Cyltezo (adalimumab-adbm)

Cyltezo generic or biosimilar

Cyltezo (adalimumab-adbm) is a biosimilar of the brand-name biologic drug Humira. The reason “-adbm” appears at the end of the drug’s name is to show that the drug is distinct from other biosimilar medications that may be created in the future.

Drug manufacturers use chemicals to make traditional drugs. However, they use living cells to make biologics. It’s possible to make exact copies of brand-name chemical drugs. These are called generics. But it’s not possible to make exact copies of brand-name biologic drugs. Instead, drug manufacturers produce biosimilars.

Like generics, biosimilars are considered as safe and effective as the original brand-name drug.

Cyltezo cost

As with all medications, the cost of Cyltezo can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance: If you need financial support to pay for Cyltezo, or if you need help understanding your insurance coverage, help is available.

To learn more about saving money on prescriptions, check out this article.

Biosimilar form: Cyltezo is a biosimilar of the brand-name biologic drug Humira. A biosimilar medication is a drug that’s similar to a brand-name biologic drug (the parent drug).

Drug manufacturers use chemicals to make traditional drugs. But biologics contain living cells. It’s possible to make exact copies of brand-name chemical drugs. These are called generics. However, it’s not possible to make exact copies of brand-name biologic drugs. Instead, drug manufacturers make biosimilars.

Biosimilars are considered as safe and effective as their parent drug. And like generics, biosimilars tend to cost less than brand-name medications.

Common questions about Cyltezo

Here are answers to some frequently asked questions about Cyltezo.

How does Cyltezo compare with Humira?

Cyltezo (adalimumab-adbm) is a biosimilar* of the brand-name biologic drug Humira (adalimumab). It’s as effective as Humira and can cause the same side effects. The Food and Drug Administration (FDA) has approved Cyltezo for interchangeable use with Humira. This means that clinical trials have shown it’s possible to switch between Humira and Cyltezo without any changes in effectiveness or side effects. (The reason “-adbm” appears at the end of the drug’s name is to show that the drug is distinct from other biosimilar medications that may be created in the future.)

These drugs are mostly approved for the same uses, but Humira has some additional uses. For example, Humira is approved for uveitis (a type of eye inflammation). It’s also approved for ulcerative colitis and hidradenitis suppurativa in some children.

Cyltezo is not approved for these uses in children or for uveitis.

Both drugs are given as a subcutaneous injection. They both come as a single-dose prefilled syringe and injection pen. However, Humira also comes as a single-dose vial.

Biosimilars such as Cyltezo typically cost less than the original brand-name drug they are based on. To find out Cyltezo’s cost vs. Humira, talk with your doctor or pharmacist.

* To learn more about biosimilars, see the “Cyltezo generic or biosimilar” section above.

Can Cyltezo cause long-term side effects?

Yes, Cyltezo can cause some long-term side effects. For example, it can raise your risk of developing cancer. Cyltezo has a boxed warning for this side effect. A boxed warning is a serious warning from the FDA. To learn more about this warning, see the “Cyltezo precautions” section below.

If you’re concerned about long-term side effects with Cyltezo, talk with your doctor. They can discuss the risks and benefits of taking the drug long term.

Will Cyltezo cure my plaque psoriasis?

No, Cyltezo won’t cure plaque psoriasis. Currently, there is no cure for this condition. However, Cyltezo can significantly reduce or clear up symptoms of plaque psoriasis. In clinical trials, most people who took Cyltezo had minimal symptoms or clearer skin after 16 weeks. But your psoriasis symptoms may come back or worsen if you stop taking Cyltezo.

To learn more about what you can expect with Cyltezo treatment, talk with your doctor or pharmacist.

Cyltezo dosage

The Cyltezo dosage your doctor prescribes will depend on several factors. These include:

• the type and severity of the condition you’re using Cyltezo to treat
• your age
• other medications you may take
• body weight in children

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Cyltezo comes as a liquid in a single-dose prefilled syringe and injection pen.

