Side Effects Requiring Immediate Medical Attention
Along with its needed effects, golimumab 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 while taking golimumab:
More common
- 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
How Supplied/storage And Handling
Simponi Aria® Injection is a colorless to light yellow solution available in packs of 1 vial NDC 57894-350-01.
Vial
Each single-dose vial contains 50 mg of Simponi Aria per 4 mL of solution.
Storage and Handling
Refrigerate Simponi Aria at 36ºF to 46ºF and protect from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.
If needed, Simponi Aria may be stored at room temperature up to 77ºF for a maximum single period of 30 days in the original carton to protect from light. Once Simponi Aria has been stored at room temperature, do not return the product to the refrigerator. If not used within 30 days at room temperature, discard Simponi Aria.
How Simponi Is Given
Simponi is given as a subcutaneous injection. This is an injection thats given just under the skin. The drug comes in two forms: a prefilled single-dose syringe and a SmartJect autoinjector. You can talk with your doctor about which form you prefer to use.
Your doctor or pharmacist should be able to show you how to self-inject so you can give yourself doses at home. They can train you on the best injection technique for you.
Whichever form you use, youll inject your dose into the front of your thigh, your lower belly, or the back of your upper arm. For detailed instructions on how to use the prefilled syringe or autoinjector, see the drugs Instructions for use. The manufacturers website also has instruction videos.
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Can Older People Use Simponi Or Simponi Aria
In most cases, older people can use Simponi or Simponi Aria. In studies, there were no differences in side effects between older and younger people using Simponi for RA, PsA, or AS.
There were not enough older adults in the studies to determine if there would be a difference in side effects in people using Simponi for UC. Its also not known if older adults may be at an increased risk of side effects when using Simponi Aria.
However, older people may be at an increased risk of developing infections. Simponi and Simponi Aria may weaken the immune system. The immune system also becomes less effective as you age. So older adults who use the medications may be more likely than usual to develop infections, some of which can be serious.*
If youre an older adult thinking of using Simponi or Simponi Aria, talk with your doctor to see if it may be a good treatment option for you.
Simponi and Simponi Aria come with several precautions.
Simponi And Simponi Aria And Other Medications
Below is a list of medications that can interact with Simponi and Simponi Aria. This list does not contain all drugs that may interact with Simponi and Simponi Aria.
Before using Simponi and Simponi Aria, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Types of drugs that may interact with Simponi or Simponi Aria may include:
- Other biologic drugs. Using Simponi or Simponi Aria in combination with other
about serious infection. A boxed warning is the most serious warning from the Food and Drug Administration . For more information, see Side effect details in the Simponi and Simponi Aria side effects section above.
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Simponi And Simponi Aria Expiration Storage And Disposal
When you get Simponi from the pharmacy, the pharmacist will add an expiration date to the label on the package. This date is typically 1 year from the date they dispensed the medication.
The expiration date helps guarantee that the medication is effective during this time. The of the Food and Drug Administration is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.
Simponi And Simponi Aria And Birth Control
It is not known if Simponi and Simponi Aria are safe to use during pregnancy. If youre sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while using Simponi or Simponi Aria.
For more information about using Simponi and Simponi Aria during pregnancy, see the Simponi and Simponi Aria and pregnancy section above.
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Simponi Aria For Polyarticular Juvenile Idiopathic Arthritis
Simponi Aria is approved to treat polyarticular juvenile idiopathic arthritis thats active in children ages 2 years and older. Simponi is not approved for this use.
Polyarticular arthritis affects five or more joints. Active means the condition currently causes symptoms.
pJIA is a type of autoimmune condition. With an autoimmune condition, your immune system attacks your own body by mistake.
Juvenile idiopathic arthritis is a form of arthritis that affects children. pJIA involves five or more joints. Symptoms of pJIA may include:
- joint pain
- limping or avoiding using an arm or leg
For more details about pJIA and other forms of arthritis, see our arthritis hub.
Effectiveness for juvenile idiopathic arthritis
Simponi Aria is an effective treatment option for children with pJIA. In fact, the ACR treatment guidelines recommend this medication for children with pJIA.
For more information about how Simponi Aria worked in clinical trials to treat pJIA, see the drugs prescribing information.
What Are Simponis And Simponi Arias Side Effects
As with most drugs, Simponi and Simponi Aria may cause mild or serious side effects. The lists below describe some of the more common side effects that Simponi and Simponi Aria may cause. These lists dont include all possible side effects.
