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Simlandi

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

Simlandi (adalimumab or adalimumab-ryvk) is an injectable medication used to treat many autoimmune conditions, including rheumatoid arthritis, Crohn's disease, and plaque psoriasis. It's an interchangeable biosimilar to Humira (adalimumab). Simlandi (adalimumab) is given as an injection under the skin every week or every other week. Side effects include infections, injection site reactions, and headache.

Reviewed by:
reviewer
Kristianne Hannemann, PharmD
reviewer
Allison Gourley, PharmD
Last reviewed on June 18, 2024
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageInteractionsCostAlternativesLatest newsReferencesPricesMedicare
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What is Simlandi (adalimumab)?

What is Simlandi (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 (UV) - adults only

How Simlandi (adalimumab) works

Simlandi (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, Simlandi (adalimumab) can help relieve symptoms caused by inflammation like pain, swelling, and stiffness.

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

Drug Facts

Common BrandsSimlandi
Drug ClassBiologic DMARD
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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What are the side effects of Simlandi (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%)

Other Side Effects

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

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
  • Low blood cell counts: fever that doesn't go away, easy bruising or bleeding, pale skin
  • Severe allergic reaction: rash, trouble breathing, swelling of your face, eyes, lips, or mouth, hives
  • 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: DailyMed

The following 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.

pros-and-cons

Pros and cons of Simlandi (adalimumab)

thumbs-up

Pros

Available as a prefilled autoinjector

Can be used at home, if your prescriber says it's safe to do so

Not made with natural rubber latex, which might be a good option for people with latex allergies

Only needs to be injected a couple times a month

thumbs-down

Cons

Raises the risk of serious infections

Might be difficult to inject for some people

Can cause unpleasant side effects like injection site reactions, stomach pain, headache, and rash

Live vaccines aren't recommended while taking the medication

pharmacist-tips

Pharmacist tips for Simlandi (adalimumab)

pharmacist

  • You should receive injection training from your prescriber or another member of your healthcare team. If you haven't, contact the clinic or the manufacturer at 1-888-483-8279. Don't try to give yourself a Simlandi (adalimumab) injection until you're comfortable doing it safely and properly.

    • Store Simlandi (adalimumab) in the refrigerator. Keep it in its original container to protect it from light. Never freeze it because this could damage the medication.

      • If you're traveling or don't have access to a refrigerator, Simlandi (adalimumab) can be left at room temperature for 14 days. After 14 days, it should be thrown away.

        • Once you're ready for your injection, take Simlandi (adalimumab) out of the refrigerator and let it warm up to room temperature. This takes about 15 to 30 minutes, and will help prevent discomfort and pain with the injection. Don't try to warm it up by putting it in the microwave or in hot water.

          • Don't use Simlandi (adalimumab) if you accidentally drop it. Some parts are made of glass and can break. If this happens, call your pharmacist.

            • Wash your hands with soap and water and clean the site where you'll inject Simlandi (adalimumab) with an alcohol swab. This helps prevent infection.

              • After preparing your Simlandi (adalimumab) autoinjector and pushing it against your skin, you'll hear a click. This means the injection is starting and it might take up to 10 seconds to finish. The injection is done when you hear a second click and the orange indicator has stopped moving.

                • After you inject Simlandi (adalimumab), throw away the autoinjector in a sharps container. You can buy an FDA-cleared container or use a heavy-duty plastic container you have at home.

                  • Simlandi (adalimumab) can rarely cause a condition called lupus-like syndrome. Contact your prescriber if you experience rash, easy bruising or bleeding, or feel more tired than usual.

                    faqs

                    Frequently asked questions about Simlandi (adalimumab)

                    When will Simlandi (adalimumab) be available?
                    Simlandi (adalimumab) was FDA approved in February 2024. According to the manufacturer, it has been available in the United States since May 2024.
                    How do you inject Simlandi (adalimumab)?
                    Simlandi (adalimumab) is injected under the skin. You can inject it into your lower abdomen (at least 2 inches away from your belly button) or on the front of your thighs. To allow your skin to heal, be sure to rotate injection sites each time. Don't inject Simlandi (adalimumab) into skin that's hard, sore, red, or bruised. Also, never inject this medication through clothing.
                    Does Simlandi (adalimumab) cause weight gain?
                    Weight gain wasn't reported as a side effect of Simlandi (adalimumab) during clinical studies. If you notice sudden weight gain, contact your primary care provider so they can help determine the cause. Fast weight gain could be a sign of new or worsening heart failure, which has been rarely reported with other TNF blockers and adalimumab products.
                    Does Simlandi (adalimumab) weaken your immune system?
                    Yes, Simlandi (adalimumab) can affect how well your immune system works to fight off infections. Simlandi (adalimumab) reduces inflammation by blocking a protein called tumor necrosis factor (TNF). TNF is important for your immune system to work normally. By blocking it, your immune system might not be able to respond to infections as well. This can put you at a higher risk for serious infections.
                    How long can Simlandi (adalimumab) be left out of the refrigerator?
                    You can keep Simlandi (adalimumab) at room temperature for up to 14 days. However, make sure to protect it from light while it's outside of the refrigerator. After 14 days, throw Simlandi (adalimumab) away because it might not work well anymore.
                    What should I do if I miss a dose of Simlandi (adalimumab)?
                    If you forget to take your dose of Simlandi (adalimumab), inject your dose as soon as you remember. After that, continue taking your doses per your usual schedule. If you have questions about when you should inject Simlandi (adalimumab), contact your prescriber or pharmacist.
                    Is Simlandi (adalimumab) a biologic?
                    Yes, Simlandi (adalimumab) is a biologic medication. This means it's made from living sources. Simlandi (adalimumab) is a monoclonal antibody, which is a protein that's made in a laboratory.
                    What's the difference between Simlandi (adalimumab) and Humira (adalimumab)?
                    Simlandi (adalimumab) is a biosimilar to Humira (adalimumab). Biosimilars are medications that are highly similar to each other, with studies showing similarities in safety and how well they work. They're both injected under the skin and treat the same conditions. However, Humira (adalimumab) is approved for certain children with HS and UV while only adults with these conditions are approved for Simlandi (adalimumab). Talk to your primary care provider to learn more about these treatment options.
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                    What are the risks and warnings for Simlandi (adalimumab)?

