Repatha
Pronunciation: ri-PAth-a
Generic name: evolocumab
Dosage form: prefilled single-dose SureClick autoinjector (140 mg/mL), prefilled single-dose syringe (140 mg/mL), single-dose Pushtonex system (420 mg/3.5mL; on-body infusor with prefilled cartridge)
Drug class: PCSK9 inhibitors
What is Repatha?
Repatha is used to lower high cholesterol alongside dietary changes and to reduce the risk of major cardiovascular events in those with cardiovascular disease, such as death from cardiovascular disease, heart attack, stroke, angina requiring hospitalization, or certain types of heart surgery.
Repatha is given as an injection under the skin (subcutaneously), every 2 weeks or 1 time each month.
FDA-approved uses and indications
Repatha (evolocumab) is an injectable prescription medicine approved:
- Cardiovascular Risk Reduction: to reduce the risk of major adverse cardiovascular (CV) events, such as death from cardiovascular disease, heart attack, stroke, certain types of chest pain conditions (unstable angina) requiring hospitalization, or certain types of heart surgery, in adults with established cardiovascular disease
- Primary Hyperlipidemia Treatment: to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH) as an adjunct to diet, alone, or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies
- Pediatric HeFH Treatment: to reduce LDL-C in children aged 10 years and older with HeFH as an adjunct to diet and other LDL-C-lowering therapies
- Homozygous Familial Hypercholesterolemia (HoFH): to reduce LDL-C in adults and children aged 10 years and older with HoFH as an adjunct to other LDL-C-lowering therapies.
It is not known if Repatha is safe and effective in children with HeFH or HoFH who are younger than 10 years of age or in children with other types of hyperlipidemia.
Repatha received FDA approval on August 27, 2015. There is no Repatha generic or biosimilar.
How Repatha Works: PCSK9 Inhibition Mechanism
Mechanism of action
Repatha works by helping the liver reduce levels of "bad" cholesterol (low-density lipoprotein, or LDL) circulating in your blood.
Its mechanism involves binding to and blocking a protein called PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) in the liver.
- Normally, PCSK9 attaches to LDL receptors on liver cells and triggers their degradation.
- These receptors are responsible for removing LDL ("bad") cholesterol from the blood.
- By inhibiting PCSK9, Repatha prevents the degradation of LDL receptors, allowing more of them to remain on liver cell surfaces and remove more LDL cholesterol from the blood.
- Clinical trials report significant reductions in blood LDL cholesterol levels (often 50-60% or more).
Repatha Cost and Insurance Coverage
How much does Repatha cost?
Repatha has broad coverage over most insurance types, so the cost of Repatha depends on the type of insurance you have. For example, with the Repatha Co-Pay card, those with commercial insurance pay as little as $15 a month. For those with Medicaid, 99% of Repatha prescriptions cost people $10 or less. See How much does Repatha cost? for more information.
Repatha Side Effects
Common side effects
The most common side effects of Repatha are:
- Cold symptoms like a runny nose and sore throat
- Flu or flu-like symptoms
- Back pain
- High blood sugar/diabetes
- Injection site reactions such as redness, pain, or bruising.
Serious side effects and warnings
Repatha can cause the following serious side effects:
Serious allergic reactions
Some people taking Repatha have had serious allergic reactions. Stop taking Repatha and call your healthcare provider or seek emergency medical help right away if you or your child has any of these symptoms:
- trouble breathing or swallowing
- raised bumps (hives)
- rash, or itching
- swelling of the face, lips, tongue, throat, or arms.
Latex allergy warning
Repatha is available as prefilled single-dose SureClick autoinjectors and prefilled single-dose syringes that either contain dry natural rubber (a derivative of latex) in the needle cover or are not made with natural rubber latex. Ask your healthcare provider for the Repatha SureClick autoinjector or injection that does not contain dry natural rubber if you are sensitive to latex.
Tell your healthcare provider if you or your child has any side effect that bothers you or does not go away. This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects or see the Repatha Package Insert. You may report side effects to the FDA at 1-800-FDA-1088.
Related/similar drugs
Before taking this medicine
You should not use Repatha if you are allergic to evolocumab, Repatha, or any ingredients in the Repatha injection (see below for a list of ingredients).
Before you or your child start using Repatha, tell your healthcare provider about all your medical conditions, including if you or your child:
- are allergic to rubber or latex. Repatha is available as prefilled single-dose SureClick autoinjectors and prefilled single-dose syringes that either contain dry natural rubber (a derivative of latex) in the needle cover or are not made with natural rubber latex. The carton and “Repatha Instructions for Use” will state if your prefilled single-dose SureClick autoinjector or prefilled single-dose syringe contains dry natural rubber.
- The single-dose Pushtronex® system (on-body infusor with prefilled cartridge) is not made with natural rubber latex.
- have liver or kidney disease
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Do not give Repatha to a child without medical advice, and it is not approved for use by anyone younger than 10 years old. For certain conditions, Repatha should not be given to a child of any age.
