Evolocumab

Evolocumab is a prescription medication used:

• along with diet alone or with other cholesterol-lowering medicines to reduce bad cholesterol (low-density lipoprotein (LDL)) in adults with high cholesterol called primary hyperlipidemia (including a type of high cholesterol called heterozygous familial hypercholesterolemia)
• along with diet and with other cholesterol-lowering medicines in those who need additional lowering of LDL cholesterol and who have a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH)
• to reduce the risk of heart attack, stroke, and certain types of heart surgery in adults with heart disease 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

It is not known if this medication is safe and effective in children with HoFH who are younger than 13 years of age or in children who do not have HoFH.

Evolocumab may be found in some form under the following brand names:

• Repatha

Serious side effects have been reported with evolocumab. See the “Evolocumab Precautions” section.

• runny nose
• sore throat
• symptoms of the common cold
• flu or flu-like symptoms
• back pain
• redness
• pain
• 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 evolocumab. Ask your healthcare provider or pharmacist for more information.

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

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with evolocumab including allergic reactions.

Evolocumab may cause allergic reactions. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including:

• severe rash
• redness
• severe itching
• a swollen face
• trouble breathing

Do not use evolocumab if you are allergic to evolocumab or any of its ingredients. 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of evolocumab, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you start using evolocumab, tell your healthcare provider about all your medical conditions, including allergies, and if you:

• are allergic to rubber or latex. The needle covers on the single-use prefilled syringes and within the needle caps on the single-use prefilled SureClick autoinjectors contain dry natural rubber.
• are pregnant or plan to become pregnant. It is not known if evolocumab will harm your unborn baby. 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. You should not do both without talking to your healthcare provider first.

Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies.

There are no well-controlled studies that have been done in pregnant women. Evolocumab should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

It is not known if evolocumab crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using evolocumab.

Use evolocumab exactly as your healthcare provider tells you to use it.

• Evolocumab is given as an injection under the skin (subcutaneously), every 2 weeks or 1 time each month.
• Evolocumab can be injected under the skin in the abdomen, thigh, or upper arm. Make sure to rotate the injection site. 
• Evolocumab comes as a single-use (1 time) pre-filled autoinjector or as a single-use pre-filled syringe. Your healthcare provider will prescribe the type and dose that is best for you.
• If your healthcare provider prescribes you the (420 mg) monthly dose, you will give yourself 3 separate injections in a row, using a different syringe for each injection. Give all of these injections within 30 minutes.
• If your healthcare provider decides that you or a caregiver can give the injections of evolocumab, you or your caregiver should receive training on the right way to prepare and administer evolocumab. Do not try to inject evolocumab until you have been shown the right way by your healthcare provider or nurse.
• Do not inject evolocumab together with other injectable medicines at the same injection site.
• Always check the label of your syringe to make sure you have the correct medicine and the correct dose of evolocumab before each injection.
• Prior to use, allow evolocumab to warm to room temperature for at least 30 minutes. Do not warm in any other way

If you forget to use evolocumab or are not able to take the dose at the regular time, inject your missed dose as soon as you remember, as long as there are more than 7 days until the next scheduled dose. If there are 7 days or less until your next scheduled dose, administer the next dose according to the original schedule. This will put you back on your original schedule. If you are not sure when to take evolocumab after a missed dose, ask your healthcare provider or pharmacist.

Do not stop using evolocumab without talking with your healthcare provider. If you stop using evolocumab, your cholesterol levels can increase.

The recommended dose of evolocumab in patients primary hyperlipidemia with heterozygous familial hypercholesterolemia (HoFH) or with established clinical atherosclerotic CVD is either 140 mg every 2 weeks OR 420 mg once monthly. 

The recommended dose of evolocumab in patients with heterozygous familial hypercholesterolemia (HoFH) is 420 mg once monthly. Your doctor will monitor your LDL levels 4 to 8 weeks after starting evolocumab.

If an every 2 week or once monthly dose is missed, instruct the patient to:

• Administer evolocumab as soon as possible if there are more than 7 days until the next scheduled dose, or,
• Omit the missed dose and administer the next dose according to the original schedule.

When switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of the prior regimen.

If you take too much evolocumab, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store refrigerated at 2° to 8°C (36° to 46°F) in the original carton.
• Alternatively, evolocumab can be kept at room temperature (up to 25°C (77°F)) in the original carton; however, under these conditions, evolocumab must be used within 30 days. If not used within the 30 days, discard evolocumab.
• Protect evolocumab from direct light and do not expose to temperatures above 25°C (77°F).
• Keep evolocumab all medicines out of the reach of children.