The prefilled syringe is available in three strengths:

• 10 milligrams in 0.2 milliliters of solution (10 mg/0.2 mL)
• 20 mg/0.4 mL
• 40 mg/0.8 mL

The injection pen comes in one strength: 40 mg/0.8 mL.

Cyltezo is a subcutaneous injection. A healthcare professional may administer Cyltezo in their office or clinic. Alternatively, they may teach you or your caregiver how to administer Cyltezo at home.

Dosage for plaque psoriasis

For plaque psoriasis in adults, you’ll start treatment with a loading dose. A loading dose gets effective levels of medication into your body rapidly so it can start working right away.

The recommended dosage for adults is as follows:

• loading dose of 80 mg
• 1 week later, you’ll start taking 40 mg every other week

Dosage for psoriatic arthritis

The recommended dosage for psoriatic arthritis in adults is 40 mg every other week.

Dosage for rheumatoid arthritis

The recommended dosage for rheumatoid arthritis in adults is 40 mg every other week.

If you’re not taking methotrexate (Otrexup, Trexall, others) with Cyltezo, your doctor may increase your dosage to 40 mg weekly or 80 mg every other week.

Dosage for ankylosing spondylitis

The recommended dosage for ankylosing spondylitis in adults is 40 mg every other week.

Dosage for ulcerative colitis

For ulcerative colitis, you’ll start treatment with a loading dose. A loading dose gets effective levels of medication into your body rapidly so it can start working right away.

The recommended dosage for adults is as follows:

• loading dose of 160 mg (you may take this all on day 1 or split it into two doses and take it on day 1 and day 2)
• 2 weeks later (on day 15), you’ll take a dose of 80 mg
• 2 weeks later (on day 29), you’ll start taking 40 mg every other week

Dosage for hidradenitis suppurativa

For hidradenitis suppurativa, you’ll start treatment with a loading dose. A loading dose gets effective levels of medication into your body rapidly so it can start working right away.

The recommended dosage for adults is as follows:

• loading dose of 160 mg (you may take this all on day 1 or split it into two doses and take it on day 1 and day 2)
• 2 weeks later (on day 15), you’ll take a dose of 80 mg
• 2 weeks later (on day 29), you’ll start taking 40 mg or 80 mg every other week

Dosage for juvenile idiopathic arthritis

The dosage for juvenile idiopathic arthritis in children ages 2 years and older depends on the child’s body weight in kilograms (kg). One kg is about 2.2 pounds (lb). Recommended dosages are as follows:

• Children weighing 10 kg to less than 15 kg (about 22 lb to 33 lb): 10 mg every other week
• Children weighing 15 kg to less than 30 kg (about 33 lb to 66 lb): 20 mg every other week
• Children weighing 30 kg (about 66 lb) or more: 40 mg every other week

Dosage for Crohn’s disease

For Crohn’s disease, you’ll start treatment with a loading dose. A loading dose gets effective levels of medication into your body rapidly so it can start working right away.

For adults, the recommended dosage is as follows:

• loading dose of 160 mg (you may take this all on day 1 or split it into two doses and take it on day 1 and day 2)
• 2 weeks later (on day 15), you’ll take a dose of 80 mg
• 2 weeks later (on day 29), you’ll start taking 40 mg every other week

For children, the recommended dosage depends on the child’s body weight as follows:

• Children weighing 17 kg to less than 40 kg (about 37 lb to 88 lb):
  • loading dose of 80 mg
  • 2 weeks later (on day 15), they’ll take a dose of 40 mg
  • 2 weeks later (on day 29), they’ll start taking 20 mg every other week
• Children weighing 40 kg (88 lb) or more:
  • loading dose of 160 mg (they may take this all on day 1 or split it into two doses and take it on day 1 and day 2)
  • 2 weeks later (on day 15), they’ll take a dose of 80 mg
  • 2 weeks later (on day 29), they’ll start taking 40 mg every other week

Children’s dosage

Cyltezo is approved for the following uses in children:

• juvenile idiopathic arthritis in children ages 2 years and older
• Crohn’s disease in children ages 6 years and older

The recommended dosages for these uses in children are described in the individual sections just above.

