Skyrizi

What is Skyrizi?

Skyrizi is a prescription medicine used to treat:

• moderate to severe plaque psoriasis in adults who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
• active psoriatic arthritis in adults.
• moderate to severe Crohn’s disease in adults.

It is not known if Skyrizi is safe and effective in children under 18 years of age.

What is the most important information I should know about Skyrizi?

Skyrizi may cause serious side effects, including:

• Serious allergic reactions. Stop using Skyrizi and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:
  • fainting, dizziness, feeling lightheaded (low blood pressure)
  • swelling of your face, eyelids, lips, mouth, tongue, or throat
  • trouble breathing or throat tightness
  • chest tightness
  • skin rash, hives
  • itching
• Infections. Skyrizi may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with Skyrizi and may treat you for TB before you begin treatment with Skyrizi if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with Skyrizi. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
  • fever, sweats, or chills
  • cough
  • shortness of breath
  • blood in your mucus (phlegm)
  • muscle aches
  • warm, red, or painful skin or sores on your body different from your psoriasis
  • weight loss
  • diarrhea or stomach pain
  • burning when you urinate or urinating more often than normal

See “What are the possible side effects of Skyrizi?” for more information about side effects.

Who should not use Skyrizi?

Do not use Skyrizi if you are allergic to risankizumab-rzaa or any of the ingredients in Skyrizi. See below for a complete list of ingredients in Skyrizi.

What should I tell my healthcare provider before using Skyrizi?

Before using Skyrizi, tell your healthcare provider about all of your medical conditions, including if you:

• have any of the conditions or symptoms listed in the section “What is the most important information I should know about Skyrizi?”
• have an infection that does not go away or that keeps coming back.
• have TB or have been in close contact with someone with TB.
• have recently received or are scheduled to receive an immunization (vaccine). Medicines that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with Skyrizi. Tell your healthcare provider that you are taking Skyrizi before receiving a vaccine.
• are pregnant or plan to become pregnant. It is not known if Skyrizi can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Skyrizi passes into your breast milk.
• If you become pregnant while taking Skyrizi, you are encouraged to enroll in the Pregnancy Registry. The purpose of the pregnancy registry is to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use Skyrizi?

See the detailed “Instructions for Use” that comes with Skyrizi for information on how to prepare and inject a dose of Skyrizi, and how to properly throw away (dispose of) a used Skyrizi prefilled pen, prefilled syringe, or prefilled cartridge with on-body injector.

• Use Skyrizi exactly as your healthcare provider tells you to use it.
• Your healthcare provider will tell you how much Skyrizi is right for you and how often you should receive it.
• Before self-injecting with Skyrizi prefilled pen, prefilled syringe, or prefilled cartridge with on-body injector, your healthcare provider should show you how to inject Skyrizi.
• If you miss your Skyrizi dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. Call your healthcare provider if you are not sure what to do.
• If you inject more Skyrizi than prescribed, call your healthcare provider right away.

Adults with plaque psoriasis or psoriatic arthritis will receive Skyrizi as an injection under the skin (subcutaneous injection) using the prefilled pen or prefilled syringe.

Adults with Crohn’s disease will receive their starter doses with Skyrizi through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. After completing the starter doses, patients will receive Skyrizi as an injection under the skin (subcutaneous injection) using the prefilled cartridge with on-body injector.

What are the possible side effects of Skyrizi?

Skyrizi may cause serious side effects. See “What is the most important information I should know about Skyrizi?”

• Liver problems in Crohn’s disease. A person with Crohn’s disease who received Skyrizi by intravenous infusion (through a vein in the arm) developed changes in liver blood tests with a rash that led to hospitalization. Your healthcare provider will do blood tests to check your liver before, during, and up to 12 weeks of treatment with Skyrizi. Your healthcare provider may stop treatment with Skyrizi if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms:
  • unexplained rash
  • vomiting
  • tiredness (fatigue)
  • yellowing of the skin and eyes (jaundice)
  • nausea
  • stomach (abdominal) pain
  • loss of appetite
  • dark urine

The most common side effects of Skyrizi in people treated for Crohn’s disease include:

• upper respiratory infections
• injection site reactions
• headache
• stomach (abdominal) pain
• joint pain
• low red blood cells (anemia)
• fever
• back pain

The most common side effects of Skyrizi in people treated for plaque psoriasis and psoriatic arthritis include:

• upper respiratory infections
• feeling tired
• injection site reactions
• headache
• fungal skin infections

These are not all of the possible side effects of Skyrizi. 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 Skyrizi

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Skyrizi for a condition for which it was not prescribed. Do not give Skyrizi to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Skyrizi that is written for health professionals.

How should I store Skyrizi?

• Store Skyrizi in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze Skyrizi.
• Do not shake Skyrizi.
• Keep Skyrizi in the original carton to protect it from light.
• Skyrizi is not made with natural rubber latex.

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

What are the ingredients in Skyrizi?

