All About Cyltezo

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Find answers to some commonly asked questions about Cyltezo.

Is Cyltezo similar to Humira?

Yes, Cyltezo is similar to Humira. Both drugs contain the active ingredient adalimumab-adbm.* This is a biologic medication, which means it’s made from parts of living organisms. Cyltezo is a biosimilar form of Humira. (Biosimilars are like generic drugs. But unlike generics, which are made for non-biologic drugs, biosimilars are made for biologic drugs.)

Cyltezo is considered just as safe and effective as Humira. However, although they’re similar, the two drugs have some differences. For example, Humira can be used in some children to treat ulcerative colitis (UC) and Hidradenitis suppurativa, while Cyltezo is only approved to treat these conditions in adults.

Cyltezo and Humira are available as a liquid solution that’s given as an injection under your skin. Both drugs come in a prefilled syringe or pen, but Humira also comes in a vial.

Talk with your doctor if you have questions about which drug may be best for treating your condition.

Can Cyltezo cure ulcerative colitis?

No, there’s currently no cure for UC. But Cyltezo works to manage your UC symptoms. For example, during treatment, you may notice a decrease in diarrhea, weight loss, or fatigue (low energy) from your condition.

If you have additional questions about how Cyltezo may work to treat your UC, talk with your doctor.

Does Cyltezo cause long-term side effects?

It’s possible for Cyltezo to cause long-term side effects. In fact, Cyltezo has a boxed warning for the risk of cancer, which can occur from using this drug. For more information, see “What should be considered before starting Cyltezo?” below.

It’s also possible for Cyltezo to cause other long-term side effects, including:

It’s important to note that most side effects caused by Cyltezo are mild. Still, it’s important to be aware of the risk of long-term side effects. If you have questions or concerns about possible long-term side effects from this medication, talk with your doctor before starting treatment.

Like most drugs, Cyltezo can cause mild to serious side effects. Below are some of the more common side effects this drug may cause. (These lists don’t include all possible side effects.)

Keep in mind that side effects of a drug can depend on:

• your age
• other health conditions you have
• other medications you take

Your doctor or pharmacist can tell you more about the potential side effects of Cyltezo. They can also suggest ways to help reduce or manage them.

Mild side effects

Mild side effects have been reported with Cyltezo. These include:

Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

To learn about other mild side effects of Cyltezo, talk with your doctor or pharmacist or read the drug’s prescribing information.

* To learn more about this side effect, see the “Allergic reaction” section below.

Serious side effects

Serious side effects from Cyltezo can occur, but they aren’t common. If you experience serious side effects, call your doctor right away. But if you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects of Cyltezo that have been reported include:

* For more information, see “What should be considered before starting Cyltezo?” below.
† To learn more about this side effect, see the “Allergic reaction” section just below.

Allergic reaction

Some people may have an allergic reaction to Cyltezo. Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms can include:

• swelling under your skin (usually in your eyelids, lips, hands, or feet)
• swelling of your tongue, mouth, or throat, which can cause trouble breathing

Call your doctor right away if you have an allergic reaction to Cyltezo. But if you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Your doctor will recommend the dosage of Cyltezo that’s right for you. Below are commonly used dosages, but always follow your doctor’s dosing instructions.

Forms and strengths

Cyltezo is available as a liquid solution that’s given as an injection under your skin. It comes in either a prefilled pen or glass syringe.

The prefilled pen is available in one strength of 40 milligrams (mg) of medication in 0.8 milliliters (mL) of liquid solution.

The glass syringe is available in the following strengths:

• 10 mg of medication in 0.2 mL of solution
• 20 mg of medication in 0.4 mL of solution
• 40 mg of medication in 0.8 mL of solution

Recommended dosages

In most cases, you’ll inject Cyltezo once every other week. But if you have rheumatoid arthritis or Hidradenitis suppurativa, your doctor may recommend injecting your dose every week instead. Be sure to follow your doctor’s dosing instructions.

To learn more about Cyltezo’s dosage, see this article.

Questions about Cyltezo’s dosing

Below are some common questions about Cyltezo’s dosing.

