CLINICAL NEWS
participants experienced infusion-related
systemic or neurologic adverse events –
which are commonly reported with CAR
T-cell infusions.
“Infusion of autologous multiTAA-
targeted T cells … has been safe,” they
concluded, “and despite concerns that
endogenous T cells directed against
shared/cancer testis antigens would be of
insufficient affinity to produce prolonged
benefit, [our cells] were able to induce
durable CRs.”
The findings of this study were limited
by the small study population and single-
center design.
The authors report relationships with
Marker Therapeutics, which sponsored the study.
REFERENCE
Carrum G, Lulla P, Tzannou I, et al. Targeting lymphomas using non-
engineered, multi-antigen-specific T cells. Abstract #24. Presented at
the Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR,
February 20, 2019; Houston, TX.
Beta-Thalassemia Gene Therapy
Continues to Show Efficacy in
Longer-Term Follow-up
Updated results from the phase I/II HGB-
204 and HGB-207 trials indicated that
several patients with severe, transfusion-
dependent beta-thalassemia have remained
70+ Year Commitment
to the Hematology Community
Baxalta and Shire Are Now Takeda
FEIBA Indications and Detailed Important Risk Information
WARNINGS AND PRECAUTIONS (continued)
Safety and effi cacy of FEIBA for breakthrough bleeding in patients
receiving emicizumab has not been established. Cases of thrombotic
microangiopathy (TMA) were reported in a clinical trial where subjects
received FEIBA as part of a treatment regimen for breakthrough bleeding
following emicizumab treatment. Consider the benefi ts and risks
with FEIBA if considered required for patients receiving emicizumab
prophylaxis. If treatment with FEIBA is required for patients receiving
emicizumab, the hemophilia treating physician should closely monitor
for signs and symptoms of TMA. In FEIBA clinical studies TMA has not
been reported.
Hypersensitivity and allergic reactions, including severe anaphylactoid
Detailed Important Risk Information for FEIBA
reactions, can occur. Symptoms include urticaria, angioedema,
gastrointestinal manifestations, bronchospasm, and hypotension.
WARNING: EMBOLIC AND THROMBOTIC EVENTS
Reactions can be severe and systemic (e.g., anaphylaxis with urticaria
• Thromboembolic events have been reported during post-marketing
and angioedema, bronchospasm, and circulatory shock). Other infusion
surveillance following infusion of FEIBA, particularly following the
reactions, such as chills, pyrexia, and hypertension have also been
administration of high doses (above 200 units per kg per day)
reported. If signs and symptoms of severe allergic reactions occur,
and/or in patients with thrombotic risk factors.
immediately discontinue FEIBA and provide appropriate supportive care.
• Monitor patients receiving FEIBA for signs and symptoms of
Because FEIBA is made from human plasma it may carry a risk of
thromboembolic events.
transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-
Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob
CONTRAINDICATIONS
disease (CJD) agent.
FEIBA is contraindicated in patients with:
FEIBA contains blood group isohemagglutinins (anti-A and anti-B).
• History of anaphylactic or severe hypersensitivity reactions to
Passive transmission of antibodies to erythrocyte antigens, e.g., A, B, D,
FEIBA or any of its components, including factors of the kinin
may interfere with some serological tests for red cell antibodies, such as
generating system
antiglobulin test (Coombs test).
• Disseminated intravascular coagulation (DIC)
ADVERSE REACTIONS
• Acute thrombosis or embolism (including myocardial infarction)
Most frequently reported adverse reactions observed in >5% of subjects
WARNINGS AND PRECAUTIONS
in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B
Thromboembolic events (including venous thrombosis, pulmonary
surface antibody positive, nausea, and vomiting.
embolism, myocardial infarction, and stroke) can occur, particularly
Serious adverse reactions seen are hypersensitivity reactions and
following the administration of high doses (>200 units/kg/day) and/or
thromboembolic events, including stroke, pulmonary embolism and
in patients with thrombotic risk factors.
deep vein thrombosis.
Patients with DIC, advanced atherosclerotic disease, crush injury,
DRUG INTERACTIONS
septicemia, or concomitant treatment with recombinant factor VIIa
Consider possibility of thrombotic events when systemic antifi brinolytics
have an increased risk of developing thrombotic events due to
such as tranexamic acid and aminocaproic acid are used with FEIBA.
circulating tissue factor or predisposing coagulopathy. Potential
No adequate and well-controlled studies of combined or sequential use
benefi t of treatment should be weighed against potential risk of these
of FEIBA and recombinant factor VIIa, antifi brinolytics, or emicizumab,
thromboembolic events.
have been conducted. Use of antifi brinolytics within approximately 6 to
Infusion should not exceed a single dose of 100 units/kg and daily doses 12 hours after FEIBA is not recommended.
of 200 units/kg. Maximum injection or infusion rate must not exceed
Clinical experience from an emicizumab clinical trial suggests that a
2 units/kg/minute. Monitor patients receiving >100 units/kg for the
potential drug interaction may exist with emicizumab.
development of DIC, acute coronary ischemia and signs and symptoms
of other thromboembolic events. If clinical signs or symptoms occur, such Please see accompanying FEIBA Brief Summary of full Prescribing
Information, including BOXED WARNING on Embolic and
as chest pain or pressure, shortness of breath, altered consciousness,
Thrombotic Events.
vision, or speech, limb or abdomen swelling and/or pain, discontinue
FEIBA and initiate appropriate diagnostic and therapeutic measures.
Indications for FEIBA
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.
transfusion-free up to four years after
treatment with LentiGlobin gene therapy.
Usanarat Anurathapan, MD, from Ramat-
hibodi Hospital and Mahidol University in