CLINICAL NEWS
to be more common in the bosutinib group
(12.7% and 8.7%, respectively). However,
a higher percentage of imatinib-treated
patients discontinued for not achieving pre-
specified efficacy endpoints (7.5% and 2.2%;
p value not reported).
At 12 months, the rate of major
molecular response (MMR; primary
endpoint; defined as <0.1% BCR-ABL1 by
real-time quantitative polymerase chain
reaction assay) was significantly higher
in the bosutinib-treated group than in
the imatinib-treated group: 47.2 percent
versus 36.9 percent (odds ratio [OR] =
1.55; 95% CI 1.07-2.23; p=0.02).
The authors assessed molecular
response every three months. Three months
after treatment initiation, the incidence of
MMR was higher in the bosutinib group:
4.1 percent versus 1.7 percent (hazard ratio
= 1.34; 95% CI 1.06-1.69; p=0.017).
The relationship remained statistically
significant through the first year of treat-
ment, even for deeper molecular responses:
• MR4 (defined as a BCR-ABL1:ABL1
ratio consistently <0.01%): 20.7%
for bosutinib vs. 12.0% for imatinib
(p=0.01)
• MR5 (defined as a BCR-ABL1:ABL1
ratio consistently <0.001%): 8.1% vs.
3.3% (p=0.02)
A Leader in Hematology
FEIBA [Anti-Inhibitor Coagulant Complex] Indications and Selected Important
Risk Information for Healthcare Professionals
Indications for FEIBA [Anti‐Inhibitor Coagulant Complex]
FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use
in hemophilia A and B patients with inhibitors for:
• Control and prevention of bleeding episodes
• Perioperative management
• Routine prophylaxis to prevent or reduce the frequency
of bleeding episodes.
FEIBA is not indicated for the treatment of bleeding episodes
resulting from coagulation factor defi ciencies in the absence of
inhibitors to coagulation factor VIII or coagulation factor IX.
Selected Important Risk Information for FEIBA [Anti‐Inhibitor
Coagulant Complex]
WARNING: THROMBOEMBOLIC EVENTS
• Thromboembolic events have been reported during
post-marketing surveillance following infusion of FEIBA,
particularly following the administration of high doses
and/or in patients with thrombotic risk factors.
• Monitor patients receiving FEIBA for signs and symptoms
of thromboembolic events.
The use of FEIBA is contraindicated in patients with:
• Known anaphylactic or severe hypersensitivity reactions
to FEIBA or any of its components, including factors of
the kinin generating system
• Disseminated intravascular coagulation (DIC)
• Acute thrombosis or embolism (including
myocardial infarction)
Thromboembolic events (including venous thrombosis, pulmonary
embolism, myocardial infarction, and stroke) can occur with FEIBA,
particularly following the administration of high doses (above
200 units per kg per day) and/or in patients with thrombotic
risk factors.
Infusion of FEIBA should not exceed a dose of 100 units per kg
body weight every 6 hours and daily doses of 200 units per kg body
weight. Maximum injection or infusion rate must not exceed 2 units
per kg of body weight per minute. Monitor patients receiving more
than 100 units per kg of body weight of FEIBA for the development
of DIC, acute coronary ischemia, and signs and symptoms of
other thromboembolic events. If clinical signs or symptoms occur,
such as chest pain or pressure, shortness of breath, altered
consciousness, vision, or speech, limb or abdomen swelling and/
or pain, discontinue the infusion and initiate appropriate diagnostic
and therapeutic measures.
Hypersensitivity and allergic reactions, including severe
anaphylactoid reactions, can occur following the infusion
of FEIBA. The symptoms include urticaria, angioedema,
gastrointestinal manifestations, bronchospasm, and hypotension.
These reactions can be severe and systemic (e.g., anaphylaxis
with urticaria and angioedema, bronchospasm, and circulatory
shock). Other infusion reactions, such as chills, pyrexia, and
hypertension have also been reported. If signs and symptoms
of severe allergic reactions occur, immediately discontinue
administration of FEIBA and provide appropriate supportive care.
Because FEIBA is made from human plasma it may carry a
risk of transmitting infectious agents, e.g., viruses, the variant
Creutzfeldt‐Jakob disease (vCJD) agent and, theoretically, the
Creutzfeldt-Jakob disease (CJD) agent.
The most frequently reported adverse reactions observed in
>5% of subjects in the prophylaxis trial were anemia, diarrhea,
hemarthrosis, hepatitis B surface antibody positive, nausea,
and vomiting.
The serious adverse reactions seen with FEIBA are
hypersensitivity reactions and thromboembolic events, including
stroke, pulmonary embolism, and deep vein thrombosis.
Use of antifi brinolytics within approximately 6 to 12 hours after
the administration of FEIBA is not recommended.
Please see FEIBA Brief Summary of full Prescribing
Information continued on the following page.