Home' Australian Pharmacist : September 2011 Contents Vol.30–September#09,2011
Daivobet 50/500 gel
Daivobet 50/500 gel, a new fixed-
dose combination, once daily topical
application for chronic stable plaque
type scalp psoriasis in adults, was
PBS listed on 1 September.1 Associate
Professor Peter Foley, a dermatologist
from Melbourne and President of The
Skin and Cancer Foundation, said,
‘Patients with scalp psoriasis have
often found it hard to control their
symptoms with currently available
treatments. Daivobet 50/500 gel for
scalp offers a new treatment option
for people living with scalp psoriasis.
It has the potential for better patient
acceptance when compared to others
that have had limited efficacy and side
effects including smell, greasiness and
the potential to stain.’ Psoriasis affects
2.6% of the Caucasian population of
Australia, with the incidence higher
for people living in southern states.
Up to 80% of people with psoriasis
experience scalp involvement.3
The Therapeutic Goods Administration
has approved a new dosing schedule
for Mircera (methoxy polyethylene
glycol-epoetin beta), an erythropoiesis
stimulating agent (ESA) for the
treatment of anaemia associated
with chronic kidney disease (CKD),
that includes once-monthly dosing
for treatment-naïve patients not yet
was previously indicated only in
the maintenance phase of anaemia
management for CKD patients.
Product Information (PI) change is
based on results from the CORDATUS
study, recently published in
Nephrology Dialysis Transplantation.3
The 28-week, open-label, randomised
trial in over 300 non-dialysis CKD
patients who had not received any
prior ESA treatment, evaluated
the safety and efficacy of Mircera
versus darbepoetin alfa, another
currently available ESA in Australia.1,3
The haemoglobin response rate for
Mircera was 94.1%, significantly
higher than the protocol specified
response rate (60%), and comparable
with response rates for darbepoetin
In addition, the proportions of patients
experiencing a haemoglobin level
greater than 120 g/L during the first
eight weeks of treatment were 25.8%
in the Mircera group and 47.7% in
the darbepoetin alfa group.1,3 This is
significant as the key goal of anaemia
Gilenya (fingolimod) is PBS listed for RRMS1
Novartis Pharmaceuticals Australia has announced that as of 1 September 2011, oral once-
daily Gilenya 0.5mg is PBS listed (Authority Required) for eligible patients with relapsing
remitting multiple sclerosis (RRMS).1 Gilenya is the first in a new class of sphingosine
1-phosphate receptor modulators that targets the immune system by retaining lymphocytes
in the lymph nodes, preventing them from reaching the CNS.2 In TRANSFORMS, a 1-year
randomised, double-blind, active-controlled trial in 1292 patients with RRMS, Gilenya had
superior efficacy to IM Interferon β-1a.3 While Gilenya is also indicated for secondary
progressive MS with superimposed relapses,
this indication is not reimbursed.
1. Pharmaceutical Benefits Schedule (PBS). Available at: www.pbs.gov.au
2. Brinkmann V et al. Nat Rev Drug Discov 2010;9:883–97.
3. Cohen JA et al. N Engl J Med 2010;362:402–15.
4. GILENYA Approved Product Information.
PBS Information: Authority Required. For use in patients with
relapsing-remitting multiple sclerosis who meet certain criteria.
Refer to PBS Schedule for full Authority Required information.
See approved Product Information before prescribing. Approved Product Information available
on request from Novartis Pharmaceuticals Australia Pty Limited.
management is to achieve a stable
target haemoglobin level within a
narrow target range.4
1. MIRCERA Product Information, 17 May 2011.
2. MIRCERA Product Information, 10 Jul 2009.
3. Roger SD et al. C.E.R.A . once every 4 weeks corrects
anaemia and maintains haemoglobin in patients with
chronic kidney disease not on dialysis. Nephrol Dial
Transplant 2011;0:1–7. doi: 10.1093/ndt/gfr160.
4. McMahon L. Haemoglobin Guideline. Nephrology
2008;13:S44–S56. The CARI Guidelines
EpiPen and EpiPen Jr
Alphapharm has launched a new look
EpiPen and EpiPen Jr Adrenaline
Auto-Injector, the first adrenaline
auto-injector with built-in needle
protection before and after use.
In an anaphylactic emergency,
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