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

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

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

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

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

CYLTEZO 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 CYLTEZO, 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 CYLTEZO 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 CYLTEZO 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 CYLTEZO?

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

To reduce the signs and symptoms of:
- moderate to severe RA in adults. CYLTEZO 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. CYLTEZO can be used alone or with methotrexate.
- psoriatic arthritis (PsA) in adults. CYLTEZO 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 CYLTEZO?

CYLTEZO may not be right for you. Before starting CYLTEZO, 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 CYLTEZO?"
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 CYLTEZO. Children should be brought up to date with all vaccines before starting CYLTEZO.
are allergic to rubber or latex. The needle cap on the CYLTEZO Pen and prefilled syringe contains dry natural rubber or latex. Tell your doctor if you have any allergies to rubber or latex.
are allergic to CYLTEZO or to any of its ingredients. See the end of this Medication Guide for a list of ingredients in CYLTEZO.
are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. You and your doctor should decide if you should take CYLTEZO while you are pregnant or breastfeeding.
have a baby and you were using CYLTEZO 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 CYLTEZO while you are also using one of these medicines.
RITUXAN (rituximab). Your doctor may not want to give you CYLTEZO 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 CYLTEZO?

CYLTEZO is given by an injection under the skin. Your doctor will tell you how often to take an injection of CYLTEZO. This is based on your condition to be treated. Do not inject CYLTEZO 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 CYLTEZO.
Make sure you have been shown how to inject CYLTEZO before you do it yourself. You can call your doctor or 1-800-542-6257 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 CYLTEZO.
Do not try to inject CYLTEZO 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 CYLTEZO at home, you should receive training on the right way to prepare and inject CYLTEZO.
Do not miss any doses of CYLTEZO unless your doctor says it is okay. If you forget to take CYLTEZO, 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 CYLTEZO, call your doctor or pharmacist.
If you take more CYLTEZO than you were told to take, call your doctor.

What are the possible side effects of CYLTEZO?

CYLTEZO can cause serious side effects, including:

See "What is the most important information I should know about CYLTEZO?"

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 CYLTEZO and during treatment with CYLTEZO. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking CYLTEZO. 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 CYLTEZO:

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 CYLTEZO. Your doctor should do blood tests before you start treatment, while you are using CYLTEZO, and for several months after you stop treatment with CYLTEZO. 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 CYLTEZO. 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 worsening symptoms of heart failure while taking CYLTEZO, 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 CYLTEZO.
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 CYLTEZO.

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

The most common side effects of CYLTEZO 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 CYLTEZO. 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 CYLTEZO?

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

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

General information about the safe and effective use of CYLTEZO.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CYLTEZO for a condition for which it was not prescribed. Do not give CYLTEZO to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about CYLTEZO. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about CYLTEZO that is written for health professionals. For more information, go to www.cyltezo.com or call 1-800-542-6257.

What are the ingredients in CYLTEZO?

Active ingredient: adalimumab-adbm

CYLTEZO Pen 40 mg/0.8 mL, CYLTEZO 40 mg/0.8 mL prefilled syringe, CYLTEZO Pen 40 mg/0.4 mL, CYLTEZO 40 mg/0.4 mL prefilled syringe, CYLTEZO 20 mg/0.4 mL prefilled syringe, and CYLTEZO 10 mg/0.2 mL prefilled syringe

Inactive ingredients: glacial acetic acid, polysorbate 80, sodium acetate trihydrate, trehalose dihydrate, and Water for Injection.

Manufactured by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA

US License Number 2006

CYLTEZO^®is a registered trademark of and is used under license from Boehringer Ingelheim International GmbH.

Other trademarks referenced are owned by third parties not affiliated with Boehringer Ingelheim Pharmaceuticals, Inc.

For more information about CYLTEZO, including Prescribing Information and Medication Guide, go to www.cyltezo.com, scan the code or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

INSTRUCTIONS FOR USE

CYLTEZO^®(sil-TEE-zoh) Pen

(adalimumab-adbm)

injection, for subcutaneous use

The CYLTEZO Pen is a single-dose prefilled pen that delivers a fixed dose of medicine. The CYLTEZO Pen cannot be reused.

Important: Read these instructions before using a CYLTEZO Pen.

Do not use a CYLTEZO Pen until you have been shown the right way to give the injections and have read and understood this Instructions for Use. If your doctor decides that you or a caregiver may be able to give your injections of CYLTEZO at home, you should receive training on the right way to prepare and inject CYLTEZO. To help you remember when to inject CYLTEZO, you can mark your calendar ahead of time.
Do not remove the cap until you are ready to inject.

