Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Repatha?
Repatha contains the active ingredient evolocumab. Repatha is used to treat high cholesterol.
Repatha is also used to treat high cholesterol in adults and people 12 years and older
who have high cholesterol because of a condition that runs in their family. Repatha
can be used with other cholesterol lowering medicines in adults with heart disease
to reduce the risk of heart attack, stroke, and certain heart procedures to restore
blood flow to the heart.
2. What should I know before I use Repatha?
Do not use if you have ever had an allergic reaction to evolocumab or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Repatha and affect how it works.
4. How do I use Repatha?
Repatha is injected under the skin (subcutaneous)
Repatha can be self-administered by injection under the skin after training from your
doctor or nurse.
5. What should I know while using Repatha?
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Things you should do
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Remind any doctor, dentist, pharmacist or nurse you visit that you are using Repatha.
Keep all of your doctor's appointments so that your progress can be monitored.
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Things you should not do
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Do not stop using this medicine or lower your dose without checking with your doctor.
Do not give your medicine to anyone else, even if they have the same condition as
you.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how Repatha
affects you.
Repatha has no known effects on the ability to drive or use machines, but as a general
precaution, avoid driving soon after you have an injection.
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Looking after your medicine
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Store in a refrigerator at 2°C to 8°C. Do not freeze. Do not shake.
Keep your medicine in the carton in order to protect from light.
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6. Are there any side effects?
Side effects that require urgent medical attention include: signs of an allergic reaction,
such as rash with, shortness of breath, wheezing or difficulty breathing, swelling
of the face, mouth, lips, tongue, throat or other parts of the body.
Common side effects include: flu or flu-like symptoms, such as high temperature, runny
nose, cough and chills, sore throat or sinus infections, nausea, rash, joint pain,
back pain, injection site reactions including redness, bruising, pain, swelling or
bleeding.
Active ingredient(s):
Evolocumab (rch) - e" voe lok' ue mab
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Repatha. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Repatha.
Where to find information in this leaflet:
1. Why am I using Repatha?
Repatha contains the active ingredient evolocumab. Repatha is a protein (human monoclonal antibody) that lowers cholesterol. Repatha
is given as an injection under the skin (subcutaneous).
Repatha is used with other cholesterol lowering medicines in adults with heart disease
to reduce the risk of heart attack, stroke, and certain heart procedures to restore
blood flow to the heart. Risk factors of heart disease include a history of heart
attack, stroke or blood vessel disease.
Repatha is used in adults who cannot control their cholesterol levels by cholesterol
lowering diet and exercise. You should stay on your cholesterol lowering diet and
exercise as directed by your doctor while taking this medicine.
Cholesterol is one of several fatty substances found in the bloodstream. Your total
cholesterol is made up mainly of Low Density Lipoprotein (LDL) and High Density Lipoprotein
(HDL) cholesterol.
Repatha lowers LDL cholesterol and triglycerides. It can raise your HDL cholesterol
as well.
LDL cholesterol 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 helps to keep LDL 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 can be used with other cholesterol lowering medicines in adults to treat high
cholesterol. When a statin cannot be used or does not work well, Repatha can be used
alone or together with other cholesterol lowering medicines.
Repatha can be used with other cholesterol lowering medicines for people 12 years
and older who have high cholesterol because of a condition that runs in their family
(homozygous familial hypercholesterolaemia).
2. What should I know before I use Repatha?
Warnings
Do not use Repatha if:
you are allergic to evolocumab, or any of the ingredients listed at the end of this
leaflet or medicines or other products that are produced by DNA technology using Chinese
Hamster Ovary cells.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Repatha has not been tested in pregnant women. It is not known if Repatha will affect
your unborn baby.
If you are taking another cholesterol lowering medicine with Repatha, read the patient
leaflet of that particular medicine as well.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known whether Repatha is found in breast milk.
Your doctor will help you decide whether to stop breast-feeding, or whether to stop
using Repatha, considering the benefit of breast-feeding to the baby and the benefit
of Repatha to the mother.
Your doctor can discuss with you the risks and benefits involved.
Use in children and adolescents
Do not give this medicine to a child under the age of 18 years except for children
over 12 years with a rare form of high cholesterol.
Repatha has only been studied in children over 12 years with a rare form of high cholesterol
which runs in families, called homozygous familial hypercholesterolaemia.
Repatha has not been studied in children under 12 years and has not been studied in
children with high cholesterol due to other causes.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Repatha can be used with other cholesterol lowering medicines unless they cannot be
used or do not work well.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Repatha.