Active ingredient: risankizumab-rzaa

Inactive ingredients:

150 mg/mL, 360 mg/2.4 mL, and 600 mg/ 10 mL: glacial acetic acid, polysorbate 20, sodium acetate, trehalose, and Water for Injection, USP.

75 mg/0.83 mL: sodium succinate, polysorbate 20, sorbitol, succinic acid, and Water for Injection, USP.

For more information, call 1-866-SKYRIZI (1-866-759-7494) or go to www.SKYRIZI.com.

Instructions for use for Skyrizi

Skyrizi (sky-RIZZ-ee)
(risankizumab-rzaa)
injection, for subcutaneous use

• Single-Dose Prefilled Syringe 75 mg/0.83 ml
• Single-Dose Prefilled Syringe 150mg/ml
• Single-Dose Pen
• On-Body Injector and 360 mg/2.4 ml Prefilled Cartridge

Skyrizi Single-Dose Prefilled Syringe 75 mg/0.83 ml

Important Information:

• Keep Skyrizi in the original carton to protect from light until time to use.
• The liquid should look clear to slightly yellow and may contain tiny white or clear particles.
• Do not use Skyrizi if the liquid is cloudy or contains flakes or large particles.
• Do not use Skyrizi if the expiration date (EXP:) shown on the carton and prefilled syringe has passed.
• Do not use Skyrizi if the liquid has been frozen (even if thawed).
• Do not shake Skyrizi.
• Do not use Skyrizi if the syringe has been dropped or damaged.
• Do not use Skyrizi if carton perforations are broken. Return product to the pharmacy.
• Do not remove the needle cover until right before giving the injections.

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

Please Read Complete Instructions For Use Before Using Skyrizi Syringe

Before Injecting:

• Receive training on how to inject Skyrizi before giving injections. Call your healthcare provider or (866) Skyrizi or (866) 759-7494 if you need help.
• Mark your calendar ahead of time to remember when to take Skyrizi.
• Leave the carton at room temperature and out of direct sunlight for 15 to 30 minutes to warm.
  • Do not remove the prefilled syringes from the carton while allowing Skyrizi to reach room temperature.
  • Do not warm Skyrizi in any other way (for example, Do not warm it in a microwave or in hot water).

Important Information:

• The liquid should look clear to slightly yellow and may contain tiny white or clear particles.
• Do not use Skyrizi if the liquid is cloudy or contains flakes or large particles.
• Do not use Skyrizi if the expiration date (EXP:) shown on the carton and prefilled syringe has passed.
• Do not use Skyrizi if the syringe has been dropped or damaged.
• Do not use Skyrizi if carton perforations are broken. Return product to the pharmacy.

Storage Information:

• Store Skyrizi in your refrigerator between 36° F to 46°F (2° to 8°C).
• Do not shake Skyrizi.
• Keep Skyrizi in the original carton to protect from light until time to use.
• Skyrizi is not made with natural rubber latex.
• Do not use if liquid has been frozen (even if thawed).

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

Call your healthcare provider or (866) Skyrizi or (866) 759-7494 if you need help or Do not know how to proceed.

Step 1

Gather the supplies for the injections and place the following on a clean, flat surface:

• 2 prefilled syringes and 2 alcohol swabs (included)
• 2 cotton balls or gauze pads (not included)
• FDA-cleared sharps disposal container (not included). See “Used Skyrizi Prefilled Syringe Disposal” for information on how to throw away (dispose of) used prefilled syringes.

Wash and dry your hands.
Start with 1 prefilled syringe for first injection.

Step 2

Pick from the 3 injectable areas:

• Front of left thigh or right thigh
• Your abdomen (belly) at least 2 inches from your navel (belly button)

Wipe the injection site in a circular motion with the alcohol swab (before both injections)

• Do not touch or blow on the injection site after it is cleaned. Allow the skin to dry before injecting.
• Do not inject through clothes.
• Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks, or into areas affected by psoriasis.

Step 3

Hold the prefilled syringe with covered needle facing down, as shown.

Check the liquid in the prefilled syringe.

• It is normal to see 1 or more bubbles in the window.
• The liquid should look clear to slightly yellow and may contain tiny white or clear particles.
• Do not use the prefilled syringe if liquid is cloudy or contains flakes or large particles.

Step 4

Remove the needle cover.

• Hold the syringe in 1 hand between the finger grip and needle cover.
• With the other hand, gently pull the needle cover straight off.
• Do not hold or pull plunger rod when removing the needle cover.
• You may see a drop of liquid at the end of the needle. This is normal.
• Throw away the needle cover.
• Do not touch the needle with your fingers or let the needle touch anything.

Step 5

Hold the body of the prefilled syringe in 1 hand between the thumb and index fingers.

Gently pinch the area of cleaned skin with your other hand and hold it firmly.

Insert the needle into the skin at about a 45-degree angle using a quick, short movement. Hold angle steady.

Step 6

Slowly push the plunger rod all the way in until all of the liquid is injected, and the syringe is empty.

Pull the needle out of the skin while keeping the syringe at the same angle.

