Home' Australian Pharmacist : Australian Pharmacist January 2014 Contents Australian Pharmacist January 2014 I ©Pharmaceutical Society of Australia Ltd. 79
Xifaxan 550 was PBS listed on 1 December
2013. It is indicated for the prevention of
the recurrence of hepatic encephalopathy
where other treatments have failed or are
contraindicated.1 Hepatic encephalopathy
(HE) is a deterioration of brain function
that occurs when the liver is no longer
able to remove toxic substances from the
blood. It is commonly caused by diseases
that reduce liver function such as hepatitis
Symptoms of severe HE include
disorientation, confusion, inappropriate
behaviour and personality change.
Episodes of overt HE frequently result in
hospitalisation and may be predictive of
Associate Professor Amany Zekry,
Chairperson of the Australian Liver
Association said, 'the listing of Xifaxan 550
is positive news for patients affected by
this disease. We welcome improved access
to evidence based treatments for hepatic
encephalopathy. The condition can
significantly impair quality of life for those
affected and this will provide patients with
another avenue for affordable treatment.'
There is evidence that twice daily
Xifaxan 550 plus lactulose treatment
reduces the risk of a breakthrough HE
episode by 58%. It can also reduce the
risk of hospitalisation attributable to the
condition by 50% when compared to
placebo plus lactulose over six months3.
The rate of adverse and serious adverse
events in patients treated with Xifaxan
550 in this study were similar to those
reported in the placebo group3.
1. Xifaxan 550 PI. 25 Sep 2013.
2. Poordad F. Aliment Pharmacol Ther. 2006;25 (Suppl 1) 3--9.
3. Bass N et al N Eng J of Medicine. 2010;362(12)1071--81.
Eylea (aflibercept) has been approved by
the Therapeutic Goods Administration
(TGA) for the treatment of visual
impairment due to macular oedema
secondary to central retinal vein
occlusion (CRVO) in adults.1 This is
a condition affecting nearly 30,000
Australians aged 50 years or over.3,4
This marks the second registration
milestone for Eylea in Australia, which
was listed on the Pharmaceutical
Benefits Scheme (PBS) for the treatment
of wet AMD in December 2012. It follows
FDA approval for CRVO in adults in
the US in late 2012 and recent backing
in July 2013 from the Committee for
Medicinal Products for Human Use
(CHMP) of the European Medicines
According to Professor Ian McAllister,
ophthalmologist and Director of Clinical
Services at the Lions Eye Institute based
in Perth, EYLEA is a welcome addition to
the treatment suite for CRVO.
'Eylea has been proven in two well
conducted Phase III trials to be effective
in this condition in improving visual
outcomes substantially over what could
be expected to occur in the natural
history of this disease. The addition
of Eylea is very welcome news to
ophthalmologists and their patients
with this disease across the country,'
The recommended dose for Eylea in its
new indication is 2 mg administered as
an intravitreal injection every four weeks
for the first three months, with clinicians
then able to extend the injection
interval based on a patient's visual and
1. Eylea (aflibercept) Product Information. 7 Nov 2013.
2. Lucentis (ranibizumab) Product Information. 5 Oct 2012.
3. Mitchell P, Smith W, Chang A. Prevalence and associations
of retinal vein occlusion in Australia. The Blue Mountains
Eye Study. Arch Opthalmol. Oct 1996;114(10):1243--7.
4. ABS. Australian demographic statistics Mar 2013.At:
The 2 December 2013 PBS listing of
Tafinlar (dabrafenib mesilate) on will lead
to improved access to the medicine for
melanoma patients in Australia according
to GlaxoSmithKline (GSK). Tafinlar
treats unresectable stage III melanoma
(melanoma that cannot be removed by
surgery) or stage IV metastatic melanoma
(melanoma which has spread to other
parts of the body) in patients with BRAF
V600 mutation.1 Among those with
melanoma, approximately half have a
BRAF mutation, which is an abnormal
change in a gene that can enable some
melanoma tumours to grow and spread.1-3
The approval and reimbursement of
Tafinlar in Australia is based on positive
results derived from several multi-centre
global trials, including a Phase III study
that showed significant improvement in
progression free survival.1, 4-6
BRAF is a key component of the MAPK
pathway, which regulates the normal
growth and death of cells, including skin
cells. In approximately 50% of melanomas,
a mutated BRAF protein in the MAPK
pathway disrupts normal cellular
regulation and promotes increased cell
production.1-3 A diagnostic test is required
to identify patients with unresectable
stage III or metastatic melanoma who
have the BRAF V600 mutation.1 Tafinlar
binds to the mutated BRAF protein, which
may lead to an inhibition of oncogenic
signalling, thereby inhibiting the
proliferation of tumour cells.1
1. Tafinlar Approved Product Information.
2. Davies H, et al. Nature. 2002;417:949--54.
3. Curtin JA, et al. N Engl J Med. 2005;353:2135.
4. Ascierto PA, et al. J Clin Oncol. 2013;31:3205--11.
5. Long GV, et al. Lancet Oncol. 2012;13:1087--95.
6. Hauschild A, et al. Lancet, 2012;380:358--65.
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