Simponi and Simponi Aria: Cost, uses, administration, and more - Medical News Today

Simponi and Simponi Aria can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while using Simponi and Simponi Aria. These lists do not include all possible side effects.

For more information about the possible side effects of Simponi and Simponi Aria, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you've had with Simponi and Simponi Aria, you can do so through MedWatch.

Mild side effects

Mild side effects* of Simponi or Simponi Aria can include:

Most of these side effects may go away within a few days to a couple of weeks. But if they become more severe or don't go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Simponi and Simponi Aria. To learn about other mild side effects, talk with your doctor or pharmacist, or refer to the prescribing information for Simponi and Simponi Aria.
† For more information about this side effect, see "Side effect details" below.

Serious side effects

Serious side effects from Simponi and Simponi Aria are not common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you're having a medical emergency.

Serious side effects and their symptoms can include:

* For more information about this side effect, see "Side effect details" below.
† Simponi and Simponi Aria have a boxed warning about this side effect. A boxed warning is the most serious warning from the FDA.

Side effect details

Here's some detail on certain side effects this drug may cause.

Serious infections

Using Simponi or Simponi Aria may increase the risk of developing a serious infection.* In fact, both drugs have boxed warnings about this risk. A boxed warning is the most serious type of warning from the FDA. The purpose of a boxed warning is to help make sure that people prescribing and using the medication are aware of its risks.

Because Simponi and Simponi Aria may weaken your immune system, you're at an increased risk of infections while using either drug. Most infections are typically mild. But they could be severe and lead to a hospital stay or, in some cases, death. Severe infections can include fungal and bacterial infections, and tuberculosis (TB).

* To find out how often serious infections occurred in clinical studies, see the prescribing information for Simponi and Simponi Aria.

Symptoms of infection

Throughout your treatment with Simponi or Simponi Aria, your doctor will monitor you for infection. Symptoms to watch for may include:

If you develop symptoms of an infection, see your doctor right away. They can determine the cause and recommend treatment so that it doesn't become serious. If you develop a serious infection, your doctor will usually have you stop taking the drug. They'll also treat the infection.

Other steps your doctor may take

Your doctor will also likely test you for certain infections before you start treatment with Simponi or Simponi Aria. For example, they may test you for tuberculosis (TB) or hepatitis B because the drugs can worsen these infections.

The medications may also cause these infections to become active again if you had them in the past but currently don't have symptoms. If you do have an infection, your doctor will recommend treating it before you start using Simponi or Simponi Aria.

If you have additional questions about the risk of serious infections during your treatment, talk with your doctor.

Cancer

The use of Simponi or Simponi Aria may increase the risk of developing certain types of cancer, such as lymphoma, leukemia, or skin cancer. Both drugs have boxed warnings about this risk. A boxed warning is the most serious warning about a drug. The purpose of the warning is to alert doctors and people who take the drug about the medication's risks.

This side effect is not common.* But the cancer may, in some cases, be fatal. Cancer has been reported in children and young adults who began taking medications called tumor necrosis factor (TNF) blockers at age 18 years or younger. Simponi and Simponi Aria are types of TNF blockers.

You should be aware of the possible symptoms of cancer so you can see your doctor right away if you develop them. These can include:

• weight loss
• frequent infections
• fever
• lump on your skin

Your doctor will also monitor you throughout your treatment with Simponi or Simponi Aria for symptoms of cancer. In addition, they may recommend that you have skin exams to check for any changes or growths on your skin that can lead to skin cancer.

If you have additional questions about the risk of cancer while using either medication, talk with your doctor. You should also tell them if you have a history of cancer. See the "Simponi and Simponi Aria precautions" section to learn more.

* To find out how often cancer occurred in clinical studies, see the prescribing information for Simponi and Simponi Aria.

Skin reactions

Skin reactions may occur with the use of Simponi or Simponi Aria. The reactions that you experience may depend on which drug you use.

Simponi is given as a subcutaneous injection, which is an injection that's given just under your skin. After injecting a dose, you may also experience pain, irritation, or itching at the injection site.

Simponi Aria is given as an IV infusion. During and after receiving a dose, a rash can occur. This was the most common infusion reaction that people using Simponi Aria reported. None of these reactions were considered serious.

In some cases, skin reactions may be symptoms of other side effects:

• Simponi and Simponi Aria can cause a type of immune system reaction called lupus-like syndrome. One of its symptoms is a rash on your cheeks or body.
• The drugs can also cause hepatitis B to come back if you have a history of the infection. A possible symptom of hepatitis B is a skin rash.
• A skin rash may also be a symptom of an allergic reaction, which can be serious. (For more information, see "Allergic reaction" below.)

If you develop a skin rash when you use Simponi or Simponi Aria, talk with your doctor. They can help determine the cause of the rash and see if it needs treatment.

To find out how often skin reactions occurred in clinical studies, see the prescribing information for Simponi and Simponi Aria. If you have additional questions about skin reactions during treatment with either drug, talk with your doctor.

Allergic reaction

As with most drugs, some people can have an allergic reaction after using Simponi or Simponi Aria.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have an allergic reaction to Simponi or Simponi Aria, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you're having a medical emergency.

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