Release the plunger rod and allow the prefilled syringe to move up until the entire needle is covered by the needle guard.

The prefilled syringe needle guard will not activate unless all the liquid has been injected.

• Press a cotton ball or gauze pad over the injection site and hold for 10 seconds.
• Do not rub the injection site. You may have slight bleeding. This is normal.

Step 7

Repeat Steps 2 through 6 with the 2nd prefilled syringe for a full dose.

• Use the 2nd prefilled syringe right after using the 1st syringe.

Step 8

Put your used prefilled syringes in a FDA-cleared sharps disposal container right away after use.

• Do not throw away (dispose of) used prefilled syringes in the household trash.

For more information, see “Used Skyrizi Prefilled Syringe Disposal” section.

Questions About Using Skyrizi

Q. What if I need help on how to inject Skyrizi?

A. Call your healthcare provider or (866) Skyrizi or (866) 759-7494 if you need help.

Q. What should I do with both used prefilled syringes after my injections?

A. Throw away (dispose of) both used prefilled syringes in a sharps disposal container and not your household trash.

You can sign up to receive sharps containers for Skyrizi syringe disposal at no additional cost by going to www.Skyrizi.com or calling (866) Skyrizi or (866) 759-7494.

Q. How do I know when the injection is complete?

A. The injection is complete when the prefilled syringe is empty, the plunger rod is pushed all the way in, and the syringe needle guard is activated.

Used Skyrizi Prefilled Syringe Disposal

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: www.fda.gov/safesharpsdisposal.

Do not recycle your used sharps disposal container.

Instructions for use revised 01/2022.

Skyrizi Single-Dose Prefilled Syringe 150mg/ml

Important Information:

• Keep Skyrizi in the original carton to protect from light until time to use.
• The liquid should look clear to slightly yellow and may contain tiny white or clear particles.
• Do not use Skyrizi if the liquid is cloudy or contains flakes or large particles.
• Do not use Skyrizi if the expiration date (EXP:) shown on the carton and prefilled syringe has passed.
• Do not use Skyrizi if the liquid has been frozen (even if thawed).
• Do not shake Skyrizi.
• Do not use Skyrizi if the syringe has been dropped or damaged.
• Do not use Skyrizi if carton perforations are broken. Return product to the pharmacy.
• Do not remove the needle cover until right before giving the injections.

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

Please Read Complete Instructions For Use Before Using Skyrizi Syringe

Before Injecting:

• Receive training on how to inject Skyrizi before giving injections. Call your healthcare provider or (866) Skyrizi or (866) 759-7494 if you need help.
• Mark your calendar ahead of time to remember when to take Skyrizi.
• Leave the carton at room temperature and out of direct sunlight for 15 to 30 minutes to warm.
  • Do not remove the syringe from the carton while allowing Skyrizi to reach room temperature.
  • Do not warm Skyrizi in any other way (for example, Do not warm it in a microwave or in hot water).

Important Information:

• The liquid should look clear to slightly yellow and may contain tiny white or clear particles.
• Do not use Skyrizi if the liquid is cloudy or contains flakes or large particles.
• Do not use Skyrizi if the expiration date (EXP:) shown on the carton and prefilled syringe has passed.
• Do not use Skyrizi if the syringe has been dropped or damaged.
• Do not use Skyrizi if carton perforations are broken. Return product to the pharmacy.

Storage Information:

• Store Skyrizi in your refrigerator between 36° F to 46°F (2° to 8°C).
• Do not shake Skyrizi.
• Keep Skyrizi in the original carton to protect from light until time to use.
• Skyrizi is not made with natural rubber latex.
• Do not use if liquid has been frozen (even if thawed).

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

Call your healthcare provider or (866) Skyrizi or (866) 759-7494 if you need help or Do not know how to proceed.

Step 1

Gather the supplies for the injections and place the following on a clean, flat surface:

• 2 prefilled syringes and 2 alcohol swabs (included)
• 2 cotton balls or gauze pads (not included)
• FDA-cleared sharps disposal container (not included). See “Used Skyrizi Prefilled Syringe Disposal” for information on how to throw away (dispose of) used prefilled syringes.

Wash and dry your hands.

Step 2

Remove prefilled syringe from cardboard sleeve by holding the finger grip.

Step 3

Pick from the 3 injectable areas:

• Front of left thigh or right thigh
• Your abdomen (belly) at least 2 inches from your navel (belly button)

Wipe the injection site in a circular motion with the alcohol swab (before both injections)

• Do not touch or blow on the injection site after it is cleaned. Allow the skin to dry before injecting.
• Do not inject through clothes.
• Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks, or into areas affected by psoriasis.

Step 4

Hold the prefilled syringe with covered needle facing down, as shown.

Check the liquid in the prefilled syringe.

• It is normal to see 1 or more bubbles in the window.
• The liquid should look clear to slightly yellow and may contain tiny white or clear particles.
• Do not use the prefilled syringe if liquid is cloudy or contains flakes or large particles.

Step 5

Remove the needle cover.

