Hulio: Uses, Side Effects and Dosage

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

HULIO is a medicine that affects your immune system. HULIO can lower the ability of your immune system to fight infections. Serious infections have happened in people taking adalimumab products. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some people have died from these infections.

• Your healthcare provider should test you for TB before starting HULIO.
• Your healthcare provider should check you closely for signs and symptoms of TB during treatment with HULIO.

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

Before starting HULIO, tell your healthcare provider if you:

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

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

• 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
• weight loss

• are being treated for an infection
• get a lot of infections or have infections that keep coming back
• have diabetes
• have TB, or have been in close contact with someone with TB
• were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your healthcare provider if you are not sure.
• live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use HULIO. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
• have or have had hepatitis B
• use the medicine ORENCIA (abatacept), KINERET (anakinra), RITUXAN (rituximab), IMURAN (azathioprine), or PURINETHOL (6–mercaptopurine, 6-MP).
• are scheduled to have major surgery

After starting HULIO, call your healthcare provider right away if you have an infection, or any sign of an infection.

HULIO can make you more likely to get infections or make any infection that you may have worse.

Cancer

• For children and adults taking Tumor Necrosis Factor (TNF)-blockers, including HULIO, the chances of getting cancer may increase.
• There have been cases of unusual cancers in children, teenagers, and young adults using TNF-blockers.
• People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
• If you use TNF blockers including HULIO your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin). These types of cancer are generally not life-threatening if treated. Tell your healthcare provider if you have a bump or open sore that does not heal.
• Some people receiving TNF blockers including HULIO developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn’s disease or ulcerative colitis with another medicine called IMURAN (azathioprine) or PURINETHOL (6-mercaptopurine, 6–MP).

What is HULIO?

HULIO is a medicine called a Tumor Necrosis Factor (TNF) blocker. HULIO is used:

• To reduce the signs and symptoms of:

  • moderate to severe RA in adults. HULIO can be used alone, with methotrexate, or with certain other medicines.
  • moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. HULIO can be used alone or with methotrexate.
  • psoriatic arthritis (PsA) in adults. HULIO can be used alone or with certain other medicines.
  • ankylosing spondylitis (AS) in adults.
  • moderate to severe hidradenitis suppurativa (HS) in adults.

• To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.

• To treat moderate to severe ulcerative colitis (UC) in adults.

  It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines.

• To treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
• To treat non-infectious intermediate, posterior, and panuveitis in adults.

What should I tell my healthcare provider before taking HULIO?

HULIO may not be right for you. Before starting HULIO, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection. See “What is the most important information I should know about HULIO?”
• have or have had cancer.
• have any numbness or tingling or have a disease that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome.
• have or had heart failure.
• have recently received or are scheduled to receive a vaccine. You may receive vaccines, except for live vaccines while using HULIO. Children should be brought up to date with all vaccines before starting HULIO.
• are allergic to HULIO or to any of its ingredients. See the end of this Medication Guide for a list of ingredients in HULIO.

• are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you should take HULIO while you are pregnant or breastfeeding.

• have a baby and you were using HULIO during your pregnancy. Tell your baby’s healthcare provider before your baby receives any vaccines.

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

Especially tell your healthcare provider if you use:

• ORENCIA (abatacept), KINERET (anakinra), REMICADE (infliximab), ENBREL (etanercept), CIMZIA (certolizumab pegol) or SIMPONI (golimumab), because you should not use HULIO while you are also using one of these medicines.
• RITUXAN (rituximab). Your healthcare provider may not want to give you HULIO if you have received RITUXAN (rituximab) recently.
• IMURAN (azathioprine) or PURINETHOL (6–mercaptopurine, 6-MP).

Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.

How should I take HULIO?

• HULIO is given by an injection under the skin. Your healthcare provider will tell you how often to take an injection of HULIO. This is based on your condition to be treated. Do not inject HULIO more often than you were prescribed.
• See the Instructions for Use inside the carton for complete instructions for the right way to prepare and inject HULIO.
• Make sure you have been shown how to inject HULIO before you do it yourself. You can call your healthcare provider or 1-800-796-9526 if you have any questions about giving yourself an injection. Someone you know can also help you with your injection after they have been shown how to prepare and inject HULIO.
• Do not try to inject HULIO yourself until you have been shown the right way to give the injections. If your healthcare provider decides that you or a caregiver may be able to give your injections of HULIO at home, you should receive training on the right way to prepare and inject HULIO.
• Do not miss any doses of HULIO unless your healthcare provider says it is okay. If you forget to take HULIO, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. This will put you back on schedule. In case you are not sure when to inject HULIO, call your healthcare provider or pharmacist.
• If you take more HULIO than you were told to take, call your healthcare provider.