• What if I miss a dose of Cyltezo? If you forget to inject your dose of Cyltezo, do so as soon as you remember. Then continue with your regular dosing schedule. If you missed your dose of Cyltezo and you’re not sure when to inject your next dose, talk with your doctor or pharmacist.
• Will I need to use Cyltezo long term? Yes, in most cases Cyltezo is used as a long-term treatment. Because it helps manage the symptoms of your condition, stopping this drug may cause the symptoms to return. If you have serious side effects from Cyltezo or it’s not working for you, your doctor may recommend stopping the drug and trying a different treatment. But you should never stop using Cyltezo without first talking with your doctor.
• How long does Cyltezo take to work? Cyltezo will begin to work as soon as you inject your first dose. But it may take weeks for you to notice your symptoms improving. How long it takes may also depend on your condition and how severe it is. If you have additional questions about how long Cyltezo should take to work for you, talk with your doctor.

Cyltezo helps decrease the symptoms of certain autoimmune conditions. These conditions can occur when your immune system is overactive and attacks your body. It’s possible that an overactive immune system may be caused by too much tumor necrosis factor (TNF). Cyltezo works to block TNF, which then decreases symptoms you experience from your condition.

Cyltezo helps manage symptoms of certain intestinal conditions and skin conditions, an eye condition, and several forms of autoimmune arthritis. The specific conditions the drug treats are described below.

Intestinal conditions

Ulcerative colitis (UC) and Crohn’s disease are intestinal conditions that can cause bloody stool, abdominal pain, and weight loss. In most cases, Crohn’s disease affects the small intestine, and UC affects the large intestine.

Cyltezo is prescribed for adults and certain children ages 6 years and older with Crohn’s disease.

Cyltezo is also prescribed to treat UC in adults, but there’s a limitation of the drug’s use for treating this condition. It’s not known whether the drug is effective in people who have already tried a TNF blocker that didn’t work to treat their UC. (Cyltezo is a TNF blocker.)

Skin conditions

Cyltezo is prescribed for plaque psoriasis in certain adults. This is a condition where you develop raised, dry, scaly patches on your skin.

This drug is also used to treat Hidradenitis suppurativa in adults. This condition causes painful bumps to form on your skin.

Eye condition

Cyltezo is prescribed for uveitis in adults. This is a condition where your eye may become swollen and red.

Arthritis

Cyltezo is prescribed to treat several forms of arthritis. These include:

These forms of arthritis can all cause swollen and painful joints.

Cyltezo can also be used to treat ankylosing spondylitis in adults. This is a type of arthritis that affects the spine.

Your doctor will explain how you should inject Cyltezo, including how much and how often. Be sure to follow their instructions.

Administering Cyltezo

Cyltezo comes as a liquid solution in either a prefilled pen or syringe. The drug is given as an injection under your skin.

Accessible medication containers and labels

Certain pharmacies may provide medication labels that:

• have large print
• use braille
• contain a code you can scan with a smartphone to change the text to audio

Your doctor or pharmacist may be able to recommend a pharmacy that offers these options if your current pharmacy doesn’t.

Before starting Cyltezo, talk with your doctor about any other medications you take or medical conditions you have. They’ll help make sure Cyltezo is safe for you.

Interactions

Taking a medication with certain vaccines, foods, and other things can affect how the medication works. These effects are called interactions.

Before starting Cyltezo, be sure to tell your doctor about all of the drugs you take, including prescription and over-the-counter kinds. You should also describe any vitamins, herbs, or supplements you use. Your doctor or pharmacist can tell you about any interactions these items may cause with Cyltezo.

For information about drug-condition interactions, see the “Other warnings” section below.

Interactions with drugs or supplements

Cyltezo can interact with several kinds of drugs. These include:

This list does not contain all types of drugs that may interact with Cyltezo. Your doctor or pharmacist can tell you more about these interactions and any others that may occur with Cyltezo.

* With a narrow safety range, small changes in blood levels of the drug can have significant effects. For example, a small increase in the dose may result in harmful side effects. Or if less drug is absorbed by the body, the drug may not work at all.

Boxed warnings

Cyltezo has boxed warnings about the risks of cancer and serious infection. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA). They alert doctors and patients about drug effects that may be dangerous. Cyltezo’s boxed warnings include:

Risk of cancer. You may have an increased risk of developing certain kinds of cancer from using Cyltezo.

This drug may increase your risk of skin cancer. Due to this risk, your doctor may recommend regular skin checks. Be sure to tell them if you have any changes to your skin, such as sores that don’t heal.

Cyltezo may also increase the risk of lymphoma, especially in children or young adults using the drug for rheumatoid arthritis. Their doctor may monitor people in this age range more often for lymphoma symptoms, such as fever, swollen lymph nodes, or night sweats.