4. How do I use Repatha?
How much to take / use
The recommended dose for adults with high cholesterol and heart disease to reduce
the risk of heart attack, stroke and certain heart procedures is either 140 mg single
SureClick pen every two weeks or 420 mg once monthly.
For homozygous familial hypercholesterolaemia the recommended starting dose is 420
mg once monthly. After 12 weeks your doctor may decide to increase the dose to 420
mg every 2 weeks. If you also receive apheresis, a procedure similar to dialysis
where cholesterol and other fats are removed from the blood, your doctor may decide
to start you on a dose of 420 mg every two weeks to coincide with your apheresis treatment.
If you have been prescribed the 420 mg dose, this can be given as three 140 mg SureClick
pens. The three injections should be given consecutively within 30 minutes. Alternatively,
the single-use automated mini-doser (AMD) can be used.
Follow the instructions provided and use Repatha until your doctor tells you to stop.
When to take / use Repatha
Before starting Repatha, you should be on a cholesterol lowering diet and regularly
exercising to lower your cholesterol.
You should stay on your cholesterol lowering diet and exercise as directed by your
doctor while taking Repatha.
If your doctor has prescribed Repatha along with other cholesterol lowering medicines,
follow your doctor’s instructions on how to take these medicines together. Please
read the patient leaflet for those medicines as well.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist
or nurse has told you. Check with your doctor, pharmacist or nurse if you are not
sure.
How to use Repatha
Repatha is injected under the skin.
If your doctor decides that you or a caregiver can give the injections of Repatha
you or your caregiver will receive training on the right way to prepare and inject
Repatha.
If using the pre-filled pen, place the correct (yellow) end of the pre-filled pen
on the skin before injecting
Follow the "Instructions for Use" leaflet in the pack which provides instructions
about the right way to store, prepare, and give your Repatha injections at home.
If you forget to use Repatha
Repatha should be used regularly at the same time every 2 weeks or once a month. If
you miss your dose at the usual time, use Repatha as soon as you can after the missed
dose.
Contact your doctor who will tell you when you should schedule your next dose. Follow
that schedule exactly as your doctor has told you.
Do not take a double dose to make up for the dose you missed.
If you use too much Repatha
If you think that you have used too much Repatha, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Repatha?
Things you should do
If you are about to be started on any new medicine, remind your doctor, pharmacist
or nurse that you are using Repatha.
Tell any other doctor, nurses, and pharmacist who treat you that you are using this
medicine.
If you become pregnant while using this medicine, tell your doctor immediately.
Keep all your doctor's appointments so that your progress can be checked.
Things you should not do
Do not use Repatha to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop using your medicine or lower the dosage without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Repatha
affects you.
Repatha has no known effects on the ability to drive or use machines, but as a general
precaution, avoid driving soon after you have an injection.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Store in a refrigerator at 2°C to 8°C. Do not freeze. Do not shake.
Keep your medicine in the carton to protect from light.
Your medicine may be left outside the refrigerator to reach room temperature (up to
25°C) before injection. This will make the injection more comfortable.
Follow the instructions in the carton on how to take care of your medicine properly.
Keep it where young children cannot reach it.
When to discard your medicine
After removal from the refrigerator, your medicine may be stored at room temperature
(up to 25°C) in the original carton and must be used within 30 days.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Very serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Repatha contains
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Active ingredient
(main ingredient)
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evolocumab
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Other ingredients
(inactive ingredients)
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proline
glacial acetic acid
polysorbate 80
water for injections
sodium hydroxide
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Do not take this medicine if you are allergic to any of these ingredients.
What Repatha looks like
Repatha is a solution which is clear to opalescent, colourless to yellowish, and practically
free from particles.
Do not use this medicine if you notice it is discoloured or contains large lumps,
flakes or coloured particles.
Repatha is available as:
A pack that contains one single-use SureClick pre-filled pen with 140 mg of evolocumab
in 1 mL of solution (140 mg/mL) (Aust R 231152)
A pack that contains one single-use automated mini-doser (AMD) and one pre-filled
cartridge with 420 mg of evolocumab in 3.5 mL of solution (120 mg/mL) (Aust R 348651).
Who distributes Repatha
Amgen Australia Pty Ltd
Level 11, 10 Carrington St
Sydney NSW 2000
Ph: 1800 803 638
This leaflet was prepared in March 2023.