CARDIOVASCULAR JOURNAL OF AFRICA • Volume 25, No 2, March/April 2014
AFRICA
91
drugs, low-molecular weight heparin
administered by subcutaneous injection,
followed by a vitamin K antagonist, a
complex and often problematic regimen.
5
About Xarelto
®
(rivaroxaban)
Rivaroxaban is the most broadly indicated
new oral anticoagulant and is marketed
under the brand name Xarelto
®
. To date,
Xarelto is now approved for six distinct
uses in the venous–arterial thrombo-
embolic space:
•
the prevention of stroke and systemic
embolism in adult patients with non-
valvular AF
•
the treatment of DVT
•
the treatment of PE
•
the prevention of recurrent PE
•
the prevention of recurrent DVT
•
the prevention of VTE in patients
undergoing major orthopaedic surgery
of the lower limbs.
Rivaroxaban is an oral anticoagulant that
was discovered in Bayer HealthCare’s
Wuppertal laboratories in Germany,
and is being jointly developed by Bayer
HealthCare and Janssen Research &
Development, LLC (a Johnson & Johnson
Company). It has a rapid onset of action
with a predictable dose response and high
bioavailability, no requirement for routine
coagulation monitoring, as well as a limited
potential for food and drug interactions.
Anticoagulant medicines are potent
therapies used to prevent or treat serious
illnesses and potentially life-threatening
conditions. Before initiating therapy with
anticoagulant medicines, doctors should
carefully assess the benefit and risk for
the individual patient.
Responsible use of Xarelto
®
is a very
high priority for Bayer, and the company
has developed a prescriber’s guide for
doctors and a Xarelto
®
patient card for
patients to support best practice.
Prior to the new indications, Xarelto
®
was available for the prevention of VTE
in patients undergoing major orthopaedic
surgery of the lower limbs.
6
Rivaroxaban
is the only oral anticoagulant that has
consistently demonstrated superior
efficacy over enoxaparin for VTE
prophylaxis in adult patients undergoing
total hip or total knee replacement surgery.
7
Rivaroxaban is approved in more than
120 countries worldwide and marketed
by Bayer HealthCare in these indications,
except in the US where it is marketed by
Janssen Pharmaceuticals, Inc.
In the US, rivaroxaban has been avail-
able since July 2011 for VTE preven-
tion in adult patients following elective
hip- or knee-replacement surgery. On
4 November 2013, rivaroxaban received
further marketing approval to reduce the
risk of stroke in patients with atrial fibril-
lation and for the treatment of DVT and
PE in November 2012.
In Europe, Xarelto has been avail-
able since 2008 for VTE prevention in
adult patients following elective hip- or
knee-replacement surgery. Rivaroxaban
received further marketing approval in
December 2009 for the prevention of
stroke and systemic embolism in patients
with atrial fibrillation, and the treatment
of DVT and prevention of recurrent DVT
and pulmonary embolism following an
acute DVT in adult patients. The treat-
ment of PE followed in April 2012 and
in May 2013 rivaroxaban 2.5 mg bid,
co-administered with acetylsalicylic acid
(ASA) alone or with ASA plus clopi-
dogrel or ticlopidine, for the prevention
of atherothrombotic events after an acute
coronary syndrome in adult patients with
elevated cardiac biomarkers.
In South Africa, Xarelto has been
available since March 2010 for VTE
prevention in adult patients undergoing
major orthopaedic surgery of the lower
limbs and today it is available for stroke
prevention in non-valvular AF, treatment
of PE and DVT and the prevention of
recurrent PE and DVT.
The extensive clinical trial programme
supporting rivaroxaban makes it the most
studied and widely published oral, direct
factor Xa inhibitor. The studies, reported
and ongoing, involve over 100 000
patients for the prevention and treatment
of VAT disorders across a broad range of
acute and chronic conditions, including
stroke prevention in patients with atrial
fibrillation, DVT/PE treatment and the
prevention of recurrent DVT or PE, the
secondary prevention of acute coronary
syndrome, coronary or peripheral artery
disease and chronic heart failure.
To learn more about thrombosis, please
visit
About Bayer HealthCare
The Bayer group is a global enterprise
with core competencies in the fields of
healthcare, agriculture and high-tech
materials. Bayer HealthCare, a subgroup
of Bayer AG with annual sales of
EUR18.6 billion (2012), is one of the
world’sleadinginnovativecompaniesinthe
healthcare and medical products industry
and is based in Leverkusen, Germany.
The company combines the global
activities of the Animal Health, Consumer
Care, Medical Care and Pharmaceuticals
divisions. Bayer HealthCare’s aim is
to discover, develop, manufacture and
market products that will improve human
and animal health worldwide. Bayer
HealthCare has a global workforce of
55 300 employees (31 December 2012)
and is represented in more than 100
countries. More information is available
at
.
Contacts
Anel Berning:
Thrombosis Marketing
Manager;
Lionel Dobell:
Xarelto Product Manager;
Dr Naren Jairam:
Xarelto Medical
Advisor;
1.
Stefansdottir H,
et al
. Trends in the inci-
dence and prevalence of atrial fibrillation
in Iceland and future projections.
Europace
2011;
13
: 1110–1117
2.
CammAJ-2010-Eur Heart J-v31p2369-MK.
3.
CohenAT-2007-ThrombHaemost-v98p756-
MK.
4.
Naess_JThrombHaemost_2007.
5.
Ansell J. 2004.
Chest
2004 Sep;126(3
Suppl):204S-233S. ... American College
of Chest Physicians Conference on
Antithrombotic and Thrombolytic Therapy.
6.
Xarelto 10 South African Package Insert.
7.
Turpie AGG, Lassen MR, Eriksson BI,
et al
. Rivaroxaban for the prevention of
venous thromboembolism after hip or knee
arthroplasty: Pooled analysis of four studies.
Thromb Haemost
2011;
105
: 444–453.