Pregnancy
It is not known if Repatha will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking Repatha. If you or your child are pregnant during Repatha treatment, you are encouraged to call Amgen at 1-800-772-6436 (1-800-77-AMGEN) or visit their adverse event and product complaint reporting page to share information about the health of you and your baby or your child and your child’s baby.
Breastfeeding
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks. If you or your child breastfeeds during Repatha treatment, you are encouraged to call Amgen at 1-800-772-6436 (1-800-77-AMGEN) or visit https://wwwext.amgen.com/products/global-patient-safety/adverse-event-reporting to share information about the health of you and your baby or your child and your child’s baby.
How to use Repatha: Injection Instructions
See the detailed Instructions for Use that come with the Repatha Package Insert about the right way to prepare and give Repatha.
Key Injection Instructions
- Use Repatha exactly as your healthcare provider tells you or your child to use it.
- Repatha is given under the skin (subcutaneously), every 2 weeks or 1 time a month.
- If your healthcare provider decides that you or your child, or a caregiver, can give Repatha, you or your child or your caregiver should receive training on the right way to prepare and inject Repatha.
- Do not try to inject Repatha until you or your child has been shown the right way by your healthcare provider or nurse.
Repatha Injection Sites
- You or your child can inject Repatha into the thigh, upper arm, or stomach (abdomen), except for a two-inch area around the belly button.
- Your healthcare provider will show you the best places on your body to inject Repatha or place the on-body infusor.
- Use a different place each time you give an injection. Do not inject into the same place twice in a row.
- Do not choose an area where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch.
Special Dosing for HoFH Patients
If you or your child has HoFH, the recommended starting dose is 420 mg once a month. After 12 weeks, your healthcare provider may increase the dose to 420 mg every two weeks.
If you or your child receives lipid apheresis, your healthcare provider may decide to start you or your child on a dose of 420 mg every two weeks to match the apheresis treatment, and you or your child should take the dose after the apheresis treatment.
Repatha Delivery Systems
Repatha comes as a:
- Prefilled single-dose SureClick autoinjector
- Prefilled single-dose syringe,
- Single-dose Pushtronex system (on-body infusor with prefilled cartridge).
Your healthcare provider will prescribe the type and dose that is best for you or your child.
Important Timing Information
- It may take up to 15 seconds to inject Repatha using a prefilled syringe or a SureClick autoinjector.
- If you use more than one injection at a time, be sure to finish all injections within 30 minutes.
- Each single-use prefilled syringe, cartridge, or injection device is for one use only. Throw away after one use, even if there is still some medicine left inside.
Repatha Pushtonex On-Body Infusor System
The Pushtronex on-body infusor is a special hands-free device placed on the skin that delivers Repatha slowly. Read and carefully follow all instructions for using this product.
You need to wear the device for about 9 minutes to get the full dose. While wearing the on-body infusor, you may perform moderate activities such as walking, bending, or reaching.
Repatha Dosing Information
Repatha is usually given 1 time a month or once every 2 weeks.
- Depending on your dose amount, you may need to use up to 3 separate injections at one time.
- Follow your doctor's dosing instructions very carefully.
Adult Repatha Dose for Hyperlipidemia:
- 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously 1 time a month.
Adult Repatha Dose for Heterozygous Familial Hypercholesterolemia:
- 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously 1 time a month.
Adult Repatha Dose for Homozygous Familial Hypercholesterolemia:
- Initial: 420 mg subcutaneously 1 time a month.
- Titration: May increase to 420 mg every 2 weeks if a clinically meaningful response is not achieved in 12 weeks.
Note: Adults on lipid apheresis may initiate treatment with 420 mg subcutaneously every 2 weeks to correspond with their apheresis schedule; administer after the apheresis session is complete.
Adult Repatha Dose for Cardiovascular Risk Reduction:
- 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously 1 time a month.
Pediatric Repatha Dosing (Ages 10 and Older)
Usual Child Dose (10 and older) for Homozygous Familial Hypercholesterolemia:
- Initial: 420 mg subcutaneously 1 time a month.
- Titration: May increase to 420 mg every 2 weeks if a clinically meaningful response is not achieved in 12 weeks.
Note: Children on lipid apheresis may initiate treatment with 420 mg subcutaneously every 2 weeks to correspond with their apheresis schedule; administer after the apheresis session is complete.
Usual Child Dose (10 and older) for Heterozygous Familial Hypercholesterolemia:
- 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously 1 time a month.
What to Do If You Miss a Repatha Dose?
If you or your child forgets to use Repatha or cannot administer the dose at the regular time, inject your or your child’s missed dose as soon as you remember, as long as it is within 7 days of the missed dose.
More than 7 days from the missed dose
- Every-2-week dosing: Inject the next dose based on the original schedule. This will put you or your child back on the original schedule.
- Monthly dosing: Inject the dose and start a new schedule using this date.
If you or your child are not sure when to take Repatha after a missed dose, ask your healthcare provider or pharmacist. Do not use extra medicine to make up a missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Repatha?
Do not inject Repatha into skin that is bruised, sore, scarred, or hardened.
Do not shake Repatha. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for more medicine.
What other drugs will affect Repatha?
Other drugs may interact with evolocumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
How do I store Repatha?