Keep in mind that side effects of a drug can depend on:
- your age
- other health conditions you have
- other medications you take
Your doctor or pharmacist can tell you more about the potential side effects of Simponi and Simponi Aria. They can also suggest ways to help reduce side effects.
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Dosage In Adults With Rheumatoid Arthritis Psoriatic Arthritis And Ankylosing Spondylitis
The Simponi Aria dosage regimen is 2 mg per kg given as an intravenous infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter. Follow the dilution and administration instructions for Simponi Aria .
For patients with rheumatoid arthritis , Simponi Aria should be given in combination with methotrexate.
The efficacy and safety of switching between intravenous and subcutaneous formulations and routes of administration have not been established.
What Should I Discuss With My Healthcare Provider Before Using Golimumab
You should not use golimumab if you are allergic to it.
Tell your doctor if you have ever had:
- active or chronic infections
- psoriasis or
- if you are scheduled to receive any vaccine.
Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.
Using golimumab may increase your risk of developing autoimmune disorders or cancer, including skin cancer. Talk to your doctor about this risk and what symptoms to watch for.
Golimumab may cause a rare type of lymphoma of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.
Tell your doctor if you are pregnant or plan to become pregnant. Your baby could have an increased risk of infection for up to 6 months if you use golimumab during pregnancy.
If you use golimumab during pregnancy, your baby should not receive a live vaccine for the first 6 months after birth.
You should not breastfeed while using this medicine.
Do not give this medication to anyone under 18 years old without medical advice.
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Simponi And Simponi Aria Cost
As with all medications, the cost of Simponi injections and Simponi Aria infusions can vary. To find current prices for Simponi in your area, check out GoodRx.com.
The cost you find on GoodRx.com is what you may pay without insurance. The actual price youll pay depends on your insurance plan, your location, and the pharmacy you use.
For Simponi Aria, the price will also depend on the cost of the visit to a healthcare professional to receive your doses.
Keep in mind that you may be able to get a 90-day supply of Simponi. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If youre interested in this option, check with your doctor, pharmacist, or insurance company.
Before approving coverage for Simponi and Simponi Aria, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.
If youre not sure if youll need to get prior authorization for Simponi and Simponi Aria, contact your insurance company.
How To Take Simponi
Use Simponi exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
If you have ever had tuberculosis or hepatitis B, golimumab can cause these conditions to come back or get worse. You should be tested for these conditions before you start using golimumab.
Golimumab is sometimes given as an infusion into a vein. A healthcare provider will give you this type of injection once every 4 to 8 weeks.
Golimumab may also be injected under the skin once every 2 to 4 weeks. A healthcare provider may teach you how to properly use the medication by yourself.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you have questions.
Prepare your injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.
Your care provider will show you the best places on your body to inject golimumab. Do not inject into the same place two times in a row.
Golimumab can weaken your immune system. Your blood will need to be tested often.
Store the medication in its original carton in the refrigerator, do not freeze. Protect from light.
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What Is Aria Side Effect
Amyloid-related imaging abnormality is a known class side effect of antibodies like Aduhelm that target amyloid plaque in the brain. Its most common form, a type of cerebral edema called ARIA-E, can be associated with headache, confusion, nausea and gait disturbances, among other symptoms.
How quickly does Simponi aria work?
Simponi can take about 2 weeks before patients start to feel its effects. Some patients notice a benefit shortly after their first dose, while in others it can take several weeks. It can take 4 to 12 weeks before patients feel a lot of benefit.
Simponi And Simponi Aria And Alcohol
There are no known interactions between alcohol and Simponi or Simponi Aria. But in some cases, your doctor may prescribe either drug in combination with methotrexate .* Methotrexate may cause liver problems. Because alcohol may also cause liver problems, taking methotrexate and drinking alcohol may further increase your risk.
Talk with your doctor to determine how much alcohol, if any, you can drink while you use Simponi or Simponi Aria.
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What About Other Medications
Many patients need to continue to take other oral medications for RA, like methotrexate or plaquenil, while on Golimumab. When you are taking Golimumab, it is very important that your doctors know if you are taking any other medicine. This includes prescription and non-prescription medicines as well as birth control pills, vitamins, and herbal supplements. Golimumab can be taken with other medications NSAIDS , prednisone, methotrexate, and hydroxychloroquine. You should not take any other biologic medications such as Enbrel® or Humira® while taking Golimumab.
