What does it mean for Cyltezo (adalimumab) to be interchangeable with Humira (adalimumab)?

Cyltezo (adalimumab) is the first [interchangeable](https://www.goodrx.com/cyltezo/cyltezo-is-first-interchangeable-humira-biosimilar) biosimilar to Humira (adalimumab). This means it meets [additional requirements by the FDA](https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices#:~:text=An-,interchangeable,-biosimilar%20product%20is) that allows it to be substituted for the original approved biologic (Humira). In other words, in some states your pharmacist could dispense Cyltezo (adalimumab) for you instead of Humira (adalimumab) without needing a new prescription from your provider. This is similar to how generics can be dispensed in place of brand name products, as long as your provider didn't specify otherwise.

What's the difference between Cyltezo (adalimumab) and other Humira (adalimumab) biosimilars?

While Humira (adalimumab) biosimilars work the same way, there are some differences between them. __(1)__ Some Humira biosimilars are available as different strengths and dosage forms compared to Cyltezo (adalimumab). For example, Cyltezo (adalimumab) is available as prefilled syringes, while other Humira biosimilars are available as [autoinjectors](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6080662/#:~:text=patient%20preference%20for-,autoinjectors,-(pens)%20over%20prefilled) to help make giving the injection easier. __(2)__ Another difference is that Cyltezo (adalimumab) is approved to treat JIA and CD in children, whereas other biosimilars haven't been approved in children with CD. __(3)__ Also, Cyltezo (adalimumab) is latex-free and citrate-free while other biosimilars contain them.

Is it okay to take other arthritis medications with Cyltezo (adalimumab)?

Whether or not you can take other medications with Cyltezo (adalimumab) depends on which type of arthritis you have and your treatment plan. For RA, Cyltezo (adalimumab) can be used alone or with methotrexate or other [non-biologic DMARDs](https://www.goodrx.com/conditions/psoriatic-arthritis/psoriatic-arthritis-treatment#:~:text=modifying%20antirheumatic%20drugs-,DMARDs,-are%20medications%20that). For JIA, Cyltezo (adalimumab) can be used alone or together with methotrexate. And for PsA, it can be used alone or together with non-biologic DMARDs. Speak to your provider about which medications are safe to take together with Cyltezo (adalimumab).

Cyltezo

adalimumab-adbm

Used for Ankylosing Spondylitis, Crohn's Disease, Hidradenitis Suppurativa, Juvenile Idiopathic Arthritis, Plaque Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Uveitis

Cyltezo (adalimumab or adalimumab-adbm) is an injectable medication used to treat several autoimmune conditions, including plaque psoriasis, ulcerative colitis, Crohn's disease, and certain types of arthritis. It's the first interchangeable biosimilar to Humira (adalimumab). It was approved by the FDA in 2017, but it's not expected to be available until July 2023.

Reviewed by:

Kristianne Hannemann, PharmD

Daisy Chau, PharmD

Last reviewed on December 23, 2022

What is Cyltezo (adalimumab)?

What is Cyltezo (adalimumab) used for?

Rheumatoid arthritis (RA) - adults only
Juvenile idiopathic arthritis (JIA) - people age 2 and older
Psoriatic arthritis (PsA) - adults only
Ankylosing spondylitis (AS) - adults only
Crohn's disease (CD) - people age 6 and older
Ulcerative colitis (UC) - adults only
Plaque psoriasis - adults only
Hidradenitis suppurativa (HS) - adults only
Uveitis - adults only

How Cyltezo (adalimumab) works

Cyltezo (adalimumab) is a biologic disease-modifying antirheumatic drug (DMARD). It blocks tumor necrosis factor (TNF), which is a protein in your body that plays a role in inflammation. By blocking TNF, Cyltezo (adalimumab) lowers inflammation to relieve symptoms in different parts of your body.

Are you looking for information on Humira (adalimumab) instead?