• Hold the syringe in 1 hand between the finger grip and needle cover.
• With the other hand, gently pull the needle cover straight off.
• Do not hold or pull plunger rod when removing the needle cover.
• You may see a drop of liquid at the end of the needle. This is normal.
• Throw away the needle cover.
• Do not touch the needle with your fingers or let the needle touch anything.

Step 6

Hold the body of the prefilled syringe in 1 hand between the thumb and index fingers.

Pinch the area of cleaned skin with your other hand and hold it firmly.

Insert the needle into the skin at about a 45-degree angle using a quick, short movement. Hold angle steady.

Step 7

Slowly push the plunger rod all the way in until all of the liquid is injected, and the syringe is empty.

Pull the needle out of the skin while keeping the syringe at the same angle.

Release the plunger rod and allow the prefilled syringe to move up until the entire needle is covered by the needle guard.

The prefilled syringe needle guard will not activate unless all the liquid has been injected.

• Press a cotton ball or gauze pad over the injection site and hold for 10 seconds.
• Do not rub the injection site. You may have slight bleeding. This is normal.

Step 8

Put your used prefilled syringes in a FDA-cleared sharps disposal container right away after use.

• Do not throw away (dispose of) used prefilled syringes in the household trash.

For more information, see “Used Skyrizi Prefilled Syringe Disposal” section.

Questions About Using Skyrizi

Q. What if I need help on how to inject Skyrizi?

A. Call your healthcare provider or (866) Skyrizi or (866) 759-7494 if you need help.

Q. What should I do with both used prefilled syringes after my injections?

A. Throw away (dispose of) both used prefilled syringes in a sharps disposal container and not your household trash.

You can sign up to receive sharps containers for Skyrizi syringe disposal at no additional cost by going to www.Skyrizi.com or calling (866) Skyrizi or (866) 759-7494.

Q. How do I know when the injection is complete?

A. The injection is complete when the prefilled syringe is empty, the plunger rod is pushed all the way in, and the syringe needle guard is activated.

Used Skyrizi Prefilled Syringe Disposal

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: www.fda.gov/safesharpsdisposal.

Do not recycle your used sharps disposal container.

Instructions for use revised 01/2022.

Skyrizi Single-Dose Pen

Important Information

• Store Skyrizi in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Keep Skyrizi in the original carton to protect from light until you are ready to use.
• Before injecting, take the Skyrizi carton out of the refrigerator. Leave the carton at room temperature and out of direct sunlight for 30 to 90 minutes.
• The liquid in the inspection window should look clear to yellow and may contain tiny white or clear particles.
• Do not use Skyrizi if the liquid is cloudy or contains flakes or large particles.
• Do not use Skyrizi if the expiration date (EXP) has passed.
• Do not use Skyrizi if the liquid has been frozen, even if it has been thawed.
• Do not shake Skyrizi.
• Do not use if the Skyrizi Pen has been dropped or damaged.
• Do not use Skyrizi if carton perforations are broken. Return product to pharmacy.
• Do not remove the dark gray cap until right before injection.
• Skyrizi is not made with natural rubber latex.

Prepare Skyrizi injection

Step 1

Take the Skyrizi carton out of the refrigerator. Leave the carton at room temperature and out of direct sunlight for 30 to 90 minutes before injecting.

• Do not remove the Pen from the carton while allowing Skyrizi to reach room temperature.
• Do not warm Skyrizi in any other way. For example, do not warm it in a microwave or in hot water.
• Do not use the Pen if the liquid has been frozen, even if it has been thawed.

Step 2

Check expiration date (EXP). Do not use the Pen if expiration date has passed.
Place the following on a clean, flat surface:

• 1 single-dose Skyrizi Pen (included)
• 1 alcohol swab (not included)
• 1 cotton ball or gauze pad (not included)
• FDA-cleared sharps disposal container (not included). See “Used Skyrizi Prefilled Pen Disposal” for information on how to throw away (dispose of) used Pens.

Wash and dry your hands.

Step 3

Choose an injection site:

• on the front of your thighs or
• your abdomen (belly) at least 2 inches from your navel (belly button)

Wipe the injection site in a circular motion with the alcohol swab and let it dry.

• Do not touch or blow on the injection site after it is cleaned. Allow the skin to dry before injecting.
• Do not inject through clothes.
• Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis.

Step 4

Hold the Pen with the dark gray cap pointing up.

• Pull the dark gray cap straight off.
• Throw the dark gray cap away.

Check the liquid through the inspection window.

• It is normal to see 1 or more bubbles in the liquid.
• The liquid should look clear to yellow and may contain tiny white or clear particles.
• Do not use if the liquid is cloudy or contains flakes or large particles.

Give Skyrizi injection

Step 5

Hold the Pen with your fingers on the gray hand grips.
Turn the Pen so that the white needle sleeve points toward the injection site and you can see the green activator button.
Pinch the skin at your injection site to make a raised area and hold it firmly.
Place the white needle sleeve straight (90-degree angle) against the raised injection site.