                    Simlandi (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.

                    risk-warning

                    Serious infections

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

                      Simlandi (adalimumab) blocks TNF, a protein that plays an important role in your immune system. As a result, it can raise your risk of serious infections. Some infections can be life-threatening. 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.

                      Before starting Simlandi (adalimumab), discuss your medical history with your prescriber. 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 Simlandi (adalimumab), you might have to stop the medication in order to give your immune system a chance to fight the infection.

                      risk-warning

                      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

                        In clinical studies, there was a greater number of people who developed cancer while taking a medication like Simlandi (adalimumab) compared to people who didn't take that medication. Some of the most commonly reported types of cancer in people who used that medication were lymphoma, leukemia, and skin cancers. Your prescriber will determine your risk before starting Simlandi (adalimumab) and monitor you while you're taking the medication. Talk to your healthcare team if you have any concerns.

                        risk-warning

                        Severe allergic reactions

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

                        risk-warning

                        Nervous system effects

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

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

                          risk-warning

                          Low blood cell counts

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

                          risk-warning

                          Heart failure

                          People taking medications like Simlandi (adalimumab) have had new or worsening cases of heart failure. If you currently have heart failure, your prescriber will weigh the benefits and risks to determine if Simlandi (adalimumab) is right for you. Get medical help right away 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.

                          risk-warning

                          Live vaccines

                          It's fine to get some vaccines while you're taking Simlandi (adalimumab), but avoid getting live vaccines (e.g., MMR II (measles, mumps, and rubella vaccine)). This is because it isn't known if they're safe or work well while you're taking Simlandi (adalimumab). It's recommended that children get all of their appropriate shots before starting Simlandi (adalimumab). Ask your prescriber or pharmacist to make sure that you can get the appropriate vaccines while taking this medication.

                          dosage

                          Simlandi (adalimumab) dosage forms

                          Typical dosing for Simlandi (adalimumab)

                          Adults

                          • Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: The typical dose is 40 mg injected under the skin every other week.

                          • Crohn's disease and ulcerative colitis: The typical dose is 160 mg injected under the skin on Day 1, followed by 80 mg on Day 15, then 40 mg every other week starting Day 29.

                          • Plaque psoriasis and uveitis: The typical dose is 80 mg injected under the skin on Day 1, followed by 40 mg every other week starting 1 week after the first dose.

                          • Hidradenitis suppurativa: The typical dose is 160 mg injected under the skin on Day 1, followed by 80 mg on Day 15, then 40 mg every week OR 80 mg every other week starting Day 29.

                          Children

                          • Juvenile idiopathic arthritis - age 2 years and older who weigh at least 66 lbs: The typical dose is 40 mg injected under the skin every other week.

                          • Crohn's disease - age 6 years and older who weigh at least 88 lbs: The typical dose is 160 mg injected under the skin on day 1, followed by 80 mg on Day 15, then 40 mg every other week starting Day 29.

                          interactions

                          Interactions between Simlandi (adalimumab) and other drugs

                          Simlandi (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 Simlandi (adalimumab). Please note that only the generic name of each medication is listed below.

                          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.

                          drug-cost

                          How much does Simlandi (adalimumab) cost?

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                          Simlandi (brand)
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                          alternatives

                          What are alternatives to Simlandi (adalimumab)?

                          There are a number of medications that your doctor can prescribe in place of Simlandi (adalimumab). Compare a few possible alternatives below.
                          Simlandi (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 (UV) - adults only

                          $1041.11 Lowest GoodRx priceView Prices
                          Enbrel (etanercept)
                          Used for:

                          • Rheumatoid arthritis (RA)

                          • Plaque psoriasis (PsO) and psoriatic arthritis (PsA)

                          • Ankylosing spondylitis (AS)

                          • Childhood arthritis (polyarticular juvenile idiopathic arthritis, JIA)

                          $8131.98 Lowest GoodRx priceView Prices
                          Remicade (infliximab)
                          Used for:

                          • Moderate-to-severe Crohn's disease (CD)

                          • Moderate-to-severe ulcerative colitis (UC)

                          • Moderate-to-severe rheumatoid arthritis (RA)

                          • Ankylosing spondylitis (AS)

                          • Psoriatic arthritis (PsA)

                          • Severe plaque psoriasis (PsO)

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                          References

                          Best studies we found

                          Jeremias, S. (2024). FDA approves 10th adalimumab biosimilar, Simlandi. American Journal of Managed Care.

                          Solhjoo, M., et al. (2023). Drug-induced lupus erythematosus. StatPearls.

                          Teva Pharmaceuticals USA, Inc. (2024). Simlandi- adalimumab-ryvk kit [package insert]. DailyMed.

                          View All References (1)

                          Teva Pharmaceuticals USA, Inc. (2024). Teva and Alvotech announce Simlandi® (adalimumab-ryvk) injection now available in the U.S. Business Wire.

                          GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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