Repatha 140 mg solucion inyectable en pluma precargada
Introduction
Label: information for the user
Repatha 140mg injectable solution in pre-filled syringe
evolocumab
Read this label carefully before starting to use this medicine, because it contains important information for you.
- Keep this label, as you may need to read it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this label. See section4.
- The warnings and instructions contained in this document are directed at the person using the medicine. If you are the parent/caregiver responsible for administering the medicine to another person, for example, a child, you must follow this information as applicable.
1. What is Repatha and how is it used
What is Repatha and how it works
Repatha is a medication that reduces the levels of "bad" cholesterol, a type of fat found in the blood.
Repatha contains the active ingredient evolocumab, a monoclonal antibody (a type of specialized protein designed to bind to a specific substance in the body). Evolocumab is designed to bind to a substance called PCSK9 that influences the liver's ability to take up cholesterol. By binding and removing PCSK9, the medication increases the amount of cholesterol that enters the liver and reduces the level of cholesterol in the blood.
For what Repatha is used
Repatha is used as a complement to diet to reduce cholesterol in patients:
- adults with high levels of cholesterol in the blood (primary hypercholesterolemia [familial heterozygous and non-familial] or mixed dyslipidemia). It is administered:
- along with a statin or another medication to reduce cholesterol, if cholesterol levels are not reduced enough with the maximum dose of a statin.
- alone or along with other medications to reduce cholesterol when statins do not work well or cannot be used.
- pediatric patients from 10 years old with high levels of cholesterol in the blood due to a genetic disorder (familial heterozygous hypercholesterolemia or HFhe). It is administered alone or along with other treatments to reduce cholesterol.
- adults and pediatric patients from 10 years old with high levels of cholesterol in the blood due to a genetic disorder (familial homozygous hypercholesterolemia or HFho). It is administered along with other medications to reduce cholesterol.
- adults with high levels of cholesterol in the blood and established atherosclerotic cardiovascular disease (history of heart attack, stroke, or vascular problems). It is administered:
- along with a statin or another medication to reduce cholesterol, if cholesterol levels are not reduced enough with the maximum dose of a statin.
- alone or along with other medications to reduce cholesterol when statins do not work well or cannot be used.
Repatha is used in patients who cannot control their cholesterol levels solely through diet to reduce cholesterol. While using this medication, you must follow the diet prescribed to reduce cholesterol. Repatha may help prevent heart attacks, strokes, and certain cardiovascular interventions performed to restore blood flow to the heart, due to the accumulation of fat deposits in their arteries (also known as atherosclerotic cardiovascular disease).
2. What you need to know before starting to use Repatha
Do not use Repatha if you are allergic to evolocumab or any of the other components of this medication (listed in section 6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Repatha if you have a liver disease.
The cap of the pre-filled syringe needle is made of natural rubber (a latex derivative), which can cause severe allergic reactions.
In order to improve the traceability of this medication, your doctor or pharmacist should record in your medical history the name and batch number of the medication that has been administered to you. We recommend that you also note this information in case you are asked about it in the future.
Children and adolescents
Repatha has been studied in children aged 10 years and older who are receiving treatment for familial heterozygous or homozygous hypercholesterolemia.
Repatha has not been studied in children under 10 years of age.
Other medications and Repatha
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.
Repatha has not been studied in pregnant women. It is unknown whether Repatha can harm the fetus.
It is unknown whether Repatha is present in breast milk.
It is essential that you inform your doctor if you are breastfeeding your child or intend to breastfeed. Your doctor will help you decide whether to stop breastfeeding or the Repatha treatment, taking into account the benefits of breastfeeding for the baby and the benefits of Repatha for the mother.
Driving and operating machines
The influence of Repatha on the ability to drive and operate machines is negligible or insignificant.
Repatha contains sodium
This medication contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".
3. How to Use Repatha
Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.
The recommended dose depends on the underlying disease:
- for adults with primary hypercholesterolemia and mixed dyslipidemia the dose is 140mg every two weeks or 420mg once a month.