Step 6

Hold the Pen so that you can see the green activator button and inspection window.
Push and keep pressing the Pen down against the raised injection site.

• The Pen will activate only if the white needle sleeve is pressed down against the injection site before pressing the green activator button.

Press the green activator button and hold the Pen for 15 seconds.

• The first loud “click” means the start of the injection.

Step 7

Keep pressing the Pen down against the injection site.
The injection is complete when:

• the Pen has made a second “click” or
• the yellow indicator has filled the inspection window

This takes up to 15 seconds.

After Skyrizi injection

Step 8

When the injection is complete, slowly pull the Pen straight out from the skin.
The white needle sleeve will cover the needle tip and make another “click.”
After completing the injection, place a cotton ball or gauze pad on the skin at the injection site.

• Do not rub the injection site.
• Slight bleeding at the injection site is normal.

Step 9

Throw away (dispose of) the used Pen in a FDA-cleared sharps disposal container right away after use.

• Do not dispose of used Pens in your household trash unless your community guidelines permit this.
• Do not recycle your sharps disposal container.

The dark gray cap, alcohol swab, cotton ball or gauze pad, and packaging may be placed in your household trash.
For more information, see “Used Skyrizi Prefilled Pen Disposal”.

Important Information

• Store Skyrizi in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Keep Skyrizi in the original carton to protect from light until you are ready to use.
• Before injecting, take the Skyrizi carton out of the refrigerator. Leave the carton at room temperature and out of direct sunlight for 30 to 90 minutes.
• The liquid in the inspection window should look clear to yellow and may contain tiny white or clear particles.
• Do not use Skyrizi if the liquid is cloudy or contains flakes or large particles.
• Do not use Skyrizi if the expiration date (EXP) has passed.
• Do not use Skyrizi if the liquid has been frozen, even if it has been thawed.
• Do not shake Skyrizi.
• Do not use if the Skyrizi Pen has been dropped or damaged.
• Do not use Skyrizi if carton perforations are broken. Return product to pharmacy.
• Do not remove the dark gray cap until right before injection.
• Skyrizi is not made with natural rubber latex.

Keep the Skyrizi Pen and sharps disposal container out of the reach of children.

Call your healthcare provider or (866) Skyrizi or (866) 759-7494 if you need help or do not know how to proceed.

Questions About Using the Skyrizi Pen

Q. What if I need help on how to inject Skyrizi?

A. Call your healthcare provider or (866) Skyrizi or (866) 759-7494 if you need help.

Q. I have removed the dark gray cap and pressed the green activator button. Why isn’t my injection starting?

A. The green activator button will not start the injection unless the white needle sleeve is pressed firmly against the injection site.

Q. How do I know when the injection is complete?

A. The injection is complete if the Pen makes a second “click” or the yellow indicator fills the inspection window. This takes up to 15 seconds.

Q. What should I do if there are more than a few drops of liquid on the injection site?

A. Call (866) Skyrizi or (866) 759-7494 for help.

Q. What should I do with the used Pen after my injection?

A. Dispose of the used Pen in a sharps disposal container right after use. Do not dispose of the used Pen in your household trash.

You can sign up to receive sharps containers for Skyrizi Pen disposal at no additional cost by going to www.Skyrizi.com or calling (866) Skyrizi or (866) 759-7494.

Call (866) Skyrizi or (866) 759-7494 or go to www.Skyrizi.com for help with your injection.

To help remember when to inject, mark your calendar with the date you give your Skyrizi injection.

Keep the Skyrizi Pen and sharps disposal container out of the reach of children.

Call your healthcare provider or (866) Skyrizi or (866) 759-7494 if you need help or have questions about the use of Skyrizi.

Used Skyrizi Prefilled Pen Disposal

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 Pens.

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: www.fda.gov/safesharpsdisposal.

Do not recycle your used sharps disposal container.

Instructions for use revised 01/2022.

Skyrizi On-Body Injector and 360 mg/2.4 ml Prefilled Cartridge

Important information you need to know before injecting Skyrizi

• Receive training on how to inject Skyrizi before giving an injection.
• Do not shake the Skyrizi carton, On-Body Injector or prefilled cartridge.
• Do not remove the On-Body Injector or prefilled cartridge from the carton until you are ready to inject.  Inject the medicine within 5 minutes after loading the cleaned prefilled cartridge into the On-Body Injector. Waiting will dry out the medicine and the On-Body Injector will not work afterwards.
• Do not touch the start button until you place the On-Body Injector loaded with the prefilled cartridge onto your skin and are ready to inject.
  • You can only press the start button 1-time.
  • Do not use On-Body Injector or prefilled cartridge if either has been dropped or damaged.
  • Do not reuse On-Body Injector or prefilled cartridge. The On-Body Injector and prefilled cartridge are for 1-time (single-dose) use only.
  • Do not let the On-Body Injector get wet with water or any other liquids.
  • This single-dose On-Body Injector is designed for use with Skyrizi prefilled cartridge only.
  • Physical activity should be limited during the injection process. Moderate physical activities can be done, such as walking, reaching and bending.
  • Do not use Skyrizi if the expiration date (EXP:) has passed.
  • Do not use the prefilled cartridge if the liquid is cloudy or contains flakes or large particles. The liquid should look clear to yellow and may contain tiny white or clear particles.
  • The On-Body Injector and the prefilled cartridge are not made with natural rubber latex.
  • Keep Skyrizi and all medicines out of the reach of children.

