What is Praluent?

Praluent (alirocumab) is an injectable medicine that is given under your skin (subcutaneously) which may be used in adults with:

• cardiovascular disease to reduce the risk of heart attack, stroke, and certain types of
  chest pain conditions (unstable angina) that would normally require hospitalization
• high blood cholesterol (also called primary hyperlipidemia) including an inherited type of high cholesterol called heterozygous familial hypercholesterolemia (HeFH), to reduce low-density lipoprotein cholesterol (LDL-C) or bad cholesterol together with dietary changes. Praluent can be used alone or in addition to other cholesterol-lowering medicines
• another inherited type of high cholesterol called homozygous familial hypercholesterolemia, who require additional lowering of their LDL-C.

Praluent may also be used in children aged 8 years and older with HeFH to reduce LDL-C, alongside dietary changes and other LDL-lowering treatments.

Praluent works by helping your liver reduce levels of “bad” cholesterol (low-density lipoprotein, or LDL) circulating in your blood. It does this by blocking the effects of the PCSK9 enzyme, which is an enzyme that binds to LDL receptors preventing LDL from being removed from the blood. This results in more receptors being available to remove LDL from the blood, which decreases LDL blood levels.

Praluent was first FDA-approved on July 24, 2015.

Warnings

Hypersensitivity reactions including inflammation of the blood vessels (vasculitis), swelling under the skin (angioedema), and other allergic reactions requiring hospitalization, have been reported with Praluent. Discontinue Praluent and tell your healthcare provider right away if you have an allergic reaction.

It is not known if Praluent is safe and effective in children who are younger than 8 years of age or in children with other types of high cholesterol (hyperlipidemias).

Before taking this medicine

You should not use Praluent if you are allergic to alirocumab, Praulent, or any of the inactive ingredients in the injection.

Pregnancy and breastfeeding

It is not known if Praluent will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking Praluent, you are encouraged to call Regeneron at 1-844-734-6643 to share information about the health of you and your baby.

It is not known whether Praluent passes into breast milk or if it could harm a nursing baby. You should not breastfeed while using it.

How should I use Praluent?

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

• Praluent comes as a single-dose (1 time) pre-filled pen (autoinjector). Your healthcare provider will prescribe the dosage that is best for you.
• Praluent is injected under the skin (subcutaneously) every 2 weeks or every 4 weeks (monthly).
• Do not shake this medicine. Prepare an injection only when you are ready to give it. Do not use it if the medicine has changed color or has particles in it. Call your pharmacist for new medicine.
• Take the medicine out of the refrigerator and allow it to reach room temperature for 30 to 40 minutes before injecting your dose. Do not heat an injection pen or prefilled syringe, and do not leave the pen at room temperature for longer than 30 days.
• You can inject the medicine just under the skin of your upper thigh or abdomen (but keep at least 2 inches away from your belly button), or a caregiver can give it to you into the outer area of your upper arm.
• Each injection pen or prefilled syringe is for one use only. Throw it away after one use in a puncture-proof “sharps” container, even if there is still medicine left inside. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Praluent is only part of a complete treatment program that also includes diet, statin medication, and regular blood testing. Follow your doctor’s instructions very closely.

Further administration instructions

If your healthcare provider prescribes you the monthly dose, give 2 separate injections in a row, using a different pen for each injection and 2 different injection sites.

• Do not inject it with other injectable medicines at the same injection site.
• Always check the label of your pen to make sure you have the correct medicine and the correct dose
• If your healthcare provider decides that you or a caregiver can give the injections of Praluent, you or your caregiver should receive training on the right way to prepare and give it.
• Do not try to inject Praluent until you have been shown the right way by your healthcare provider or nurse.
• In children aged 12 to 17 years, Praluent should be given by or under the supervision of an adult.
• In children aged 8 to 11 years, Praluent should be given by a caregiver.

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

Praluent dosing information

Follow all your healthcare provider’s instructions.

• The LDL-C lowering effect may be measured as early as 4 weeks after initiating therapy.
• In some patients, LDL-C can vary considerably during 4-week dosing intervals, therefore measure LDL-C just before the next scheduled dose.

Usual Adult Dose for Hyperlipidemia or Heterozygous Familial Hypercholesterolemia

• 75 mg SC every 2 weeks OR 300 mg SC once every 4 weeks
• May be adjusted up to 150mg SC every 2 weeks with an inadequate LDL-C (low-density lipoprotein) response.
• Maximum dose: 150 mg SC every 2 weeks.

Usual Adult Dose for Heterozygous Familial Hypercholesterolemia (HeFH) undergoing LDL Apheresis

• 150 mg SC once every 2 weeks; dose may be administered without regard to the timing of apheresis

What happens if I miss a dose?

