Approved Use

Repatha® is an injectable prescription medicine used:

  • in adults with cardiovascular disease to reduce the risk of heart attack, stroke, and certain types of heart surgery. READ MORE
  • 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]) to reduce low-density lipoprotein (LDL) or bad cholesterol.

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Paying for Repatha®

The majority of commercial and Medicare plans cover Repatha®. The list price for Repatha® is $519.82*,† per month. Most patients do not pay the list price. Your actual cost will vary and will depend on your insurance coverage.

The guide below will help you find the insurance coverage most like yours.

With the Repatha Copay Card®, eligible commercially insured patients may pay $5 per month. Program maximums apply. Learn more.

Which best describes your insurance coverage?

Examples of commercial insurance include PPO, HMO, or COBRA through your or your spouse's employer or a private insurance carrier. What you pay for Repatha® will vary depending on your insurance plan.

Now, more than 80% of prescriptions for Repatha patients cost less than $50 per month.1,*

Repatha® Copay Card

With the Repatha® Copay Card, eligible commercially insured patients may pay $5 per month. Program maximums apply.

Click here to learn more about the Repatha® Copay Card.

*Based on IQVIA claims data from 01/2020 through 12/2020 using commercial, health exchange, Medicare, and Medicaid claims.

Eligibility Information and Repatha® Copay Program Terms & Conditions and program maximums apply. See the full Repatha® Copay Card Program full terms and conditions below.

72% of Medicare prescriptions for Repatha® patients cost less than $50 per month.1

If you have Medicare Part D coverage and are eligible for Part D Low Income Subsidy, you can expect to pay less than $10 per month.2,‡

*Based on IQVIA claims data from 01/2020 through 12/2020.

If you are unsure whether you qualify for Extra Help and would like more information, please visit https://www.ssa.gov/benefits
/medicare/prescriptionhelp/.

If you don’t qualify for Low Income Subsidy, your out-of-pocket costs will vary based on which phase of the Part D benefit you are currently in. It is important to talk with your pharmacist for options. You can also call 1-844-REPATHA and speak with a financial counselor for additional information.

Your out-of-pocket costs can vary throughout the year depending on which phase of the Part D benefit you are currently in. Medicare Part D drug coverage is divided into four phases, each with a different cost-sharing amount. Those phases are 1) Deductible, 2) Initial coverage, 3) Coverage gap, 4) Catastrophic.

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100% of patients pay less than $50, with most patients paying less than $10 per month.1

To find out if you qualify for Medicaid, or for more information about copayments in your state, please visit: https://www.medicaid.gov/state-overviews/index.html.

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If you do not have prescription drug coverage or cannot afford medication, you may be able to receive Amgen medications at no cost from the Amgen Safety Net Foundation.

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1. Data on file, Amgen; 2020. 2. Find your level of Extra Help (Part D). Medicare. https://www.medicare.gov/your-medicare-costs/get-help-paying-costs/find-your-level-of-extra-help-part-d. Accessed November 12, 2020.

*List price is also referred to as wholesale acquisition cost or WAC. WAC is the price at which Amgen sells its products to wholesalers.
 †Updated on July 01, 2022.

REPATHA COPAY CARD FULL TERMS & CONDITIONS


SUMMARY OF TERMS AND CONDITIONS

It is important that every patient read and understand the full Repatha® (evolocumab) Copay Card Terms and Conditions. The following summary is not a substitute for reviewing the Terms and Conditions in their entirety.

As further described below, in general:

  • The Repatha® Copay Card is open to patients with commercial insurance, regardless of financial need. The program is not valid for patients whose Repatha® prescription is paid for in whole or in part by Medicare, Medicaid, or any other federal or state programs. It is not valid for cash-paying patients or where prohibited by law. (See ELIGIBILITY section below.)
  • With the Repatha® Copay Card, a commercially insured patient who meets eligibility criteria may pay as little as a $5 Copay per month for their Repatha® monthly out-of-pocket costs. Monthly out-of-pocket costs include copayment, co-insurance, and deductible out-of-pocket costs. Amgen will pay the remaining eligible out-of-pocket costs on behalf of the patient up to a Maximum Monthly Benefit, a Maximum Annual Program Benefit and/or the Patient Total Program Benefit. Patients are responsible for all amounts that exceed these limits. (See PROGRAM DETAILS section below.)
  • The program provides assistance up to a Maximum Monthly Benefit except that the Maximum Monthly Benefit will not apply to the first three (3) fills of the Repatha® Copay Card for Repatha® in any given calendar year.
  • Offer is subject to change or discontinuation without notice.
  • The Repatha® Copay Card provides support up to the Maximum Monthly Benefit, the Maximum Annual Program Benefit and/or Patient Total Program Benefit. If a patient’s commercial insurance plan imposes different or additional requirements on patients who receive Repatha® Copay Card benefits, Amgen has the right to reduce or eliminate those benefits. Whether you are eligible to receive the Maximum Monthly Benefit, Maximum Program Benefit or Patient Total Program Benefit is determined by the type of plan coverage you have. Please ask your RepathaReady® counselor to help you understand eligibility for the Repatha® Copay Card, and whether your particular insurance coverage is likely to result in your reaching the Maximum Monthly Benefit, the Maximum Annual Program Benefit, or your Patient Total Program Benefit , by calling 1-844-REPATHA (1-844-737-2842). (See PROGRAM BENEFITS section below.)

Repatha® Copay Card Full Terms & Conditions
  1. ELIGIBILITY
  2. Eligibility Criteria: Subject to program limitations and terms and conditions, the Repatha® Copay Card is open to patients who have a Repatha® prescription and who have commercial or private insurance, including plans available through state and federal healthcare exchanges. This program helps eligible patients cover out-of-pocket costs related to Repatha®, up to program limits. There is no income requirement to participate in this program.

    This offer is not valid for patients whose Repatha® prescription is paid for in whole or in part by Medicare, Medicaid, or any other federal or state programs. It is not valid for cash-paying patients or where prohibited by law. A patient is considered cash-paying where the patient has no insurance coverage for Repatha® or where the patient has commercial or private insurance but Amgen in its sole discretion determines the patient is effectively uninsured because such coverage does not provide a material level of financial assistance for the cost of a Repatha® prescription. This offer is only valid in the United States, Puerto Rico, and the US territories.

  3. PROGRAM BENEFITS
  4. The Repatha® Copay Card helps provide out-of-pocket support to eligible patients for their Repatha® prescription up to program limits. See PROGRAM DETAILS for full description.

    The Repatha® Copay Card offer does not cover out-of-pocket costs for any patient whose selected coverage option under their commercial insurance plan does not apply Repatha® Copay Card payments to satisfy the patient’s copayment, deductible, or co-insurance for Repatha®. Patients with these plan limitations are not eligible for the Repatha® Copay Card but may be eligible for other needs-based assistance provided by Amgen. These programs are often referred to as accumulator adjustment programs. If you believe your commercial insurance plan may have such limitations, please contact RepathaReady® at 1-844-REPATHA (1-844-737-2842).

    The Repatha® Copay Card also may provide a reduced benefit amount, unilaterally determined by Amgen in its sole discretion, to satisfy the out-of-pocket cost-sharing requirement for any patient whose plan or plan agent (including, but not limited to, a Pharmacy Benefit Manager (PBM)) requires enrollment in the Repatha® Copay Card as a condition of the plan or PBM waiving some or all of an otherwise applicable patient out-of-pocket cost-sharing amount. These programs are often referred to as copay maximizer programs. If you believe your commercial insurance plan may have such limitations, please contact RepathaReady® at 1-844-REPATHA (1-844-737-2842). Health plans, specialty pharmacies, and Pharmacy Benefit Managers (individually and collectively “Plan Administrators”) are prohibited from enrolling patients in the Repatha® Copay Card. Plan Administrators are prohibited from assisting patients with enrollment in the Repatha® Copay Card. The patient, or his/her legal representative, must personally enroll in the Repatha® Copay Card in order to be eligible for program benefits.

