Patient information: uses, side effects, how to take - Simlandi

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

SIMLANDI is a medicine that affects your immune system. SIMLANDI 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 doctor should test you for TB before starting SIMLANDI.
Your doctor should check you closely for signs and symptoms of TB during treatment with SIMLANDI.

You should not start taking SIMLANDI if you have any kind of infection unless your doctor says it is okay.

Before starting SIMLANDI, tell your doctor 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 doctor 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 SIMLANDI. Ask your doctor 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 SIMLANDI, call your doctor right away if you have an infection, or any sign of an infection.

SIMLANDI 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 SIMLANDI, 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 SIMLANDI, 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 doctor if you have a bump or open sore that does not heal.
Some people receiving TNF blockers including SIMLANDI 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 SIMLANDI?

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

To reduce the signs and symptoms of:
- moderate to severe RA in adults. SIMLANDI 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. SIMLANDI can be used alone or with methotrexate.
- psoriatic arthritis (PsA) in adults. SIMLANDI can be used alone or with certain other medicines.
- ankylosing spondylitis (AS) in adults.
- moderate to severe hidradenitis suppurativa (HS) in people 12 years and older.
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 and children 2 years of age and older.

What should I tell my doctor before taking SIMLANDI?

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

have an infection. See “What is the most important information I should know about SIMLANDI?”
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 SIMLANDI. Children should be brought up to date with all vaccines before starting SIMLANDI.
are allergic to SIMLANDI or to any of its ingredients. See the end of this Medication Guide for a list of ingredients in SIMLANDI.
are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. You and your doctor should decide if you should take SIMLANDI while you are pregnant or breastfeeding.
have a baby and you were using SIMLANDI during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines.

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

Especially tell your doctor if you use:

ORENCIA (abatacept), KINERET (anakinra), REMICADE (infliximab), ENBREL (etanercept), CIMZIA (certolizumab pegol) or SIMPONI (golimumab), because you should not use SIMLANDI while you are also using one of these medicines.
RITUXAN (rituximab). Your doctor may not want to give you SIMLANDI 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 doctor and pharmacist each time you get a new medicine.

How should I take SIMLANDI?

SIMLANDI is given by an injection under the skin. Your doctor will tell you how often to take an injection of SIMLANDI. This is based on your condition to be treated. Do not inject SIMLANDI 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 SIMLANDI.
Make sure you have been shown how to inject SIMLANDI before you do it yourself. You can call your doctor or 1-888-483-8279 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 SIMLANDI.
Do not try to inject SIMLANDI yourself until you have been shown the right way to give the injections. If your doctor decides that you or a caregiver may be able to give your injections of SIMLANDI at home, you should receive training on the right way to prepare and inject SIMLANDI.
Do not miss any doses of SIMLANDI unless your doctor says it is okay. If you forget to take SIMLANDI, 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 SIMLANDI, call your doctor or pharmacist.
If you take more SIMLANDI than you were told to take, call your doctor.

What are the possible side effects of SIMLANDI?

SIMLANDI can cause serious side effects, including:

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

Serious Infections.

Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with SIMLANDI and during treatment with SIMLANDI. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking SIMLANDI. People who had a negative TB skin test before receiving adalimumab products have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking SIMLANDI:

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 SIMLANDI. Your doctor should do blood tests before you start treatment, while you are using SIMLANDI, and for several months after you stop treatment with SIMLANDI. Tell your doctor 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 SIMLANDI. Call your doctor 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 doctor right away if you get new or worsening symptoms of heart failure while taking SIMLANDI, 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 SIMLANDI.
Liver problems. Liver problems can happen in people who use TNF-blocker medicines. These problems can lead to liver failure and death. Call your doctor 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 doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with SIMLANDI.

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

The most common side effects of SIMLANDI include:

injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. Call your doctor 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 SIMLANDI. Tell your doctor if you have any side effect that bothers you or that does not go away. Ask your doctor 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 SIMLANDI ?

Store SIMLANDI in the refrigerator at 36°F to 46°F (2°C to 8°C). Store SIMLANDI in the original carton until use to protect it from light.
Do not freeze SIMLANDI . Do not use SIMLANDI if frozen, even if it has been thawed.
Refrigerated SIMLANDI may be used until the expiration date printed on the SIMLANDI carton, dose tray, autoinjector or prefilled syringe. Do not use SIMLANDI after the expiration date.
If needed, for example when you are traveling, you may also store SIMLANDI at room temperature up to
77°F (25°C) for up to 30 days. Store SIMLANDI in the original carton until use to protect it from light.
Throw away SIMLANDI if it has been kept at room temperature and not been used within 30 days.
Record the date you first remove SIMLANDI from the refrigerator on the carton and dose tray.
Do not store SIMLANDI in extreme heat or cold.
Do not use SIMLANDI if the liquid is cloudy, discolored, or has flakes or particles in it.
Do not drop or crush SIMLANDI. The prefilled syringe is glass.

