Wezlana (Ustekinumab): Uses, Side Effects and Dosage

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

WEZLANA is a medicine that affects your immune system. WEZLANA can increase your risk of having serious side effects, including:

• Serious infections. WEZLANA may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have serious infections during treatment with ustekinumab products, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection.

  • Your healthcare provider should check you for TB before starting WEZLANA.
  • If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with WEZLANA and during treatment with WEZLANA.
  • Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with WEZLANA.

  You should not start WEZLANA if you have any kind of infection unless your healthcare provider says it is okay.

  Before starting WEZLANA, tell your healthcare provider if you:

  • think you have an infection or have symptoms of an infection such as:

• fever, sweat, or chills
• muscle aches
• cough
• shortness of breath
• blood in phlegm

• weight loss
• warm, red, or painful skin or sores on your body
• diarrhea or stomach pain
• burning when you urinate or urinate more often than normal
• feel very tired

• are being treated for an infection or have any open cuts.
• get a lot of infections or have infections that keep coming back.
• have TB or have been in close contact with someone with TB.

After starting WEZLANA, call your healthcare provider right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. WEZLANA can make you more likely to get infections or make an infection that you have worse.

• People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections. These infections can spread throughout the body and cause death. People who take WEZLANA may also be more likely to get these infections.
• Cancers. WEZLANA may decrease the activity of your immune system and increase your risk for certain types of cancers. Tell your healthcare provider if you have ever had any type of cancer. Some people who are receiving ustekinumab products and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with WEZLANA, tell your healthcare provider if you develop any new skin growths.

What is WEZLANA?

WEZLANA is a prescription medicine used to treat:

• adults and children 6 years of age and older with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
• adults and children 6 years of age and older with active psoriatic arthritis.
• adults with moderately to severely active Crohn's disease.
• adults with moderately to severely active ulcerative colitis.

It is not known if WEZLANA is safe and effective in children less than 18 years of age with ulcerative colitis or in children less than 6 years of age with plaque psoriasis or psoriatic arthritis.

Who should not use WEZLANA?

Do not use WEZLANA if you are allergic to any ustekinumab product or any of the ingredients in WEZLANA. See the end of this Medication Guide for a complete list of ingredients in WEZLANA.

Before you use or receive WEZLANA, 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 WEZLANA?"
• ever had an allergic reaction to ustekinumab products. Ask your healthcare provider if you are not sure.
• have recently received or are scheduled to receive an immunization (vaccine). People who are being treated with WEZLANA should avoid receiving live vaccines. Tell your healthcare provider if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system and can cause serious problems. You should avoid receiving the BCG vaccine during the 1 year before receiving WEZLANA or 1 year after you stop receiving WEZLANA.
• have any new or changing lesions within psoriasis areas or on normal skin.
• are receiving or have received allergy shots, especially for serious allergic reactions. Allergy shots may not work as well for you during treatment with WEZLANA. WEZLANA may also increase your risk of having an allergic reaction to an allergy shot.
• receive or have received phototherapy for your psoriasis.

• are pregnant or plan to become pregnant. It is not known if WEZLANA can harm your unborn baby. You and your healthcare provider should decide if you will receive WEZLANA.

• are breastfeeding or plan to breastfeed. WEZLANA can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive WEZLANA.

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

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use WEZLANA?

• Use WEZLANA exactly as the healthcare provider tells you to. The healthcare provider will determine the right dose of WEZLANA, the amount for each injection, and how often it should be given. Be sure to keep all scheduled follow-up appointments.
• The needle cover on the WEZLANA prefilled syringe does not contain latex.
• Adults with Crohn's disease and ulcerative colitis will receive the first dose of WEZLANA through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. It takes at least 1 hour to receive the full dose of medicine. WEZLANA will then be received as an injection under the skin (subcutaneous injection) 8 weeks after the first dose of WEZLANA, as described below.
• Adults and children 6 years of age and older with plaque psoriasis or psoriatic arthritis will receive WEZLANA as an injection under the skin as described below.

