Evolocumab

What is Evolocumab?

• Evolocumab (Repatha) is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor used to treat certain patients with high cholesterol.

What are the uses of this medicine?

This medicine is used:

• in adults with cardiovascular disease to reduce the risk of heart attack, stroke, and certain types of heart surgery.
• 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.
• along with other LDL-lowering medicine in people with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH), who need additional lowering of LDL cholesterol.

How does this medicine work?

• Evolocumab (e" voe lok' ue mab) is a human IgG1 monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9), a serine protease that decreases the activity of the LDL cholesterol receptor in the liver.
• Inhibition of PCSK9 increases the low density lipoprotein (LDL) cholesterol receptor, leading to an increased uptake of LDL particles and a decrease in serum LDL cholesterol.
• Patients with a genetic deficiency in PCSK9 have low levels of LDL cholesterol, and inhibition of the protein activity with monoclonal antibody leads to a marked lowering of LDL cholesterol.
• In several controlled trials, evolocumab was shown to lower LDL cholesterol in persons with heterozygosity for familial hypercholesterolemia and in persons at risk for atherosclerosis who have been unable to achieve adequate cholesterol lowering with standard lipid lowering agents (statins).

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha.

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with Repatha.

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

Recommended Dosage: In adults with established cardiovascular disease or with primary hyperlipidemia:

• The recommended dosage of Repatha is either 140 mg every 2 weeks OR 420 mg once monthly administered subcutaneously.

In patients with HoFH:

• The initial recommended dosage of Repatha is 420 mg once monthly administered subcutaneously
• The dosage can be increased to 420 mg every 2 weeks if a clinically meaningful response is not achieved in 12 weeks.
• Patients on lipid apheresis may initiate treatment with 420 mg every 2 weeks to correspond with their apheresis schedule. Administer Repatha after the apheresis session is complete.

• Assess LDL-C when clinically appropriate. The LDL-lowering effect of Repatha may be measured as early as 4 weeks after initiation.

Administration

• Use Repatha exactly as your healthcare provider tells you to use it.
• Repatha is given under the skin (subcutaneously), every 2 weeks or 1 time each month.
• If you have HoFH, the recommended starting dose is 420 mg once monthly. After 12 weeks, your healthcare provider may decide to increase the dose to 420 mg every two weeks. If you receive lipid apheresis, your healthcare provider may decide to start you on a dose of 420 mg every two weeks to coincide with your apheresis treatment and you should take your dose after the apheresis treatment.
• Repatha comes as a single-dose (1 time) prefilled autoinjector (SureClick® autoinjector), as a single-dose prefilled syringe or as a single-dose Pushtronex® system (on-body infusor with prefilled cartridge). Your healthcare provider will prescribe the type and dose that is best for you.
• If your healthcare provider prescribes you the 420 mg dose, you may use:
• a single-dose on-body infusor with prefilled cartridge to give the injection over 5 minutes, or
• 3 separate injections in a row, using a different single-dose prefilled syringe or single-dose prefilled autoinjector for each injection. Give all of these injections within 30 minutes.
• If your healthcare provider decides that you or a caregiver can give Repatha, you or your caregiver should receive training on the right way to prepare and inject Repatha. Do not try to inject Repatha until you have been shown the right way by your healthcare provider or nurse.
• If you are using the prefilled autoinjector, put the yellow safety guard (needle inside) of the SureClick® autoinjector on the skin before injecting.
• You can inject into the thigh, upper arm, or stomach (abdomen), except for a two-inch area around your 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 single-dose prefilled autoinjector, single-dose prefilled 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.
• If you forget to use Repatha or are not able to take the dose at the regular time, inject your 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 are using the every-2-week dose, inject the next dose based on your original schedule. This will put you back on your original schedule.
• If it is more than 7 days from the missed dose and you are using the 1 time each-month dose, inject the dose and start a new schedule using this date.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 140 mg/mL solution single-dose prefilled syringe
• Injection: 140 mg/mL solution single-dose prefilled SureClick® autoinjector
• Injection: 420 mg/3.5 mL solution single-dose Pushtronex® system (on-body infusor with prefilled cartridge)

This medicine is available in fallowing brand namesː

• Repatha

What side effects can this medication cause?

The most common side effects of this medicine 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
• bruising at the injection site

Repatha can cause serious side effects including:

• Serious Allergic Reactions

What special precautions should I follow?

• Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha.
• If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha, treat according to the standard of care, and monitor until signs and symptoms resolve.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Available data from clinical trials and postmarketing reports on Repatha use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Repatha in combination with diet and other LDL-C-lowering therapies for the treatment of HoFH have been established in pediatric patients aged 13 years and older.
• The safety and effectiveness of Repatha have not been established in pediatric patients with HoFH who are younger than 13 years old or in pediatric patients with primary hyperlipidemia.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: evolocumab
• Inactive Ingredients: proline, glacial acetic acid, polysorbate 80, water for injection USP, and sodium hydroxide.

Who manufactures and distributes this medicine?

• Manufactured by:
• Amgen Inc. One Amgen Center Drive, Thousand Oaks, California

What should I know about storage and disposal of this medication?

• Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
• Do not freeze.
• Do not shake.
• For convenience, Repatha may be kept at room temperature at 68°F to 77°F (20°C to 25°C) in the original carton for 30 days.
• If not used within the 30 days, discard Repatha.

• Dailymed label info on Evolocumab
• FDA Evolocumab

Evolocumab Resources
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