About taking Cyltezo

Below you’ll find information about key dosage issues.

• When to take: You should take Cyltezo every 1 or 2 weeks, depending on the condition you’re using it to treat.Taking the medication on the same day of the week and around the same time of day can help you remember to take it.
• If you miss a dose: If you miss a dose, take it as soon as possible. Then take your next dose as scheduled to put you back on your usual schedule. If it’s almost time for your next scheduled dose and you’re not sure whether to take a missed dose, call your doctor.
• Length of use: Cyltezo is meant to be used as a long-term treatment. If you and your doctor determine that Cyltezo is safe and effective for you, you’ll likely take it long term.

How to inject

You should take Cyltezo according to the instructions your doctor gives you.

Cyltezo is given as a subcutaneous injection. A healthcare professional may administer Cyltezo in their office or clinic. Alternatively, they may teach you or your carer how to administer Cyltezo at home.

You can find instructions for injecting Cyltezo in the drug’s prescribing information.

Where and when to inject

A health professional, you, or a caregiver should inject Cyltezo into the front of your upper thigh or belly (avoiding the area 2 inches around your belly button). Each time you use Cyltezo, you should inject it in a slightly different place, at least 1 inch from your previous injection site.

You’ll typically inject Cyltezo every other week, but this depends on the condition you’re treating. Always follow your doctor’s instructions for when to inject Cyltezo.

Overdose

Do not use more Cyltezo than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Cyltezo

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

Cyltezo side effects

Cyltezo can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Cyltezo. These lists do not include all possible side effects.

For more information about the possible side effects of Cyltezo, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may concern or bother you.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Cyltezo, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Cyltezo. To learn about other mild side effects, talk with your doctor or pharmacist, or view Cyltezo’s prescribing information.

Mild side effects of Cyltezo can include:

• injection site reactions, such as pain, swelling, skin redness or discoloration, itching, or bleeding
• upper respiratory infections, such as the common cold
• skin rash
• headache
• mild allergic reaction*

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

* For more information about allergic reaction and Cyltezo, see “Allergic reaction” below.

Serious side effects

Serious side effects from Cyltezo aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Heart failure. Symptoms can include:
  • shortness of breath
  • swollen ankles or feet
  • sudden weight gain
• Lupus-like syndrome (an immune system reaction). Symptoms can include:
  • shortness of breath
  • joint pain
  • chest pain or discomfort that does not go away
  • rash on the cheeks or arms that gets worse in the sun
• Liver problems, such as liver failure. Symptoms can include:
  • abdominal pain
  • loss of appetite
  • jaundice
• Blood problems, such as low levels of red blood cells, white blood cells, or platelets. Symptoms can include:
  • fever
  • bruising or bleeding easily
  • looking paler than usual
• Nerve problems, such as multiple sclerosis and Guillain-Barré syndrome. Symptoms can include:
  • tingling or numbness
  • weakness in the arms or legs
  • dizziness
  • vision problems
• Risk of serious infection.*
• Risk of cancer.*
• Severe allergic reaction.†

* Cyltezo has a boxed warning for this side effect. This is a serious warning from the FDA. To learn more, see the “Cyltezo precautions” section below.
† For details about allergic reaction and Cyltezo, see “Allergic reaction” below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after taking Cyltezo. This was a rare side effect in clinical trials of this drug.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

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

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have an allergic reaction to Cyltezo, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Cyltezo uses

The Food and Drug Administration (FDA) approves prescription drugs such as Cyltezo to treat certain autoimmune conditions.

