How to inject citrate-free CYLTEZO

Take control of your treatment journey by learning how to confidently inject CYLTEZO® (adalimumab-adbm). The injection process for CYLTEZO also applies to Adalimumab-adbm.

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For most patients, CYLTEZO is injected at home

CYLTEZO is available in a single-dose pen and a single-dose prefilled syringe. Using either a pen or a prefilled syringe, CYLTEZO is injected under the skin. Your doctor may prescribe a dose that requires you to use more than one pen or prefilled syringe. It is important to talk to your doctor to be sure you understand your dosing instructions. They will tell you how often you need to inject CYLTEZO and make sure you’re able to inject it yourself. Speak to your doctor before starting injections on your own to ensure that you have the proper injection training, and read the Instructions for Use.

Watch and learn how to inject with the CYLTEZO Pen.

Video Length: 8:49    PC-US-136986

This video will show you how to inject CYLTEZO with the CYLTEZO Pen.

Please read the complete Instructions for Use contained in your CYLTEZO package.

Do not use a CYLTEZO Pen until you have been shown how to correctly use it and have read and understood the Instructions for Use. If your doctor decides that you can use the CYLTEZO Pen, you should receive education to prepare and inject CYLTEZO. Call your doctor or BI Solutions Plus at 1-833-CYLTEZO with any questions about how to use the CYLTEZO Pen.

Your doctor will tell you how often to inject CYLTEZO. This is based on your condition. Inject CYLTEZO just as your doctor has prescribed it.

Please see the Medication Guide and Instructions for Use on the CYLTEZO patient website. Please see accompanying full Prescribing Information and discuss with your doctor.

Hello, my name is Maria, and I'm here to show you how to use the CYLTEZO Pen. If you're new to this and are feeling a little nervous about it, I totally understand. I'm here to walk you through every step. When you receive your CYLTEZO Pen, it will come in a box like this one. The first thing to do is check the expiration date. It's printed on the box.

If the date is good, just put the whole box in the refrigerator. Don't take the pen out of the box until the day you're going to inject CYLTEZO. Until then, it needs to be kept cold - in the refrigerator. If the date has already passed, contact your specialty pharmacy to get new pens. You can find your specialty pharmacy's telephone number on the information label on the box your CYLTEZO Pens came in, or call BI Solutions Plus at 1-833-CYLTEZO.

BI Solutions Plus is a patient support program that can help provide additional information, or the support you need during your CYLTEZO treatment journey. This one is good to go. Now, since today is injection day for me, I'm going to leave the pen out so that the medicine inside can warm up a little.

It's okay to take the pen out of the container. Just don't leave it in direct sunlight. It should take 15 to 30 minutes for the medicine to warm up to room temperature.

While I was waiting for the pen to warm up, I laid out all the things I'll need for my injection. Focusing on getting organized keeps me calm. For the injection, I like to find a spot at home where I'm really comfortable. Back to your supplies. You'll need alcohol wipes, cotton balls, and your sharps disposal container. Keep the Instructions for Use handy as well.

Start by washing your hands with soap and warm water. I enjoy this moment. It's soothing for me. For a minute or so, I take the time I need to focus, center myself and relax. When it's time to give an injection, I like to make sure I'm comfortable. Sitting down helps me focus and breathe. Now let's take a look at the CYLTEZO Pen.

There are just a few parts you should be aware of. The injection button; the grip; the window, which allows you to see the medicine inside; the plunger, which is inside; the tip, which guards the needle; and the cap. You won't have to snap any pieces together or twist any parts, and you won't have to refill it with medicine.

When you take the pen out of the box, look at the color of the medicine inside. It's normal to see a few bubbles, but if the medicine looks milky or discolored, if any part of the pen is broken or if the pen has been dropped, contact your specialty pharmacy right away. You can find your specialty pharmacy’s telephone number on the information label on the box your CYLTEZO Pens came in, or call BI Solutions Plus at 1-833-CYLTEZO.

Okay, the pen is good. Let's start the injection process, which can be summed up in four steps. Select, wipe, inject and count. First, select an injection site. You can use your stomach or thigh. If this is not your first injection, use a location that's at least 1 inch away from the spot you used last time. And if you choose your stomach, leave 2 inches around your belly button.

Today, I'll be using my left thigh. Two things to keep in mind. Never inject through clothing and don't inject into tender, bruised, red, hard or scarred skin. All right, let's move on to step two. Now that you've selected an injection site, clean it using an alcohol wipe or alcohol and a cotton ball. Take a few seconds to let the injection site air dry.

Step three is inject. I was a little nervous at first, but it turned out to be easier than I thought. First, pull the cap off the pen. Just pull, don't twist. Twisting the cap could damage the needle. Next, squeeze or pinch the area around the injection site. Hold the pen in one hand, needle end down, and touch that end to the injection site at a 90-degree angle. Be sure not to cover the injection window with your hand. The injection button will unlock when you place the pen against your skin. Now, take a deep breath and, using your thumb, press and hold the injection button. You will hear a click which tells you the injection has started.

