Simponi
Simponi (golimumab) is a tumor necrosis factor (TNF) blocker (or inhibitor). It's used to treat many types of inflammatory conditions in adults, such as rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and ulcerative colitis (UC). Simponi (golimumab) is given as an injection under the skin, typically once per month. Side effects of this medication include upper respiratory tract infections, injection-site reactions, and high blood pressure.
What is Simponi (golimumab)?
What is Simponi (golimumab) used for?
- Moderate-to-severe rheumatoid arthritis (RA) (in combination with methotrexate (Trexall))
- Moderate-to-severe psoriatic arthritis (PsA) (alone or in combination with methotrexate (Trexall))
- Ankylosing spondylitis (AS)
- Moderate-to-severe ulcerative colitis (UC) when other treatment options haven't worked well
How Simponi (golimumab) works
Simponi (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 (golimumab) lowers inflammation in your body to treat pain and swelling in your joints and gut caused by autoimmune conditions.
Drug facts
Side effects of Simponi (golimumab)
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
- Upper respiratory tract infection (16%)
- Injection site reactions, including pain and bruising (6%)
- Viral infections (5%)
- Higher liver enzymes (up to 4%)
- High blood pressure (3%)
Note: Side effects were reported by people who also took other medications (including methotrexate or corticosteroids) at the same time.
Less Common Side Effects
- Constipation
- Other infections
- Bronchitis
- Tingling sensation
- Dizziness
Simponi (golimumab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious infections: fever, difficulty breathing, cough, weakness, sweating, chills, diarrhea, stomach pain, burning when you urinate, urinating more frequently
- Heart failure: shortness of breath; swelling in the legs, ankles, or feet; irregular heartbeat; inability to exercise; tiredness; weakness
- Possible signs of cancer: loss of appetite; fatigue; lumps on skin; swollen lymph nodes in your neck, armpits, or groin; weight loss; nosebleeds
- Allergic reactions: hives, itching, swelling of face or tongue, difficulty breathing
More on Simponi (golimumab) side effects
The following Simponi (golimumab) 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
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.
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Pros and cons of Simponi (golimumab)
Pros
- Can be injected at home (after training from the prescriber)
- Available in a prefilled syringe or autoinjector
- Can be stored at room temperature for up to 30 days
- Injected monthly for most conditions
Cons
- Only approved for adults
- Not available as a generic
- Raises the risk of serious infections
- Given as an injection
Pharmacist tips for Simponi (golimumab)
- You might experience injection-site reactions (e.g., pain, redness, bruising, itching) from Simponi (golimumab) injections. These are typically mild and should go away as you continue to use the medication.
- Simponi (golimumab) can raise your risk of getting a serious infection. If you develop and infection, your healthcare team might ask you to stop taking Simponi (golimumab) so your body recover. Get medical help right away if you develop symptoms of an infection, such as fever, weakness, sweating, chills, cough, or difficulty breathing.
- Share a list of all the medications you're taking, or have recently taken, before starting Simponi (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 (golimumab) before receiving any vaccines. You won't be able to receive live vaccines (e.g., MMR (measles, mumps, and rubella), FluMist Quadrivalent (live-attenuated influenza vaccine)), while taking Simponi (golimumab) because it's not known how your body might react.
- Let your care team know if you're pregnant, thinking of becoming pregnant, or are breastfeeding before taking Simponi (golimumab). They'll discuss with you the risks and benefits of using this medication.
- If you have a rubber or latex allergy, don't touch the needle cover of the prefilled syringe or the inside of the autoinjector cap because they're made of a rubber material similar to latex.
Tips for under-the-skin injections of Simponi (golimumab):
- Your care team might let you inject Simponi (golimumab) at home after proper training. Carefully follow the instructions on how to inject Simponi (golimumab), based on whether you have the prefilled syringe or autoinjector. Ask your care team if you have any questions about how to take the medication.
- Keep Simponi (golimumab) in the refrigerator and in the original carton to protect it from light. Before it's time for your dose, take the medication out of the refrigerator. Lay it on a flat surface for at least 30 minutes so it can reach room temperature. Don't try to warm up the medication any other way.
- Before using Simponi (golimumab), check the expiration date and look at the liquid inside of the syringe or viewing window of the autoinjector. It should be clear to slightly yellow. It might have tiny white or clear particles, or air bubbles. Don't use it if it looks cloudy, discolored, or has large particles inside. Don’t shake Simponi (golimumab).
- Before each Simponi (golimumab) injection, wash your hands well with soap and warm water and clean the injection site with an alcohol swab and allow it to air dry.
- You need to inject Simponi (golimumab) within 5 minutes after you remove the needle cover or the cap off of the medication. So only remove the needle cover or cap when you're ready to inject.
- For Simponi (golimumab) prefilled syringe, gently pinch the area of skin you're going to inject into with one hand. Then, use a dart-like motion to insert the needle of the prefilled syringe into the skin at a 45-degree angle with your other hand.
- For Simponi (golimumab) autoinjector, twist the cap to break the seal. Hold the autoinjector at a 90-degree angle to your skin. Don't pinch the skin while injecting.
- Inject Simponi (golimumab) under the skin into the fat tissue of your upper thighs or stomach area (at least 2 inches away from your belly button). Avoid injecting into skin that's tender, bruised, red, hard, or scarred. Don't inject into your muscle or vein; it's not meant to be injected this way.