    If at any time a patient begins receiving prescription drug coverage under any state or government program (including but not limited to Medicare, Medicaid, TRICARE, Department of Defense, or Veteran Affairs programs), the patient will no longer be able to use this card and they must contact RepathaReady® at 1-844-REPATHA (1-844-737-2842) to stop their participation in this program.

    Patients may not seek reimbursement for the value received from the Repatha® Copay Card from any third-party payers, including a flexible spending account or healthcare savings account. Participating in this program means that you are ensuring you comply with any required disclosure regarding your participation in the Repatha® Copay Card of your insurance carrier or Pharmacy Benefit Manager. Restrictions may apply. Offer is subject to change or discontinuation without notice. This is not health insurance.

  5. PROGRAM DETAILS
  6. With the Repatha® Copay Card, a commercially insured patient who meets eligibility criteria may pay as little as a $5 Copay per month for their Repatha® monthly out-of-pocket costs.

    • For all eligible patients, the Repatha® Copay Card offers:
      • A program benefit that covers the patient’s eligible out-of-pocket prescription costs for Repatha® (copay, deductible, or co-insurance) on behalf of the patient, up to a Maximum Monthly Benefit and/or a Maximum Annual Program Benefit.
      • Repatha® patients may pay $5 out of pocket at the first fill and at every refill, and Amgen will pay on behalf of the patient the remaining eligible out-of-pocket prescription costs (up to the Patient Total Program Benefit described below; Repatha® patients are responsible for all amounts that exceed this limit).
      • The Maximum Monthly Benefit will apply every month except that the first three (3) fills for Repatha® in each calendar year will not have a Maximum Monthly Benefit.
    • Maximum Monthly Benefit, Maximum Annual Program Benefit, and/or Patient Total Program Benefit and Benefits May Change, End, or Vary without notice.
    • The Maximum Annual Program Benefit must be applied to the Repatha® patient’s out-of-pocket costs (copay, deductible, or co-insurance).
    • The Patient Total Program Benefit amounts are unilaterally determined by Amgen in its sole discretion and will not exceed the Maximum Monthly Benefit or Maximum Annual Program Benefit. The Patient Total Program Benefit may be less than the Maximum Monthly Benefit or Maximum Annual Program Benefit, depending on the terms of a patient’s prescription drug plan, and may vary among individual patients covered by different plans, based on factors determined solely by Amgen, to ensure all programs funds are used for the benefit of the patient. Each patient is responsible for costs above the Patient Total Program Benefit amounts. Please ask your RepathaReady® representative to help you understand whether your particular insurance coverage is likely to result in your reaching the Maximum Monthly Benefit, Maximum Annual Program Benefit or your Patient Total Program Benefit amount by calling 1-844-REPATHA (1-844-737-2842) and follow the prompts.
    • Participating patients are solely responsible for updating Amgen with changes to their prescription health insurance including, but not limited to, initiation of insurance provided by the government, the addition of any coverage terms that do not apply Repatha® Copay Card benefits to reduce a patient’s out-of-pocket costs, such as accumulator adjustment benefit design or a copay maximization program. Participating patients are responsible for providing Amgen with accurate information necessary to determine program eligibility. By accepting payments from Amgen made on behalf of participating patients, participating PBMs and Plans likewise are responsible for providing Amgen with accurate information regarding patient eligibility.
    • Patients may use the card every time they fill their Repatha® prescription. Benefits reset each calendar year. Re-enrollment in the program is required at regular intervals. Patients may participate in the program as long as s/he re-enrolls as required by Amgen and s/he continues to meet all of the program’s eligibility requirements during participation in the program. Patients can enroll/re-enroll by calling 1-844-REPATHA (1-844-737-2842) or by going to Repatha.com/copaycard.

