Repatha

Repatha is used to lower high cholesterol alongside dietary changes and to reduce the risk of major adverse cardiovascular events (MACE) in those at increased risk for these events, such as death from cardiovascular disease, heart attack, stroke, angina requiring hospitalization, or certain types of surgery or procedures to restore arterial blood flow to the heart and other parts of the body.

Repatha is given as an injection under the skin (subcutaneously), every 2 weeks or once a month.

Repatha injection is approved:

• For cardiovascular risk reduction, to reduce the risk of major adverse cardiovascular events (MACE), such as death from cardiovascular disease, heart attack, stroke, certain types of chest pain conditions (unstable angina) requiring hospitalization, or certain types of surgery or procedures to restore arterial blood flow to the heart and other parts of the body, in adults at increased risk for these events
• Along with diet and exercise, to reduce the low-density lipoprotein cholesterol (LDL-C) in: Hypercholesterolemia in adults Heterozygous familial hypercholesterolemia (HeFH) in adults and children 10 years and older Homozygous Familial Hypercholesterolemia (HoFH) in adults and children aged 10 years and older.

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 first gained FDA approval on August 27, 2015. There is no generic or biosimilar.

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.

See the detailed “Instructions for Use” that comes with the Repatha Patient Information about the right way to prepare and give Repatha.

• 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 each month.
• If you or your child has HoFH, the recommended starting dose is 420 mg one time each month. After 12 weeks, your healthcare provider may decide to 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 comes as a:

• Prefilled single-dose pen
• 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.

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 a prefilled cartridge to give the injection over 5 minutes, or
• 3 separate injections in a row, using a different prefilled single-dose pen, prefilled single-dose SureClick autoinjector, or prefilled single-dose syringe for each injection. Give all of these injections within 30 minutes.

If your healthcare provider decides that you, your child, or a caregiver can give Repatha, you, 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.

• If you or your child is using the prefilled single-dose Repatha SureClick autoinjector, put the yellow safety guard (needle inside) of the prefilled single-dose 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 prefilled single-dose pen, prefilled single-dose SureClick autoinjector, prefilled single-dose syringe, or single-dose on-body infusor with prefilled cartridge to make sure you have the correct medicine and the correct dose of Repatha before each injection.

Do not stop using Repatha without talking with your healthcare provider. If you or your child stops using Repatha, the cholesterol levels can increase.

If your healthcare provider has prescribed Repatha along with other cholesterol-lowering medicines for you or your child, follow instructions from your healthcare provider. Read the Patient Information for those medicines.

Important Timing Information

• It may take up to 15 seconds to inject Repatha using a prefilled single-dose pen, prefilled syringe, or a Repatha 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.

• Your healthcare provider will show you the best places on your body to inject Repatha or place the on-body infusor.
• 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.

Do not receive Repatha if you are allergic to evolocumab, Repatha, Repatha SureClick, or any ingredients in the Repatha injection (see below for a list of ingredients).

Before you or your child starts using Repatha, tell your healthcare provider about all your medical conditions, including if you or the person using Repatha:

• Is 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 “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) and the prefilled single-dose pen are not made with natural rubber latex.
• Have liver or kidney disease
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed.

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 becomes 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.

Common Side Effects

The most common side effects of Repatha are:

• Runny nose
• Sore throat
• Cold, flu or flu-like symptoms
• Back pain
• High blood sugar levels
• Redness, pain, or bruising at the injection site.

Serious side effects and warnings

Repatha injection 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 allergies. Repatha is available with or without rubber latex. If you are sensitive to latex, ask your healthcare provider for the Repatha SureClick autoinjector or syringe that does not contain rubber latex.

Tell your healthcare provider if you or your child has a side effect 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.

Repatha (evolocumab) targets a protein called PCSK9, which binds to LDL receptors on liver cells and destroys them. This reduces the liver's ability to remove LDL cholesterol (the "bad" cholesterol) from the bloodstream. By binding to PCSK9, more receptors are available to clear LDL cholesterol from the bloodstream, lowering LDL-C levels. Clinical trials report significant reductions in blood LDL cholesterol levels (often 50-60% or more).

Repatha (evolocumab) belongs to the drug class called PCSK9 inhibitors.

Adult Dose of Repatha for Adults at Risk for CV Events or with Hypercholesterolemia

• 140 mg subcutaneously (SC) every 2 weeks OR 420 mg SC 1 time a month.
• If switching dosage regimens, administer the first dose of the new regimen on the next scheduled dose of the prior regimen.

Adult and Child ≥10 years Dose of Repatha for HeFH

• 140 mg subcutaneously (SC) every 2 weeks OR 420 mg SC 1 time a month.
• If switching dosage regimens, administer the first dose of the new regimen on the next scheduled dose of the prior regimen.

Adult and Child ≥10 years Dose of Repatha for HoFH

• 420 mg subcutaneously 1 time a month.
• The dosage can be increased to 420 mg every 2 weeks if a clinically meaningful response is not achieved in 12 weeks.

Note: Patients on lipid apheresis may initiate treatment with 420 mg subcutaneously every 2 weeks to correspond with their apheresis schedule. Administer Repatha after the apheresis session is complete.

If you or your child forgets to use Repatha or is 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.

• If it is more than 7 days from the missed dose and you or your child is 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 is not sure when to take Repatha after a missed dose, ask your healthcare provider or pharmacist.

If you or your child uses more Repatha than you should, talk to your healthcare provider or pharmacist.

Other drugs may interact with Repatha, 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.

Store Repatha in the refrigerator in its original carton and protect it 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 a new medicine.

Do not shake Repatha. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for more medicine.

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 pen (not made with natural rubber latex)
• 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).

Repatha (evolocumab) is manufactured by Amgen Inc., One Amgen Center Drive, Thousand Oaks, California 91320-1799. U.S. License Number 1080.