Evolocumab (e-voe-LOK-ue-mab)

Treats high levels of LDL cholesterol. Reduces the risk of heart attack, stroke, and heart surgery in patients with a heart and blood vessel disease.

Brand Name(s):

Repatha, Repatha 420MG/3.5ML, Repatha SureClick

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the stomach, thighs, or upper arms.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine comes in 3 forms: single-dose prefilled pen (autoinjector), single-dose prefilled syringe, and single-use Pushtronex™ system (on-body infusor with prefilled cartridge). Your doctor will prescribe the type and dose that is right for you.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that have cuts, scrapes, scars, or stretch marks.
• Allow the autoinjector or syringe to warm to room temperature for at least 30 minutes before you use it, or for at least 45 minutes for the single-use Pushtronex™ system. Do not heat or shake the medicine.
• Use a new autoinjector or syringe (device) for each injection. Do not give more than one injection with one device or save leftover medicine in a used device.
• If you need more than one injection to get your full dose, give all the injections within 30 minutes.
• Carefully follow your doctor's instructions about any special diet.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember, as long as it is within 7 days of the missed dose.
  • More than 7 days from your missed dose and you are using an every-2-week-dose: Inject the dose based on your regular schedule.
  • More than 7 days from your missed dose and you are using a once-a-month-dose: Inject the dose and start a new schedule using this date.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. You may also keep the medicine in the original carton at room temperature for up to 30 days. Throw away any unused medicine after 30 days.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have a latex allergy.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing

If you notice these less serious side effects, talk with your doctor:

• Back pain
• Cough, stuffy or runny nose, sore throat
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088