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with a subsequent biopsy negative for HL then received 30 Gy
ISRT (the recommended standard radiation therapy for HL
patients per the International
Lymphoma Radiation Oncology
Group and the National Comprehensive Cancer Network).
Those with a positive PET result
and positive biopsy for lympho-
ma were subsequently treated
off study.
Twenty-nine patients received BV + AVD; 25 of these
patients received the additional
treatment of 30.6 Gy ISRT in
17 daily fractions. Of the four
patients who did not receive
ISRT, two had biopsy-confirmed
refractory classic HL, one
elected to come off study to receive proton beam radiotherapy
to the mantle field, and one
elected to come off study to receive chemotherapy alone with
two additional cycles of ABVD
after four cycles of brentuximab
vedotin plus AVD.
Adverse events (AEs) associated with BV + AVD, with
or without ISRT, were generally
grade 1-2 toxicities and “easily
managed,” the authors noted.
The most common grade ≥3 AE
associated with BV + AVD was
neutropenia (n=16; 53%), and
peripheral neuropathy was observed in 40 percent of patients
(n=12). Serious AEs occurred in
six patients receiving BV + AVD,
s
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 reac tions and thromboembolic events, including stroke, pulmonary embolism
and deep vein thrombosis. Use of antifibrinolytics within approximately 6 to 12 hours after the administration of FEIBA is not recommended.
Please see next page for FEIBA Brief Summary of Prescribing Information. To see the Full Prescribing Information, including
Boxed Warning, go to www.FEIBA.com
References: 1. FEIBA Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; November 2013.
2. Antunes SV, Tangada S, Stasyshyn O, et al. Randomized comparison of prophylaxis and ondemand regimens with FEIBA
NF in the treatment of haemophilia A and B with inhibitors. Haemophilia. 2014;20(1):65-72.
Baxalta and Feiba are trademarks of Baxalta Incorporated January 2016 USBS/145/15-0065
including grade 3 febrile neutropenia (n=3) and grade 1/2 fever
without neutropenia (n=2). The
most common acute toxicities associated with ISRT were
fatigue (n=22; 88%), dermatitis
(n=20), dysphagia (n=20), and
esophagitis (n=13).
No clinically significant,
drug-related pulmonary toxicity