• Injecting WEZLANA under the skin

  • WEZLANA is intended for use under the guidance and supervision of a healthcare provider.
  • In children, it is recommended that WEZLANA be administered by a healthcare provider. If a healthcare provider decides that you or a caregiver may give the injections of WEZLANA at home, you or a caregiver should receive training on the right way to prepare and give the injections.
  • Do not try to inject WEZLANA until you have been shown how to give the injections by a healthcare provider.
  • WEZLANA can be injected under the skin in the upper arms, buttocks, upper legs (thighs) or stomach area (abdomen).
  • Do not give an injection in an area of the skin that is tender, bruised, red or hard.
  • Use a different injection site each time you use WEZLANA.
• If you inject too much WEZLANA, call the healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest emergency room right away.

Read the detailed Instructions for Use for instructions about how to prepare and inject a dose of WEZLANA, and how to properly throw away (dispose of) used needles, syringes, and vials. The syringe, needle and vial must never be re-used. After the rubber stopper is punctured, WEZLANA can become contaminated by harmful bacteria which could cause an infection if re-used. Therefore, throw away any unused portion of WEZLANA.

What should I avoid while using WEZLANA?

You should avoid receiving a live vaccine during treatment with WEZLANA. See "Before you use or receive WEZLANA, tell your healthcare provider about all of your medical conditions, including if you:"

What are the possible side effects of WEZLANA?

WEZLANA may cause serious side effects, including:

• See "What is the most important information I should know about WEZLANA?"
• Serious allergic reactions. Serious allergic reactions including death can occur with WEZLANA. Stop using WEZLANA and get medical help right away if you get any of the following symptoms of a serious allergic reaction:

• feeling faint
• swelling of your face, eyelids, tongue, or throat
• chest discomfort

• trouble breathing
• skin rash

• Posterior Reversible Encephalopathy Syndrome (PRES). PRES is a rare condition that affects the brain and can cause death. Tell your healthcare provider right away if you get any symptoms of PRES during treatment with WEZLANA, including:

• headache
• seizures

• confusion
• vision problems

• Lung inflammation. Cases of lung inflammation have happened in some people who receive ustekinumab products and may be serious. These lung problems may need to be treated in a hospital. Tell your healthcare provider right away if you develop shortness of breath or a cough that doesn't go away during treatment with WEZLANA.

The most common side effects of WEZLANA include:

• nasal congestion, sore throat, and runny nose
• upper respiratory infections
• fever
• headache
• tiredness
• itching
• nausea and vomiting
• influenza

• redness at the injection site
• vaginal yeast infections
• urinary tract infections
• sinus infection
• bronchitis
• diarrhea
• stomach pain
• joint pain

These are not all of the possible side effects of WEZLANA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to 1-800-77-AMGEN (1-800-772-6436).

How should I store WEZLANA?

• Store WEZLANA vials and prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C).
• Store WEZLANA in the original carton to protect it from light until time to use it.
• Do not freeze WEZLANA.
• Do not shake WEZLANA.
• If needed, individual WEZLANA prefilled syringe and 45 mg vial may also be stored at room temperature up to 86°F (30°C) for a maximum single period of up to 30 days in the original carton to protect from light.
• Record the date when the prefilled syringe or the 45 mg vial is first removed from the refrigerator on the carton in the space provided.
• After a prefilled syringe or the 45 mg vial has been stored at room temperature, do not return it to the refrigerator.
• Throw away (discard) the prefilled syringe or the 45 mg vial if it is not used within 30 days at room temperature storage.
• Do not use WEZLANA after the expiration date on the carton or on the prefilled syringe or on the 45 mg vial.

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

General information about the safe and effective use of WEZLANA.

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

What are the ingredients in WEZLANA?

