Simlandi
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.
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.
Drug facts
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%)
Less Common Side Effects
- High cholesterol
- High blood pressure
- Back pain
- Stomach pain
- Blood in the urine
- Flu-like symptoms
Simlandi (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
- 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
The following Simlandi (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
ear congestion
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
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
coughing or spitting up blood
decreased urination
decreased vision
difficulty with breathing
difficulty, burning, or painful urination
dimpling of the breast skin
dizziness
drowsiness
fainting
fast, slow, or irregular heartbeat
forgetfulness
frequent urge to urinate
general feeling of illness
headache
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
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
sore on the skin of the breast that does not heal
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
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
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.
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Pros and cons of Simlandi (adalimumab)
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
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 for Simlandi (adalimumab)
- 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.
Common questions about Simlandi (adalimumab)
Simlandi (adalimumab) was FDA approved in February 2024. According to the manufacturer, it has been available in the United States since May 2024.
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.
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.
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.
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.
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.
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.
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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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.
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.
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.
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.
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.
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.
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.
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.
Simlandi (adalimumab) dosage
Carton| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 1 autoinjector of 40mg/0.4ml | 2 cartons | $967.44 | $483.72 |
| 2 autoinjectors of 40mg/0.4ml | 1 carton | $967.44 | $967.44 |
| 2 prefilled syringes of 40mg/0.4ml | 1 carton | $1,002.73 | $1,002.73 |
| 2 prefilled syringes of 20mg/0.2ml | 1 carton | $1,002.73 | $1,002.73 |
| 1 prefilled syringe of 80mg/0.8ml | 1 carton | $1,002.73 | $1,002.73 |
| 1 autoinjector of 80mg/0.8ml | 2 cartons | $1,999.21 | $999.61 |
Typical dosage 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 between Simlandi (adalimumab) and other drugs
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.
- Abatacept
- Adenovirus Vaccine
- Anakinra
- Bacillus of Calmette and Guerin Vaccine, Live
- Cholera Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Infliximab
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Rilonacept
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Vaccine
- Tofacitinib
- Typhoid Vaccine, Live
- Varicella Virus Vaccine, Live
- Yellow Fever Vaccine
- Zoster Vaccine, Live
How much does Simlandi (adalimumab) cost?
$277.00
What are alternatives to Simlandi (adalimumab)?