Cyltezo for rheumatoid arthritis

Cyltezo is FDA-approved to treat moderate to severely active rheumatoid arthritis (RA) in adults. Active means the disease is causing symptoms.

With RA, you have inflammation (swelling) in your joints. This makes the joints stiff and painful, which can cause trouble with daily activities. Over time, the inflammation can damage and deform your joints.

Your doctor may prescribe Cyltezo by itself or with other drugs for RA. Examples of other arthritis drugs that you may take with Cyltezo include methotrexate (Otrexup, Trexall, and others) and sulfasalazine (Azulfidine).

To learn more about RA, refer to our rheumatoid arthritis hub.

Cyltezo for psoriatic arthritis

Cyltezo is FDA-approved to treat active psoriatic arthritis (PsA) in adults. Active means the disease is causing symptoms.

Your doctor may prescribe Cyltezo alone or with other drugs for PsA. Examples of other arthritis drugs that you may take with Cyltezo include methotrexate (Otrexup, Trexall, and others).

PsA is a form of arthritis that can develop in some people with psoriasis. Psoriasis is an autoimmune condition. It’s caused by your immune system mistakenly attacking your skin. With PsA, your immune system also mistakenly attacks your joints.

To learn more about PsA, refer to our arthritis hub.

Cyltezo for ankylosing spondylitis

Cyltezo is FDA-approved to treat active ankylosing spondylitis (AS) in adults. Active means the disease is causing symptoms.

With AS, you have inflammation (swelling) in your spine and hip joints. This makes the joints stiff and painful, which can cause difficulty with bending and daily activities. Over time, the inflammation can damage the joints and cause your vertebrae (bones in your spine) to fuse. This can lead to loss of flexibility and deformity in your spine.

To learn more about AS, refer to our arthritis hub.

Cyltezo for ulcerative colitis

Cyltezo is FDA-approved to treat moderate to severely active ulcerative colitis (UC) in adults. Active means the disease is causing symptoms.

Cyltezo belongs to a class of drugs called tumor necrosis factor (TNF) blockers. It’s unknown if Cyltezo effectively treats people for whom other TNF blockers stopped working or caused bothersome side effects.

Ulcerative colitis is a form of inflammatory bowel disease. It affects the colon (large intestine) and rectum. It’s partly caused by overactivity in your immune system.

With UC, you have inflammation (swelling) and, in severe cases, ulcers in your colon and/or rectum. This can cause symptoms such as diarrhea, abdominal pain or cramps, blood in your stool, and weight loss.

Cyltezo for plaque psoriasis

Cyltezo is FDA-approved to treat moderate to severe chronic (long-term) plaque psoriasis in adults. A doctor may recommend and prescribe it when your condition could benefit from systemic treatment (medication taken as tablets or injections) or phototherapy (light treatment).

Cyltezo is typically only used when other systemic therapies are less suitable. Doctors will closely monitor people taking Cyltezo for psoriasis.

With plaque psoriasis, thick, scaly patches called plaques develop on your skin. On darker skin tones, the plaques may appear dark brown or purple with gray scales. They may appear red or pink with white scales on lighter skin tones.

To learn more about plaque psoriasis, refer to our psoriasis hub.

Cyltezo for hidradenitis suppurativa

Cyltezo is FDA-approved to treat moderate to severe hidradenitis suppurativa (HS) in adults.

HS is a long-term skin condition that causes repeated breakouts of painful, inflamed lumps deep in the skin. These usually develop in areas such as the armpits, groin, and inner thighs. The lumps may look like pimples, boils, cysts, or abscesses. If they break open, blood and pus can leak out. As the skin heals, this can lead to scarring.

This condition may be partly caused by overactivity in your immune system.

Cyltezo for juvenile idiopathic arthritis

Cyltezo is FDA-approved to treat moderate to severely active polyarticular juvenile idiopathic arthritis (JIA) in children ages 2 years and older. Active means the disease is causing symptoms. Polyarticular means that the arthritis has affected at least five joints.