Active ingredient: ustekinumab-auub

Inactive ingredients: Single-dose prefilled syringe and single-dose vial for subcutaneous use contain histidine, histidine hydrochloride monohydrate, Polysorbate 80, and sucrose. Single-dose vial for intravenous infusion contains edetate disodium, histidine, histidine hydrochloride monohydrate, methionine, Polysorbate 80, and sucrose.

WEZLANA^® (ustekinumab-auub)

Manufactured for Nuvaila, Dublin, Ireland

Manufactured by: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799 U.S.A.

US License Number 1080

© 2025-2026 Amgen Inc. All rights reserved.

1xxxxxx – v4

INSTRUCTIONS FOR USE

WEZLANA^® (wez-LAH-nah)

(ustekinumab-auub)

injection, for subcutaneous use

single-dose prefilled syringe

This Instructions for Use contains information on how to inject WEZLANA using a prefilled syringe.

The WEZLANA prefilled syringe is for subcutaneous use only (inject directly under the skin).

Getting to Know The Prefilled Syringe

Step 1. Important Information You Need to Know Before Injecting WEZLANA

Dosing:

• WEZLANA comes in two different doses: 45 mg and 90 mg. Check the prescription to make sure you have the correct dose.

  • If the dose is 45 mg, you will receive one 45 mg prefilled syringe.
  • If the dose is 90 mg, you will receive either one 90 mg prefilled syringe or two 45 mg prefilled syringes. If you receive two 45 mg prefilled syringes for a 90 mg dose, you will need to give two injections, one right after the other.
• The look of the prefilled syringe will be different for each dose. The amount of medicine in the syringe will also be different for each dose.
• The 45 mg dose will have a smaller amount of medicine and the 90 mg dose will have a larger amount of medicine. Check the figures below to see what the dose looks like in the syringe.

45 mg/0.5 mL		90 mg/mL

Using the WEZLANA prefilled syringe:

• It is important that you do not try to give the injection until you have fully read and understood this Instructions for Use.
• If a healthcare provider decides that you or a caregiver can give the WEZLANA injection at home, you should receive training on the right way to prepare and give the injections. Do not try to inject WEZLANA until you have been shown the right way to give the injections by a healthcare provider.
• Do not use the syringe if the carton is damaged or seal is broken.
• Do not use the syringe after the expiration date on the label.
• Do not shake the syringe.
• Do not remove the needle cap from the syringe until you are ready to inject.
• Do not use the syringe if it has been frozen.
• Do not use the syringe if it has been dropped on a hard surface. Part of the syringe may be broken even if you cannot see the break. Use a new syringe and call 1-800-77-AMGEN (1-800-772-6436).
• The syringe is not made with natural rubber latex.

Frequently asked questions:

For additional information and answers to frequently asked questions, visit www.WEZLANA.com.

Where to get help:

If you want more information or help using WEZLANA:

• Contact your healthcare provider
• Visit www.WEZLANA.com, or
• Call 1-800-77-AMGEN (1-800-772-6436).

Step 2. Storing and Preparing to Inject WEZLANA

2a Refrigerate the syringe carton until you are ready to use it.

• Keep the syringe in the refrigerator between 36 °F to 46 °F (2 °C to 8 °C).
• Keep the syringe in the original carton to protect it from light or physical damage until you are ready to use it.
• Do not freeze the syringe.
• Do not store the syringe in extreme heat or cold. For example, avoid storing in your vehicle`s glove box or trunk.

2b Grasp the syringe by the body and remove it from the carton. To prevent early activation of the needle safety guard, do not touch the NEEDLE GUARD CLIPS at any time during use.

• Do not grab the plunger rod, finger grip or the needle cap.
• Do not grab the needle guard clips.
• Remove the number of syringes you need for your injection.
• Put any unused syringes back into refrigerator.

WAIT

2c Wait 30 minutes for the syringe to reach room temperature.

• Let the syringe warm up naturally.
• Do not heat with hot water, a microwave, or direct sunlight.
• Do not shake the syringe at any time.
• Using the syringe at room temperature allows for a more comfortable injection.

2d If needed, individual WEZLANA prefilled syringes may be stored at room temperature for up to 30 days.