Drug facts

Common Brands	Cyltezo
Drug Class	Biologic DMARD
Controlled Substance Classification	Not a controlled medication
Generic Status	No lower-cost generic available
Availability	Prescription only

Common Brands

Cyltezo

Drug Class

Biologic DMARD

Controlled Substance Classification

Not a controlled medication

Generic Status

No lower-cost generic available

Availability

Prescription only

Side effects of Cyltezo (adalimumab)

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

Injection site reaction (20%)
Upper respiratory tract infection (17%)
Headache (12%)
Rash (12%)
Sinus inflammation (11%)
Accidental injury (10%)
Nausea (9%)
Urinary tract infection (UTI) or bladder infection (8%)

Less Common Side Effects

High cholesterol
High blood pressure
Back pain
Stomach pain
Hair loss
Blood in the urine
Flu-like symptoms

Cyltezo (adalimumab) serious side effects

Contact your healthcare provider immediately if you experience any of the following.

Serious infection: fever, cough, weight loss, muscle aches, dark urine, chills, vomiting
Severe allergic reaction: rash, trouble breathing, swelling of your face, eyes, lips, or mouth, hives
Low blood cell counts: fever that doesn't go away, easy bruising or bleeding, pale skin
Heart failure: shortness of breath, swelling in the legs, ankles, or feet, irregular heartbeat, tiredness, sudden weight gain
Liver problems: feeling tired, vomiting, yellow skin or whites of the eyes, stomach pain

Source: Prescribing Information

The following Cyltezo (adalimumab) side effects have also been reported

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain

cough

ear congestion

gas with stomach pain

hoarseness

lightheadedness

loss of voice

lower back or side pain

muscle aches and pains

pain or tenderness around the eyes or cheekbones

rapid and sometimes shallow breathing

shivering

stomach fullness

stuffy nose

sunken eyes

thirst

trouble sleeping

warmth on the skin

wrinkled skin

Less common

Abnormal vaginal bleeding or discharge

agitation

arm, back, or jaw pain

black, tarry stools

bleeding from the gums or nose

blindness

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the stool or change in bowel habits

bloody or cloudy urine

blurred vision

broken bones

change in size, shape, or color of an existing mole

change in skin color

chest pain, tightness, or heaviness

chills

clear or bloody discharge from the nipple

cold hands and feet

confusion

constipation

cough

coughing or spitting up blood

decreased urination

decreased vision

depression

difficulty with breathing

difficulty, burning, or painful urination

dimpling of the breast skin

dizziness

drowsiness

eye pain

fainting

fast, slow, or irregular heartbeat

fever

forgetfulness

frequent urge to urinate

general feeling of illness

hair loss

headache

hives, itching, skin rash

increased thirst

inverted nipple

irregular breathing

irregular pulse

irritability

light colored stools

loss of appetite

lump in the breast or under your arm

lump or swelling in the stomach

mole that leaks fluid or bleeds

muscle cramps or spasms

nausea

new mole

night sweats

no blood pressure or pulse

noisy breathing

numbness or tingling in your arms, legs, or face

pain, redness, or swelling in the arms or legs without any injury present

pale skin

persistent non-healing sore on your skin

pink growth

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

raised, firm, or bright red patch

redness or swelling of the breast

seeing or hearing things that are not there

seizures

sharp back pain just below your ribs

shiny bump on your skin

slurred speech or problems with swallowing

sneezing

sore on the skin of the breast that does not heal

sore throat

sores, ulcers, or white spots on the lips or mouth

spitting up blood

stiff neck

stomach pain

stopping of the heart

sudden high fever or low grade fever for months

sweating

swelling of the face, fingers, feet, or lower legs

swollen glands

swollen neck veins

tiredness

trouble breathing

trouble thinking

unconsciousness

unexplained bruising or bleeding

unpleasant breath odor

unusual tiredness or weakness

unusual weight gain or loss

visual disturbances

vomiting

vomiting of blood or material that looks like coffee grounds

yellow skin or eyes

Incidence not known

Blistering, peeling, or loosening of the skin

diarrhea

inability to move the arms and legs

joint or muscle pain

pinpoint red spots on the skin

red skin lesions, often with a purple center

red, irritated eyes

red, scaling, or crusted skin

sudden numbness and weakness in the arms and legs

unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bladder pain

bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

pounding in the ears

Less common

Abnormal healing

decrease in height

difficulty with moving

difficulty with walking

dry mouth

heartburn

indigestion

loss of hearing

loss of strength or energy

menstrual changes

muscle or joint stiffness, tightness, or rigidity

muscle pain or weakness

pain in the back, ribs, arms, or legs

shakiness in the legs, arms, hands, and feet

swelling or redness in the joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See more Cyltezo (adalimumab) side effects