Common questions about financial support

If you have commercial or private prescription insurance through your employer, your spouse’s employer, or through a private insurance carrier, the Repatha® Copay Card reduces your out-of-pocket costs for Repatha® if you’re eligible. These costs include copayments, co-insurance, and prescription deductibles, subject to plan design. Eligible commercially insured adults may pay $5 per month** with the Repatha® Copay Card. You are not eligible if you are enrolled in any government-funded healthcare program, such as Medicare, Medicare Advantage, Medicare Part D, the Retiree Drug Subsidy program, Medicaid, Medigap, Veterans Affairs, Department of Defense, or TRICARE®. Once your copay card has been activated, you can use the card every time you fill your Repatha® prescription, up to program maximums. The card must be renewed at regular intervals either by clicking here or by calling 1-844-REPATHA (1-844-737-2842).

If you are currently on Repatha®, you can enroll in the RepathaReady® program to sign up for and activate your card if you’re eligible. Click here to activate your card or call 1-844-REPATHA.

If you have commercial or private insurance through your employer, your spouse’s employer, or through a private insurance carrier, you may be eligible for the Repatha® Copay Card. Eligible commercially insured adults may pay $5 per month** with the Repatha® Copay Card. You can enroll in the RepathaReady® program by visiting Repatha.com/repathaready-services/ or by contacting 1-844-REPATHA (1-844-737-2842).

For adults with Medicare or Medicaid, if you’re enrolled in Medicare Extra Help or Low Income Subsidy (LIS), you’ll pay no more than $10 per month for Repatha®. For more information about Medicare Extra Help, or to enroll if you’re eligible, you can visit Medicare.gov or call 1-800-MEDICARE. If you don't have insurance, RepathaReady® can help you with other potential financial assistance options.

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REPATHA COPAY CARD FULL TERMS & CONDITIONS

SUMMARY OF TERMS AND CONDITIONS

It is important that every patient read and understand the full Repatha® (evolocumab) Copay Card Terms and Conditions. The following summary is not a substitute for reviewing the Terms and Conditions in their entirety.

As further described below, in general:

  • The Repatha® Copay Card is open to patients with commercial insurance, regardless of financial need. The program is not valid for patients whose Repatha® prescription is paid for in whole or in part by Medicare, Medicaid, or any other federal or state programs. It is not valid for cash-paying patients or where prohibited by law. (See ELIGIBILITY section below.)
  • With the Repatha® Copay Card, a commercially insured patient who meets eligibility criteria may pay as little as a $5 Copay per month for their Repatha® monthly out-of-pocket costs. Monthly out-of-pocket costs include copayment, co-insurance, and deductible out-of-pocket costs. Amgen will pay the remaining eligible out-of-pocket costs on behalf of the patient up to a Maximum Monthly Benefit, a Maximum Annual Program Benefit and/or the Patient Total Program Benefit. Patients are responsible for all amounts that exceed these limits. (See PROGRAM DETAILS section below.)
  • The program provides assistance up to a Maximum Monthly Benefit except that the Maximum Monthly Benefit will not apply to the first three (3) fills of the Repatha® Copay Card for Repatha® in any given calendar year.
  • The program provides assistance up to a Maximum Monthly Benefit except that the Maximum Monthly Benefit will not apply to the first three (3) fills of the Repatha® Copay Card for Repatha® in any given calendar year.
  • Offer is subject to change or discontinuation without notice.
  • The Repatha® Copay Card provides support up to the Maximum Monthly Benefit, the Maximum Annual Program Benefit and/or Patient Total Program Benefit. If a patient’s commercial insurance plan imposes different or additional requirements on patients who receive Repatha® Copay Card benefits, Amgen has the right to reduce or eliminate those benefits. Whether you are eligible to receive the Maximum Monthly Benefit, Maximum Program Benefit or Patient Total Program Benefit is determined by the type of plan coverage you have. Please ask your RepathaReady® counselor to help you understand eligibility for the Repatha® Copay Card, and whether your particular insurance coverage is likely to result in your reaching the Maximum Monthly Benefit, the Maximum Annual Program Benefit, or your Patient Total Program Benefit , by calling 1-844-REPATHA (1-844-737-2842). (See PROGRAM BENEFITS section below.)

Repatha® Copay Card Full Terms & Conditions
  1. ELIGIBILITY
  2. Eligibility Criteria: Subject to program limitations and terms and conditions, the Repatha® Copay Card is open to patients who have a Repatha® prescription and who have commercial or private insurance, including plans available through state and federal healthcare exchanges. This program helps eligible patients cover out-of-pocket costs related to Repatha®, up to program limits. There is no income requirement to participate in this program.