- for children aged 10years or older with familial heterozygous hypercholesterolemia the dose is 140mg every two weeks or 420mg once a month.
- for adults or children aged 10years or older with familial homozygous hypercholesterolemia the initial recommended dose is 420mg once a month. After 12weeks, your doctor may decide to increase the dose to 420mg every two weeks. If you are also receiving apheresis, a procedure similar to dialysis in which cholesterol and other fats are removed from the blood, your doctor may decide to start with a dose of 420mg every twoweeks to coincide with the apheresis treatment.
- for adults with established atherosclerotic cardiovascular disease (history of heart attack, stroke, or vascular problems) the dose is 140mg every two weeks or 420mg once a month.
Repatha is administered via subcutaneous injection.
If your doctor prescribes a dose of 420mg, you must use three pre-filled pens since each pre-filled pen contains only 140mg of medication. After reaching room temperature, all injections must be administered within a 30minute interval.
If your doctor considers that you or a caregiver can administer the Repatha injections, you or your caregiver must receive training on how to prepare and inject Repatha correctly. Do not attempt to inject Repatha until your doctor or nurse has shown you how to do it.
See the detailed usage instructions that appear at the end of this leaflet for information on how to store, prepare, and administer Repatha injections at home. If you use the pre-filled pen,place the correct end (yellow) of the pen on the skin before injection.
Before starting treatment with Repatha, you must be following a diet to reduce cholesterol. While using Repatha, you must continue with this diet to reduce cholesterol.
If your doctor has prescribed Repatha along with another cholesterol-lowering medication, follow their instructions on how to use these medications together. In this case, also read the administration instructions in the leaflet for that specific medication.
If you use more Repatha than you should
Contact your doctor or pharmacist immediately.
If you forgot to take Repatha
Administer the missed dose as soon as possible. Then, contact your doctor to inform them when to administer the next dose, and follow the new schedule exactly as your doctor has instructed.
4. Possible Adverse Effects
Like all medications, this medication may produce adverse effects, although not all people will experience them.
Frequent(may affect up to1 in 10people)
- Common cold, such as runny nose, sore throat, or sinus infection (nasopharyngitis or upper respiratory tract infections)
- Uncomfortable feeling (nausea)
- Back pain
- Joint pain (arthralgia)
- Muscle pain
- Reactions at the injection site, such as hematoma, redness, bleeding, pain, or swelling
- Allergic reactions, including skin rash
- Headache
Less frequent(may affect up to1 in 100people)
- Red itchy patches on the skin (urticaria)
- Flu-like symptoms
Rare(may affect up to1 in 1,000people)
- Swelling of the face, mouth, tongue, or throat (angioedema)
Reporting Adverse Effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.
5. Repatha Storage
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the label and packaging after CAD or EXP. The expiration date is the last day of the month indicated.
Store in refrigerator (between 2°C and 8°C). Do not freeze.
Store in the original packaging to protect it from light.
The preloaded pen can be left out of the refrigerator to reach room temperature (up to 25°C) before injection. This will make the injection less uncomfortable. Once out of the refrigerator, Repatha can be stored at room temperature (up to 25°C) in the original packaging and should be used within 1 month.
Do not use this medication if you observe any change in color or if it contains lumps, flakes, or large, colored particles.
Medications should not be disposed of through drains or trash.
Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
Composition of Repatha
- The active ingredient is evolocumab. Each pre-filled SureClick pen contains 140mg of evolocumab in 1ml of solution.
- The other components are proline, glacial acetic acid, polisorbate80, sodium hydroxide, and water for injection.
Appearance of the product and contents of the pack
Repatha is a transparent to opalescent, colorless to yellowish solution, and practically free of particles.
Each pack contains one, two, three, or six pre-filled SureClick pens for single use.