• Keep WEZLANA at room temperature between 68 °F to 77 °F (20 °C to 25 °C) for a maximum single period of up to 30 days.
• Do not use WEZLANA if the prefilled syringe has been stored above 86 ºF (30 ºC).
• Do not put WEZLANA back in refrigerator after it has been stored at room temperature.
• Record the date you removed WEZLANA from the refrigerator and use within 30 days.

2e Gather and place the following items for the injection on a clean, flat, and well-lit surface:

• WEZLANA syringe (room temperature)
• Sharps disposal container (see Step 5. Disposing of WEZLANA and Checking the Injection Site)
• Alcohol wipe
• Adhesive bandage
• Cotton ball or gauze pad

Step 3. Getting Ready for The Injection

3a Inspect the medicine through the viewing window. It should be clear to white like an opal and colorless to light yellow.

• It is okay to see air bubbles.
• Do not use WEZLANA if the medicine is frozen, cloudy, discolored, or has large particles.

3b Check the expiration (Exp.) date and inspect the syringe for damage.

• Do not use if the expiration date has passed.

• Do not use the syringe if:

  • the needle cap is missing or loose
  • it has cracks or broken parts
  • it has been dropped on a hard surface or dropped without the needle cap in place
• Make sure you have the right medicine and dose.

3c Select the stomach area (abdomen) or upper legs (thighs) for the injection.

• Only a healthcare provider or a caregiver should inject into the back of the upper arm or buttocks.
• Choose a different location (site) for each injection.
• The areas in blue are the recommended injection locations.

3d Wash your hands thoroughly with soap and water.

3e Clean the injection site with alcohol wipe.

• Let your skin dry on its own.
• Do not touch the clean area again before injecting.

Step 4. Injecting WEZLANA

4a Pull the needle cap straight off while holding the syringe body.

• Do not hold the plunger or plunger head while removing the needle cap.
• Do not twist or bend the needle cap.
• Never put the needle cap back on. It may damage the needle.
• Do not let anything touch the needle after the cap is removed.
• Do not place the syringe on any surface after the cap is removed.
• Do not try to push air bubbles out. It is okay to see air bubbles.
• A drop of medicine at the needle tip is normal.

PINCH

4b Pinch the skin around injection site before injection.

• Gently pinch the skin with 1 hand between the thumb and index finger to create a bump for the injection.
• If possible, the bump should be about 2 inches wide.

INSERT

4c Insert the needle into the pinched skin.

• Insert the needle into the pinched skin at about a 45-degree angle.
• Do not place your finger on the plunger rod while inserting the needle, as this may result in lost medicine.

INJECT

4d Inject all of the liquid by slowly pressing the plunger head all the way down with your thumb until it is completely between the needle guard clips. Hold the finger grips with your fingers as shown in the figure.

• Do not pull back on the plunger rod at any time.
• Do not remove the syringe until all medicine has been injected.

LIFT

4e Keep pressure on the plunger head with your thumb and remove the needle from your skin.

• Let go of the skin after the needle is removed.
• Slowly take your thumb off the plunger head. This will let the empty syringe move up until the entire needle is automatically covered by the needle guard.

4f Repeat steps 1 to 5 if a second injection is required.

• Check the prescription for the dose.

• If the dose is 90 mg, you will receive either one 90 mg prefilled syringe or two 45 mg prefilled syringes.

  • If you receive two 45 mg prefilled syringes for a 90 mg dose, you will need to give a second injection right after the first injection.
  • Repeat Steps 1 to 5 for the second injection using a new syringe.
  • Choose a different site for the second injection.

Step 5. Disposing of WEZLANA and Checking the Injection Site

5a Place the used syringe and needle cap in an FDA-cleared sharps disposal container right away after use.

• Do not reuse the syringe.

5b Check injection site.

• Do not rub the injection site.
• If there is blood, press a cotton ball or gauze pad on the injection site.
• Apply an adhesive bandage if necessary.