Step four is count. Holding the pen against the pinched skin, count slowly to ten. Be sure to stay still. It's important that you don't move the pen during this time. As you count, keep an eye on the injector window on the side of the pen. A plunger will appear there to indicate that the injection is complete. Once you see the plunger, gently lift the pen away and release the squeezed or pinched skin and you're done.

The needle guard in the tip of the pen will automatically cover the needle. So don't use the cap to recover it. Just place the used pen into your sharps disposal container. If you see a drop of blood, use the cotton ball to wipe it away. Don't press on or rub the injection site. And that's it. I hope seeing this helps simplify the process for you and maybe even help to ease some nervousness. After you do it a couple of times, the whole thing will become routine. And remember, you can always watch this video if you want to review some of the steps.

In the meantime, if you have questions about any of the things I've shown you or if you have any questions about CYLTEZO or the CYLTEZO Pen, call your doctor or BI Solutions Plus at 1-833-CYLTEZO.

To learn more about CYLTEZO, including the complete Instructions for Use, storage and handling requirements, and possible side effects, please see the Medication Guide and Instructions for Use available on the website and the following Important Safety Information.

Arthritis Foundation Certification

The CYLTEZO Pen has been certified by the Arthritis Foundation as an Ease of Use product.

The Arthritis Foundation recognizes products proven to make life easier for people with arthritis and other physical limitations. Ease of Use is proven through independent testing.

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How can you save on CYLTEZO?

The CYLTEZO Copay Program may help eligible patients with commercial insurance, including health insurance exchanges, federal employee plans, or state employee plans, pay as little as $0 per fill of CYLTEZO. Terms and Conditions apply and may change without notice.

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What is CYLTEZO?

This important information also applies to Adalimumab-adbm injection for subcutaneous use.

CYLTEZO is a medicine called a tumor necrosis factor (TNF) blocker. CYLTEZO is used:

  • To reduce the signs and symptoms of:
  • moderate to severe rheumatoid arthritis (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 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.
Important Safety Information for CYLTEZO® (adalimumab-adbm) injection, for subcutaneous use

This important information also applies to Adalimumab-adbm injection for subcutaneous use.

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

You should discuss the potential benefits and risks of CYLTEZO with your doctor. CYLTEZO is a TNF-blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking CYLTEZO if you have any kind of infection unless your doctor says it is okay.

  • 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 and check you closely for signs and symptoms of TB during treatment with CYLTEZO, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.
  • Cancer. For children and adults taking TNF blockers, including CYLTEZO, the chances of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including CYLTEZO, your chances of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn’t heal.

What should I tell my doctor BEFORE starting CYLTEZO?

Tell your doctor about all of your health conditions, including if you:

  • Have an infection, are being treated for infection, or have symptoms of 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, or were born in, lived in, or traveled where there is more risk for getting TB.
  • Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use CYLTEZO. Ask your doctor if you are unsure whether you have lived in an area where these infections are common.
  • Have or have had hepatitis B.
  • Are scheduled for major surgery.
  • Have or have had cancer.
  • Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome.
  • Have or had heart failure.
  • Have recently received or are scheduled to receive a vaccine. CYLTEZO patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting CYLTEZO.
  • Are allergic to rubber or latex.
  • Are allergic to any CYLTEZO ingredients.
  • Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.
  • Have a baby and you were using CYLTEZO during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines.

Also tell your doctor about all the medicines you take. You should not take CYLTEZO with ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab),
ENBREL® (etanercept), CIMZIA® (certolizumab pegol), or SIMPONI® (golimumab). Tell your doctor if you have ever used RITUXAN® (rituximab), IMURAN®
(azathioprine), or PURINETHOL® (mercaptopurine, 6-MP).

What should I watch for AFTER starting CYLTEZO?

CYLTEZO can cause serious side effects, including:

  • Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss,
    or loss of body fat and muscle.
  • Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite,
    vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
  • Allergic reactions. Symptoms of a serious allergic reaction include hives; trouble breathing; and swelling of your face, eyes, lips, or mouth.
  • Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
  • Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very
    easily, or looking very pale.
  • Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
  • Immune reactions, including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
  • Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach
    (abdomen). These problems can lead to liver failure and death.
  • Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care right away if you develop any of the above symptoms.

The most common side effects of CYLTEZO include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus
infections), headaches, and 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.

Remember to tell your doctor right away if you have an infection or symptoms of an infection, including:

  • 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
  • Urinating more often than normal
  • Feeling very tired
  • Weight loss

These are not all the possible side effects of CYLTEZO. For more information, speak with your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

CL-CTZ-100017 SEPT 2023