What are the possible side effects of HULIO?

HULIO can cause serious side effects, including:

See “What is the most important information I should know about HULIO?”

• Serious Infections.

  Your healthcare provider will examine you for TB and perform a test to see if you have TB. 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 HULIO and during treatment with HULIO. Even if your TB test is negative your healthcare provider should carefully monitor you for TB infections while you are taking HULIO. People who had a negative TB skin test before receiving adalimumab products have developed active TB. Tell your healthcare provider if you have any of the following symptoms while taking or after taking HULIO:

• cough that does not go away
• low grade fever

• weight loss
• loss of body fat and muscle (wasting)

• Hepatitis B infection in people who carry the virus in their blood.

  If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use HULIO. Your healthcare provider should do blood tests before you start treatment, while you are using HULIO, and for several months after you stop treatment with HULIO. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B infection:

• muscle aches
• feel very tired
• dark urine
• skin or eyes look yellow
• little or no appetite
• vomiting

• clay-colored bowel movements
• fever
• chills
• stomach discomfort
• skin rash

• Allergic reactions. Allergic reactions can happen in people who use HULIO. Call your healthcare provider or get medical help right away if you have any of these symptoms of a serious allergic reaction:

• hives
• trouble breathing

• swelling of your face, eyes, lips or mouth

• Nervous system problems. Signs and symptoms of a nervous system problem include: numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
• Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
• New heart failure or worsening of heart failure you already have. Call your healthcare provider right away if you get new worsening symptoms of heart failure while taking HULIO, including:

• shortness of breath
• sudden weight gain

• swelling of your ankles or feet

• Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that gets worse in the sun. Symptoms may improve when you stop HULIO.

• Liver problems. Liver problems can happen in people who use TNF-blocker medicines.

  These problems can lead to liver failure and death. Call your healthcare provider right away if you have any of these symptoms:

• feel very tired
• poor appetite or vomiting

• skin or eyes look yellow
• pain on the right side of your stomach (abdomen)

• Psoriasis. Some people using adalimumab products had new psoriasis or worsening of psoriasis they already had. Tell your healthcare provider if you develop red scaly patches or raised bumps that are filled with pus. Your healthcare provider may decide to stop your treatment with HULIO.

Call your healthcare provider or get medical care right away if you develop any of the above symptoms. Your treatment with HULIO may be stopped.

The most common side effects of HULIO include:

• injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. Call your healthcare provider right away if you have pain, redness or swelling around the injection site that does not go away within a few days or gets worse.
• upper respiratory infections (including sinus infections).
• headaches.
• rash.

These are not all the possible side effects with HULIO. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. 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.

How should I store HULIO?

• Store HULIO in the refrigerator at 36ºF to 46ºF (2ºC to 8ºC). Store HULIO in the original carton until use to protect it from light.
• Do not freeze HULIO. Do not use HULIO if frozen, even if it has been thawed.
• Refrigerated HULIO may be used until the expiration date printed on the HULIO carton, dose tray, Pen or prefilled syringe. Do not use HULIO after the expiration date.
• If needed, for example when you are traveling, you may also store HULIO at room temperature up to 77°F (25°C) for up to 14 days. Store HULIO in the original carton until use to protect it from light.
• Throw away HULIO if it has been kept at room temperature and not been used within 14 days.
• Record the date you first remove HULIO from the refrigerator in the spaces provided on the carton and dose tray.
• Do not store HULIO in extreme heat or cold.
• Do not use a Pen or prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it.

Keep HULIO, injection supplies, and all other medicines out of the reach of children.

General information about the safe and effective use of HULIO.

Medicines are sometimes prescribed for purposes other than those listed in a Medication

Guide. Do not use HULIO for a condition for which it was not prescribed. Do not give

HULIO to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about HULIO. If you

would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about HULIO that is written for health professionals.

What are the ingredients in HULIO?

Active ingredient: adalimumab-fkjp

HULIO Pen 40 mg/0.8 mL, HULIO 40 mg/0.8 mL prefilled syringe, HULIO 20 mg/0.4 mL prefilled syringe.