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Avg retail price

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$550.00

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Pros and cons of Cyltezo (adalimumab)

Pros

Works treat many autoimmune conditions
Can be injected at home, if your provider says it's safe to do so
Doesn't contain citrate, so injections might be less painful compared to some other adalimumab products
Can be stored at room temperature for up to 14 days if needed

Cons

Raises risk for infections
The needle caps contain natural rubber latex, which might not be the best option for people with a latex allergy
Might be difficult to use for some people
Only FDA approved for use in children for JIA and CD

Pharmacist tips for Cyltezo (adalimumab)

Before using Cyltezo (adalimumab) at home, you should receive injection training from your healthcare provider or care team. Don't try to give yourself an injection until you've been shown how to do it correctly. If you have questions, call your provider or 1-800-542-6257.
Mark when your doses of Cyltezo (adalimumab) are due on your calendar. This medication works best when it's taken consistently.
When you're ready for your dose, take Cyltezo (adalimumab) out of the refrigerator and let it warm up to room temperature for about 15 to 30 minutes. This can lower discomfort with the injection. Don't warm it up by putting it in the microwave or in hot water because this could damage the medication.
Keep unused Cyltezo (adalimumab) in the refrigerator in its original container to protect it from light. But you can store it at room temperature for 14 days, just make sure to throw it away after that time.
Throw away used needles, syringes, and autoinjectors in a sharps container to prevent needlestick injuries. You can use an FDA-cleared container or heavy-duty plastic container you have at home. Check your local laws and guidelines for how to dispose of your container once it's almost full.
Before getting any vaccines, let your provider or pharmacist know you're taking Cyltezo (adalimumab). It's recommended to avoid live vaccines while you're taking this medication. Make sure your child gets all of their appropriate shots before starting Cyltezo (adalimumab).

Common questions about Cyltezo

Cyltezo is the first interchangeable biosimilar to Humira (adalimumab). This means it meets additional requirements by the FDA that allows it to be substituted for the original approved biologic (Humira). In other words, in some states your pharmacist could dispense Cyltezo for you instead of Humira (adalimumab) without needing a new prescription from your provider. This is similar to how generics can be dispensed in place of brand name products, as long as your provider didn't specify otherwise.

While Humira (adalimumab) biosimilars work the same way, there are some differences between them. (1) Some Humira biosimilars are available as different strengths and dosage forms compared to Cyltezo. For example, Cyltezo is available as prefilled syringes, while other Humira biosimilars are available as autoinjectors to help make giving the injection easier. (2) Another difference is that Cyltezo is approved to treat JIA and CD in children, whereas other biosimilars haven't been approved in children with CD. (3) Also, Cyltezo is latex-free and citrate-free while other biosimilars contain them.

You can inject Cyltezo into the fatty area under the skin of your lower stomach (at least 2 inches away from your belly button) or on the front of your thighs. To allow your skin to heal, rotate injection sites each time. Don't inject it into skin that's sore, hard, red, or bruised.

If you forget to take your dose of Cyltezo, inject a dose as soon as possible. Then, take your next dose at your regularly scheduled time. If you aren't sure when you should inject Cyltezo, contact your provider.

Whether or not you can take other medications with Cyltezo depends on which type of arthritis you have and your treatment plan. For RA, Cyltezo can be used alone or with methotrexate or other non-biologic DMARDs. For JIA, Cyltezo can be used alone or together with methotrexate. And for PsA, it can be used alone or together with non-biologic DMARDs. Speak to your provider about which medications are safe to take together with Cyltezo.