Storage and preparation for use

• Keep Skyrizi in the original carton to protect from light and physical damage until time to use.
• Store Skyrizi in your refrigerator between 36°F to 46°F (2°C to 8°C).
• When ready to use, take the carton out of the refrigerator and leave it at room temperature for at least 45 minutes up to 90 minutes to allow Skyrizi to warm.
• Do not leave out in direct sunlight.
• Do not remove the On-body Injector or prefilled cartridge from the carton while allowing Skyrizi to reach room temperature.
• Do not warm Skyrizi in any other way. For example, do not warm it in a microwave or in hot water.
• Do not use if liquid has been frozen (even if thawed).
• Do not use Skyrizi if carton perforations are broken. Return product to the pharmacy.
• Do not use the On-Body Injector and prefilled cartridge if the white paper tray seal is missing or damaged and return the carton to the pharmacy.

Get to know your Skyrizi On-Body Injector and prefilled cartridge

Please read complete Instructions for Use before using Skyrizi. Call your healthcare provider or (866) Skyrizi or (866) 759-7494 or go to www.Skyrizi.com if you need help or if you do not know how to proceed.

Step 1 Get ready

Before using Skyrizi, you should receive training on how to inject Skyrizi.

Check expiration date

• Remove the carton from the refrigerator.
• Check expiration date (EXP:) on the carton.
• Do not use Skyrizi if the expiration date (EXP:) has passed.

Wait at least 45 minutes

• Leave unopened carton at room temperature to warm.
• Keep out of direct sunlight.
• Wait at least 45 minutes up to a maximum of 90 minutes to allow Skyrizi to warm.
• Do not warm Skyrizi in any other way (for example, do not warm it in a microwave or in hot water).

Open the carton and remove the plastic tray

• Lift up the flap on the side of the carton.
• Take out the plastic tray.

Gather all supplies and wash hands

• Place the following on a clean surface:
  • plastic tray containing the On-Body Injector and prefilled cartridge (included)
  • 2 alcohol wipes (not included)
  • cotton ball or gauze pad (not included)
  • sharps disposal container (not included) (see “Disposing of Skyrizi”)
• Wash and dry your hands.

Remove the white paper tray seal

• Locate the black arrow.
• Peel away the white paper tray seal from the plastic tray.
• Do not use the On-Body Injector and prefilled cartridge if the white paper tray seal is missing or damaged and return the carton to the pharmacy.

Lift the plastic cover

• Locate the rounded opening on the top cover.
• Insert your pointer finger in the opening and place your thumb on the opposite side.
• Lift the cover to remove and set aside.

Inspect the On-Body Injector

• Check that the On-Body Injector is intact and undamaged.
• Do not close the gray door before the prefilled cartridge is loaded.
• The gray door should be slightly open.
• If the gray door does not open, press in firmly on the gray door ridges (left side of door) and swing open the door.
• Do not use On-Body Injector if you drop it, discover missing pieces, or it is damaged.
• Do not let the On-Body Injector get wet with water or any other liquids.
• Do not touch the gray start button until it is time to inject. It can be pressed 1-time only. If the gray start button is pressed before placing it on your body, the On-Body Injector can no longer be used. Call (866) Skyrizi or (866) 759-7494.
• Do not touch the needle cover or the needle.
• Proceed to Set up On-Body Injector.

Step 2 Set up On-Body Injector

Fully open the gray door

• Avoid touching the needle cover or the needle on the back of the On-Body Injector. The needle is behind the needle cover.
• Swing the gray door all the way to the right to open it.
• If the gray door does not open, press in firmly on the gray door ridges (left side of door) and swing open the door.
• Do not close the gray door before the prefilled cartridge is loaded.
• Do not touch the needle cover or needle.
• Put the On-Body Injector aside.

Inspect the prefilled cartridge

• Carefully remove the prefilled cartridge from the plastic tray.
• Do not twist or remove cartridge top.
• Check the prefilled cartridge to make sure:
  • The expiration date (EXP:) has not passed.
  • The liquid should look clear to yellow and may contain tiny white or clear particles. It is normal to see one or more bubbles.
  • The prefilled cartridge parts appear intact, and the clear plastic is not cracked or broken.
• Do not use if the expiration date (EXP:) has passed.
• Do not use if the liquid is cloudy, discolored, or contains flakes or large particles.
• Do not use if the liquid has been frozen (even if thawed).  Do not use the prefilled cartridge if you drop it, discover missing pieces, or it is damaged.