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

General information about the safe and effective use of SIMLANDI .

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SIMLANDI for a condition for which it was not prescribed. Do not give SIMLANDI to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about SIMLANDI. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about SIMLANDI that is written for health professionals.

What are the ingredients in SIMLANDI ?

Active ingredient: adalimumab-ryvk.

Inactive ingredients: polysorbate 80, sodium chloride, sucrose, and Water for Injection. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH.

Brands listed are the trademarks of their respective owners.

Manufactured By: Alvotech USA Inc., Leesburg, VA 20175

U.S. License No. 2225

Product of Iceland

Marketed By: Teva Pharmaceuticals, Parsippany, NJ 07054

For more information go to www.SIMLANDI.com or call 1-888-483-8279.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 10/2025

INSTRUCTIONS FOR USE SIMLANDI^®(sim-LAN-dee) (adalimumab-ryvk) injection, for subcutaneous use 40 mg/0.4 mL Single-Dose Autoinjector
Before Injecting: Your healthcare provider should show you how to use SIMLANDI before you use it for the first time. Call your healthcare provider or 1-888-483-8279 if you have any questions. SIMLANDI Autoinjector Parts Important Information You Need to Know Before Injecting SIMLANDI Do not use the Autoinjector and call your healthcare provider or pharmacist if:
Liquid is cloudy, discolored, or has flakes or particles in it Expiration date has passed	Liquid has been frozen (even if thawed) or left in direct sunlight The Autoinjector has been dropped or crushed
Keep the Clear Cap on until right before your injection. How should I store SIMLANDI?
Store SIMLANDI in the refrigerator between 36°F to 46°F (2°C to 8°C). Store SIMLANDI in the original carton until use to protect it from light. Do not freeze Refrigerated SIMLANDI may be used until the expiration date printed on the SIMLANDI carton, dose tray or Autoinjector. If needed, for example when you are traveling, you may also store SIMLANDI at room temperature up to 77°F (25°C) for up to 30 days.	Throw away SIMLANDI if it has been kept at room temperature and not used within 30 days. Record the date you first remove SIMLANDI from the refrigerator in the spaces provided on the carton and dose tray. Do not store SIMLANDI in extreme heat or cold. Do not drop or crush SIMLANDI. The prefilled syringe is glass.
Keep SIMLANDI, injection supplies, and all other medicines out of reach of children.
Read Instructions on All Pages Before Using the SIMLANDI Autoinjector
Step 1
	Take SIMLANDI out of the refrigerator (see Figure A). Leave SIMLANDI at room temperature for 15 to 30 minutes before injecting (see Figure B). Do not remove the Clear Cap while allowing SIMLANDI to reach room temperature. Do not warm SIMLANDI in any other way. For example, do not warm it in a microwave or in hot water. Do not use the Autoinjector if liquid has been frozen (even if thawed).
Step 2
	Check expiration date on the Autoinjector label (see Figure C). Do not use the Autoinjector if expiration date has passed. Place the following on a clean, flat surface (see Figure D): 1 single-dose Autoinjector and alcohol swab 1 cotton ball or gauze pad (not included) Puncture-resistant sharps disposal container (not included). See Step 9 at the end of this Instructions for Use for instructions on how to throw away (dispose of) your SIMLANDI Autoinjector Wash and dry your hands (see Figure E).
Step 3
	Choose an injection site (see Figure F): On the front of your thighs or Your abdomen (belly) at least 2 inches from your navel (belly button) Different from your last injection site Wipe the injection site in a circular motion with the alcohol swab (see Figure G). Do not inject through clothes Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques
Step 4
	Hold the Autoinjector with the Gray Body Grip Area facing up. Check the window (see Figure H). It is normal to see a different plunger stopper position, from about halfway down to higher up in the inspection window It is normal to see 1 or more bubbles in the window Make sure the liquid is clear and colorless Do not use the Autoinjector if the liquid is cloudy, discolored, or has flakes or particles in it Do not use the Autoinjector if it has been dropped or crushed
Step 5
	Pull the Clear Cap straight off of the Autoinjector (see Figure I). Throw the Clear Cap away. It is normal to see a few drops of liquid come out of the needle Never put the clear cap back on. It may damage the needle. Turn the Autoinjector so that the orange needle sleeve points toward the injection site.
Step 6
	Squeeze the skin at your injection site to make a raised area and hold it firmly until the injection is complete. Place the orange needle sleeve straight (90° angle) against the injection site (see Figure J). Hold the Autoinjector so that you can see the window.
Step 7
	It is important that you firmly push the Autoinjector down all the way against the injection site. Keep pushing the Autoinjector down during the injection (see Figure K). The first “click” will signal the start of the injection (see Figure K). It may take up to 10 seconds after the first ‘click’ to complete. Injection is complete when the orange indicator has stopped moving and you hear a second ‘click’ (see Figure L). Do not lift up or let go of the pressure from the injection site, until you have confirmed the injection is complete.
Step 8
	When the injection is completed, slowly pull the Autoinjector from the skin. The orange needle sleeve will cover the needle tip (see Figure M). A small amount of liquid on the injection site is normal If there are more than a few drops of liquid on the injection site, call 1-888-483-8279 for help. After completing the injection, place a cotton ball or gauze pad on the skin of the injection site. Do not rub Slight bleeding at the injection site is normal
Step 9
	Put your used Autoinjectors in a FDA-cleared sharps disposal container right away after use (see figure N). Do not throw away (dispose of) the Autoinjector in the household trash. If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
The Clear Cap, alcohol swab, cotton ball or gauze pad, dose tray, and packaging may be placed in your household trash.
Questions About Using the SIMLANDI Autoinjector What if I have not received in person training from a healthcare provider? Call your healthcare provider or visit www.SIMLANDI.com if you need help How do I know when the injection is complete? The orange indicator has stopped moving and you hear a second ‘click’. This takes up to 10 seconds. What should I do if there are more than a few drops of liquid on the injection site? Call 1-888-483-8279 for help What if I do not have an FDA-cleared sharps disposal container or proper household container? 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 and 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. Always keep the Autoinjector and the sharps disposal container out of reach of children. Keep a record of the dates and locations of your injections. To help remember when to take SIMLANDI, mark your calendar ahead of time. Manufactured By: Alvotech USA Inc., Leesburg, VA 20175 U.S. License No. 2225 Product of Iceland Marketed By: Teva Pharmaceuticals, Parsippany, NJ 07054

