Key takeaways:
Simponi (golimumab) is an injectable medication that treats inflammation and swelling from autoimmune conditions, such as rheumatoid arthritis.
Injection site reactions and upper respiratory infections are common Simponi side effects. High blood pressure and dizziness are also possible. These symptoms are usually mild and can often be managed at home.
Rare but serious Simponi side effects include an increased risk of cancer or serious infection. You can work with your healthcare provider to prevent, manage, and monitor these risks.
If you’re living with inflammation in your joints or gut, you may have heard of Simponi (golimumab). This medication is a monoclonal antibody, and it works by blocking tumor necrosis factor (TNF)-alpha — a protein that causes inflammation and swelling. It’s approved to reduce pain and swelling from various autoimmune conditions, such as rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.
Different formulations of Simponi are available to tackle these inflammatory health conditions. It comes as a subcutaneous (under the skin, SQ) injection and an intravenous (into the vein, IV) infusion. The injection is dispensed as a single-use syringe or autoinjector (Simponi), while the infusion comes from a single-dose vial (Simponi Aria). How you receive it depends on many factors, including your medical condition, age, and other medications you take.
Like any medication, Simponi can cause side effects. And since Simponi and Simponi Aria contain the same active ingredient, they share many of the same side effects. Below, we’ll discuss eight of the most notable golimumab side effects and how you can manage them.
When given SQ, Simponi is injected once a month. Injection site reactions are common — especially after your initial doses. Most reactions are mild and include symptoms like redness, itching, and pain in the area where the injection is given. As you continue to use Simponi, you should notice a decrease in frequency and severity of these reactions.
To lower the risk of injection site reactions, try to change the location of your injection site with each dose. You can do this by switching arms or areas on your stomach or thighs. It’s also best to avoid injecting Simponi into areas where the skin is broken or bruised. Waiting until the medication comes to room temperature can also help minimize injection discomfort.
Ask your healthcare provider if it’s safe for you to take over-the-counter (OTC) medications, like acetaminophen (Tylenol) or ibuprofen (Motrin, Advil). These medications may help with pain and redness from injection site reactions. But if your injection site reactions worsen or last longer than a few days, contact your provider. This could be a sign of an infection or that you’re not injecting Simponi correctly.
Simponi lowers your body’s ability to fight infections. Because of this, upper respiratory infections (URIs) are a relatively common side effect. The common cold is the URI that’s seen most often. But URIs can also involve the voice box or the back of the throat.
Because bacteria don’t cause most URIs, antibiotics won’t be helpful. If you develop symptoms of a mild upper respiratory infection, you should get plenty of rest and stay hydrated. The URI should clear on its own.
Depending on your symptoms, you can also try OTC medications, like pseudoephedrine (Sudafed), to temporarily help with your stuffy nose. But check with your healthcare provider before starting a new medication. Decongestants like pseudoephedrine aren’t ideal if you have high blood pressure or diabetes.
In initial studies, liver function tests (LFTs) slightly worsened in a small percentage of people taking Simponi. LFTs are blood tests that measure your liver health; worsening numbers point toward possible liver injury. This side effect is usually mild to moderate and goes away on its own.
However, Simponi has been known to contribute to actual liver damage in rare cases. The risk may be higher if you’ve had liver problems or hepatitis B in the past or take non-steroidal anti-inflammatory drugs (NSAIDs), like ibuprofen or naproxen (Aleve, Naprosyn).
Let your healthcare provider know immediately if you have symptoms of liver problems (such as yellow eyes or skin, pain in the upper-right area of your stomach, or confusion).
Simponi may raise your blood pressure. Your healthcare provider may want to monitor your blood pressure before and during treatment with Simponi.
If you’re checking your blood pressure at home, let your healthcare provider know if your blood pressure readings are higher than usual. This is especially important if you have a history of high blood pressure, diabetes, or other heart problems.
Some people may feel dizzy while taking Simponi, especially when you first start taking it or after a dose adjustment. Thankfully, it’s usually temporary and short-lived.