Clean the smaller bottom tip of the prefilled cartridge

• Locate the smaller bottom tip of the prefilled cartridge.
• Clean the smaller bottom tip of the prefilled cartridge with an alcohol wipe. Make sure to use the alcohol wipe to clean the center of the smaller bottom tip of the prefilled cartridge.
• Do not touch the smaller bottom tip of the prefilled cartridge after cleaning.

Load the cleaned prefilled cartridge into the On-Body Injector

• Do not twist or remove the prefilled cartridge top.
• Insert the smaller bottom tip of the prefilled cartridge into the On-Body Injector first.
• Firmly push down on the prefilled cartridge top until you hear a “click”.
• After loading the prefilled cartridge, you may see a few drops of medicine on the back of the On-Body Injector. This is normal.
• Make sure that you start the injection within 5 minutes after inserting the prefilled cartridge into the On-Body Injector Waiting will dry out the medicine.

Close the gray door

• Swing the gray door to the left, then squeeze firmly and listen for the gray door to "snap" shut.
• The gray door should stay locked after loading the prefilled cartridge.
• Do not close the gray door if the prefilled cartridge is not fully inserted or is missing.
• Proceed without delay to Prepare to inject

Step 3 Prepare to inject

Keep electronic devices including cell phones at least 12 inches (30 cm) from On-Body Injector until injection is complete

Pick your injection area

Locate a firm and flat area on your bare skin. Make sure the area is clear of clothing:

• Your abdomen (belly) at least 2 inches from your navel (belly button).
• The front of your left thigh or your right thigh.
• Do not inject into areas of the skin that naturally fold or bulge because the On-Body Injector could fall off during wear.
• Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks, moles or excessive hair. You can trim the excessive hair from the injection area.

Clean the injection area

• Clean injection area with an alcohol wipe.
• Allow the injection area to completely dry.
• Do not touch cleaned injection area before placing the On-Body Injector on the skin.

Peel both tabs to expose adhesive

• Turn the On-Body Injector over to find both green pull tabs.
• Avoid touching the needle cover (needle inside).
• Peel away the large section using the green pull tab to expose the adhesive.
• Peel away the small section using the green pull tab to expose the adhesive. This will remove the clear plastic strip, activating the On-Body Injector.
• Do not pull the adhesive material off the OnBody Injector or allow the sticky side to fold and stick to itself.
• Check the status light when the On-Body Injector beeps.
• The status light will flash blue when the OnBody Injector is activated.
• If the status light does not flash blue, call (866) Skyrizi or (866) 759-7494.  Do not press the gray start button yet.
• Do not touch the needle cover or the needle.

Prepare the On-Body Injector for placement

• For the abdomen (belly), move and hold the skin to create a firm, flat surface for injection at least 2 inches from your navel (belly button). Make sure to adjust your posture (sit up straight) to avoid skin folds and bulges.
• You do not need to pull the skin flat for the front of left thigh or right thigh.
• Make sure to position the On-Body Injector so that you can see the blue status light.

Place the On-Body Injector on your skin

• When the blue light flashes, the On-Body Injector is ready. Place the On-Body Injector onto the cleaned skin with the status light visible.
• Do not place the On-Body Injector on clothes. Only place on bare skin.
• Run your finger around the adhesive material to secure it. Make sure all of the adhesive is attached to your skin.
• Do not move or adjust the On-Body Injector after it has been placed on your skin.
• When the On-Body Injector is on your skin, proceed to Inject medicine

Step 4 Inject medicine

Start injection

• Firmly press the gray start button until you hear a click. Then release the gray start button.
• Do not touch the gray start button until you place the On-Body Injector loaded with the prefilled cartridge onto your skin and are ready to inject. You can only press the start button 1 time.
• You may feel a needle pinch.
• Check the status light when the On-Body Injector beeps.
• After starting the injection, the status light will continuously flash green.
• You will hear pumping sounds as the OnBody Injector delivers the medicine.
• Do not continue to use the On-Body Injector if status light flashes red and beeps. Carefully remove from skin if the status light flashes red. Call (866) Skyrizi or (866) 759-7494.

Wait for the injection to finish

• It may take up to 5 minutes to complete full dose of medicine. The On-Body Injector will automatically stop when the injection is finished.
  During the injection:
  • the status light will continue to flash green.
  • you will hear pumping sounds as the OnBody Injector continues delivering the medicine.
  • moderate physical activities can be done, such as walking, reaching and bending.
• Do not continue to use the On-Body Injector if the status light flashes red and beeps. Carefully remove it from the skin if the status light flashes red and beeps. Call (866) Skyrizi or (866) 759-7494.

Injection is finished

• The On-Body Injector will stop on its own.
• After the injection is finished, you will hear beeps and the status light will change to solid green. Check the status light. If it has changed to solid green, this means that the injection is finished.
• When the injection is finished, proceed to next step.

