Simponi Aria (golimumab) is a tumor necrosis factor (TNF) blocker (or inhibitor). It's used to treat rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and polyarticular juvenile idiopathic arthritis (PJIA). Simponi Aria (golimumab) is given as an infusion into the veins typically once a month for 2 doses, then once every 2 months after that. Side effects of this medication include upper respiratory tract infections and rash.
Moderate-to-severe rheumatoid arthritis (RA) (in combination with methotrexate (Trexall)) in adults
Ankylosing spondylitis (AS) in adults
Moderate-to-severe psoriatic arthritis (PsA) (alone or in combination with methotrexate (Trexall)) in people ages 2 years and older
Polyarticular juvenile idiopathic arthritis (PJIA) in people ages 2 years and older
Simponi Aria (golimumab) is a type of biologic disease-modifying antirheumatic drug (DMARD) that's classified as a tumor necrosis factor (TNF) blocker (or inhibitor). TNF is a protein in the body that plays a key role in inflammation. By blocking TNF, Simponi Aria (golimumab) lowers inflammation in your body to treat pain and swelling in your joints caused by autoimmune conditions.
Source: DailyMed
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
chills
difficulty with breathing
ear congestion
headache
loss of voice
muscle aches
stuffy or runny nose
trouble breathing
unusual tiredness or weakness
Less common
Blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
cough with mucus
dizziness
general feeling of discomfort or illness
hoarseness
joint pain
loss of appetite
nervousness
pain or tenderness around the eyes and cheekbones
painful cold sores or blisters on the lips
pounding in the ears
shivering
slow or fast heartbeat
sweating
tender, swollen glands in the neck
tightness in the chest
trouble with sleeping
trouble with swallowing
voice changes
vomiting
Rare
Bone pain
frequent or painful urination
redness, soreness, or itching of the skin
severe stomach pain
sores, welts, or blisters
yellow eyes or skin
Incidence not known
Hives, skin rash
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
red, scaling, or crusted skin
swelling of the face, throat, or tongue
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:
Less common
Bleeding, blistering, burning, coldness, discoloration of the 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
burning or stinging of the skin
difficulty having a bowel movement
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.
Given once every 2 months (except at the start of treatment)
Can be used in children ages 2 years old with PsA and pJIA
Not made with rubber latex (unlike Simponi)
Needs to be infused through the veins by a healthcare professional
Infusion can take about 30 minutes
Raises the risk for serious infections
Each Simponi Aria (golimumab) infusion takes about 30 minutes. You're recommended to wear comfortable clothing that allows for easy access to your arm because this medication is typically infused through the arm. Consider bringing books or music to help you pass the time. Ask your healthcare team if they have any specific instructions for you to help you prep for the infusion.
Some people might experience infusion-related reactions with Simponi Aria (golimumab). Let your healthcare team know if you experience rash, trouble breathing, or chest pain.
You'll receive Simponi Aria (golimumab) monthly for the first 2 doses, then every other month after that. If you miss an appointment, call you healthcare team to make another appointment as soon as possible.
Simponi Aria (golimumab) raises your risk of getting a serious infection. Let your healthcare team know right away if you have symptoms of an infection, such as fever, body ache, or chills. They can examine you to see what kind of infection you might have and talk with you about next steps.
Share a list of all the medications you're taking, or have recently taken, before starting Simponi Aria (golimumab). They'll review your medications and will make sure they're all safe to take together.
Tell your care team that you're taking Simponi Aria (golimumab) before receiving any vaccines. You won't be able to receive any live vaccines (e.g., MMR (measles, mumps, and rubella), FluMist Quadrivalent (live-attenuated influenza vaccine)) while taking Simponi Aria (golimumab) and for 6 months after your last infusion. You're recommended to be up-to-date on vaccines before starting treatment.
Let your care team know if you're pregnant, thinking of becoming pregnant, or are breastfeeding before taking Simponi Aria (golimumab). They'll discuss with you the risks and benefits of receiving this medication.
Simponi Aria (golimumab) 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 factors: Taking other medications that weaken your immune system | Taking Orencia (abatacept) or Kineret (anakinra) | Ages 65 years and older | Active, long-term, or frequent infections | Living in or traveling to places with high rates of TB or fungal infections | Conditions that can raise your risk for infection
Simponi Aria (golimumab) can affect your body's ability to fight off infections. This raises your risk of serious or life-threatening bacterial, viral, or fungal infections. Your risk is higher if you’re already taking other medications that weaken your immune system (e.g., steroids, methotrexate). Before starting Simponi Aria (golimumab), tell your prescriber about your medical conditions and medications so they can make sure Simponi Aria (golimumab) is appropriate for you.
Treatment with Simponi Aria (golimumab) can also cause new or old tuberculosis (TB) infections to come back. Similarly, the medication can reactivate the hepatitis B virus (HBV) if you're a carrier of the virus. For these reasons, you'll need to get tested for both TB and HBV before starting Simponi Aria (golimumab) and get treatment if you test positive (meaning you're infected with TB or HBV).
If you develop symptoms of an infection (e.g., fever, cough, difficulty breathing, diarrhea, weakness, sweating, chills) while taking Simponi Aria (golimumab), get medical help right away. Your healthcare team might ask you to stop taking Simponi Aria (golimumab) so your body can fight the infection.