If you forget to use Praluent or are not able to take the dose at your regular time, inject your missed dose as soon as you remember, within 7 days.

• Then, if you inject every 2 weeks take your next dose in 2 weeks from the day you missed your dose or if you inject every 4 weeks take your next dose in 4 weeks from the day you missed your dose. This will put you back on your original schedule.

If you missed a dose by more than 7 days and you inject every 2 weeks wait until your next scheduled dose to restart Praluent or if you inject every 4 weeks start a new schedule from the time you remember to take your dose.

• If you are not sure when to restart Praluent, ask your healthcare provider or pharmacist.

What happens if I overdose?

What happens if I miss a dose?

Give an injection within 7 days after the missed dose. Then give the next injection 2 to 4 weeks after the missed dose was due, to put you back on your regular injection schedule.

If you are more than 7 days late for an injection:

• If you inject every 2 weeks, skip the missed dose and use your next dose at the regular time.
• If you inject every 4 weeks, start a new schedule based on the date you used the missed injection.

Do not use two doses at one time.

What happens if I overdose?

If you use more Praluent than you should, talk to your healthcare provider or pharmacist or call the Poison Help line .

What should I avoid while using Praluent?

Do not inject Praluent into skin that is sunburned, infected, swollen, or otherwise irritated.

Praluent side effects

Praluent can cause serious side effects, including:

• allergic reactions. These can be severe and require treatment in a hospital. Stop using Praluent and call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including:
  • a severe rash
  • severe itching
  • redness or swelling of the face
  • trouble breathing lips, throat, or tongue
  • hives.

Common side effects of Praluent affecting more than 5% of patients include:

• redness, itching, swelling, pain, or tenderness at the injection site
• muscle pain
• flu or flu-like symptoms
• muscle spasms
• diarrhea
• bruising.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Praluent. Ask your healthcare provider or pharmacist for more information.

What is Repatha?

Repatha is used to lower high cholesterol alongside dietary changes and to reduce the risk of major cardiovascular events in those with cardiovascular disease, such as death from cardiovascular disease, heart attack, stroke, angina requiring hospitalization, or certain types of heart surgery.

It is given as an injection under the skin (subcutaneously), every 2 weeks or 1 time each month.

FDA-approved uses and indications

Repatha (evolocumab) is an injectable prescription medicine approved:

• to reduce the risk of major adverse cardiovascular (CV) events, such as death from cardiovascular disease, heart attack, stroke, certain types of chest pain conditions (unstable angina) requiring hospitalization, or certain types of heart surgery, in adults with established cardiovascular disease
• to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH) as an adjunct to diet, alone, or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies 
• to reduce LDL-C in children aged 10 years and older with HeFH as an adjunct to diet and other LDL-C-lowering therapies 
• to reduce LDL-C in adults and children aged 10 years and older with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other LDL-C-lowering therapies.

It is not known if Repatha is safe and effective in children with HeFH or HoFH who are younger than 10 years of age or in children with other types of hyperlipidemia.

Repatha received FDA approval on August 27, 2015. There is no Repatha generic or biosimilar.

Mechanism of action

Repatha works by helping the liver reduce levels of “bad” cholesterol (low-density lipoprotein, or LDL) circulating in your blood.

Its mechanism involves binding to and blocking a protein called PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) in the liver.

• Normally, PCSK9 attaches to LDL receptors on liver cells and triggers their degradation.
• These receptors are responsible for removing LDL (“bad”) cholesterol from the blood.
• By inhibiting PCSK9, Repatha prevents the degradation of LDL receptors, allowing more of them to remain on liver cell surfaces and remove more LDL cholesterol from the blood.

Clinical trials report significant reductions in blood LDL cholesterol levels (often 50-60% or more).

How much does Repatha cost?

Repatha has broad coverage over most insurance types, so the cost of Repatha depends on the type of insurance you have. For example, with the Repatha Co-Pay card, those with commercial insurance pay as little as $15 a month. For those with Medicaid, 99% of Repatha prescriptions cost people $10 or less.

Side effects

The most common side effects of Repatha are:

• Cold symptoms like a runny nose and sore throat
• Flu or flu-like symptoms
• Back pain
• High blood sugar/diabetes
• Injection site reactions such as redness, pain, or bruising.

Serious side effects and warnings

Repatha can cause the following serious side effects:

• Serious allergic reactions. Some people taking Repatha have had serious allergic reactions. Stop taking Repatha and call your healthcare provider or seek emergency medical help right away if you or your child has any of these symptoms:
  • trouble breathing or swallowing
  • raised bumps (hives)
  • rash, or itching
  • swelling of the face, lips, tongue, throat, or arms.