Risks and warnings for Cyltezo (adalimumab)

Cyltezo (adalimumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

Serious infections

Risk factors: Taking other medications that weaken the immune system | Older adults | Active, long-term, or an infection that keeps coming back | Traveling to high risk areas | Having other conditions that raise the risk of infection

Black Box Warning Cyltezo (adalimumab) can raise your risk of serious or life-threatening infections. Your risk is higher if you're an older adult, taking other medications that can weaken the immune system (e.g., methotrexate, Orencia (abatacept), Kineret (anakinra), corticosteroids), or if you have other health conditions. For your safety, discuss your medical history with your provider. Be sure to let them know if you've ever had tuberculosis or hepatitis B. They'll review your risk before starting the medication. If you develop a serious infection while taking Cyltezo (adalimumab), you might have to stop the medication in order to give your immune system a chance to fight the infection.

Cancers

Risk factors: Taking other medications that weaken the immune system | History of cancer | People with chronic obstructive pulmonary disease (COPD) with a history of smoking

Black Box Warning During clinical studies with a medication like Cyltezo (adalimumab), there was a greater number of people who developed cancer while taking that medication when compared to people not taking it. Lymphoma, leukemia, and skin cancers were some of the most commonly reported types of cancer in people who used that medication. Your provider will determine your risk before starting Cyltezo (adalimumab) and monitor you while you're taking it. Speak to your provider if you have any concerns.

Severe allergic reactions

Products containing adalimumab (the active ingredient in Cyltezo) have caused allergic reactions. Although rare, some reactions can be life threatening (e.g., anaphylaxis). If you experience rash, trouble breathing, or swelling in your face, lips, tongue, or throat, get medical help right away.

Nervous system effects

Risk factors: Currently have or recently developed a nervous system condition

Although rare, people taking medications like Cyltezo (adalimumab) have developed conditions that affect the nervous system, such as multiple sclerosis (MS) and Guillain-Barré syndrome. Let your provider know if you currently have nerve problems. They'll want to monitor you closely while you're taking Cyltezo (adalimumab), since it can make them worse. Contact your provider if you notice any vision problems, numbness or tingling, weakness in your arms or legs, or dizziness.

Low blood cell counts

Although rare, some people taking medications like Cyltezo (adalimumab) have had low amounts of blood cells. This can raise your risk for bleeding and lower your body's ability to fight infections. Contact your provider if you develop a fever that doesn't go away, easy bruising, pale skin, or bleeding.

Heart failure

People taking medications like Cyltezo (adalimumab) have had new or worsening cases of heart failure. Talk to your provider if you currently have heart failure. They'll weigh the benefits and risks to determine if Cyltezo (adalimumab) is right for you. Get medical help if you start to have shortness of breath, swelling in the legs, ankles, or feet, irregular heartbeat, or tiredness or weakness, as these can be signs of heart failure.

Lupus-like syndrome

Rarely, Cyltezo (adalimumab) can cause a condition called lupus-like syndrome. Call your provider if you feel more tired than usual, experience easy bruising or bleeding, or a rash.

Cyltezo (adalimumab) dosage

The average cost for 1 carton of 2 pens of 40mg/0.4ml of Cyltezo (adalimumab) is $6,638.16 with a free GoodRx coupon. This is 15.89% off the average retail price of $7,892.59.

Carton

Dosage	Quantity	Price as low as	Price per unit
2 syringes of 40mg/0.8ml	2 cartons	$13,267.27	$6,633.64
2 pens of 40mg/0.8ml	1 carton	$6,410.63	$6,410.63
2 syringes of 20mg/0.4ml	1 carton	$6,638.16	$6,638.16
2 syringes of 10mg/0.2ml	1 carton	$6,638.16	$6,638.16
Psoriasis starter pack of 40mg/0.8ml	1 carton	$12,825.35	$12,825.35
Crohn's starter pack of 40mg/0.8ml	1 carton	$19,235.02	$19,235.02
2 pens of 40mg/0.4ml	1 carton	$6,638.16	$6,638.16
2 syringes of 40mg/0.4ml	1 carton	$6,638.16	$6,638.16
Crohn's starter pack of 40mg/0.4ml	1 carton	$19,422.83	$19,422.83
Psoriasis starter pack of 40mg/0.4ml	1 carton	$13,267.27	$13,267.27

See more Cyltezo (adalimumab) dosage

Interactions between Cyltezo (adalimumab) and other drugs

Cyltezo (adalimumab) may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with Cyltezo (adalimumab). Please note that only the generic name of each medication is listed below.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.