    This offer is not valid for patients whose Repatha® prescription is paid for in whole or in part by Medicare, Medicaid, or any other federal or state programs. It is not valid for cash-paying patients or where prohibited by law. A patient is considered cash-paying where the patient has no insurance coverage for Repatha® or where the patient has commercial or private insurance but Amgen in its sole discretion determines the patient is effectively uninsured because such coverage does not provide a material level of financial assistance for the cost of a Repatha® prescription. This offer is only valid in the United States, Puerto Rico, and the US territories.

  3. PROGRAM BENEFITS
  4. The Repatha® Copay Card helps provide out-of-pocket support to eligible patients for their Repatha® prescription up to program limits. See PROGRAM DETAILS for full description.

    The Repatha® Copay Card offer does not cover out-of-pocket costs for any patient whose selected coverage option under their commercial insurance plan does not apply Repatha® Copay Card payments to satisfy the patient’s copayment, deductible, or co-insurance for Repatha®. Patients with these plan limitations are not eligible for the Repatha® Copay Card but may be eligible for other needs-based assistance provided by Amgen. These programs are often referred to as accumulator adjustment programs. If you believe your commercial insurance plan may have such limitations, please contact RepathaReady® at 1-844-REPATHA (1-844-737-2842).

    The Repatha® Copay Card also may provide a reduced benefit amount, unilaterally determined by Amgen in its sole discretion, to satisfy the out-of-pocket cost-sharing requirement for any patient whose plan or plan agent (including, but not limited to, a Pharmacy Benefit Manager (PBM)) requires enrollment in the Repatha® Copay Card as a condition of the plan or PBM waiving some or all of an otherwise applicable patient out-of-pocket cost-sharing amount. These programs are often referred to as copay maximizer programs. If you believe your commercial insurance plan may have such limitations, please contact RepathaReady® at 1-844-REPATHA (1-844-737-2842). Health plans, specialty pharmacies, and Pharmacy Benefit Managers (individually and collectively “Plan Administrators”) are prohibited from enrolling patients in the Repatha® Copay Card. Plan Administrators are prohibited from assisting patients with enrollment in the Repatha® Copay Card. The patient, or his/her legal representative, must personally enroll in the Repatha® Copay Card in order to be eligible for program benefits.

    If at any time a patient begins receiving prescription drug coverage under any state or government program (including but not limited to Medicare, Medicaid, TRICARE, Department of Defense, or Veteran Affairs programs), the patient will no longer be able to use this card and they must contact RepathaReady® at 1-844-REPATHA (1-844-737-2842) to stop their participation in this program.

    Patients may not seek reimbursement for the value received from the Repatha® Copay Card from any third-party payers, including a flexible spending account or healthcare savings account. Participating in this program means that you are ensuring you comply with any required disclosure regarding your participation in the Repatha® Copay Card of your insurance carrier or Pharmacy Benefit Manager. Restrictions may apply. Offer is subject to change or discontinuation without notice. This is not health insurance.

  5. PROGRAM DETAILS
  6. With the Repatha® Copay Card, a commercially insured patient who meets eligibility criteria may pay as little as a $5 Copay per month for their Repatha® monthly out-of-pocket costs.