Inactive ingredients: methionine, monosodium glutamate, polysorbate 80, sorbitol and Water for Injection. Hydrochloric acid is added as necessary to adjust pH.

Manufactured by: Biocon Biologics Inc, 245 Main St, 2nd Floor, Cambridge, MA 02142, U.S.A.

Product of Japan

U.S. License Number 2324

For more information, call Biocon Biologics at 1-833-986-1468 or you can enroll in a patient support program by calling 1-833-44-HULIO (1-833-444-8546).

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 02/2025

INSTRUCTIONS FOR USE - Pen

HULIO^® Pen (hue lee oh)

(adalimumab-fkjp) injection

40 mg/0.8 mL

Single-Dose Pen

Important Information:

• Do not try to inject HULIO yourself until you have been shown the right way to give the injections and have read and understand this Instructions for Use.
• If your healthcare provider decides that you or a caregiver may be able to give your injections of HULIO at home, you should receive training on the right way to prepare and inject HULIO.
• There will be a “click” during your injections. You should practice injecting HULIO with your healthcare provider so that you are not startled by this “click” when you start giving yourself injections at home.
• It is important that you read, understand, and follow these instructions so that you inject HULIO the right way. It is also important to talk to your healthcare provider to be sure you understand your HULIO dosing instructions.
• To help you remember when to inject HULIO, you can mark your calendar ahead of time.
• Call your healthcare provider if you or your caregiver have any questions about the right way to inject HULIO.
• Each HULIO Pen can only be used one time. Throw the used Pen away (See How should I throw away (dispose of) the used HULIO Pen) after one dose, even if there is still medicine left in it. Do not reuse your HULIO Pen.

For Questions or Assistance, Call Biocon Biologics at 1-833-986-1468

The figure below shows what the HULIO Pen looks like. See Figure A.

Step 1. Gather the Supplies for Your Injection

• Take your HULIO Pen out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature.

  • Do not warm HULIO in any other way (for example, do not warm it in a microwave or in hot water).
  • Do not use HULIO if it has been frozen, even if it has been thawed.
  • Do not put the HULIO Pen back in the refrigerator after reaching room temperature.

• Do not uncap your HULIO Pen until you are ready to inject and will not be interrupted.

You will need the following supplies for each injection of HULIO.

• 1 HULIO Pen (See Figure A)
• 1 alcohol swab
• 1 cotton ball or gauze pad (not included in your HULIO carton)
• Puncture-resistant sharps disposal container for HULIO Pen disposal (not included in your HULIO carton). See the “How should I throw away (dispose of) the used HULIO PEN?” section at the end of this Instructions for Use.

If you do not have all the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist.

Find a clean, flat surface to place the supplies on.

Step 2. Check the Carton, Dose Tray and HULIO Pen

• Make sure the name HULIO appears on the carton, dose tray, and HULIO Pen label.
• Check the seals on the top or bottom of the carton to make sure they are not broken or missing.
• Check the expiration date on the carton, dose tray, and HULIO Pen.

• Do not usethe HULIO Pen and call your healthcare provider or pharmacist if:

  • you drop or crush your HULIO Pen.
  • the seals on the top or bottom of the carton are broken or missing.
  • the expiration date on the carton, dose tray, and Pen has passed.
  • The HULIO PEN has been frozen or left in direct sunlight.
  • HULIO has been kept at room temperature for longer than 14 days or HULIO has been stored above 77°F (25°C).
  • the liquid in the HULIO Pen is cloudy, discolored or has flakes or particles in it.

See the “How should I store HULIO?” section at the end of this Instructions for Use.

Check the fluid level in the Pen:

• Hold the Pen with the protective clear cap covering the orange activator pointed down. (See Figure B).
• Make sure the amount of liquid in the Pen is at the fill line or close to the fill line seen through the window. You may need to shake gently to see the liquid. This is the full dose of HULIO that you will inject. (See Figure B).
• If the Pen does not have the full amount of liquid, do not use that Pen. Call your pharmacist.

• Turn the Pen and hold with the protective clear cap covering the orange activator pointed sideways. (See Figure C).

• Check the solution through the windows on the side of the Pen to make sure the liquid is clear and colorless to pale brownish-yellow.
• Do not use your HULIO Pen if the liquid is cloudy, discolored, or if it has flakes or particles in it. Call your pharmacist.
• It is normal to see one or more bubbles in the window.