- If you need to, you can cover the Simponi (golimumab) injection site with a bandage. Avoid rubbing it, since this might change the way the medication is absorbed in your body.
- Choose a different area of skin to inject Simponi (golimumab) into each time; it should be at least an inch away from the previous area you injected into. You can alternate between the stomach area and thigh. This helps lower your risk for bruising and skin irritation.
- After you inject Simponi (golimumab), throw away the used prefilled syringe in a sharps container or some heavy-duty plastic container, such as an empty milk carton or laundry detergent bottle. This helps lower the risk for needle-stick injuries. Don't throw away syringes in your trash can. Visit the FDA's website for guidance on how to throw away a full sharps container safely in your specific state.
Common questions about Simponi (golimumab)
Both Simponi and Simponi Aria are medications that contain golimumab as the active ingredient. Both medications are used for rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). One difference is that only Simponi is approved for ulcerative colitis (UC), while only Simponi Aria is approved for polyarticular juvenile idiopathic arthritis (PJIA). Another difference is that Simponi is only approved for adults, but Simponi Aria can be used in children as young as 2 years old for PsA and PJIA. Lastly, Simponi is given as an injection under the skin, whereas Simponi Aria is given as an infusion into the veins over 30 minutes. Talk to your healthcare professional (HCP) if you have specific questions about either brand name.
In general, it takes about 10 weeks for most of Simponi (golimumab) to leave your body after you've been taking this medication for a while. This timeframe is estimated based on the half-life of Simponi (golimumab) and can differ from person to person. Talk with your prescriber if you have more questions about how long this medication stays in your body.
People who took Simponi (golimumab) in clinical studies didn't report weight gain as a side effect. But taking Simponi (golimumab) can cause or worsen symptoms of heart failure, including weight gain due to fluid build-up. Speak with your prescriber right away if you experience unusual weight gain after starting Simponi (golimumab).
Simponi (golimumab) can cause certain side effects that lead to fatigue. For example, Simponi (golimumab) can raise the risk for infections (e.g., cold, flu), heart failure symptoms, and lupus-like symptoms. All of these conditions can cause you to feel tired or fatigued. Let your healthcare team know if you feel a noticeable drop in your energy level after starting Simponi (golimumab). They can examine you to better understand what might be causing your symptoms. If needed, they might ask you to pause Simponi (golimumab) treatment.
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Risks and warnings for Simponi (golimumab)
Simponi (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.
Serious infections
- Risk factors: Taking other medications that weaken your immune system | Taking Orencia (abatacept) or Kineret (anakinra) | Age 65 years and older | Active, long-term, or frequent infection | Living in or traveling to places with high rates of TB or fungal infections | Conditions that can raise your risk for infection
Simponi (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. Serious infections are more likely to happen if you’re older than 65 or if you have other long-term conditions. Your risk is higher if you’re already taking other medications that weaken your immune system (e.g., steroids, methotrexate). Before starting Simponi (golimumab), tell your prescriber about your medical conditions and medications so they can make sure Simponi (golimumab) is appropriate for you.
Treatment with Simponi (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 (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 (golimumab), get medical help right away. Your healthcare team might ask you to stop taking Simponi (golimumab) so your body can fight the infection.
Risk of cancer
- 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 (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 (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.
Heart failure
- Risk factors: History of heart failure
Simponi (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 (golimumab), stop the medication and contact your HCP.
Nervous system problems
- Risk factors: History of a nervous system problem (e.g., multiple sclerosis, Guillain-Barré syndrome)
Although rare, TNF blockers like Simponi (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 (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 (golimumab).
Lupus-like syndrome
Simponi (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 (golimumab) and contact your prescriber if you have any of these symptoms. Once you stop taking the medication, your symptoms should go away.
Lower blood cell counts
Although rare, people taking TNF blockers like Simponi (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 (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.
Serious medication interactions
Your healthcare team shouldn't prescribe Simponi (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 (golimumab).
Allergic reactions
- Risk factors: Known latex or rubber allergy
Serious allergic reactions have been reported after using Simponi (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 (golimumab).
The inside of the removable autoinjector cap and the needle shield of the prefilled syringe contains dry natural rubber, an ingredient that is very similar to latex. Touching the shield or prefilled syringe can cause a severe allergic reaction if you're allergic to latex or rubber. Let your prescriber know if you're allergic to these ingredients.
Simponi (golimumab) dosage
Typical dosage for Simponi (golimumab)
Simponi (golimumab) is given as an injection under the skin (subcutaneous or SQ) either in the front of the thighs or lower stomach (at least 2 inches from the belly button).
- Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: The typical dose is 50 mg injected under the skin once a month.
- Ulcerative colitis: The starting dose is 200 mg injected under the skin as a one-time dose. After two weeks, inject 100 mg under the skin as another one-time dose. The typical maintenance dose is 100 mg every four weeks.
Note: Golimumab is also available as the brand name Simponi Aria, which is given as an infusion into the veins (IV)
Interactions between Simponi (golimumab) and other drugs
More on Simponi (golimumab) interactions
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 Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Anakinra
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Infliximab
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- 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 Simponi (golimumab) cost?
$5,943.50
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