Additional information about your sharps disposal container

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.

Disposing of sharps containers:

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.

For more information or help call 1-800-77-AMGEN (1-800-772-6436).

Manufactured for Nuvaila, Dublin, Ireland

Manufactured by: Amgen Inc., One Amgen Center Drive, Thousand Oaks, California 91320-1799

US License Number 1080

© 2025-2026 Amgen Inc. All rights reserved.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 05/2026

v3

INSTRUCTIONS FOR USE

WEZLANA^® (wez-LAH-nah)

(ustekinumab-auub)

injection, for subcutaneous use

single-dose vial

This Instructions for Use contains information on how to inject WEZLANA using a vial.

Read this Instructions for Use before you start using WEZLANA. A healthcare provider should show you how to prepare, measure the dose, and give the injection the right way.

If you cannot give the injection:

• ask a healthcare provider to help you, or
• ask someone who has been trained by a healthcare provider to give the injections.

Do not try to inject WEZLANA until you have been shown the right way to give the injections by a healthcare provider.

Important Information You Need to Know Before Injecting WEZLANA:

• For subcutaneous use only (inject directly under the skin).

• Before you start, check the carton to make sure that the number of vials and strength is correct. You will have either 45 mg or 90 mg as prescribed by the healthcare provider.

  • If the dose is 45 mg or less, you will receive one 45 mg vial.
  • If the dose is more than 45 mg, you will receive two 45 mg vials and you will need to give two injections, one right after the other.
  • Make sure you know the proper amount (volume) to remove from the vial(s) and type of syringe(s) needed for dosing. If you do not know the amount or type of syringe(s) needed, contact your healthcare provider for further instructions.
• Check the expiration date on the vial and carton. If the expiration date has passed, do not use it. If the expiration date has passed, call the healthcare provider or pharmacist, or call 1-800-77-AMGEN (1-800-772-6436) for help.
• Check the vial for any particles or discoloration. The liquid in the vial should look clear to white like an opal and colorless to light yellow.
• Do not use if it is frozen, discolored, cloudy or has large particles. Get a new vial.
• Do not shake the vial at any time. Shaking the vial may damage the WEZLANA medicine. If the vial has been shaken, do not use it. Get a new vial.
• Do not use a WEZLANA vial more than 1 time, even if there is medicine left in the vial. After the rubber stopper is punctured, WEZLANA can become contaminated by harmful bacteria which could cause an infection if re-used. Therefore, throw away any unused WEZLANA after you give the injection.
• Safely throw away (dispose of) WEZLANA vials, needles, and syringes after use. See " Step 6: Disposing of needles, syringes, and vials ."
• Do not re-use syringes or needles.
• To avoid needle-stick injuries, do not recap needles.

Storing WEZLANA vials

• Store WEZLANA vials in a refrigerator between 36 °F to 46 °F (2 °C to 8 °C).
• Store WEZLANA vials in the original carton to protect from light until the time of use.
• Do not freeze WEZLANA vials.
• If needed, the WEZLANA vial can also be stored at room temperature up to 86 °F (30 °C) for a maximum single period of up to 30 days in the original carton to protect from light. Write the date that you removed WEZLANA from the refrigerator on the carton in the space provided.
• Do not use WEZLANA if it has been stored above 86 °F (30 °C).
• Do not put WEZLANA back in the refrigerator after it has been stored at room temperature.
• Throw away (discard) the vial if it is not used within 30 days of room temperature storage.

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

Gather the supplies you will need to prepare WEZLANA and to give the injection. (See Figure A)

You will need:

• a syringe with the needle attached, you will need a prescription from a healthcare provider to get syringes with the needles attached from a pharmacy
• alcohol wipes
• cotton balls or gauze pads
• adhesive bandage
• your prescribed dose of WEZLANA
• FDA-cleared sharps disposal container. See "Step 6: Dispose of the needles, syringes, and vials."

Figure A

Step 1. Preparing the injection

• Choose a well-lit, clean, flat work surface.
• Wash your hands well with soap and warm water.