Simponi And Simponi Aria For Rheumatoid Arthritis
Both Simponi and Simponi Aria are FDA-approved to treat moderate to severe rheumatoid arthritis in adults when its active. The term active means the condition currently causes symptoms. For this purpose, you should use both drugs in combination with another medication called methotrexate .
RA is a type of autoimmune condition. With an autoimmune condition, your immune system attacks your own body by mistake. With RA, your immune system targets your joints. Symptoms of RA may include:
- joint pain or stiffness
To find more articles about RA and other forms of arthritis, visit our arthritis hub.
Effectiveness for rheumatoid arthritis
Simponi and Simponi Aria are effective treatment options for people with RA. The American College of Rheumatology guidelines recommend these medications. The guidelines specify the drugs for the treatment of moderate to severe RA when used in combination with methotrexate.
For more information about how these medications worked in clinical trials to treat RA, see the prescribing information for Simponi and Simponi Aria.
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Label Update: Simponi Aria Improves Fatigue In Psa Ra
Simponi Aria from Janssen Pharmaceutical Company of Johnson & Johnson is the first and only fully human anti-tumor necrosis factor biologic approved by the FDA to include language in its product label stating that the treatment results in improvement in fatigue for adult patients with active PsA and for adult patients with moderately to severely active RA.
The effect of Simponi Aria on fatigue was measured by the Functional Assessment of Chronic Illness Therapy Fatigue , which tracks self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue.
Simponi Aria joins Janssens Tremfya ® as the only products in PsA to have improvement in fatigue, as measured by FACIT-F, included in their respective labels.
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Is Hair Loss A Side Effect Of Simponi Or Simponi Aria
No, hair loss isnt a known side effect of either Simponi or Simponi Aria. In clinical trials, hair loss was not reported.
Other medications that may be used to treat the same conditions as Simponi and Simponi Aria may cause hair loss. These medications include methotrexate and leflunomide . Hair loss has also, rarely, been reported with adalimumab and etanercept .
Simponi or Simponi Aria may be prescribed in combination with methotrexate for some of the conditions theyre used to treat. However, hair loss hasnt been reported with either Simponi or Simponi Aria.
If youre experiencing hair loss, talk with your doctor or pharmacist. They can review your treatment plan to see if any medications may be causing this side effect.
Learn more about some of the side effects that Simponi and Simponi Aria may cause.
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What To Do In Case You Receive Too Much Simponi Or Simponi Aria
Call your doctor if you think youve received too much Simponi or Simponi Aria. You can also call 800-222-1222 to reach the American Association of Poison Control Centers, or use its online resource. But if you have severe symptoms, immediately call 911 or your local emergency number or go to the nearest emergency room.
If you have a certain kind of autoimmune disease, your doctor may prescribe Simponi or Simponi Aria for you.
Talk with your doctor or pharmacist if you have questions about these medications.
You may also want to ask your doctor about other treatment options for your condition. These articles may be helpful to you:
for the risk of serious infection and cancer. To learn more, see Side effect focus under What are Simponis and Simponi Arias side effects? above.
If you have questions about your risk of certain side effects with Simponi or Simponi Aria, talk with your doctor.
Answers represent the opinions of our medical experts. All content is strictly informational and should not be considered medical advice.
Simponi Simponi Aria And Alcohol
There arent any known safety issues with drinking alcohol during your treatment with Simponi or Simponi Aria.
But keep in mind that drinking large amounts of alcohol can cause liver problems. And Simponi and Simponi Aria can cause a high level of liver enzymes , which may be a sign of liver damage. Because of this combined risk of liver problems, it may be best to limit the amount of alcohol you drink while receiving Simponi or Simponi Aria.
If you drink alcohol, talk with your doctor about the amount that may be safe for you to drink during your treatment.
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Simponi And Simponi Aria And Pregnancy
It is not known if it is safe to use Simponi and Simponi Aria during pregnancy or what effects the drugs may have on a developing fetus. However, both drugs can go through the placenta . So, the developing fetus can be exposed to either drug if you use it during pregnancy.
In animal studies, high doses of Simponi given to pregnant animals did not cause problems with fetal development. But animal studies dont always indicate what may happen in humans.
If youre pregnant or planning to become pregnant, talk with your doctor before using Simponi or Simponi Aria. They can advise you on the right treatment plan for you.