Repatha is available as prefilled single-dose SureClick autoinjectors and prefilled single-dose syringes that either contain dry natural rubber (a derivative of latex) in the needle cover or are not made with natural rubber latex. Ask your healthcare provider for the Repatha SureClick autoinjector or injection that does not contain dry natural rubber if you are sensitive to latex. 

Tell your healthcare provider if you or your child has any side effect that bothers you or does not go away. This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects or see the Repatha Package Insert.

Before taking this medicine

You should not use Repatha if you are allergic to evolocumab, Repatha, or any ingredients in the Repatha injection (see below for a list of ingredients).

Before you or your child start using Repatha, tell your healthcare provider about all your medical conditions, including if you or your child:

• are allergic to rubber or latex. Repatha is available as prefilled single-dose SureClick autoinjectors and prefilled single-dose syringes that either contain dry natural rubber (a derivative of latex) in the needle cover or are not made with natural rubber latex. The carton and “Repatha Instructions for Use” will state if your prefilled single-dose SureClick autoinjector or prefilled single-dose syringe contains dry natural rubber.
  • The single-dose Pushtronex® system (on-body infusor with prefilled cartridge) is not made with natural rubber latex.
• have liver or kidney disease
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Do not give Repatha to a child without medical advice and is not approved for use by anyone younger than 10 years old. For certain conditions, Repatha should not be given to a child of any age.

Pregnancy

It is not known if Repatha will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking Repatha. If you or your child are pregnant during Repatha treatment .

Breastfeeding

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks. If you or your child breastfeeds during Repatha treatment, you are encouraged to call Amgen at 1-800-772-6436 (1-800-77-AMGEN) or visit https://wwwext.amgen.com/products/global-patient-safety/adverse-event-reporting to share information about the health of you and your baby or your child and your child’s baby.

How is Repatha given?

See the detailed Instructions for Use that come with the Repatha Package Insert about the right way to prepare and give Repatha.

• Use Repatha exactly as your healthcare provider tells you or your child to use it.
• Repatha is given under the skin (subcutaneously), every 2 weeks or 1 time each month.
• If your healthcare provider decides that you or your child, or a caregiver, can give Repatha, you or your child or your caregiver should receive training on the right way to prepare and inject Repatha.
  • Do not try to inject Repatha until you or your child has been shown the right way by your healthcare provider or nurse.
• You or your child can inject Repatha into the thigh, upper arm, or stomach (abdomen), except for a two-inch area around the belly button.
  • Your healthcare provider will show you the best places on your body to inject Repatha or place the on-body infusor. Use a different place each time you give an injection. Do not inject into the same place twice in a row.
  • Do not choose an area where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch.

If you or your child has HoFH, the recommended starting dose is 420 mg once a month. After 12 weeks, your healthcare provider may increase the dose to 420 mg every two weeks.

• If you or your child receives lipid apheresis, your healthcare provider may decide to start you or your child on a dose of 420 mg every two weeks to match the apheresis treatment, and you or your child should take the dose after the apheresis treatment.

Repatha comes as a prefilled single-dose (1 time) autoinjector (SureClick autoinjector), as a prefilled single-dose 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 or your child.

• It may take up to 15 seconds to inject Repatha using a prefilled syringe or a SureClick autoinjector. If you use more than one injection at a time, be sure to finish all injections within 30 minutes.
• Each single-use prefilled syringe, cartridge, or injection device is for one use only. Throw away after one use, even if there is still some medicine left inside. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.
• Full patient instructions with diagrams are available on the Repatha Package Insert.
• Ask your doctor or pharmacist if you have any questions about your injection device, or call the manufacturer at 1-844-737-2842.

If your healthcare provider prescribes you or your child the 420 mg dose, you or your child may use:

• a single-dose on-body infusor with the prefilled cartridge to give the injection over 5 minutes, or
• 3 separate injections in a row, using a different prefilled single-dose SureClick autoinjector or prefilled single-dose syringe for each injection. Give all of these injections within 30 minutes.

If you or your child is using the prefilled single-dose SureClick autoinjector, put the yellow safety guard
(needle inside) of the prefilled single-dose SureClick autoinjector on the skin before injecting.

You should not stop using Repatha without your doctor’s advice, or your LDL cholesterol levels may increase.

Repatha is only part of a complete treatment program that also includes diet, statin medication, and regular blood testing. Follow your doctor’s instructions very closely.