Step 3. Choose the Injection Site

• Wash your hands with soap and water and dry well.

• Choose an injection site on:

  • the front of your thighs or
  • your lower abdomen (belly). If you choose your abdomen, do not use the area 2 inches around your belly button (navel). (See Figure D).
• Choose a different site (rotate) each time you give yourself an injection. Each new injection should be given at least 1 inch from a site you used before.

• Do not inject HULIO into skin that is:

  • sore (tender)
  • bruised
  • red
  • hard
  • Scarred or where you have stretch marks
• If you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions on your skin.
• Do not inject through your clothes.

Figure D

Step 4: Prepare the Injection Site

• Wipe the injection site with an alcohol prep (swab) using a circular motion.
• Do not touch this area again before giving the injection.
• Allow the skin to dry before injecting. Do not fan or blow on the clean area.

Step 5. Prepare the HULIO PEN

• Do not remove the protective clear cap until right before your injection.
• Hold the middle of the Pen (white body) with one hand so that you are not touching the protective clear cap. Turn the Pen so that the orange activator end is pointing down. See (Figure E).

• With your other hand, pull the protective clear cap straight off (do not twist the cap). Make sure the small needle cover of the syringe has come off with the protective clear cap. (See Figure F).

• Important: Do not put the protective clear cap back on. It may damage the needle.
• Throw away the protective clear cap.
• The orange activator which covers the needle is where the needle comes out. The needle can now be seen.

• Caution:

  • Never put your thumb, fingers, or hand over the orange activator after the protective clear cap is removed.
  • Never press or push the orange activator with your thumb, fingers, or hand.
  • If accidental injection to your fingers or hands happens, apply first-aid and either call your healthcare provider or go to the nearest hospital emergency room if needed.
  • Do not touch the needle with your fingers or let the needle touch anything.
• You may see a few drops of liquid come out of the needle. This is normal.
• Turn the Pen so the white end is pointed up. (See Figure G).

• Hold the Pen so that you can see the window. (See Figure H). It is normal to see one or more bubbles in the window.

Step 6. Position the Pen

• Squeeze the area of the cleaned skin and hold it firmly until the injection is complete. (See Figure I). You will inject into this raised area of skin.

• Place the orange activator end of the Pen straight (at a 90º angle) and flat against the raised area of your skin that you are squeezing.
• Place the Pen so that it will not inject the needle into your fingers that are holding the raised skin. (See Figure J).

Step 7. Inject HULIO

• It is important that you firmly push the Pen down all the way against the injection site to begin the injection. Try not to cover the window. (See Figure K).
• Do not move, twist, or rotate the Pen during the injection.

• Keep pushing down to prevent the Pen from moving away from the skin during the injection.
• You will hear a loud ‘click’ when the orange activator is pressed down against the injection site. The loud click means the start of the injection.
• Continue to push the Pen against your squeezed, raised skin until all the medicine is injected. This can take up to 10 seconds, so count slowly to ten. Keep pushing the Pen against the squeezed, raised skin of your injection site for the whole time so you get the full dose of medicine.
• You will know that the injection has finished when:
• A 2nd ‘Click’ was heard, and
• Orange indicator has stopped moving and completely blocked the viewing window (See Figure L)
• 10 seconds has passed.
• Make sure all 3 of these have happened to make certain all the medicine was delivered. If the needle did not retract or you do not think you received the full dose, contact your healthcare provider for help.

• When the injection is finished, slowly pull the Pen from your skin. The white needle sleeve will move to cover the needle tip. (See Figure M).

• Do not touch the needle. The white needle sleeve is there to prevent you from touching the needle.
• If the needle did not retract or you do not think you received the full dose, contact your healthcare provider for help.
• There may be a small amount of liquid on the injection site. This is normal.
• Press a cotton ball or gauze pad over the injection site and hold it for 10 seconds. Do not rub the injection site. You may have slight bleeding. This is normal.

Step 8. Throw away (dispose of) your used HULIO Pen in a sharps disposal container right away after use. See the section “How should I throw away (dispose of) the used HULIO Pen?”

How should I throw away (dispose of) the used HULIO PEN?

• Put your Pen in an FDA-cleared sharps disposal container right away after use. (See Figure N). Do not throw away the Pen in your household trash.
• Do not try to touch the needle. The orange needle sleeve is there to prevent you from touching the needle.

