Repatha

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Evolocumab 140 mg/mL;  

Available from:

Amgen New Zealand Limited

Dosage:

140 mg

Pharmaceutical form:

Solution for injection

Composition:

Active: Evolocumab 140 mg/mL   Excipient: Glacial acetic acid Polysorbate 80 Proline Sodium hydroxide Water for injection

Prescription type:

Prescription

Therapeutic indications:

Repatha is indicated as an adjunct to diet and exercise in: Hypercholesterolaemia Repatha is indicated in adults with primary hypercholesterolaemia (including heterozygous familial hypercholesterolaemia and non-familial hypercholesterolaemia) to reduce low-density lipoprotein cholesterol (LDL-C): - in combination with a statin or statin with other lipid lowering therapies, or - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant. Homozygous Familial Hypercholesterolaemia Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.

Product summary:

Package - Contents - Shelf Life: Syringe, glass, Type I pre-filled 1 mL - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 days from date of manufacture stored at or below 25°C protect from light. no return to refrigeration allowed

Authorization date:

2017-10-16

Patient Information leaflet

Repatha

1
REPATHA
®
_Evolocumab (rch) - e” voe lok’ ue mab _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS CMI
This leaflet answers some common
questions about Repatha.
It does not contain all the available
information. It does not take the
place of talking to your doctor, nurse
or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Repatha
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR, PHARMACIST OR NURSE.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT REPATHA IS USED
FOR
Repatha is a medicine to lower
increased levels of cholesterol.
Repatha lowers levels of total
cholesterol, "bad" cholesterol (LDL
cholesterol), and fatty substances
called triglycerides in the blood. In
addition, Repatha raises levels of
"good" cholesterol (HDL
cholesterol).
Evolocumab, the active ingredient of
Repatha, works by helping the liver’s
ability to remove bad cholesterol
from the blood.
Cholesterol is one of several fatty
substances found in the bloodstream.
Your total cholesterol is made up
mainly of LDL and HDL. LDL
cholesterol is often called "bad"
cholesterol because it can build up in
the walls of your arteries forming
plaque. Eventually this plaque build-
up can lead to a narrowing of the
arteries. This narrowing can slow or
block blood flow to vital organs such
as the heart and brain. This blocking
of blood flow can result in a heart
attack or stroke and can cause other
health problems.
HDL cholesterol is often called
"good" cholesterol because it helps
keep the bad cholesterol from
building up in the arteries and
protects against heart disease.
Triglycerides are another form of fat
in your blood that may increase your
risk for heart disease.
Repatha is used in adults who cannot
control their cholesterol levels by a
cholesterol lowering diet. You
should stay on your cholesterol
lowering diet as directed by your
doctor while taking this medicine.
Repatha is used in addi

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Repatha – 27 June 2021
PAGE 1 OF 26
This medicine is not currently marketed in New Zealand
1.
REPATHA
® (140 MG SOLUTION FOR INJECTION)
Repatha 140 mg solution for injection pre-filled syringe
Repatha 140 mg solution for injection pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL single-use pre-filled syringe and pen contain 140 mg of
evolocumab in 1 mL
(140 mg/mL).
Evolocumab is produced using recombinant DNA technology in Chinese
hamster ovary
(CHO) cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Repatha is a sterile, preservative-free solution, clear to opalescent;
colourless to yellowish
solution for injection, practically free from particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Repatha is indicated as an adjunct to diet and exercise in:
Prevention of Cardiovascular Events
Repatha is indicated to reduce the risk of cardiovascular events
(myocardial infarction,
stroke and coronary revascularisation) in adults with established
cardiovascular disease in
combination with an optimally dosed statin and/or other lipid-lowering
therapies (see section
5.1 Pharmacodynamic properties, Clinical efficacy).
Hypercholesterolaemia
Repatha is indicated in adults with primary hypercholesterolaemia
(including heterozygous
familial hypercholesterolaemia and non-familial hypercholesterolaemia)
to reduce low-
density lipoprotein cholesterol (LDL-C):

in combination with a statin or statin with other lipid lowering
therapies, or

alone or in combination with other lipid-lowering therapies in
patients who are statin-
intolerant.
NEW ZEALAND DATA SHEET
Repatha – 27 June 2021
PAGE 2 OF 26
Homozygous Familial Hypercholesterolaemia
Repatha is indicated in adults and adolescents aged 12 years and over
with homozygous
familial hypercholesterolaemia in combination with other
lipid-lowering therapies.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
_Hypercholesterolaemia and Prevention of Cardiovascular Events _
The recomm