Home' Australian Pharmacist : Australian Pharmacist December2016 Contents Australian Pharmacist December 2016 I ©Pharmaceutical Society of Australia Ltd.
Australia's only locally manufactured,
quadrivalent seasonal influenza vaccine
(QIV) received Therapeutic Goods
Administration (TGA) approval on
15 July. Afluria Quad, Seqirus' four-strain,
inactivated seasonal influenza vaccine,
is indicated for people aged 18 years
and older.1 The quadrivalent vaccine will
replace the company's trivalent vaccine
(TIV), Fluvax for the 2017 flu season.
For the past eight years, the Australian
manufactured trivalent vaccine has been
exported overseas, marketed as Afluria.
The vaccine's name change from Fluvax
to Afluria will bring consistency across
Seqirus' global influenza brand portfolio.
Dr Lorna Meldrum, Vice President,
Commercial Operations, Asia Pacific said
Seqirus was thrilled to be adding Afluria
Quad to its product portfolio comprising
seasonal, pre-pandemic and pandemic
influenza vaccines. Afluria Quad is the
third major influenza product approval
for Seqirus in 2017. Afluria Quad vaccine
is indicated for use only in persons aged
18 years and over. It must not be used in
persons under 18 years.
1. Afluria Quad Product Information 2016.
TALTZ® (ixekizumab) approved by TGA
Lilly has announced the TGA registration
of TALTZ® (ixekizumab), a new
humanised IgG4 monoclonal antibody
with high binding affinity for IL17A
(<3 pM; in vitro data may not necessary
predict human clinical effect). TALTZ
is indicated for adult patients with
moderate-to-severe plaque psoriasis
who are candidates for systemic therapy
TALTZ is administered via subcutaneous
injection and will be available in a
pre-filled autoinjector pen.
The approved dosing regimen for TALTZ
is a starting dose of 160 mg (two 80 mg
injections), followed by one 80 mg
injection every two weeks for the first
12 weeks and one 80 mg injection every
four weeks thereafter.
A Patient Support Program, offering
injection training, customised nurse
support and additional resources,
will be available for patients starting
TALTZ treatment, the manufacturer said.
Please review the Product Information
before prescribing, available from www.
Eli Lilly Australia Pty Ltd. 112 Wharf Road, West
Ryde NSW 2114. ABN 39 000 233 992. PP-IX-
AU-0059. ELT0068/WPS/AJP. Date of preparation:
1. Taltz Product Information, 14 October 2016.
Teva Pharma Australia
Teva Pharma Australia has announced
the Pharmaceutical Benefits Scheme
(PBS) listing (Authority Required) of
Nuvigil (armodafinil), a once daily
non-amphetamine based wakefulness
promoting agent, for patients suffering
excessive sleepiness caused by the sleep
Nuvigil (armodafinil) is the longer-
lasting R-isomer of racemic modafinil.
It is approved in Australia to improve
wakefulness in excessive sleepiness
associated with narcolepsy. For patients
with excessive sleepiness associated
with narcolepsy, Nuvigil significantly
improved wakefulness, as measured
by Maintenance of Wakefulness Tests
(MWT) from 9am to 3pm and the
Epworth Sleepiness Scale (ESS). 1 In
clinical trials, it was generally well
tolerated and most adverse events were
mild to moderate.1 The most common
adverse events (≥5%) occurring more
frequently than in placebo patients
included headache, nausea, dizziness
Dr David Cunnington, Sleep Physician
and Director at Melbourne Sleep
Disorders Centre said: 'Irregular sleep
patterns and sleep disorders can be life
changing for the individual in question.
Narcolepsy is a debilitating condition
that can have a significant impact on all
spheres of a patient's life.'
Ron Grunstein, Professor of Sleep
Medicine at the Woolcock Institute in
Sydney said: 'Whilst we already have
treatments for narcolepsy, a once a day
non-amphetamine based option that
is on the PBS provides an important
treatment option for these patients.'
1. Harsh JR, et al. The efficacy and safety of armodafinil as
treatment for adults with excessive sleepiness associated with
narcolepsy, Cur Med Res and Opinion. 2006;22:4,761--74.
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