Store Repatha in the refrigerator in its original carton and protect from light and heat. Do not freeze. Throw away any medicine that has been frozen.
Take the medicine out of the refrigerator and allow it to reach room temperature for 30 to 45 minutes before injecting your dose. Do not heat a syringe or injection device.
You may also store Repatha in the original carton at cool room temperature, away from light and heat. Use the medicine within 30 days if it is kept at room temperature.
Handle this medicine carefully. Dropping an injection device can cause it to break. Do not use an injection device that has been dropped onto a hard surface, even if you cannot see a break in it. Call your pharmacist for new medicine.
What are the ingredients in Repatha?
Active ingredient: evolocumab
Inactive ingredients: proline; acetate; polysorbate 80; water for injection, USP; and sodium hydroxide.
Available as:
- Injection: 140 mg/mL solution prefilled single-dose SureClick autoinjector (with or without latex)
- Injection: 140 mg/mL solution prefilled single-dose syringe (with or without latex)
- Injection: 420 mg/3.5 mL solution single-dose Pushtronex system (on-body infusor with prefilled cartridge) (with or without latex)
Who makes Repatha?
Repatha (evolocumab) is made by Amgen, a biotechnology company headquartered in California. Notable drugs from Amgen include:
- Enbrel (rheumatoid arthritis, psoriasis)
- Prolia/Xgeva (osteoporosis/bone disorders)
- Neulasta/Neupogen (boost white blood cells during chemotherapy)
- Otezla (psoriasis, psoriatic arthritis)
- Lumakras (lung cancer)
- Amjevita (biosimilar to Humira)
- Epogen/Aranesp (anemia)
- Tezspire (severe asthma - partnered with AstraZeneca)
Amgen has been particularly significant in developing biologics (protein-based drugs) and biosimilars. They were one of the first biotech companies to successfully develop and commercialize recombinant DNA technology for medical treatments.
Repatha Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Repatha.
Repatha (evolocumab) - Amgen Inc.
| Formulation type | Strength |
|---|---|
| Autoinjector | 140 mg/mL Discontinued |
| Autoinjector | 420 mg/3.5 mL Discontinued |
| Pre-Filled Syringe | 140 mg/mL |
Popular FAQ
Why was Repatha Pushtronex discontinued and replaced?
Repatha Pushtronex was discontinued in order to uphold Amgen’s standards for patient experience and care. It was not discontinued because of safety or efficacy concerns. Continue reading
Are there any dangers of taking Repatha?
A serious danger of taking Repatha (evolocumab) includes a possibly life-threatening allergic reaction. Also tell your doctor if you are allergic to rubber or latex. Other side effects, which could be serious in some people, include high blood sugar levels (diabetes), respiratory tract infections, urinary tract infections (UTI), high blood pressure, and influenza (flu). Continue reading
Praluent vs Repatha: What's the difference?
The differences between Repatha (evolocumab) and Praluent (alirocumab) are their active ingredients, number of treatment indications, dosage forms available and number of strengths available in syringe and pens forms. Continue reading
What is the difference between Leqvio and Repatha?
Leqvio and Repatha are both injectable medicines that are used for the treatment of high cholesterol, by specifically lowering low density lipoprotein (LDL) levels. Although they both inhibit PCSK9 they work by different mechanisms. Repatha is a monoclonal antibody that binds directly to PCSK9 in the liver preventing it from binding to LDL receptors. Leqvio blocks the PCSK9 protein by interfering with the translation of PCSK9 messenger RNA. Both have the same result – and that is freeing up LDL receptors on the surface of liver cells which allows LDL cholesterol to be removed from the blood.
Continue readingWhat is the best time of day to take Repatha?
You can inject Repatha at any time of the day, but usually people prefer injecting Repatha during daylight hours because it takes 30 to 45 minutes for it to warm up to room temperature, and you need to be able to easily see what you are doing while you are injecting it. Continue reading
How long can Repatha be kept unrefrigerated?
Repatha can be left unrefrigerated for up to 30 days at room temperature between 68°F to 77°F (20°C to 25°C) as long as it is kept in its original box and is not kept somewhere that gets hotter than 77°F (25°C), for example, a car glove box. This makes it easier to take your medicine with you when you’re on the go. Do not put Repatha back in the refrigerator once you have taken it out. Continue reading
Can Repatha cause high blood pressure?
Repatha can cause high blood pressure (hypertension) as a side effect. Continue reading
What are PCSK9 Inhibitors and how do they work?
The PCSK9 inhibitors are used for the treatment of high-risk patients with elevated cholesterol, especially when statins aren't adequate. They work by blocking PCSK9, leaving more receptors available to capture your "bad" cholesterol (LDL) for break down and removal from the blood. Continue reading
Does Repatha cause weight gain or loss?
Weight gain or weight loss is not a reported side effect of Repatha (evolocumab). Continue reading
References
More about Repatha (evolocumab)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (734)
- Drug images
- Side effects
- Dosage information
- Patient tips
- During pregnancy
- Support group
- FDA approval history
- Drug class: PCSK9 inhibitors
- Breastfeeding
Professional resources
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
