Home' Australian Journal of Pharmacy : Jan-Feb 2017 Contents Benefits of reducing LDL cholesterol levels
‘Aggressive’ reduction of low density lipoprotein cholesterol (LDL-C) for
the primary and secondary prevention of coronary heart disease has been
described as one of the major public health accomplishments of the last
An analysis of more than 300,000 patients in 49 clinical trials of statins
and other cholesterol-lowering agents concluded that the relative risk of a
major vascular event over five years is reduced by 23% with every 1 mmol/L
reduction in LDL-C . Major vascular events comprised cardiovascular death,
acute myocardial infarction or other acute coronary syndrome, coronary
revascularisation or stroke.4
About familial hypercholesterolaemia
Familial hypercholesterolaemia (FH) is an inherited condition caused by a genetic
defect in one of several genes that affect LDL-C metabolism. This results in
high cholesterol levels from an early age and an increased risk of premature
Homozygous FH (HoFH) occurs when an individual has two altered copies of a
cholesterol-regulating gene (one from each parent).6
People with HoFH, can have untreated LDL-C levels more than six times higher than
normal (e.g. 17–26 mmol/L),6 putting them at very high risk of a cardiovascular
event early in life.5
FH can be identified by genetic testing or by a simple clinical assessment tool
known as the Dutch Lipid Clinic Network (DLCN) score, which is available online
www.fhscore.com.au. The DLCN score is a validated set of criteria that includes
a patient’s family history of premature cardiovascular disease in first-degree
relatives, their own CVD history, their lipid levels (untreated) and physical signs
such as the presence of tendon xanthomata or arcus cornealis prior to the age of
45.7 The calculated score provides a patient’s likelihood of having FH.7
Repatha, a monoclonal antibody administered by subcutaneous injection,
inhibits the activity of the enzyme proprotein convertase subtilisin/kexin type 9
(PCSK9).1 By inhibiting the action of the enzyme, Repatha increases the number
of receptors available to bind with LDL-C in the liver and reduces circulating
In patients with FH, Repatha was effective in reducing LDL-C, total cholesterol,
apolipoprotein (ApoB) and non-high density lipoprotein cholesterol (non-HDL-C).1
When added to statin, Repatha delivers up to an additional 75% LDL-C reduction
overall compared with placebo plus statin.8 Up to 95% of patients achieved an
LDL-C < 1.8 mmol/L when they are treated with Repatha.8
In patients with HoFH, Repatha 420 mg once monthly demonstrated a sustained
treatment effect as evidenced by reduction in LDL-C of approximately 20–30% .9
The effect of Repatha on cardiovascular morbidity and mortality has not been
determined,1 but investigations to determine cardiovascular outcomes are
currently in progress.10
The incidence of adverse events in the clinical studies, including musculoskeletal
events, was similar between Repatha and control groups.1 Injection site reactions
including pain, erythema and bruising were reported by 3.0% of patients in control
groups and in 3.3% of those treated with Repatha.1
Repatha became available on the PBS from December 1, 2016 for patients with
homozygous FH in whom cholesterol levels are inadequately controlled by existing
treatment. To be eligible, the patient must have a diagnosis of homozygous FH
confirmed by genetic testing or by a Dutch Lipid Clinic Network Score of at least 7,
and an LDL-C of greater than 3.3 mmol/L while taking a maximum tolerated dose
of statin, or is statin intolerant or is contraindicated to statin.
1. Repatha Product Information. http://www.amgen.com.au/products/product-information. 2. Pharmaceutical Benefits Scheme (PBS). 2016. www.pbs.gov.au. 3 Rodriguez F, Harrington RA. JAMA 2016;
316:1967–68. 4. Silverman MG et al. JAMA 2016;316:1289–97. 5. Watts GF et al. Int J Cardiol 2014;171:309–25. 6. Hopkins PN et al. J Clin Lipid 2011:5(3S):S9–S17. 7. FH Australasia Network.
How to diagnose FH. http://www.athero.org.au/fh/health-professionals/how-to-diagnose-fh. 8. Robinson JG et al. JAMA 2014;311:1870–82. 9. Raal FJ et al. Lancet 2015;385:341–50.