Risk factors: Age 18 years and younger | Taking medications that weaken your immune system | History of cancer | Severe inflammatory conditions
Though rare, people who took other tumor necrosis factor (TNF) blocker have reported developing certain types of cancers, including leukemia, lymphoma, and skin cancer. Because Simponi Aria (golimumab) is a TNF blocker, it might also raise the risk of getting cancers. The risk is higher for people who are younger than 18 years old, taking other medications that weaken your immune system (e.g., mercaptopurine, azathioprine (Imuran)), or have severe inflammatory conditions. Your prescriber will assess your risk before starting Simponi Aria (golimumab) and monitor you while you're taking it. If you experience symptoms, such as swollen lymph nodes in your neck, armpits, or groin, fatigue, weight loss, loss of appetite, frequent nosebleeds, or lumps on your skin, contact your prescriber.
Risk factors: History of heart failure
Simponi Aria (golimumab) can cause new or worsening heart failure. Let your prescriber know if you currently have heart failure, since you’ll need to be closely monitored while taking this medication. If you have any new or worsening symptoms of heart failure (e.g., shortness of breath, swelling in your legs, ankles, or feet, irregular heartbeat, unable to exercise, tiredness or weakness) while taking Simponi Aria (golimumab), stop the medication and contact your HCP.
Risk factors: History of a nervous system problem (e.g., multiple sclerosis, Guillain-Barré syndrome)
Although rare, TNF blockers like Simponi Aria (golimumab) have been linked to new or worsening nervous system problems. These problems can include nerve damage and multiple sclerosis. Tell your provider if you have any neurological problems before starting Simponi Aria (golimumab). Also let your HCP know if you get dizziness, muscle weakness or spasms, changes in vision, or loss of balance while you're taking Simponi Aria (golimumab).
Simponi Aria (golimumab) can cause a lupus-like syndrome, which is a condition where your body's immune system attacks itself. If this happens, you might experience flu-like symptoms, including fever and pain in your muscles and joints. Stop taking Simponi Aria (golimumab) and contact your prescriber if you have any of these symptoms. Once you stop taking the medication, your symptoms should go away.
Although rare, people taking TNF blockers like Simponi Aria (golimumab) have reported having low blood cell counts. This can raise the risk of serious infections, bleeding, and anemia. If your blood counts drop too low, you'll probably need to stop taking Simponi Aria (golimumab). If you develop any signs of infection (e.g., fever, tiredness, chills, cough, trouble breathing) or signs of blood problems (pale skin, fast heart rate, lightheadedness, blood in your urine or stool), contact your HCP right away.
Your healthcare team shouldn't prescribe Simponi Aria (golimumab) along with Kineret (anakinra) or Orencia (abatacept). Taking these medications together can raise the risk of serious side effects, including severe infections, without any additional benefits. Let your healthcare team know if you're already taking either Kineret (anakinra) or Orencia (abatacept) before starting Simponi Aria (golimumab).
Avoid getting live vaccines while you're taking Simponi Aria (golimumab) because there's a chance that you can get sick from them. Make sure you're up-to-date with vaccines before starting Simponi Aria (golimumab). Let the healthcare provider who's administering a vaccine to you that you're on Simponi Aria (golimumab). They'll double check to make sure it's safe for you to receive the vaccine.
Serious allergic reactions have been reported after using Simponi Aria (golimumab). These reactions can include rash, hives, trouble breathing, swelling of the face or lips, and anaphylaxis. Get medical help right away if you experience an allergic reaction to Simponi Aria (golimumab).
Simponi Aria (golimumab) is given as an infusion into the veins (intravenous or IV) over 30 minutes.
Adults with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis: The typical dose is 2 mg/kg of body weight infused once a month for 2 doses, then once every 2 months thereafter.
Children with polyarticular juvenile idiopathic arthritis or psoriatic arthritis: The typical dose is calculated based on your child's body surface area, which takes into account height and weight. The typical dose is 80 mg/m2 infused once a month for 2 doses, then once every 2 months thereafter.
Note: Golimumab is also available as brand name Simponi, which is given as an injection under the skin (subcutaneous or SQ)
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.
Moderate-to-severe rheumatoid arthritis (RA) (in combination with methotrexate (Trexall)) in adults
Ankylosing spondylitis (AS) in adults
Moderate-to-severe psoriatic arthritis (PsA) (alone or in combination with methotrexate (Trexall)) in people ages 2 years and older
Polyarticular juvenile idiopathic arthritis (PJIA) in people ages 2 years and older
Rheumatoid arthritis (RA)
Plaque psoriasis (PsO) and psoriatic arthritis (PsA)
Ankylosing spondylitis (AS)
Childhood arthritis (polyarticular juvenile idiopathic arthritis, JIA)
Moderate-to-severe Crohn's disease
Moderate-to-severe rheumatoid arthritis (RA)
Moderate-to-severe plaque psoriasis (PsO)
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Leu, J.H., et al. (2022). Intravenous Golimumab in Patients with Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis and Subcutaneous Ustekinumab in Patients with Juvenile Psoriatic Arthritis: Extrapolation of Data from Studies in Adults and Adjacent Pediatric Populations. Paediatr Drugs.
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