JIA causes inflammation (swelling) in the joints, making them stiff and painful. This can make it more difficult to carry out daily activities. Over time, the inflammation can damage and deform the joints.

Your child’s doctor may prescribe Cyltezo alone or with other drugs for JIA. Examples of other JIA drugs that may your child may take with Cyltezo include methotrexate (Otrexup, Trexall, and others).

To learn more about JIA, refer to our rheumatoid arthritis hub.

Cyltezo for Crohn’s disease

Cyltezo is FDA-approved to treat moderate to severely active Crohn’s disease in adults and children ages 6 years and older. Active means the disease is causing symptoms.

Crohn’s disease is a form of inflammatory bowel disease. It can affect any part of your digestive system, from your mouth to your anus. It’s partly caused by overactivity in your immune system.

With Crohn’s disease, you have inflammation (swelling) in your digestive system. This can cause symptoms such as diarrhea, abdominal pain or cramps, blood in your stool, and weight loss.

Cyltezo and children

Cyltezo is FDA-approved for two uses in children:

• juvenile idiopathic arthritis in children ages 2 years and older
• Crohn’s disease in children ages 6 years and older

To read more about these uses, see the individual sections just above.

Cyltezo interactions

Cyltezo can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Before taking Cyltezo, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

Interactions with medications, foods, and supplements

Below is a list of medications, supplements, and foods that can interact with Cyltezo. This list does not contain all drugs that may interact with Cyltezo. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Alcohol interaction

Alcohol is not known to interact with Cyltezo. It’s likely safe to consume alcohol while taking Cyltezo.

Note that drinking alcohol can sometimes worsen symptoms of some of the conditions Cyltezo treats. For example, some people with ulcerative colitis or plaque psoriasis find that drinking alcohol can make their symptoms flare up.

If you have questions about how much alcohol is safe to drink while taking Cyltezo, talk with your doctor or pharmacist.

Similar drugs

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Cyltezo, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs are similar to Cyltezo:

• other tumor necrosis factor (TNF) blockers, such as etanercept (Enbrel) and golimumab (Simponi, Simponi Aria)
• biologic disease-modifying anti-rheumatic drugs (DMARDs), such as abatacept (Orencia) and anakinra (Kineret)
• monoclonal antibodies, such as rituximab (Rituxan) and tocilizumab (Actemra)
• Janus kinase (JAK) inhibitors, such as tofacitinib (Xeljanz, Xeljanz XR) and upadacitinib (Rinvoq)

Things to consider when taking Cyltezo

If you can become pregnant, consider the following information about pregnancy, birth control, and breastfeeding.

Cyltezo and pregnancy

It’s unknown whether you should use Cyltezo during pregnancy. However, here are some important factors to consider:

• Some of the conditions Cyltezo treats can raise the risk of problems during pregnancy. For example, rheumatoid arthritis or inflammatory bowel disease that’s not well managed during pregnancy can increase the risk of premature delivery. It can also cause the baby to have a low birth weight.
• If you do take Cyltezo during pregnancy, the newborn may have a temporarily weakened immune system. Talk with your doctor about when the baby should receive their first immunizations. Your doctor may recommend delaying live vaccinations, such as the oral rotavirus vaccine. See the “Cyltezo interactions” section above to learn more about Cyltezo’s interaction with vaccines.

If you’re planning a pregnancy or can become pregnant, talk with your doctor before using this medication.

Cyltezo and birth control

It’s unknown if it’s safe to use Cyltezo during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control during Cyltezo treatment.

Cyltezo and breastfeeding

Cyltezo can pass into breast milk. It’s unknown if it can cause side effects in a child who’s breastfed.

If you’re currently breastfeeding or planning to do so, talk with your doctor before using this medication. Your doctor may recommend other ways to feed your child during treatment with Cyltezo.