(PTPs) and 6 previously untreated patients (PUPs) with severe hemophilia
A (factor VIII less than 1% of normal), who received at least one dose of
ADYNOVATE in 3 completed multicenter, prospective, open label clinical
studies and 4 ongoing clinical studies. The median duration of participation
per subject was 401 (min-max: 3-1034) days and the median number
of exposure days to ADYNOVATE per subject was 111 (min-max: 1-322).
Table 1 lists the adverse reactions reported during clinical studies.
October 13 – 14, 2017
Portland, OR
Table 1: Adverse Reactions Reported for ADYNOVATE
MedDRA System
Organ Class
Gastrointestinal
Disorders
Immune System
Disorder
Nervous System
Disorders
Skin and Subcutaneous
Tissue Disorders
Vascular
Disorders
Diarrhea
Nausea Number of
Subjects n (%)
(N=234)
1 (0.4%)
2 (0.8%) Hypersensitivity a 1 (0.4%) 0.003
Headache 5 (2.1%) 0.026
Rash 1 (0.4%) 0.003
Flushing 1 (0.4%) 0.003
MedDRA
Preferred Term
Rate of AEs per 100
Infusions (N=30865)
0.003
0.006
a
The event of hypersensitivity was a mild transient non-serious rash, occurring in one
2-year old patient who had developed a previous rash while on ADYNOVATE.
Two cases of acute pancreatitis, with no precipitating cause identified
in one case, were reported in adults during an extension study of the
clinical trial which evaluated 137 subjects. Administration of ADYNOVATE
continued and both cases resolved.
Immunogenicity
The risk of the development of factor VIII inhibitors with the use of
ADYNOVATE was evaluated in 3 completed and 4 ongoing cl