Alirocumab (patient information)

What is Alirocumab?

alirocumab is an injectable prescription medicine called a PCSK9 inhibitor. alirocumab is used along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL) or atherosclerotic heart problems, who need additional lowering of LDL cholesterol. The effect of alirocumab on heart problems such as heart attacks, stroke, or death is not known. It is not known if alirocumab is safe and effective in children.

Who should not use Alirocumab?

Do not use alirocumab if you are allergic to alirocumab or to any of the ingredients in alirocumab. See the end of this leaflet for a complete list of ingredients in alirocumab.

What should I tell my healthcare provider before using Alirocumab?

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

• are pregnant or plan to become pregnant. It is not known if alirocumab will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking alirocumab.
• are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take alirocumab 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.

How should I use Alirocumab?

• See the detailed "Instructions for Us e" that comes with this patient information about the

right way to prepare and give your alirocumab injections.

• Use alirocumab exactly as your healthcare provider tells you to use it.
• alirocumab comes as a single-dose (1 time) pre-filled pen (autoinjector), or as a single-dose prefilled syringe. Your healthcare provider will prescribe the type and dose that is best for you.
• If your healthcare provider decides that you or a caregiver can give the injections of alirocumab,

you or your caregiver should receive training on the right way to prepare and administer alirocumab. Do not try to inject alirocumab until you have been shown the right way by your healthcare provider or nurse.

• alirocumab is given as an injection under the skin (subcutaneously) 1 time every 2 weeks.
• Do not inject alirocumab together with other injectable medicines at the same injection site.
• Always check the label of your pen or syringe to make sure you have the correct medicine and the

correct dose of alirocumab before each injection.

• If you forget to use alirocumab or are not able to take the dose at your regular time, inject your

missed dose as soon as you remember, within 7 days of your missed dose. Then, take your next dose 2 weeks from the day you missed your dose. This will put you back on your original schedule. If the missed dose is not given within 7 days, wait until your next scheduled dose to re-start alirocumab. This will keep you on your original schedule. If you are not sure when to re-start alirocumab, ask your healthcare provider or pharmacist.

• If you use more alirocumab than you should, talk to your healthcare provider or pharmacist.
• Do not stop using alirocumab without talking with your healthcare provider. If you stop using

alirocumab, your cholesterol levels can increase.

What are the possible side effects of Alirocumab?

Alirocumab can cause serious side effects, including:

• allergic reactions: alirocumab may cause allergic reactions that can be severe and require treatment in a hospital. 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, redness,severe itching, a swollen face, or trouble breathing.
• The most common side effects of alirocumab include: redness, itching, swelling, or pain/tenderness at the injection site, symptoms of the common cold, and flu or flu-like symptoms. 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 alirocumab. Ask your healthcare provider or pharmacist for more information.
• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Alirocumab

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use alirocumab for a condition for which it was not prescribed. Do not give alirocumab to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information summarizes the most important information about alirocumab. If you would like more information, talk with your healthcare provider.You can ask your pharmacist or healthcare provider for information about alirocumab that is written for health professionals. For more information about alirocumab, go to www.alirocumab.com or call 1-844-alirocumab (1- 844-772-5836).

What are the ingredients in Alirocumab?

• Active ingredient: alirocumab
• Inactive ingredients: histidine, polysorbate 20, sucrose, and water for injection.

Instructions for use

• The device is a single-dose disposable pen. It contains 75 mg of alirocumab in 1 mL.
• The alirocumab pen contains medicine prescribed by your healthcare provider.
• The medicine is injected under your skin and can be given by yourself or someone else (caregiver).
• Read all of the instructions carefully before using the alirocumab pen.
• Follow these instructions every time you use a alirocumab pen.
• Do not touch the yellow safety cover.
• Do not use the pen if it has been dropped or damaged.
• Do not use the pen if the blue cap is missing or not securely attached.
• Do not re-use a pen.
• It is important that you Do not try to give yourself or someone else the injection unless you have received training from your healthcare provider.
• This pen can only be used for 1 single injection, and must be discarded after use.

Storage of Alirocumab

• Store unused pens in the refrigerator at 36°F to 46°F (2°C to 8°C) in the outer carton to protect from light.
• Do not freeze.
• Do not expose the pen to extreme heat or direct sunlight.
• Do not shake.
• alirocumab should be allowed to warm to room temperature for 30 to 40 minutes before use. Do not keep alirocumab at room temperature for more than 24 hours.
• Keep the alirocumab pens and all medicines out of the reach of children.

If you have questions, ask your healthcare provider or call 1-844-alirocumab (1-844-772-5836).

Parts of the Alirocumab Pen

Administering alirocumab using the pen

Step A: Getting ready for your injection

Before you start you will need:

• the alirocumab pen
• 1 alcohol wipe
• 1 cotton ball or gauze
• a puncture-resistant container (see Step B8)

A1: Look at the label on the pen.

• Check that you have the correct product and the correct dose.
• Check the expiration date: Do not use if this date has passed.
  

A2: Look at the window. Check the liquid is clear, colorless to pale yellow and free from particles (see Figure A). You may see an air bubble. This is normal.

• Do not use if the window appears solid yellow (see Figure B).
• Do not use this medicine if the solution is discolored or cloudy, or if it contains visible flakes or particles.
  

A3: Let the pen warm up at room temperature for 30 to 40 minutes. This is important for administering the entire dose and helps minimize discomfort.

• Take alirocumab out of the refrigerator to warm up before using.
• Do not heat the pen, let it warm up on its own.
• Use the pen as soon as possible after it has warmed up.
• Do not put the pen back in the refrigerator.
  

A4: Prepare the injection site.

