Home' Australian Pharmacist : March 2011 Contents Vol. 30 -- March #03
Amgen and GlaxoSmithKline
Prolia (denosumab) has been
PBS listed as a treatment for
Denosumab is listed as the sole
PBS-subsidised anti-resorptive agent
for osteoporosis in a woman aged
70 years of age or older with a Bone
Mineral Density (BMD) T-score of
-3.0 or less. The date, site (femoral
neck or lumbar spine) and score of
the qualifying BMD measurement
must be documented in the patient's
medical records when treatment
is initiated.1 Prolia is also listed
as the sole PBS-subsidised anti-
resorptive agent for established
post-menopausal osteoporosis in a
woman with fracture due to minimal
trauma. The fracture must have been
demonstrated radiographically and
the year of plain x-ray or CT-scan or
MRI scan must be documented in
the patient's medical records when
treatment is initiated. A vertebral
fracture is defined as a 20% or greater
reduction in height of the anterior or
mid portion of a vertebral body relative
to the posterior height of that body,
or, a 20% or greater reduction in any
of these heights compared to the
vertebral body above or below the
affected vertebral body.1 It targets and
inhibits a protein signal called RANK
ligand, an essential regulator of the
body's natural process for breaking
down bone.2,3 In postmenopausal
osteoporosis, increased osteoclast
activity leads to increased bone loss
and fracture risk.4,5 Denosumab, the
first RANK ligand inhibitor approved
for the treatment of post menopausal
osteoporosis, is administered by an
adequately trained individual as a
single 60mg subcutaneous injection
once every six months.2
1. PBS Schedule: New Listings and Changes 1 Dec 2010.
Accessed 1 Dec at www.pbs.gov.au/info/publication/
FIRMAGON® -- new GnRH receptor blocker
now available on the PBS
FIRMAGON® (degarelix) has been listed on the PBS, Ferring
Pharmaceuticals has announced.
FIRMAGON is a gonadotrophin-releasing hormone (GnRH)
receptor blocker indicated for patients with prostate cancer in
whom androgen deprivation is warranted.
The PBS listing for FIRMAGON (Authority required, STREAMLINED) applies to patients with locally
advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate.
The recommended dose is 240mg administered as two subcutaneous injections of 120mg at a
concentration of 40mg/mL followed by a monthly maintenance dose of 80mg administered as one
subcutaneous injection at a concentration of 20mg/mL.
The PBS reimbursement covers supply of 1 Starter pack (with no repeats) and 1 Maintenance pack
(with five repeats).
Please consult Product Information before prescribing.
For further information, contact Ferring Pharmaceuticals on 1800 33 77 46.
PBS Dispensed Prices: 120mg x 2 (Starter Pack) $438.72; 80mg Maintenance pack $420.20.
Ferring Pharmaceuticals Pty Ltd, 20 Bridge Street, Pymble NSW 2073
Freephone: 1800 33 77 46 Email: firstname.lastname@example.org
PBS Information: Authority Required (STREAMLINED)
Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of
the prostate. Note: No applications for increased maximum quantity and/or repeats will be
authorised for the 120mg powder for injection.
2. Prolia (denosumab) approved Product Information.
2 Jun 2010.
3. Cumming SR, et al. Denosumab for Prevention
of Fractures in Postmenopausal Women with
Osteoporosis. NEJM 2009;361:756--65.
4. National Osteoporosis Foundation. Clinician's Guide to
Prevention and Treatment of Osteoporosis. Washington,
DC: National Osteoporosis Foundation; 2010:4--5.
5. Boyle WJ, Simonet WS, Lacey DL. Osteoclast
differentiation and activation. Nature. 2003;423:
6. Guidelines for the management of postmenopausal
osteoporosis for GPs. Aust Fam Phys Nov 2004;33:11.
7. Osteoporosis Australia website. Accessed 30 Aug 2010
The Australian Therapeutic Goods
Administration (TGA) has approved
Gilenya (fingolimod), for the treatment
of relapsing remitting multiple sclerosis
(MS) and secondary progressive MS
with super-imposed relapses to delay
the progression of physical disability
and reduce the frequency of relapse.
The safety and efficacy of Gilenya
beyond two years is unknown.1 Its
approval provides MS patients with
a new alternative treatment option.
A member of the sphingosine-1-
phosphate receptor modulators (S1PR)
class of therapies, fingolimod works
by retaining lymphocytes in the lymph
nodes, preventing them from reaching
the central nervous system where
they can attack the myelin sheaths
that protect the nerve fibres and cause
damage to the nerves.2
Fingolimod has been studied in clinical
trials involving more than 4,000
randomised MS patients demonstrating
efficacy in reducing relapses, the
risk of disability progression, and the
number of brain lesions detected by
magnetic resonance imaging (MRI)
-- a measure of inflammatory activity
in patients with relapsing forms of
MS.4,5 In a one-year study, Fingolimod
0.5 mg daily was shown to reduce
the annual relapse rate by 52%
compared to patients treated with an
intramuscular interferon beta-1a, (0.16
versus 0.33, p<0.001).4 The study also
demonstrated that patients treated
with Fingolimod 0.5 mg showed
a statistically significant reduction
in brain atrophy (a change in brain
volume) compared with intramuscular
interferon beta-1a (p<0.001)4 and 83%
of patients treated with Fingolimod
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