• 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.
• For the safety and health of you and others, never re-use your HULIO Pens.
• The used alcohol pads, cotton balls, dose trays and packaging may be placed in your household trash.
• 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.
• Always keep the sharps container out of the reach of children.

Keep a record of the dates and location of your injection sites. To help you remember when to take HULIO, you can mark your calendar ahead of time.

How should I Store HULIO?

• Store HULIO in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC).
• Store HULIO in the original carton until use to protect it from light.
• Do not freeze HULIO.
• If needed, for example when you are traveling, you may also store HULIO at room temperature up to 77°F (25°C) for up to 14 days.
• Throw away HULIO if it has been kept at room temperature and not been used within 14 days.
• Do not store HULIO in extreme heat or cold, such as a hot car, or a freezing car overnight.
• Keep HULIO, injection supplies, and all other medicines out of the reach of children.

Manufactured by and for:

Biocon Biologics Inc.

245 Main St, 2nd Floor,

Cambridge, MA 02142, U.S.A.

U.S. License No. 2324

Product of Japan

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

Issued: 02/2025

INSTRUCTIONS FOR USE - Syringe

HULIO^® (hueꞌ lee oh)

(adalimumab-fkjp) injection

40 mg/0.8 mL and 20 mg/0.4 mL

Single-Dose Prefilled Syringe

Important Information:

• Do not try to inject HULIO yourself until you have been shown the right way to give the injections and have read and understand this Instructions for Use.
• If your healthcare provider decides that you or a caregiver may be able to give your injections of HULIO at home, you should receive training on the right way to prepare and inject HULIO.
• It is important that you read, understand, and follow these instructions so that you inject HULIO the right way. It is also important to talk to your healthcare provider to be sure you understand your HULIO dosing instructions.
• To help you remember when to inject HULIO, you can mark your calendar ahead of time.
• Call your healthcare provider if you or your caregiver have any questions about the right way to inject HULIO.
• Each HULIO Prefilled Syringe can only be used one time. Throw the used Prefilled Syringe away (See How should I throw away (dispose of) the used Prefilled Syringe?) after one dose, even if there is still medicine left in it. Do not reuse your HULIO Prefilled Syringe.

For Questions or Assistance, Call Biocon Biologics at 1-833-986-1468

The figure shows what a prefilled syringe looks like. See Figure A.

Step 1. Gather the Supplies for Your Injection

• Take your HULIO prefilled syringe out of the refrigerator 15 to 30 minutes before injecting to allow the liquid to reach room temperature.

  • Do not warm HULIO in any other way (for example, do not warm it in a microwave or in hot water).
  • Do not use HULIO if it has been frozen, even if it has been thawed.
  • Do not put HULIO back in the refrigerator after reaching room temperature.
• Do not uncap your HULIO Prefilled Syringe until you are ready to inject and will not be interrupted.

You will need the following supplies for each injection of HULIO.

• 1 HULIO Prefilled Syringe (See Figure A)
• 1 alcohol swab
• 1 cotton ball or gauze pad (not included in your HULIO carton)
• Puncture-resistant sharps disposal container for HULIO prefilled syringe disposal (not included in your HULIO carton). See “How should I throw away (dispose of) the used prefilled syringes and needles?” section at the end of this Instructions for Use.

If you do not have all the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist.

Find a clean, flat surface to place the supplies on.

Step 2. Check the carton, dose tray, and prefilled Syringe

• Make sure the name HULIO appears on the dose tray and prefilled syringe label.
• Check the seals on the top or bottom of the carton to make sure they are not broken or missing.
• Check the expiration date on the carton, dose tray, and HULIO Prefilled Syringe.

• Do not use the HULIO Prefilled Syringe and call your healthcare provider or pharmacist if:

• you drop or crush your HULIO Prefilled Syringe.
• the seals on the top or bottom of the carton are broken or missing.
• the expiration date on the carton, dose tray, and HULIO Prefilled Syringe have passed.
• the prefilled syringe has been frozen or left in direct sunlight.
• HULIO has been kept at room temperature for longer than 14 days or HULIO has been

stored above 77°F (25°C).

• the liquid in the prefilled syringe is cloudy, discolored or has flakes or particles in it.

See the “How should I store HULIO?” section at the end of this Instructions for Use.

Check the fluid level in the syringe:

• Hold the syringe with the covered needle pointing down. (See Figure B).