How should I store CYLTEZO?

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

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

Step 1

Gather your supplies

Gather your supplies and place them on a clean, flat surface:

1. (a) 1 CYLTEZO Pen, removed from the refrigerator.
1. (b) FDA-cleared sharps disposal container (not included). See "How should I throw away (dispose of) the used pen?"
1. (c) Cotton ball or gauze (not included)
1. (d) 1 Alcohol wipe

Take your CYLTEZO Pen out of the refrigerator 15 to 30 minutes before injecting to allow the medicine to reach room temperature. Injecting medicine that is cold can cause discomfort.

Make sure you have all of the supplies you need to give yourself an injection. If any parts of the CYLTEZO pen appear to be missing, broken, or damaged, call your pharmacist.

Step 2

Inspect the pen

Make sure the medicine in the CYLTEZO Pen is clear to slightly cloudy and colorless to slightly yellow.
It is normal to see 1 or more bubbles in the medicine.
Do not use the CYLTEZO Pen if:
- The expiration date on the pen has passed.
- The medicine is milky, discolored, or has flakes or particles in it.
- The pen has been frozen.
- Any part of the pen appears cracked, broken or is leaking.
- The pen has been dropped.
- The pen has been exposed to extreme heat or left in direct light.

Step 3

Wash your hands

Wash your hands with soap and water, and dry them well.

Step 4

Choose the injection site

Choose an area on your:
- Upper thighs or
- Abdomen (belly), except for an area 2 inches around your belly button (navel).
Choose a different site each time you inject, at least 1 inch away from the previous injection site.
Do not inject into areas that are tender, bruised, red, hard, or scarred.
Do not inject through clothes.

Step 5

Clean the injection site

Use an alcohol wipe to clean the injection site.
Do not touch this area again before injecting. Allow the skin to dry. Do not fan or blow on the clean area.

Step 6

Remove the cap

Hold the pen with 1 hand. With the other hand gently remove the cap by pulling it straight off the pen. Do not twist the cap. Twisting the cap could damage the needle.
Throw away (discard) the cap into an FDA-cleared sharps disposal container. See "How should I throw away (dispose of) the used pen?"
Do not try to recap the pen.

Step 7

Squeeze the skin

Gently squeeze the area of cleaned skin around your injection site and hold it firmly. You will inject into this squeezed skin.

Important: Before injecting CYLTEZO, read Step 8 through Step 10 to learn how to use or give (administer) a dose of CYLTEZO the right way.

Step 8

Prepare to administer the dose

Hold the pen straight at a 90-degree angle to the injection site. Do not cover the window with your hand.
Press and hold the tip firmly against the squeezed skin at the injection site. The injection button will unlock and be ready for use.

Step 9

Administer the dose

Administer the entire dose:
- Press the injection button 1 time. You will hear a 'click' when you press the injection button. The click means the start of the injection.
- Keep holding the pen against the squeezed skin around the injection site while you slowly count to 10.
- Do not move the pen during the injection.
Before removing the pen from your skin, look in the window and make sure the plunger is at the bottom of the pen. This means that the entire dose was delivered. If the plunger does not reach the bottom of the pen, call your doctor.

Step 10

Remove the pen

Lift the pen straight up from the skin. The needle guard on the tip will automatically move down to cover the needle.
If there is blood, press a cotton ball or gauze on the injection site.
Do not rub the injection site.

Step 11

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

Put the used pen in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the pen in the household trash.

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

made of a heavy-duty plastic,
can be closed with a tight fitting, puncture-resistant lid, without sharps being able to come out,
upright and stable during use,
leak-resistant, and
properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, 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 reuse the CYLTEZO Pen.
Do not throw away (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.

Important: Always keep the sharps disposal container out of the reach of children.

If you have any problems with your injection, do not use another CYLTEZO Pen. Call your doctor for help.

For more information call 1-800-542-6257.

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

Manufactured by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA

US License Number 2006

CYLTEZO^®is a registered trademark of and is used under license from Boehringer Ingelheim International GmbH.

Other trademarks referenced are owned by third parties not affiliated with Boehringer Ingelheim Pharmaceuticals, Inc.

For more information about CYLTEZO, including Prescribing Information and Medication Guide, go to www.cyltezo.com, scan the code, or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

COL11794ED152024

Revised: 04/2024