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised 11/2025

INSTRUCTIONS FOR USE SIMLANDI^®(sim-LAN-dee) (adalimumab-ryvk) injection, for subcutaneous use 80 mg/0.8 mL Single-Dose Autoinjector
Before Injecting: Your healthcare provider should show you how to use SIMLANDI before you use it for the first time. Call your healthcare provider or 1-888-483-8279 if you have any questions. SIMLANDI Autoinjector Parts Important Information You Need to Know Before Injecting SIMLANDI Do not use the Autoinjector and call your healthcare provider or pharmacist if:
Liquid is cloudy, discolored, or has flakes or particles in it Expiration date has passed	Liquid has been frozen (even if thawed) or left in direct sunlight The Autoinjector has been dropped or crushed
Keep the Clear Cap on until right before your injection. How should I store SIMLANDI?
Store SIMLANDI in the refrigerator between 36°F to 46°F (2°C to 8°C). Store SIMLANDI in the original carton until use to protect it from light. Do not freeze. Refrigerated SIMLANDI may be used until the expiration date printed on the SIMLANDI carton, dose tray or Autoinjector. If needed, for example when you are traveling, you may also store SIMLANDI at room temperature up to 77°F (25°C) for up to 30 days.	Throw away SIMLANDI if it has been kept at room temperature and not used within 30 days. Record the date you first remove SIMLANDI from the refrigerator in the spaces provided on the carton and dose tray. Do not store SIMLANDI in extreme heat or cold. Do not drop or crush SIMLANDI. The prefilled syringe is glass.
Keep SIMLANDI, injection supplies, and all other medicines out of reach of children.
Read Instructions on All Pages Before Using the SIMLANDI Autoinjector
Step 1
	Take SIMLANDI out of the refrigerator (see Figure A). Leave SIMLANDI at room temperature for 15 to 30 minutes before injecting (see Figure B). Do not remove the Clear Cap while allowing SIMLANDI to reach room temperature. Do not warm SIMLANDI in any other way. For example, do not warm it in a microwave or in hot water. Do not use the Autoinjector if liquid has been frozen (even if thawed).
Step 2
	Check expiration date on the Autoinjector label (see Figure C). Do not use the Autoinjector if expiration date has passed. Place the following on a clean, flat surface (see Figure D): 1 single-dose Autoinjector and alcohol swab 1 cotton ball or gauze pad (not included) Puncture-resistant sharps disposal container (not included). See Step 9 at the end of this Instructions for Use for instructions on how to throw away (dispose of) your SIMLANDI Autoinjector Wash and dry your hands (see Figure E).
Step 3
	Choose an injection site (see Figure F): On the front of your thighs or Your abdomen (belly) at least 2 inches from your navel (belly button) Different from your last injection site Wipe the injection site in a circular motion with the alcohol swab (see Figure G). Do not inject through clothes Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques
Step 4
	Hold the Autoinjector with the Gray Body Grip Area facing up. Check the window (see Figure H). It is normal to see 1 or more bubbles in the window Make sure the liquid is clear and colorless Do not use the Autoinjector if the liquid is cloudy, discolored, or has flakes or particles in it Do not use the Autoinjector if it has been dropped or crushed
Step 5
	Pull the Clear Cap straight off of the Autoinjector (see Figure I). Throw the Clear Cap away. It is normal to see a few drops of liquid come out of the needle Never put the clear cap back on. It may damage the needle. Turn the Autoinjector so that the orange needle sleeve points toward the injection site.