Marketing Authorization Holder and Responsible Person for Manufacturing
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
Netherlands
Marketing Authorization Holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
Netherlands
Manufacturer
Amgen Technology (Ireland) Unlimited Company
Pottery Road
Dun Laoghaire
Co Dublin
Ireland
Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium
You can request more information about this medicine by contacting the local representative of the marketing authorization holder:
België/Belgique/Belgien s.a. Amgen n.v. Tel/Tél: +32 (0)2 7752711 | Lietuva Amgen Switzerland AG Vilniaus filialas Tel: +370 5 219 7474 |
???????? ?????? ???????? ???? ???.: +359 (0)2424 7440 | Luxembourg/Luxemburg s.a. Amgen Belgique/Belgien Tel/Tél: +32 (0)2 7752711 |
Ceská republika Amgen s.r.o. Tel: +420 221 773 500 | Magyarország Amgen Kft. Tel.: +36 1 35 44 700 |
Danmark Amgen, filial af Amgen AB, Sverige Tlf: +45 39617500 | Malta Amgen B.V. The Netherlands Tel: +31 (0)76 5732500 |
Deutschland AMGEN GmbH Tel.: +49 89 1490960 | Nederland Amgen B.V. Tel: +31 (0)76 5732500 |
Eesti Amgen Switzerland AG Vilniaus filialas Tel: +372 586 09553 | Norge Amgen AB Tel: +47 23308000 |
Ελλ?δα Amgen Ελλ?ς Φαρμακευτικ? Ε.Π.Ε. Τηλ.: +30 210 3447000 | Österreich Amgen GmbH Tel: +43 (0)1 50 217 |
España Amgen S.A. Tel: +34 93 600 18 60 | Polska Amgen Biotechnologia Sp. z o.o. Tel.: +48 22 581 3000 |
France Amgen S.A.S. Tél: +33 (0)9 69363363 | Portugal Amgen Biofarmacêutica, Lda. Tel: +351 21 422 06 06 |
Hrvatska Amgen d.o.o. Tel: +385 (0)1 562 57 20 | România Amgen România SRL Tel: +4021 527 3000 |
Ireland Amgen Ireland Limited Tel: +353 1 8527400 | Slovenija AMGEN zdravila d.o.o. Tel: +386 (0)1 585 1767 |
Ísland Vistor hf. Sími: +354 535 7000 | Slovenská republika Amgen Slovakia s.r.o. Tel: +421 2321114 49 |
Italia Amgen S.r.l. Tel: +39 02 6241121 | Suomi/Finland Amgen AB, sivuliike Suomessa/Amgen AB, filial i Finland Puh/Tel: +358 (0)9 54900500 |
K?προς C.A. Papaellinas Ltd Τηλ.: +357 22741 741 | Sverige Amgen AB Tel: +46 (0)8 6951100 |
Latvija Amgen Switzerland AG Rigas filiale Tel: +371 257 25888 | United Kingdom (Northern Ireland) Amgen Limited Tel: +44 (0)1223 420305 |
Last review date of this leaflet.
Other sources of information
The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.