Remove the On-Body Injector

• Do not put your fingers on the back side of the On-Body Injector when removing it from your skin.
• When the injection is done, grab the corner of the adhesive to carefully peel the On-Body Injector from the skin.
• Avoid touching the needle cover or needle on the back of the On-Body Injector.
• After removing the On-Body Injector, you will hear several beeps and the status light will turn off.
• The needle cover will cover the needle when the On-Body Injector is removed from the skin.
• It is normal to see a few small drops of liquid on your skin after removing the On-Body Injector. If you see more than a few small drops of liquid left on your skin, call (866) Skyrizi or (866) 759-7494.
• Press a cotton ball or gauze pad over the injection site on your skin and hold for 10 seconds.
• Do not rub the injection site.
• Slight bleeding at the injection site is normal.
• Proceed to Confirm and dispose

Step 5 Confirm and dispose

Check the On-Body Injector

• Inspect the medicine window and status light.
• Check to see that the used white plunger fills the medicine window and the solid green light turns off, letting you know that all the medicine has been injected.
• If the used white plunger does not fill the window, call (866) Skyrizi or (866) 759- 7494.

Put the used On-Body Injector in an FDA-cleared sharps disposal container right away after use

• Leave the prefilled cartridge in the On-Body Injector.
• Do not throw away (dispose of) the used OnBody Injector in your household trash.
• For more information, see “Disposing of Skyrizi” section.

Symbol Key for Skyrizi On-Body Injector

Warning or caution.
Be aware or follow closely.

Flashing blue light
On / Ready

Flashing green light
Injection has started

Solid green light
Injection has finished

No light
Off / Finished

Flashing red light
Do not continue to use the On-Body Injector. It is not working properly. Call (866) Skyrizi or (866) 759-7494 for more information.

Please read complete Instructions for Use before using Skyrizi. Call your healthcare provider or (866) Skyrizi or (866) 759-7494 or go to www.Skyrizi.com if you need help or if you do not know how to proceed.

Commonly asked questions

Q. What if I cannot open the On-Body Injector door to insert the prefilled cartridge?

A. To open the On-Body Injector door, press in firmly on the left side of the door to release the door latch. If you are still unable to open the door, call (866) Skyrizi or (866) 759-7494.

Q. What if I push the gray start button before I place the On-Body Injector on my skin?

A. The gray start button may be pressed just 1 time only. If the gray start button is pressed before placing it on your body, it can no longer be used. Call (866) Skyrizi or (866) 759-7494.

Q. What if the On-Body Injector does not beep and the blue status light does not flash when I remove the green pull tabs?

A. Peeling off small green pull tab will remove the clear plastic strip, activating the On-Body Injector. If all of the adhesive paper has been removed and the On-Body Injector still does not turn on, call (866) Skyrizi or (866) 759-7494.

Q. What if I push the start button as instructed after placing the On-Body Injector on the skin and the light remains blue?

A. Firmly press the gray start button again. If the status light remains blue or flashes red, remove the On-Body Injector by carefully peeling it away from your skin. Do not re-apply the On-Body Injector. Call (866) Skyrizi or (866) 759-7494.

Q. What if the status light flashes red and beeps while wearing the On-Body Injector?

A. If the status light continuously flashes red and beeps, do not use the On-Body Injector. If it is attached to your body, carefully remove it. Call (866) Skyrizi or (866) 759-7494.

Q. What should I do if the On-Body Injector comes off my body during the injection?

A. The loaded On-Body Injector can no longer be used. Do not re-apply it to your body. Call (866) Skyrizi or (866) 759-7494.

Q. How do I know when the injection is complete?

A. The injection is complete when the On-Body Injector beeps, the white plunger has completely filled the medicine window, and the status light turns from flashing green to solid green.

Q. What should I do if there are more than a few drops of liquid on the injection area?

A. Call (866) Skyrizi or (866) 759-7494 for help.

Q. What should I do with the used On-Body Injector after my injection?

A. Throw away (dispose of) used On-Body Injector in a FDA-cleared sharps disposal container and not your household trash. You can receive a sharps container for Skyrizi disposal at no additional cost by going to www.Skyrizi.com or by calling (866) Skyrizi or (866) 759-7494.

Q. What if I have not received in-person training from a healthcare professional?

A. Call your healthcare provider or (866) Skyrizi or (866) 759-7494 if you need help.

Disposing of Skyrizi

• Put Skyrizi in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) Skyrizi in your household trash.
• If you do not have an 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 in the state that you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal.

Do not recycle your used sharps disposal container.

Additional information

Care should be taken to use the On-Body Injector within the following specific limits and environments to avoid adversely impacting the performance (missed or incomplete Skyrizi dose).

• Keep electronic devices including cell phones at least 12 inches (30 cm) from the On-Body Injector until injection is complete. The potential impact of electronic interference is unknown when the On-Body Injector is operated within 12 inches (30 cm).
• Do not expose the On-Body Injector to Magnetic Resonance (MR) Environment (e.g., MRI).
• If it is used adjacent to other electrical equipment, observe the On-Body Injector and other equipment to ensure it is operating normally.

Also:

• Keep dry
• Sterilized using ethylene oxide
• Do not re-use
• Do not use if packaged is damaged
• Type BF Applied Part
• MR unsafe

Instructions for use approved 06/2022.