Step 6
	Squeeze the skin at your injection site to make a raised area and hold it firmly until the injection is complete. Place the orange needle sleeve straight (90° angle) against the injection site (see Figure J). Hold the Autoinjector so that you can see the window.
Step 7
	It is important that you firmly push the Autoinjector down all the way against the injection site. Keep pushing the Autoinjector down during the injection (see Figure K). The first “click” will signal the start of the injection (see Figure K). It may take up to 15 seconds after the first ‘click’ to complete. Injection is complete when the orange indicator has stopped moving and you hear a second ‘click’ (see Figure L). Do not lift up or let go of the pressure from the injection site, until you have confirmed the injection is complete.
Step 8
	When the injection is completed, slowly pull the Autoinjector from the skin. The orange needle sleeve will cover the needle tip (see Figure M). A small amount of liquid on the injection site is normal If there are more than a few drops of liquid on the injection site, call 1-888-483-8279 for help. After completing the injection, place a cotton ball or gauze pad on the skin of the injection site. Do not rub Slight bleeding at the injection site is normal
Step 9
	Put your used Autoinjectors in a FDA-cleared sharps disposal container right away after use (see figure N). Do not throw away (dispose of) the Autoinjector in the household trash. If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
The Clear Cap, alcohol swab, cotton ball or gauze pad, dose tray, and packaging may be placed in your household trash.
Questions About Using the SIMLANDI Autoinjector What if I have not received in person training from a healthcare provider? Call your healthcare provider or visit www.SIMLANDI.com if you need help How do I know when the injection is complete? The orange indicator has stopped moving and you hear a second ‘click’. This takes up to 15 seconds. What should I do if there are more than a few drops of liquid on the injection site? Call 1-888-483-8279 for help What if I do not have an FDA-cleared sharps disposal container or proper household container? 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 and 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. Always keep the Autoinjector and the sharps disposal container out of reach of children. Keep a record of the dates and locations of your injections. To help remember when to take SIMLANDI, mark your calendar ahead of time. Manufactured By: Alvotech USA Inc., Leesburg, VA 20175 U.S. License No. 2225 Product of Iceland Marketed By: Teva Pharmaceuticals, Parsippany, NJ 07054 SIMIFUAI-003

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised 02/2025

INSTRUCTIONS FOR USE

SIMLANDI^®(sim-LAN-dee)

(adalimumab-ryvk)

Injection, for subcutaneous use

Single-Dose Prefilled Syringe

Before Injecting: Your healthcare provider should show you how to use SIMLANDI before you use it for the first time. Call your healthcare provider or 1-888-483-8279 if you need help.

SIMLANDI Single-Dose Prefilled Syringe Parts

Important Information You Need to Know Before Injecting SIMLANDI

Do not use the prefilled syringe and call your healthcare provider or pharmacist if:

Liquid is cloudy, discolored, or has flakes or particles in it
Expiration date has passed

Liquid has been frozen (even if thawed) or left in direct sunlight
The prefilled syringe has been dropped or crushed

Keep the needle cover on until right before your injection.

