Pronunciation:

e-voe-LOK-ue-mab

Brand Names:

• Repatha

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antihyperlipidemic

Pharmacologic—

PCSK9 Inhibitor

Uses of This Medicine:

Evolocumab injection is used together with a proper diet, alone or together with other medicines (eg, ezetimibe, statins), to treat patients with heterozygous familial hypercholesterolemia (also called primary hyperlipidemia) or with homozygous familial hypercholesterolemia (HoFH), who need additional lowering of their LDL cholesterol. It is also used in patients with a heart and blood vessel disease to reduce the risk of heart attack, stroke, and certain types of heart surgery. This medicine is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of evolocumab injection in children younger than 10 years of age with HoFH and primary hyperlipidemia. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of evolocumab injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the stomach, thighs, or upper arms.

This medicine comes with a patient information leaflet and patient instructions. Read instructions before starting this medicine and with each refill. New information may be given. Follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Evolocumab injection may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how to use the medicine.

This medicine comes in 3 forms: a single-dose prefilled pen (autoinjector), single-dose prefilled syringe, and a 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. This will help prevent skin problems from the injections.

Do not inject on skin areas that are bruised, hard, red, or tender or have cuts, scrapes, infection, scars, or stretch marks.

If you are receiving the 420 milligrams (mg) dose of Repatha®, it can be given: over 5 minutes by using the single-use Pushtronex® system, or by 3 injections consecutively within 30 minutes using the single use prefilled syringe or autoinjector.

The autoinjector pen or prefilled syringe should be removed from the refrigerator and be allowed to reach room temperature for at least 30 minutes before using, or for at least 45 minutes for single-use Pushtronex® system. Do not shake the medicine.

Use each autoinjector pen or syringe only one time. Do not save an open pen or syringe. If the medicine in the pen or syringe has changed color, or if you see particles in it, do not use it.

In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's order about any special diet.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For primary hyperlipidemia:
    • Adults and children 10 years of age and older—140 milligrams (mg) injected under your skin every 2 weeks, or 420 mg injected under your skin once a month.
    • Children younger than 10 years of age—Use and dose must be determined by your doctor.
  • For homozygous familial hypercholesterolemia:
    • Adults and children 10 years of age and older—420 milligrams (mg) injected under your skin once a month. Your doctor may adjust your dose as needed.
    • Children younger than 10 years of age—Use and dose must be determined by your doctor.
  • To reduce the risk of heart attack, stroke, and heart surgery:
    • Adults—140 milligrams (mg) injected under your skin every 2 weeks, or 420 mg injected under your skin once a month.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

If it is less than 7 days from your missed dose: Inject the dose and resume your original schedule.

If it is more than 7 days from your missed dose and you are using an every-2-week-dose: Wait until your next dose on the original schedule.

If it is 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.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store 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 within 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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol level and to decide if you should continue to use it. Blood tests may be needed to check for unwanted effects.

Serious allergic reactions, including angioedema may occur while you are using this medicine. Tell your doctor right away if you have a rash, itching skin, difficulty with breathing or swallowing, hives, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, nausea, reddening of the skin, especially around the ears, swelling of the eyes, face, or inside of the nose, or unusual tiredness or weakness.

The needle cover of the prefilled syringe or autoinjector contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. The single use Pushtronex® system is not made with natural rubber latex. Tell your doctor if you have a latex allergy before you start using this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Difficulty with breathing or swallowing

fever

hives, itching, or rash

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

nausea

reddening of the skin, especially around the ears

swelling of the eyes, face, or inside of the nose

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

blurred vision

body aches or pain

chills

cough

dry mouth

ear congestion

flushed, dry skin

fruit-like breath odor

general feeling of discomfort or illness

headache

loss of voice

muscle aches

sneezing

sore throat

stomach ache

stuffy or runny nose

sweating

trouble breathing

unexplained weight loss

vomiting

Less common

Bladder pain

bloody or cloudy urine

diarrhea

difficult, burning, or painful urination

difficulty with moving

dizziness

frequent urge to urinate

loss of appetite

lower back or side pain

muscle or joint pain

muscle stiffness

nervousness

pain or tenderness around the eyes and cheekbones

pounding in the ears

slow or fast heartbeat

swollen joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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