Get emergency medical help if you have signs of an allergic reaction to Repatha: hives, severe itching, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Repatha Pushtonex system

The Pushtronex on-body infusor is a special hands-free device placed on the skin that delivers Repatha slowly. Read and carefully follow all instructions for using this product. You need to wear the device for about 9 minutes to get the full dose. While wearing the on-body infusor, you may perform moderate activities such as walking, bending, or reaching.

Repatha dosing instructions

Repatha is usually given 1 time a month or once every 2 weeks.

• Depending on your dose amount, you may need to use up to 3 separate injections at one time.
• Follow your doctor’s dosing instructions very carefully.

Usual Adult Dose for Hyperlipidemia: Repatha 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously 1 time a month.

Usual Adult Dose for Heterozygous Familial Hypercholesterolemia: Repatha 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously 1 time a month.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia: Repatha 420 mg subcutaneously 1 time a month.

• May increase to 420 mg every 2 weeks if a clinically meaningful response is not achieved in 12 weeks.
• Adults on lipid apheresis may initiate treatment with 420 mg subcutaneously every 2 weeks to correspond with their apheresis schedule; administer after the apheresis session is complete.

Usual Adult Dose for Cardiovascular Risk Reduction: Repatha 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously 1 time a month.

Usual Child Dose (10 and older) for Homozygous Familial Hypercholesterolemia: Repatha 420 mg subcutaneously 1 time a month.

• May increase to 420 mg every 2 weeks if a clinically meaningful response is not achieved in 12 weeks.
• Children on lipid apheresis may initiate treatment with 420 mg subcutaneously every 2 weeks to correspond with their apheresis schedule; administer after the apheresis session is complete.

Usual Child Dose (10 and older) for Heterozygous Familial Hypercholesterolemia: Repatha 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously 1 time a month.

What happens if I miss a dose of Repatha?

If you or your child forgets to use Repatha or cannot administer the dose at the regular time, inject your or your child’s missed dose as soon as you remember, as long as it is within 7 days of the missed dose.

More than 7 days from the missed dose

If it is more than 7 days from the missed dose and you or your child are using the every-2-week dose, inject the next dose based on the original schedule. This will put you or your child back on the original schedule.

If it is more than 7 days from the missed dose and you or your child are using the 1-time each-month dose, inject the dose and start a new schedule using this date.

If you or your child are not sure when to take Repatha after a missed dose, ask your healthcare provider or pharmacist. Do not use extra medicine to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Repatha?

Do not inject Repatha into skin that is bruised, sore, scarred, or hardened.

Do not shake Repatha. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for more medicine.

What other drugs will affect Repatha?

Other drugs may interact with evolocumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

How do I store Repatha?

Store Repatha in the refrigerator in its original carton and protect from light and heat. Do not freeze. Throw away any medicine that has been frozen.

Take the medicine out of the refrigerator and allow it to reach room temperature for 30 to 45 minutes before injecting your dose. Do not heat a syringe or injection device.

You may also store Repatha in the original carton at cool room temperature, away from light and heat. Use the medicine within 30 days if it is kept at room temperature.

Handle this medicine carefully. Dropping an injection device can cause it to break. Do not use an injection device that has been dropped onto a hard surface, even if you cannot see a break in it. Call your pharmacist for new medicine.

What are the ingredients in Repatha?

Active ingredient: evolocumab

Inactive ingredients: proline; acetate; polysorbate 80; water for injection, USP; and sodium hydroxide.

Available as:

• Injection: 140 mg/mL solution prefilled single-dose SureClick autoinjector (with or without latex)
• Injection: 140 mg/mL solution prefilled single-dose syringe (with or without latex)
• Injection: 420 mg/3.5 mL solution single-dose Pushtronex system (on-body infusor with prefilled cartridge) (with or without latex)

Who makes Repatha?

Repatha (evolocumab) is made by Amgen, a biotechnology company headquartered in California. Notable drugs from Amgen include:

• Enbrel (rheumatoid arthritis, psoriasis)
• Prolia/Xgeva (osteoporosis/bone disorders)
• Neulasta/Neupogen (boost white blood cells during chemotherapy)
• Otezla (psoriasis, psoriatic arthritis)
• Lumakras (lung cancer)
• Amjevita (biosimilar to Humira)
• Epogen/Aranesp (anemia)
• Tezspire (severe asthma – partnered with AstraZeneca)

Amgen has been particularly significant in developing biologics (protein-based drugs) and biosimilars. They were one of the first biotech companies to successfully develop and commercialize recombinant DNA technology for medical treatments.

Repatha Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Repatha.Repatha (evolocumab) – Amgen Inc.