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Instructions for use: Repatha pre-filled SureClick pen for single use |
Guide to the components | |||||||||||||
Before use | After use | ||||||||||||
| Yellow safety guard (needle inside) |
| |||||||||||
Important: The needle is inside the yellow safety guard. |
Important | ||
Before using a Repatha pre-filled pen, read this important information: | ||
Do notfreeze the Repatha pre-filled pen or use a pen that has been frozen. | ||
Do notremove the orange cap from the Repatha pre-filled pen before you are ready to inject. | ||
Do notuse the Repatha pre-filled pen if it has fallen onto a hard surface. It may be damaged even if you cannot see the damage. |
Step 1: Preparation | ||
A | Take a Repatha pre-filled pen out of the pack. | |
Hold the pen carefully and straight up to take it out of the pack. | ||
Put the original pack with unused pens back in the refrigerator. | ||
Wait at least 30minutes for the pen to reach room temperature naturally before injecting. | ||
Do nottry to warm the pen up using a heat source such as hot water or a microwave. | ||
Do notexpose the pen to direct sunlight. | ||
Do notshake the pen. | ||
Do notremove the orange cap from the pen before time. |
B | Inspect the Repatha pre-filled pen. | ||
Yellow safety guard (needle inside) | |||
Make sure the medicine in the window is transparent and colourless to yellowish. | |||
Check the expiry date. | |||
Do notuse the pen if the medicine is cloudy or has changed colour, or contains lumps, flakes or large particles. | |||
Do notuse the pen if any component is cracked or broken. | |||
Do notuse the pen if it has fallen. | |||
Do notuse the pen if the orange cap is not on or is loose. | |||
Do notuse the pen if the expiry date has passed. | |||
In any of these cases, use a new pen. |
C | Gather all the materials you need for the injection. |
Wash your hands thoroughly with soap and water. | |
On a clean and well-lit work surface, place: | |
A new pen. | |
Alcohol wipes. | |
A cotton ball or gauze. | |
A bandage. | |
A sharps container. | |
D | Prepare and clean the injection site. |
Upper arm | |
Abdomen | |
Thigh | |
Only use these injection sites: | |
Thigh. | |
Abdomen, except the area around the navel within 5centimetres. | |
Outer area of the upper arm (only if someone else is giving you the injection). | |
Clean the injection site with an alcohol wipe. Let the skin dry. | |
Do nottouch this area again before the injection. | |
Choose a different site for each injection. If you need to use the same site, make sure you do not inject in the same spot as the last time. | |
Do notinject in areas where the skin is painful to the touch or is red, swollen or hard. Avoid areas with scars or stretch marks. |
Step 2: Prepare | ||
A | Take the orange cap off, pulling it straight off, only when you are ready to inject.Do notleave the pen without the orange cap for more than5minutes, as this may dry out the medicine. | |
Orange cap | ||
It is normal for there to be a small drop of medicine at the tip of the needle or the yellow safety guard. | ||
Do notsqueeze, bend or move the orange cap. | ||
Do notput the orange cap back on the pen. | ||
Do notput your fingers in the yellow safety guard. | ||
Important: Do notremove the orange cap from the pen until you are ready to inject. If you cannot give yourself the injection, ask the healthcare professional who is treating you. |
B | Create a firm surface on the selected injection site (thigh, abdomen or outer area of the upper arm) using the stretching or pinching method. |
Stretching method | |
Stretch the skin firmly by sliding your thumb and fingers in opposite directions to create a 5centimetre wide area. | |
O | |
Pinch method | |
Pinch the skin firmly between your thumb and fingers, covering a 5centimetre wide area. | |
Important:It is essential to keep the skin stretched or pinched during the injection. |
Step 3: Inject | |
A | Keep the skin stretched or pinched. Once the orange cap is removed,placethe yellow safety guard on your skin at a 90degree angle. Theneedle is insidethe yellow safety guard. Do nottouch the grey start button yet. |
Yellow safety guard (needle inside) |
B | Pushfirmlythe pen onto the skin until it stops moving. |
Important:You must push the pen as far as you can, butdo nottouch the grey start button until you are ready to inject. |
C | When you are ready to inject,pressthe grey start button. You will hear aclick. |
“click” |
D | Continuepushingonto the skin. Then,removeyour finger while keeping the pen on your skin. The injection may take up to 15seconds to complete. | |
“click” | 15seconds The transparent window turns yellow when the injection is complete. You may hear a second click. | |
NOTE:Once you remove the pen from the skin, the needle will automatically cover. |
Step 4: Finish | ||
A | Dispose of the used pen and the needle. | |
Put the used pen and the needle in a sharps container. | ||
Ask the healthcare professional who is treating you how to dispose of the pens correctly. There may be local regulations. | ||
Keep the pen and the sharps container out of sight and reach of children. | ||
Do notuse the pen again. | ||
Do notput the orange cap back on the pen or put your fingers in the yellow safety guard. | ||
Do notrecycle the pen or the sharps container, or throw them away. |
B | Examine the injection site. |
If you see blood, press the injection site with a cotton ball or gauze.Do notrub the injection site. Put a bandage on if needed. |