How should I store SIMLANDI?

Store SIMLANDI in the refrigerator between
36°F to 46°F (2°C to 8°C).
Store SIMLANDI in the original carton until use to protect it from light.
Do not freeze.
Refrigerated SIMLANDI may be used until the expiration date printed on the SIMLANDI carton, dose tray or prefilled syringe.
If needed, for example when you are traveling, you may also store SIMLANDI at room temperature up to 77°F (25°C) for up to 30 days.

Throw away SIMLANDI if it has been kept at room temperature and not used within 30 days.
Record the date you first remove SIMLANDI from the refrigerator in the spaces provided on the carton and dose tray.
Do not store SIMLANDI in extreme heat or cold.

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

Read Instructions on All Pages Before Using the SIMLANDI Single-Dose Prefilled Syringe

Step 1

Figure A

Figure B

Take SIMLANDI out of the refrigerator (see Figure A).

Leave SIMLANDI at room temperature for

15 to 30 minutes before injecting (see Figure B).

Do not remove the needle cover while allowing SIMLANDI to reach room temperature
Do not warm SIMLANDI in any other way. For example, do not warm it in a microwave or in hot water.
Do not use the prefilled syringe if liquid has been frozen (even if thawed)

Step 2

Figure C

Check expiration date on the prefilled syringe label (see Figure C).

Do not use the prefilled syringe if expiration date has passed.

Check the liquid drug in the syringe to ensure it is clear and colorless (see Figure C).

Do not use the syringe and call your healthcare provider or pharmacist if: Liquid is cloudy, discolored, or has flakes or particles in it.

Step 3

Figure E

Place the following on a clean, flat surface (see Figure D):

1 single-dose prefilled syringe and alcohol swab
1 cotton ball or gauze pad (not included)
Puncture-resistant sharps disposal container (not included). See Step 9 at the end of this Instructions for Use for instructions on how to throw away (dispose of) your prefilled syringe

Wash and dry your hands (see Figure E).

Step 4

Figure F

Choose an injection site (see Figure F):

On the front of your thighs or
Your abdomen (belly) at least 2 inches from your navel (belly button)
Different from your last injection site
Wipe the injection site in a circular motion with the alcohol swab (see Figure F)
Do not inject through clothes
Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques

Step 5

Figure G

Hold the prefilled syringe in one hand (see Figure G).

Gently pull the needle cover straight off with the other hand.

Throw the needle cover away
Do not recap
Do not touch the needle with your fingers or let the needle touch anything
You may see a drop of liquid at the end of the needle. This is normal.

Step 6

Figure H

Hold the body of the prefilled syringe in one hand between the thumb and index fingers. Hold the prefilled syringe in your hand like a pencil (see Figure H).

Do not pull back on the plunger at any time.

Gently squeeze the area of cleaned skin at your injection site with your other hand. Hold the skin firmly (see Figure H).

Step 7

Figure I

Figure J

Insert the needle into the skin at about a 45-degree angle using a quick, dart-like motion (see Figure I).

After the needle is in, let go of the skin.

Slowly push the plunger all the way in until all of the liquid is injected and the prefilled syringe is empty (see Figure J).

Step 8

Figure K

When the injection is completed, slowly lift your finger from the plunger. This will let the empty syringe move up until the entire needle is covered by the needle guard (see Figure K).

The needle will not retract unless all the liquid is injected. Speak to your doctor, pharmacist or nurse if you think you have not given a full dose.
It is normal to see a spring around the plunger rod after the needle is retracted.

After completing the injection, place a cotton ball or gauze pad on the skin of the injection site.

Do not rub
Slight bleeding at the injection site is normal

Step 9

Figure L

How should I dispose of the used SIMLANDI prefilled syringe?

Put your used syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) syringes in the household trash (see Figure L).
- 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 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.

The needle cover, alcohol swab, cotton ball or gauze pad, dose tray, and packaging may be placed in your household trash.

Questions About Using the SIMLANDI Single-Dose Prefilled Syringe

What if I have not received in-person training from a healthcare provider?

Call your healthcare provider or visit www.SIMLANDI.com if you need help

What if I do not have an FDA-cleared sharps disposal container or proper household container?

Call 1-800-448-6472 for a free FDA-cleared sharps disposal container.

Always keep the prefilled syringe and the sharps disposal container out of the reach of children.

Keep a record of the dates and locations of your injections. To help remember when to take SIMLANDI, mark your calendar ahead of time.