• Wash your hands with soap and water and dry with a towel.
• Clean skin in the injection area with an alcohol wipe.
• You can inject into your (see below picture):
  • thighs
  • stomach (except for the 2 inch area around your navel)
  • upper arms
    

You can stand or sit to give yourself an injection.

Important: Change (rotate) your injection site each time you give yourself an injection. If you need to use the same injection site, make sure it is not the same spot on the site you used last time. Do not inject into areas where the skin is injured, tender, hard, red, or hot. Do not inject alirocumab into areas with visible veins, scars or stretch marks.

Step B: How to give your injection

B1: After completing all steps in "Step A: Getting ready for your injection", pull off the blue cap.

• Do not pull off the cap until you are ready to inject.
• Do not put the blue cap back on.
  

B2: Hold the alirocumab pen like this.

• Do not touch the yellow safety cover.
• Make sure you can see the window.
  

B3: Press the yellow safety cover on your skin at roughly a 90° angle.

• Press and firmly hold the pen against your body until the yellow safety cover is no longer visible.
• The pen will not work if the yellow safety cover is not depressed fully.
• If needed, pinch the skin to make sure the injection site is firm.
  

B4: Push and immediately releas e the gray button with your thumb.

• You will hear a click. Your injection has now started.
• The window will start to turn yellow.

B5: Keep holding the pen against your skin after releasing the button.

• The injection may take up to 20 seconds.
• The time required for injection to give the entire dose may be longer than for other injectable

medicines.

B6: Check the window has turned yellow, before removing the pen.

• Do not remove the pen until the entire window has turned yellow.
• Your injection is complete when the window has turned completely yellow, you may hear a second click.
• If the window does not turn completely yellow, call 1-844-772-5836 for help. Do not give yourself a second dose without speaking to your healthcare provider.

B7: Pull pen away from your skin.

• Do not rub the skin after the injection.
• If you see any blood, press a cotton ball or gauze on the site until the bleeding stops.

B8: Discard pen and cap.

• Do not put the blue cap back on.
• Throw away pen and cap in a puncture-resistant container immediately after they have been used.

Disposing of used pens:

• Put your used pens in a FDA-cleared sharps disposal container right away after use. Do not throw

away (dispose of) pens and caps in your household trash.

• If you Do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
• Do not dispose of your used sharps disposal container in your household trash unless your

community guidelines permit this. Do not recycle your used sharps disposal container.

Keep alirocumab and all medicines out of the reach of children

Parts of the Alirocumab Syringe

Administering alirocumab using the syringe

Step A: Getting ready for your injection

Before you start you will need:

• the alirocumab syringe
• 1 alcohol wipe
• 1 cotton ball or gauze
• a puncture-resistant container (see Step B6)

A1: Before you start.

• Take the syringe out of the packaging by holding the syringe body.
• Check the expiration date: Do not use if this date has passed.

A2: Look at the label on the syringe.

• Check that you have the correct product and the correct dose (green plunger for 75 mg/mL).
• Check the liquid is clear, colorless to pale yellow and free from particles .
• Check that the syringe is not open or damaged.
• Do not use this medicine if the solution is discolored or cloudy, or if it contains visible flakes or particles.

A3: Let the syringe warm up at room temperature for 30 to 40 minutes.

• This is important for administering the entire dose and helps minimize discomfort.
• Take alirocumab out of the refrigerator to warm up before using.
• Do not heat the syringe, let it warm up on its own.
• Use the syringe as soon as possible after it has warmed up.
• Do not put the syringe back in the refrigerator.

A4: Prepare the injection site.

• Wash your hands with soap and water and dry with a towel.
• Clean skin in the injection area with an alcohol wipe.
• You can inject into your (see below picture):
  • thighs
  • stomach (except for the 2 inch area around your navel)
  • upper arms

You can stand or sit to give yourself an injection.

Important: Change (rotate) your injection site each time you give yourself an injection. If you need to use the same injection site, make sure it is not the same spot on the site you used last time. Do not inject into areas where the skin is injured, tender, hard, red, or hot. Do not inject alirocumab into areas with visible veins, scars or stretch marks.

Step B: How to give your injection

B1: After completing all steps in "Step A: Getting ready for your injection", pull off the needle cap.

• Do not pull off the cap until you are ready to inject.
• Hold the syringe in the middle of the syringe body with the needle pointing away from you.
• Keep your hand away from the plunger.
• Do not try to remove any air bubbles in the syringe before the injection.
• Do not put the gray cap back on the needle.

B2: If needed pinch the skin.

• Use your thumb and first finger to pinch a fold of skin at the injection site.
• Hold the skin like this during the entire injection.

B3: Insert the needle into the fold of skin with a quick dart-like motion.

• Inject the medicine at a 90° angle if you can pinch 2 inches of skin.
• Inject the medicine at a 45° angle if you can only pinch 1 inch of skin.

B4: Push the plunger down.

• Inject all of the medicine by slowly and steadily pushing down the plunger.
• You may have to push harder on the plunger than for other injectable medicines.

B5: Before you remove the needle check the syringe is empty.

• The time required for injection to give the entire dose may be longer than for other injectable

medicines.

• Do not remove the syringe until it is completely empty.
• Pull the needle out of the skin at the same angle as it was inserted.
• Do not rub the skin after the injection.
• If you see any blood, press a cotton ball or gauze on the site until the bleeding stops.

B6: Discard syringe and cap.

• Do not put the gray needle cap back on.
• Do not re-use the syringe.
• Throw away syringe and cap in a puncture-resistant container immediately after they have been used.

Disposing of used prefilled syringes and needles:

• Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use.
• Do not throw away (dispose of) loos e needles and syringes in your household trash.
• If you Do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
• Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

Keep alirocumab and all medicines out of the reach of children.