Evolocumab
Pronunciation: e-voe-lok-ue-mab
Generic name: evolocumab
Brand name: Repatha
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 evolocumab?
Evolocumab (brand name Repatha) is used to reduce levels of "bad" cholesterol (low-density lipoprotein, or LDL) alongside a low-fat diet and other cholesterol-lowering medications in people with inherited types of high cholesterol.
Evolocumab is also used to help lower the risk of stroke, heart attack, or other heart complications in people with heart or blood vessel problems caused by plaque build-up or hardening in the arteries (also called atherosclerosis, or arteriosclerosis).
Evolocumab received FDA approval on August 27, 2015, under the brand name Repatha. There is no evolocumab generic or biosimilar.
Mechanism
Evolocumab targets a protein in the body called PCSK9 that binds to LDL receptors on the surface of liver cells, degrading them, and reducing the liver's ability to clear LDL-C from the bloodstream. By blocking PCSK9, evolocumab increases the number of available LDL-C receptors, allowing more LDL-C to be removed from the blood.
Evolocumab belongs to the drug class called PCSK9 inhibitors. It may also be called a human monoclonal antibody.
Uses and FDA approvals
Evolocumab is an injectable prescription medicine that is FDA-approved to reduce:
- the risk of heart attack, stroke, and certain types of heart surgery in adults with cardiovascular disease
- low-density lipoprotein (LDL) or bad cholesterol levels along with diet alone or together with other cholesterol-lowering medicines in adults with high blood cholesterol levels called primary hyperlipidemia (including a type of high cholesterol called heterozygous familial hypercholesterolemia [HeFH])
- LDL cholesterol in children aged 10 years and older with HeFH along with diet and other LDL-lowering medicines
- LDL cholesterol in adults and children aged 10 years and older with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH), along with other LDL-lowering medicines.
It is not known if evolocumab 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.
Evolocumab side effects
The most common side effects of evolocumab are:
- cold symptoms like runny nose and sore throat
- flu or flu-like symptoms
- back pain
- high blood sugar levels or diabetes
- injection site reactions such as redness, pain, or bruising.
Serious side effects and warnings
Evolocumab can cause serious side effects including:
Serious allergic reactions. Some people taking evolocumab have had serious allergic reactions. Stop taking evolocumab and call your healthcare provider or seek emergency medical help right away if you or your child have any of these symptoms:
- trouble breathing or swallowing
- raised bumps (hives)
- rash, or itching
- swelling of the face, lips, tongue, throat, or arms.
Evolocumab 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 evolocumab injection or autoinjector that does not contain dry natural rubber if you are sensitive to latex.
Tell your healthcare provider if you or your child have any side effect that bothers you or that 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.
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Who should not take evolocumab?
Do not use evolocumab if you or your child are allergic to it or any of the ingredients in evolocumab. See the end of this page for a complete list of ingredients in evolocumab.
What should I tell my doctor before taking evolocumab?
Before you or your child start using evolocumab, tell your healthcare provider about all your medical conditions, including if you or your child:
- are allergic to rubber or latex. The needle covers on the single-dose prefilled syringes and within the needle caps on the single-dose prefilled SureClick® autoinjectors contain dry natural rubber. The single-dose Pushtronex system (on-body infusor with prefilled cartridge) is not made with natural rubber latex
- are pregnant or plan to become pregnant. It is not known if evolocumab will harm your unborn baby. See below for more information about evolocumab and pregnancy. Tell your healthcare provider if you become pregnant while taking evolocumab
- are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take evolocumab or breastfeed. See below for more information on evolocumab and breastfeeding.
How should I use evolocumab?
You should only give yourself or someone else the injection if you have received full training from your healthcare provider on how to administer it.
Evolocumab can be given as a subcutaneous injection (injection under the skin) using:
- single-dose prefilled Sureautoinjector
- single-dose prefilled syringe
- or single-dose on-body infusor with the prefilled cartridge.
It takes up to 15 seconds to administer evolocumab using the single-dose prefilled autoinjector or single-dose prefilled syringe. If you are using the single-dose on-body infusor with a prefilled cartridge it will take 5 minutes to administer.
