ASH Clinical News ACN_5.6_Full_Issue_Digital | Page 33

HEMLIBRA:
For
hemophilia
A A
patients
with
or or
without
FVIII
inhibitors
HEMLIBRA:
For
hemophilia
patients
with
without
FVIII
inhibitors
GO HIKE. GO SEARCH.
GO AHEAD.
Are you ready to go ahead? Choose HEMLIBRA.
HEMLIBRA provided significant reduction in treated bleed rate in adults and adolescents without FVIII inhibitors
INTRA-PATIENT COMPARISON
RANDOMIZED COMPARISON
HAVEN 3*: HEMLIBRA vs prior FVIII prophylaxis
HEMLIBRA QW (n=48)
68
FEWER
% BLEEDS
vs prior FVIII prophylaxis
(95% CI: 48.6; 80.5), P<0.0001
ABR † 1.5 (95% CI: 1.0, 2.3) vs
4.8 (95% CI: 3.2, 7.1)
HAVEN 3: HEMLIBRA vs no prophylaxis (primary endpoint)
HEMLIBRA QW (n=36)
96
FEWER
% BLEEDS
vs no prophylaxis
(95% CI: 92.5; 98), P<0.0001
ABR 1.5 (95% CI: 0.9, 2.5)
HEMLIBRA Q2W (n=35)
97
FEWER
BLEEDS
% vs no prophylaxis
(95% CI: 93.4; 98.3), P<0.0001
ABR 1.3 (95% CI: 0.8, 2.3)
Learn about the impact HEMLIBRA can have on patients at hemlibra.com/stories
ABR=annualized bleed rate; CI=confidence interval; FVIII=factor VIII; QW=once weekly; Q2W=once every 2 weeks.
* HAVEN 3 (N=152) was a randomized, multicenter, open-label, clinical trial of adult and adolescent males with hemophilia A without FVIII inhibitors. Patients received HEMLIBRA prophylaxis, 3 mg/kg QW for the first 4 weeks
followed by either 1.5 mg/kg QW or 3 mg/kg Q2W thereafter, or no prophylaxis. Patients previously treated with prophylactic FVIII were enrolled in an intra-patient comparison and received HEMLIBRA prophylaxis QW.
†
ABR calculated with a negative binomial regression model, which accounts for different follow-up times.
Indication
HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency
of bleeding episodes in adult and pediatric patients ages newborn and older with
hemophilia A with or without factor VIII inhibitors.
Important Safety Information
Boxed WARNING: THROMBOTIC MICROANGIOPATHY and THROMBOEMBOLISM
Cases of thrombotic microangiopathy and thrombotic events were reported when
on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin
complex concentrate (aPCC) was administered for 24 hours or more to patients
receiving HEMLIBRA prophylaxis. Monitor for the development of
thrombotic microangiopathy and thrombotic events if aPCC is administered.
Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur.
Warnings and Precautions
Thrombotic Microangiopathy (TMA) and Thromboembolism Associated With
HEMLIBRA and aPCC
In clinical trials, TMA was reported in 0.8% of patients (3/391) and thrombotic
events were reported in 0.5% of patients (2/391). In patients who received at least
one dose of aPCC, TMA was reported in 8.1% of patients (3/37) and thrombotic
events were reported in 5.4% of patients (2/37). Patients with TMA presented with
thrombocytopenia, microangiopathic hemolytic anemia, and acute kidney injury,
without severe deficiencies in ADAMTS13.
Consider the benefits and risks if aPCC must be used in a patient receiving HEMLIBRA
prophylaxis. Monitor for the development of TMA and/or thromboembolism when
administering aPCC. Immediately discontinue aPCC and interrupt HEMLIBRA
prophylaxis if clinical symptoms, imaging, or laboratory findings consistent with TMA
and/or thromboembolism occur, and manage as clinically indicated. Consider the
benefits and risks of resuming HEMLIBRA prophylaxis following complete resolution of
TMA and/or thrombotic events on a case-by-case basis.
Laboratory Coagulation Test Interference
HEMLIBRA affects intrinsic pathway clotting-based laboratory tests, including activated
clotting time (ACT); activated partial thromboplastin time (aPTT); and all assays based
on aPTT, such as one-stage, factor VIII (FVIII) activity. Intrinsic pathway clotting-based
laboratory tests should not be used.
Results affected by HEMLIBRA: aPTT; Bethesda assays (clotting-based) for FVIII inhibitor
titers; one-stage, aPTT-based single-factor assays; aPTT-based Activated Protein C
Resistance (APC-R); ACT.
Most Common Adverse Reactions
The most common adverse reactions (incidence ≥10%) are injection site reactions,
headache, and arthralgia.
Drug Interactions
Clinical experience suggests that a drug interaction exists with HEMLIBRA and aPCC.
Pregnancy, Lactation, Females and Males of Reproductive Potential
Women of childbearing potential should use contraception while receiving HEMLIBRA.
HEMLIBRA should be used during pregnancy only if the potential benefit for the mother
outweighs the risk to the fetus. Consider developmental/health benefits, clinical need,
and potential adverse effects on the breastfed child and mother.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at [phone].
Please see Brief Summary of full Prescribing Information on adjacent page for additional
Important Safety Information, including Boxed WARNING.
HEMLIBRA ® is a registered trademark of Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
The HEMLIBRA logo is a trademark of Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
The Genentech logo is a registered trademark of Genentech, Inc.
©2019 Genentech USA, Inc. All rights reserved. EMI/020819/0025 2/19