• Hold the syringe at eye level. Look closely to make sure that the amount of liquid in the syringe is the same or close to the:
• 0.8 mL line for the 40 mg prefilled syringe. (See Figure C).
• 0.4 mL line for the 20 mg prefilled syringe. (See Figure C).

• You may need to shake gently to see liquid.
• The top of the liquid may be curved. If the syringe does not have the correct amount of liquid, do not use that syringe. Call your pharmacist.

Step 3. Choose the Injection Site

• Wash your hands with soap and water and dry well.
• Choose an injection site on:
• the front of your thighs or
• your lower abdomen (belly). If you choose your abdomen, do not use the area 2 inches around your belly button (navel). (See Figure D).
• Choose a different site (rotate) each time you give yourself an injection. Each new injection should be given at least 1 inch from a site you used before.
• Do not inject HULIO into skin that is:
• sore (tender)
• bruised
• red
• hard
• scarred or where you have stretch marks
• If you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions on your skin.
• Do not inject through your clothes.

Step 4. Prepare the Injection Site

• Wipe the injection site with an alcohol prep (swab) using a circular motion.
• Do not touch this area again before giving the injection.
• Allow the skin to dry before injecting. Do not fan or blow on the clean area.

Step 5. Prepare the HULIO Prefilled Syringe and Needle

• Do not remove the needle cover until right before your injection.
• Hold the syringe in one hand. With the other hand gently remove the needle cover. (See Figure E).
• Throw away the needle cover.

Important:

• Do not touch the needle with your fingers or let the needle touch anything.
• Do not replace the needle cover.
• Do not remove air bubble(s).
• Do not use the syringe if dropped after removing the needle cover.
• You may see a drop of liquid at the end of the needle. This is normal.

Step 6. Position the Syringe

• Hold the body of the prefilled syringe in one hand between the thumb and index finger. Hold the syringe in your hand like a pencil. (See Figure F).

• Do not pull back on the plunger at any time.
• With your other hand, gently squeeze the area of the cleaned skin and hold it firmly. (See Figure G).

Step 7. Inject HULIO

• Using a quick, dart-like motion, insert the needle into the squeezed skin at about a 45-degree angle. (See Figure H).

• After the needle is in, let go of the skin.
• Do not move, twist, or rotate the Syringe during the injection.
• Slowly push the plunger all the way in until all the liquid is injected and the syringe is empty.
• If the plunger is not pressed all the way down the Needle Safety Feature will not activate afterwards to cover the needle
• Do not move, twist, or rotate the syringe during injection.
• Pull the needle out of the skin while keeping the syringe at the same angle, then release your thumb from the plunger.
• The needle will retract and the Needle Safety Feature will cover the needle. (See Figure I).

Caution: If the needle did not retract or you do not think you received the full dose, contact your healthcare provider for help.

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

Step 8. Throw away (dispose of) your used HULIO Prefilled Syringe and needle in a sharps disposal container right away after use. (See Figure J). “How should I throw away (dispose of) used prefilled syringes and needles?”

How should I throw away (dispose of) used prefilled syringes and needles?

• Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use. (See Figure J). Do not throw away (dispose of) loose needles and syringes in your household trash.
• Do not try to touch the needle.

• 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.
• For the safety and health of you and others, needles and used syringes must never be re-used.
• The used alcohol pads, cotton balls, dose trays and packaging may be placed in your household trash.
• 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.
• Always keep the sharps container out of the reach of children.

Keep a record of the dates and location of your injection sites in the injection diary. To help you remember when to take HULIO, you can mark your calendar ahead of time.

How should I store HULIO?

• Store HULIO in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC).
• Store HULIO in the original carton until use to protect it from light.
• Do not freeze HULIO.
• If needed, for example when you are traveling, you may also store HULIO at room temperature up to 77°F (25°C) for up to 14 days. Store HULIO in the original carton until use to protect it from light.
• Throw away HULIO if it has been kept at room temperature and not been used within 14 days.
• Do not store HULIO in extreme heat or cold such as a hot car, or a freezing car overnight.
• Keep HULIO, injection supplies, and all other medicines out of the reach of children.

Manufactured by:

Biocon Biologics Inc.

245 Main St, 2nd Floor,

Cambridge, MA 02142, U.S.A.

U.S. License No. 2324

Product of Japan

Revised: 02/2025

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