It’s a good idea to use caution while driving until you know how Simponi will affect you. Be careful when you change position from sitting to standing, too. Talk with your healthcare provider if your dizziness becomes bothersome or doesn’t go away.
Simponi has a boxed warning — the FDA’s most serious warning — about potential risks of a new or worsening serious infection. These are more severe than URIs, which we discussed above.
Although rare, Simponi may lead to infections like pneumonia or cellulitis. You may be more likely to develop a serious infection if you also take other immunosuppressant medications, like methotrexate (Trexall), alongside Simponi. Your risk also goes up if you’re over the age of 65 or have another chronic medical condition.
You should tell your provider if you’re being treated for an infection or have potential symptoms of a serious infection (such as fever, cough that won’t go away, or feeling extra tired). They may delay your next dose until you’re feeling better.
Simponi can also reactivate tuberculosis or hepatitis B infections if you’ve had them before. Because of this, your healthcare provider will likely test you for them before prescribing Simponi.
Simponi has another boxed warning. Although rare, Simponi has been linked to certain types of cancer. Lymphoma and skin cancers were the most commonly reported types in initial studies. Children and people taking other immunosuppressant medications along with Simponi may be more likely to develop these types of cancers.
Your healthcare provider will determine your cancer risk before starting Simponi and monitor you while taking the medication. They’ll likely want to schedule periodic skin checks to help check for skin cancer. And make sure to talk to your provider if you notice any symptoms like swollen lymph nodes, unexplained weight loss, or abnormal spots on your skin.
While you can inject Simponi yourself, Simponi Aria is an intravenous (IV) infusion given by a healthcare professional. It’s dosed based on your body weight, and it’s administered every 8 weeks after two initial starter injections. Each Simponi Aria infusion takes about 30 minutes to receive.
Simponi Aria can cause infusion reactions. Most reactions are mild in nature. Others can be serious and include allergic symptoms, like chest pain and trouble breathing. Reactions typically occur within 1 hour after infusion. But they can happen at any point during treatment.
If you experience side effects during or after your Simponi Aria infusion, tell your medical team right away. They can give you medications to help manage your reaction. And, if you notice signs of a reaction after you return home, call your healthcare provider. Go to the nearest emergency room if you have trouble breathing, chest pain, or swelling in the face or mouth.
Good to know: Infusion reactions are specific to Simponi Aria, not Simponi. The traditional version of Simponi is injected under your skin, not into a vein. However, both forms of Simponi can cause potentially serious allergic reactions.
Listening to your body is the most important thing to do. Reach out to your healthcare provider if any side effects are bothersome or worsen at any point.
Plus, if you develop any side effects during a Simponi Aria infusion, take advantage of the close proximity to your care team. They can give you medications to help manage side effects during or after your infusion.
Infections are also important to look for. Let your healthcare provider know right away if you feel sick or under the weather. They may want to delay your next dose of Simponi until you feel better.
You should also let your healthcare provider know if you notice the symptoms of your autoimmune condition returning or getting worse while taking Simponi. Simponi may not be the right medication for you. Finding the right medication for your condition can take some time, effort, and partnership with your care team.
Injection site reactions and upper respiratory infections are the most common Simponi side effects. Infusion reactions are possible with Simponi Aria. Other common golimumab side effects include high blood pressure and dizziness. Let your healthcare provider know right away if you have any symptoms of an infection. Go to the nearest emergency room if you experience trouble breathing, chest pain, or swelling in the face or mouth.
Janssen Biotech, Inc. (2018). Medication guide: Simponi.
Janssen Biotech, Inc. (2019). Simponi [package insert].
Janssen Biotech, Inc. (2021). Simponi Aria [package insert].
MedlinePlus. (2016). Lymphoma.
National Institutes of Health. (2017). Golimumab. LiverTox.
Thomaidou, E., et al. (2019). Injection site reactions with the use of biological agents. Dermatologic Therapy.
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