If your healthcare provider prescribes you or your child the 420 mg dose, you or your child may use:
- a single-dose on-body infusor with prefilled cartridge to give the injection over 5 minutes, or
- 3 separate injections in a row, using a different single-dose prefilled syringe or single-dose prefilled autoinjector for each injection. Give all of these injections within 30 minutes.
If your healthcare provider decides that you or your child or a caregiver can give evolocumab, you or your child or your caregiver should receive training on the right way to prepare and inject evolocumab. Do not try to inject evolocumab until you or your child have been shown the right way by your healthcare provider or nurse.
- If you or your child are using the prefilled autoinjector, put the yellow safety guard (needle inside) of the SureClick® autoinjector on the skin before injecting.
You or your child can inject into the thigh, upper arm, or stomach (abdomen), except for a two-inch area around the belly button.
Do not choose an area where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.
Always check the label of your single-dose prefilled autoinjector, single-dose prefilled syringe, or single-dose on-body infusor with prefilled cartridge to make sure you have the correct medicine and the correct dose of evolocumab before each injection.
If your healthcare provider has prescribed evolocumab along with other cholesterol-lowering medicines for you or your child, follow instructions from your healthcare provider. Read the patient information for those medicines.
If you or your child use more evolocumab than you should, talk to your healthcare provider or pharmacist.
Do not stop using evolocumab without talking with your healthcare provider. If you or your child stop using evolocumab, the cholesterol levels can increase.
Full patient instructions with diagrams are available on the Repatha Package Insert.
Evolocumab dosing instructions
Evolocumab 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.
Usual Adult Dose for Hyperlipidemia: evolocumab 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously 1 time a month.
Usual Adult Dose for Heterozygous Familial Hypercholesterolemia: evolocumab 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously 1 time a month.
Usual Adult Dose for Homozygous Familial Hypercholesterolemia: evolocumab 420 mg subcutaneously 1 time a month.
- May increase to 420 mg every 2 weeks if clinically meaningful response is not achieved in 12 weeks.
- 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.
Usual Adult Dose for Cardiovascular Risk Reduction: evolocumab 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously 1 time a month.
Usual Child Dose (10 and older) for Homozygous Familial Hypercholesterolemia: evolocumab 420 mg subcutaneously 1 time a month.
- May increase to 420 mg every 2 weeks if clinically meaningful response is not achieved in 12 weeks.
- 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: evolocumab 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously 1 time a month.
What happens if I miss a dose of evolocumab?
If you or your child forget to use evolocumab or are not able to take 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
If it is more than 7 days from the missed dose and you or your child are using the every-2-week dose, inject the next dose based on the original schedule. This will put you or your child back on the original schedule.
If it is more than 7 days from the missed dose and you or your child are using the 1-time each-month dose, inject the dose and start a new schedule using this date.
If you or your child are not sure when to take evolocumab after a missed dose, ask your healthcare provider or pharmacist. Do not use extra medicine to make up a missed dose.
What should I avoid while taking evolocumab?
Do not inject evolocumab into skin that is bruised, sore, scarred, or hardened.
Interactions
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 should I store evolocumab?
- Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
- Do not freeze.
- Do not shake.
- For convenience, evolocumab may be kept at room temperature at 68°F to 77°F (20°C to 25°C) in the original carton for 30 days. If not used within 30 days, discard evolocumab.
What are the ingredients in evolocumab?
- Active Ingredient: evolocumab
- Repatha Inactive Ingredients: proline, glacial acetic acid, polysorbate 80, water for injection USP, and sodium hydroxide.
Who makes evolocumab?
Evolocumab (brand name Repatha) 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.
Evolocumab 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 evolocumab.
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 |
View Repatha information in detail.
Popular FAQ
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 reading
Does Repatha cause weight gain or loss?
Weight gain or weight loss is not a reported side effect of Repatha (evolocumab). Continue reading
Can you drink alcohol and take Repatha?
You can drink alcohol in moderation with Repatha as there is no clinical interaction between alcohol and Repatha. Continue reading
More FAQ
- How long should you take Repatha?
- Is Repatha effective without a statin?
- How long do Repatha side effects last?
References
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- During pregnancy
- Drug class: PCSK9 inhibitors
- Breastfeeding
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