Step 2. Preparing the injection site

Figure B

* Areas in blue are recommended injection sites.

• Choose an injection site around the stomach area (abdomen), or upper legs (thighs). (See Figure B)
• If a caregiver is giving the injection, the outer area of the upper arms, or the buttocks may also be used.
• Use a different injection site for each injection. Do not give an injection in an area of the skin that is tender, bruised, red or hard.
• Clean the skin with an alcohol wipe where you plan to give the injection.
• Do not touch this area again before giving the injection. Let the skin dry before injecting.
• Do not fan or blow on the clean area.

Step 3. Preparing the vial

Figure C

3a

• Remove the cap from the top of the vial. Throw away the cap but do not remove the rubber stopper. (See Figure C)

Figure D

3b

• Clean the rubber stopper with an alcohol wipe. (See Figure D)
• Do not touch the rubber stopper after you clean it.
• Put the vial on a flat surface.

Step 4. Preparing the syringe

Figure E

4a

• Pick up the syringe with the needle attached.
• Remove the cap that covers the needle. (See Figure E)
• Throw the needle cap away. Do not touch the needle or allow the needle to touch anything.

Figure F

4b

• Carefully pull back on the plunger to the line that matches the dose prescribed by the healthcare provider.
• Hold the vial between your thumb and index (pointer) finger.
• Use your other hand to push the syringe needle through the center of the rubber stopper. (See Figure F)

Figure G

4c

• Push down on the plunger until all of the air has gone from the syringe into the vial.
• Turn the vial and the syringe upside down. (See Figure G)
• Hold the WEZLANA vial with 1 hand.
• It is important that the needle is always in the liquid in order to prevent air bubbles forming in the syringe.
• Pull back on the syringe plunger with your other hand.
• Fill the syringe until the black tip of the plunger lines up with the mark that matches the prescribed dose.

Figure H

4d

• Do not remove the needle from the vial. Hold the syringe with the needle pointing up to see if it has any air bubbles inside.
• If there are air bubbles, gently tap the side of the syringe until the air bubbles rise to the top. (See Figure H)
• Slowly press the plunger up until all of the air bubbles are out of the syringe (but none of the liquid is out).
• Remove the syringe from the vial. Do not lay the syringe down or allow the needle to touch anything.

Step 5. Injecting WEZLANA

Figure I

5a

• Hold the barrel of the syringe in 1 hand, between the thumb and index fingers.
• Do not pull back on the plunger at any time.
• Use the other hand to gently pinch the cleaned area of skin. Hold firmly.
• Use a quick, dart-like motion to insert the needle into the pinched skin at about a 45-degree angle. (See Figure I)

Figure J

5b

• Push the plunger with your thumb as far as it will go to inject all of the liquid. Push it slowly and evenly, keeping the skin gently pinched. (See Figure J)
• When the syringe is empty, pull the needle out of the skin and then let go of the skin.
• When the needle is pulled out of the skin, there may be a little bleeding at the injection site. This is normal. You can press a cotton ball or gauze pad to the injection site if needed. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if necessary.

If the dose is more than 45 mg, you will receive two 45 mg vials and you will need to give a second injection right after the first. Repeat Steps 1 to 6 using a new syringe. Choose a different site for the second injection.

Step 6. Disposing of needles, syringes, and vials

• Do not re-use a syringe or needle.
• To avoid needle-stick injuries, do not recap a needle.
• Put the needles and syringes in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes 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 local or state laws about how you should throw away syringes and needles. 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 sharps disposal container.
• Throw away the vial into the container where you put the syringes and needles.
• If you have any questions, talk to your healthcare provider or pharmacist.

Manufactured for Nuvaila, Dublin, Ireland

Manufactured by: Amgen Inc., One Amgen Center Drive, Thousand Oaks, California 91320-1799

US License Number 1080

© 2025-2026 Amgen Inc. All rights reserved.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised 05/2026

v3