Repatha 420 mg solution for injection in cartridge evolocumab
What Is Repatha, And What Is It Used For?
What Repatha is and how it works
Repatha is a drug that lowers the level of “bad” cholesterol, a type of fat, in the blood. Repatha contains the active substance evolocumab, a monoclonal antibody (a specialized protein designed to bind to a target substance in the body).
Evolocumab is designed to bind a substance called PCSK9, affecting the liver’s ability to receive cholesterol. By attaching to and absorbing PCSK9, the drug increases the amount of cholesterol received by the liver and thus lowers the cholesterol level in the blood.
What is Repatha used for?
Repatha injection uses as a supplement to your cholesterol-lowering diet if you are:
- Adult with high blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial] or mixed dyslipidemia ). It is given:
- Together with a statin or other cholesterol-lowering drug if the highest statin dose does not lower the cholesterol level sufficiently.
- Alone or in combination with other cholesterol-lowering drugs when statins do not give good results or can not be used.
- Children aged 10 years or older have high blood cholesterol levels due to a hereditary condition (heterozygous familial hypercholesterolemia or HeFH). It is given alone or in combination with other cholesterol-lowering treatments
- For adults or children aged 10 years or older with high blood cholesterol levels due to a hereditary condition (so-called homozygous familial hypercholesterolemia or HoFH). It is given together with other cholesterol-lowering treatments.
- Adult with high blood cholesterol levels and established atherosclerotic cardiovascular disease (who has had a heart attack, stroke, or another vascular disease). It is given:
- Together with a statin or other cholesterol-lowering drug if the highest statin dose does not lower the cholesterol level sufficiently.
- Alone or in combination with other cholesterol-lowering drugs when statins do not give good results or can not be used.
Repatha is given to patients for whom a cholesterol-lowering diet is insufficient to control cholesterol levels. You should continue with your cholesterol-lowering diet while you are taking this medicine. This medicine can help prevent heart attack, stroke, and specific procedures to increase blood flow in the heart’s coronary arteries due to atherosclerosis (also called atherosclerotic cardiovascular disease).
What You Need To Know Before Using Repatha?
Do Not Use Repatha
Do not use Repatha if you are allergic to evolocumab or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions:
Talk to your doctor, pharmacist, or nurse before using this medicine if you have liver disease.
To facilitate the traceability of this medicine, your doctor or pharmacist should document the name and lot number of the product you received in your patient record. It may also be a good idea for you to take note of this information if you are asked about it in the future.
Children And Young People:
The use of this medicine has been studied in children 10 years of age and older who are being treated for heterozygous or homozygous familial hypercholesterolemia. Repatha injection uses have not been studied in children under 10.
Other Medicines And Repatha:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines.
Pregnancy And Breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Repatha has not been studied in pregnant women. It is not known if this medicine can harm an unborn baby. It is not known if Repatha is excreted in human milk.
You must tell your doctor if you are breastfeeding or planning to do so. Your doctor will help you decide whether to stop breastfeeding or stop taking Repatha, considering your baby’s and your benefit from this medicine.
Driving And Using Machines:
Repatha has no or negligible effect on the ability to drive and use machines.
Repatha Contains Sodium:
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie, essentially ‘sodium-free.’
How To Use Repatha?
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
The recommended dose depends on the condition to be treated:
- For adults with primary hypercholesterolemia and mixed dyslipidemia, the dose is either 140 mg every two weeks or 420 mg once a month.
- For children aged 10 years or older with heterozygous familial hypercholesterolemia, the dose is either 140 mg every two weeks or 420 mg once a month.
- For adults or children aged 10 years or older with homozygous familial hypercholesterolemia, the recommended starting dose is 420 mg once a month. After 12 weeks, your doctor may increase your dose to 420 mg every two weeks. Suppose you also get apheresis, a procedure similar to dialysis in which cholesterol and other blood fats are removed from the blood. In that case, your doctor may decide that you should start with a dose of 420 mg every two weeks so that the dosage is in line with your apheresis treatment.
- For adults with established atherosclerotic cardiovascular disease (who have had a heart attack, stroke, or another vascular disease), the dose is either 140 mg every two weeks or 420 mg once a month.
Best Time Of Day To Take Repatha:
You can inject at any time, but most people prefer to do so during the day because it takes 30 to 45 minutes to warm up to room temperature, and you need to be able to see what you’re doing while you’re doing it.
Repatha is given as an injection under the skin ( subcutaneously ). Suppose your doctor decides that you or your healthcare provider can give Repatha‑ the injections using the automatic dosing pump. In that case, you or the healthcare provider should be trained to prepare and inject Repatha correctly.
Do not attempt to use the automatic dosing pump until instructed to do so by a physician or nurse. When 10‑ to 13 ‑ year olds use the automatic dosing pump, it should be done under the supervision of an adult.
Read the detailed “Instructions for Use” at the end of this leaflet on how to store, prepare and use the Repatha automatic dosing pump at home.
Before using Repatha, you should have switched to a cholesterol-lowering diet. You should continue with this cholesterol-lowering diet while you are taking Repatha.
If your doctor has prescribed Repatha with another cholesterol-lowering medicine, you should follow your doctor’s instructions on how to take these medicines together. In this case, you should also read the other medicine’s dosing instructions in the package leaflet.
If You Use More Repatha Than You Should
Contact a doctor or pharmacist immediately.
If You Forget To Take Repatha:
Take Repatha as soon as you can after missing a dose. Then consult a doctor to tell you when to take the next dose. Follow your doctor’s instructions exactly.
Possible Repatha Side Effects:
This medicine can cause side effects like all medicines, although not everybody gets them.
Common(may affect up to 1 in 10 people)
- Influenza
- High fever
- Sore throat
- Runny nose
- Cough
- Chills
- Common cold, such as:
- Runny nose
- Sore throat, or sinus infections
- Nasopharyngitis or upper respiratory tract infection
- Nausea
- Back pain
- Joint pain
- Arthralgia
- Muscle pain
- Injection site reactions, such as:
- Bruising
- Redness
- Bleeding
- Pain, or swelling
- Allergic reactions, including rash
- Headache
Uncommon side effects for repatha (may affect up to 1 in 100 people)
- Hives
- Red itchy lumps on the skin ( urticaria )
- Flu-like symptoms
Rare(may affect up to 1 in 1,000 people)
- Swelling of the face, mouth, tongue, or throat ( angioedema )
How To Store Repatha?
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the label, and carton after EXP. The expiration date is the last day of the specified month.
- Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
- Store in the original package. Sensitive to light. Moisture sensitive.
- The drug ( cartridge and automatic dosing pump) can be taken out of the refrigerator to reach room temperature (up to 25 ° C) before injection. This makes injection more comfortable. If removed from the refrigerator, Repatha can be stored at room temperature (up to 25 ° C) in the original package and must be used within 1 month.
- Do not use this medicine if you notice that it is discolored or contains large lumps, flakes, or colored particles.
- Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information:
Content Declaration
- The active substance is evolokumab. 1 cartridge contains 420 mg of evolokumab in 3.5 ml solution (120 mg / ml).
- The other ingredients are proline, glacial acetic acid, polysorbate 80, sodium hydroxide, and water for injections.
What The Medicine Looks Like And The Contents Of The Pack?
- Repatha is a solution that is clear to opalescent, colorless to yellowish, and essentially free of particles.
- Each pack contains a cartridge together with a disposable automatic dosing pump.
Marketing Authorization Holder And Manufacturer
Amgen Europe BV
Minervum 7061
4817 ZK Breda
Netherlands