Cyltezo may also cause an increased risk of a rare cancer called hepatosplenic T-cell lymphoma. This cancer occurred in some young males* being treated for Crohn’s disease or ulcerative colitis in the drug’s studies. These young males were also taking other medications for their condition. Your doctor may monitor you for symptoms of this lymphoma, including night sweats, weight loss, or fever.

If you have concerns about developing cancer from using Cyltezo, talk with your doctor.

* In this article, we use the term “male” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article.

Risk of serious infection. Cyltezo may weaken your immune system. This can increase your risk of developing infections, some of which may be serious or even life threatening.

Before you start Cyltezo, your doctor will test you for certain infections such as tuberculosis. If you have an active infection, they’ll treat it, and they may recommend that you wait until it’s cleared before starting Cyltezo.

Throughout your treatment with Cyltezo, you should be aware of the signs of infection. Symptoms may include:

If you develop symptoms of infection during Cyltezo treatment, be sure to tell your doctor. They can help treat the infection so it doesn’t become serious. If you have additional questions about infections with Cyltezo, talk with your doctor.

Other warnings

Cyltezo can sometimes cause harmful effects in people with certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether this drug is a good treatment option for you. Talk with your doctor about your health history before starting Cyltezo. Factors to consider include those described below.

Nerve problems. It’s possible for Cyltezo to cause nervous system problems, such as multiple sclerosis. If you already have a nerve problem, Cyltezo may make your condition worse. In this case, your doctor can help determine whether this is a safe treatment for you.

Heart failure. Cyltezo may cause heart failure. If you already have this condition, Cyltezo may make it worse. Your doctor can help determine whether this drug may be safe for you.

Allergic reaction. If you’ve had an allergic reaction to rubber, latex, Cyltezo, or any of its ingredients, your doctor will likely not prescribe Cyltezo for you. Ask them about other medications that might be better options.

Hepatitis B. Tell your doctor if you’ve ever had hepatitis B. Cyltezo may weaken your immune system, which can cause the hepatitis B virus to become active again, even if you’ve already been treated for it. If you carry the hepatitis B virus, your doctor will monitor your blood throughout your treatment with Cyltezo.

Liver problems. If you have any liver conditions, tell your doctor before starting Cyltezo. This drug may cause liver problems and worsen existing ones. Your doctor can determine whether Cyltezo may be safe for you.

Cyltezo and alcohol

There are no known interactions between Cyltezo and alcohol. But alcohol may make some side effects of this drug worse. For example, both Cyltezo and alcohol may cause liver problems or headache. So consuming alcohol may increase your risk of side effects from Cyltezo.

In addition, alcohol may increase inflammation. This could cause symptoms of the condition you’re using Cyltezo to treat to get worse.

Talk with your doctor to learn how much alcohol, if any, may be safe for you to drink during Cyltezo treatment.

Pregnancy and breastfeeding

It’s not known for sure whether Cyltezo is safe to use during pregnancy or while breastfeeding. There haven’t been enough studies done in humans to determine the drug’s safety when used in these situations.

It’s important to note that if Cyltezo is used during the third trimester of pregnancy, the fetus will likely be exposed to the drug. While it’s not known exactly what effect this may have, it could affect the baby’s immune system. Because of this, your child’s doctor may recommend waiting until their immune system is fully functioning before they receive any vaccines. This is because vaccines need a functioning immune system in order to work properly.

It’s also not known if Cyltezo is safe for a breastfeeding child. The drug is present in very small amounts in breast milk, so a child who is breastfed will be exposed to it. There have been no side effects reported in breastfed infants in studies. But it’s not known for sure what effects long-term Cyltezo use may have on children who are breastfed. It’s also not known how the drug affects breast milk production.

If you’re pregnant, planning to become pregnant, or breastfeeding, talk with your doctor before starting Cyltezo.

Do not inject more Cyltezo than your doctor prescribes, as this can lead to serious side effects.

What to do in case you inject too much Cyltezo

Call your doctor if you think you’ve injected too much Cyltezo. You can also call 800-222-1222 to reach America’s Poison Centers or use its online resource. But if you have severe symptoms, immediately call 911 or your local emergency number, or go to the nearest emergency room.

If you have questions about Cyltezo treatment, talk with your doctor or pharmacist. Questions you may want to ask include:

• Can my dose of Cyltezo be decreased if I have side effects from it?
• What can I do if I can’t afford Cyltezo?
• Can my dose be increased if Cyltezo isn’t working for me?
• Do I have an increased risk of side effects because of other medications I’m taking with Cyltezo?

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Disclaimer: This article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication.

The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.