    • For all eligible patients, the Repatha® Copay Card offers:
      • A program benefit that covers the patient’s eligible out-of-pocket prescription costs for Repatha® (copay, deductible, or co-insurance) on behalf of the patient, up to a Maximum Monthly Benefit and/or a Maximum Annual Program Benefit.
      • Repatha® patients may pay $5 out of pocket at the first fill and at every refill, and Amgen will pay on behalf of the patient the remaining eligible out-of-pocket prescription costs (up to the Patient Total Program Benefit described below; Repatha® patients are responsible for all amounts that exceed this limit).
      • The Maximum Monthly Benefit will apply every month except that the first three (3) fills for Repatha® in each calendar year will not have a Maximum Monthly Benefit.
    • Maximum Monthly Benefit, Maximum Annual Program Benefit, and/or Patient Total Program Benefit and Benefits May Change, End, or Vary without notice.
    • The Maximum Annual Program Benefit must be applied to the Repatha® patient’s out-of-pocket costs (copay, deductible, or co-insurance).
    • The Patient Total Program Benefit amounts are unilaterally determined by Amgen in its sole discretion and will not exceed the Maximum Monthly Benefit or Maximum Annual Program Benefit. The Patient Total Program Benefit may be less than the Maximum Monthly Benefit or Maximum Annual Program Benefit, depending on the terms of a patient’s prescription drug plan, and may vary among individual patients covered by different plans, based on factors determined solely by Amgen, to ensure all programs funds are used for the benefit of the patient. Each patient is responsible for costs above the Patient Total Program Benefit amounts. Please ask your RepathaReady® representative to help you understand whether your particular insurance coverage is likely to result in your reaching the Maximum Monthly Benefit, Maximum Annual Program Benefit or your Patient Total Program Benefit amount by calling 1-844-REPATHA (1-844-737-2842) and follow the prompts.
    • Participating patients are solely responsible for updating Amgen with changes to their prescription health insurance including, but not limited to, initiation of insurance provided by the government, the addition of any coverage terms that do not apply Repatha® Copay Card benefits to reduce a patient’s out-of-pocket costs, such as accumulator adjustment benefit design or a copay maximization program. Participating patients are responsible for providing Amgen with accurate information necessary to determine program eligibility. By accepting payments from Amgen made on behalf of participating patients, participating PBMs and Plans likewise are responsible for providing Amgen with accurate information regarding patient eligibility.
    • Patients may use the card every time they fill their Repatha® prescription. Benefits reset each calendar year. Re-enrollment in the program is required at regular intervals. Patients may participate in the program as long as s/he re-enrolls as required by Amgen and s/he continues to meet all of the program’s eligibility requirements during participation in the program. Patients can enroll/re-enroll by calling 1-844-REPATHA (1-844-737-2842) or by going to Repatha.com/copaycard.

Important Safety Information

Do not use Repatha® if you are allergic to evolocumab or to any of the ingredients in Repatha®.

Before you start using Repatha®, tell your healthcare provider about all your medical conditions, including if you are allergic to rubber or latex, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. The needle covers on the single-dose prefilled syringes and the inside of 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.

Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines, vitamins, or herbal supplements you take.

What are the possible side effects of Repatha®?

Repatha® can cause serious side effects including, serious allergic reactions. Stop taking Repatha® and call your healthcare provider or seek emergency help right away if you have any of these symptoms: trouble breathing or swallowing, raised bumps (hives), rash or itching, swelling of the face, lips, tongue, throat or arms.

The most common side effects of Repatha® include: runny nose, sore throat, symptoms of the common cold, flu or flu-like symptoms, back pain, high blood sugar levels (diabetes), and redness, pain, or bruising at the injection site.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Repatha®. Ask your healthcare provider or pharmacist for more information. Call your healthcare provider for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information.

Important Safety Information

Do not use Repatha® if you are allergic to evolocumab or to any of the ingredients in Repatha®.

Before you start using Repatha®, tell your healthcare provider about all your medical conditions, including if you are allergic to rubber or latex, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. The needle covers on the single-dose prefilled syringes and the inside of 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.

Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines, vitamins, or herbal supplements you take.

What are the possible side effects of Repatha®?

Repatha® can cause serious side effects including, serious allergic reactions. Stop taking Repatha® and call your healthcare provider or seek emergency help right away if you have any of these symptoms: trouble breathing or swallowing, raised bumps (hives), rash or itching, swelling of the face, lips, tongue, throat or arms.

The most common side effects of Repatha® include: runny nose, sore throat, symptoms of the common cold, flu or flu-like symptoms, back pain, high blood sugar levels (diabetes), and redness, pain, or bruising at the injection site.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Repatha®. Ask your healthcare provider or pharmacist for more information. Call your healthcare provider for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information.