10. Clinicaltrials.gov. https://www.clinicaltrials.gov/ct2/show/NCT02867813?term=evolocumab&rank=14. 11. Sabatine MS et al. AHJ 2016;173:94–101.
Refer to full Product Information before prescribing; available from Amgen Australia Pty Ltd,
Ph: 1800 803 638 or at www.amgen.com.au/Repatha.PI
For more information on Repatha®, or to report an adverse event or product complaint involving Repatha®,please contact Amgen Medical Information on 1800 803 638
Minimum PI - Indication: Primary hypercholesterolaemia - heterozygous familial hypercholesterolaemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD) in adults, given in combination with diet,
exercise and other lipid lowering therapies. Homozygous familial hypercholesterolaemia (HoFH) 12 years and above given in combination with diet, exercise and other lipid lowering therapies. Contraindications:
Sensitivity to mammalian cell products, evolocumab or excipients. Precautions: Hypersensitivity reactions. Concomitant lipid lowering therapies – check all relevant prescribing information. Effect of long
term low LDL-C levels unknown. Immunogenic potential. Pregnancy Category: B1. Caution – breastfeeding. Drug interactions – approx. 20% increase in clearance of Repatha co-administered with statins
with no adverse impact on pharmacodynamic effect of Repatha. Adverse Reactions: Common – nasopharyngitis, upper respiratory tract infection, influenza, back pain, arthralgia, nausea, cough, bronchitis,
hypertension, sinusitis, oropharyngeal pain, blood creatine phosphokinase increased, gastroenteritis, constipation, injection site erythema and injection site pain. Dosage & Administration: Subcutaneous.
Aim: decrease low-density lipoprotein – cholesterol (LDL-C). HeFH and CVD: 140 mg every 2 weeks or 420 mg monthly. HoFH: Initial dose 420mg monthly. Increase to 420mg fortnightly if a clinically meaningful
response not achieved in 12 weeks. Patients on apheresis may initiate at 420mg fortnightly with apheresis schedule. See full PI. Approved Minimum PI 9 December 2015
PBS Information: Authority Required. Familial homozygous hypercholesterolaemia. Refer to PBS Schedule for full Authority Required Information.
© 2017 Amgen Australia Pty Ltd. ABN 31 051 057 428, Level 7, 123 Epping Road, North Ryde NSW 2113.
AUS5898. Date of preparation: January 2017.
REPATHA® (EVOLOCUMAB) PBS-LISTED FOR THE
TREATMENT OF INHERITED HIGH CHOLESTEROL
Dose and formulation1
In patients with homozygous FH the recommended dose of 420 mg once monthly
can be increased to 420 mg every 2 weeks if a clinically meaningful response is
not achieved in 12 weeks.
Repatha is provided as a 1 mL solution (140 mg/mL evolocumab) in a single-use
pre-filled SureClick® pen (supplied as a 1-pack, 2-pack and 3-pack). One pre-
filled SureClick® pen includes a single 140 mg dose. The 420 mg monthly dose
is administered by three pre-filled pens given consecutively within 30 minutes.
Storage and administration1
• Repatha should be stored in a refrigerator but not frozen. If removed from the
refrigerator, Repatha should be kept at controlled room temperature (up to 25°C) in
the original carton and must be used within 30 days. Repatha should be protected
from direct light and not exposed to temperatures above 25°C.
• Repatha may be administered by the patient (or a carer), provided they have
been trained in injection technique.
• Repatha should be allowed to sit at room temperature for at least 30 minutes
before injection to reduce discomfort.
• The product should not be shaken.
• Doses may be administered in the upper arm, thigh or abdomen, rotating the
• Repatha is for single use in one patient only. The pre-filled pen should be
disposed of in a sharps container.
Support for patients is available through the RepathaReady® program.
It includes a welcome kit of information and injection training resources,
injectionreminders andasharps bin. Thereisalsoa1800 phonelinethatprovides
nurse support to patients. To find out more contact the Program Administrator
on 1800 755 005.
Repatha® (evolocumab), approved for the
treatment of patients with hypercholesterolaemia
inadequately managed with statins and other
lipid-lowering therapies,1 is now available on the
PBS for a subset of patients with high cholesterol
levels due to genetic mutations.2
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