Simponi (Golimumab) Side Effects

Simponi (golimumab) is a tumor necrosis factor-alpha (TNF-alpha) inhibitor approved to treat ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis. The side effects of this medication vary and can include serious infections, bruising, a rash, and more.

Simponi works by suppressing the immune system. While this effectively decreases inflammation, it also lowers the body's ability to fight infection. It may also increase the risk of serious medical problems, including heart failure, liver damage, and cancer.

This article takes a closer look at the possible side effects associated with the immunosuppressive drug Simponi. It covers common side effects, and details other warnings you should know about.

Common Side Effects

The most common side effects of Simponi include:

• Upper respiratory infections, which can result in such symptoms as a hoarse voice, laryngitis, a sore throat, or a runny nose.
• Injection site reaction, which may result in redness, swelling, itching, bruising, or tingling around the area where you received the injection.
• Viral infections, such as the flu and oral cold sores, are also common among people using Simponi.

Serious Side Effects

Simponi blocks the action of TNF-alpha, a protein that mediates the body's immune system and may contribute to inflammation, joint swelling, and damage. This medication lowers the body's ability to fight off infection.

People taking Simponi can develop serious infections that target organ systems or can be at an increased risk of infection from bacteria, fungi, and viruses.

Some people using Simponi may develop serious side effects, such as:

• Low blood cell count: Easy bruising, bleeding, or paleness are signs of a low blood cell count. These signs could mean your body is not making enough blood cells to fight infection or stop bleeding.
• Lupus-like symptoms: Sun sensitivity, new joint or muscle pain, swelling of the feet, ankles, and/or legs, or a rash on the nose and cheeks are signs of a lupus-like syndrome.
• Anaphylaxis: Chest pain, shortness of breath, trouble swallowing or breathing, hives, and swollen eyes, lips, mouth, throat, or tongue are signs of anaphylaxis, a potentially life-threatening allergic reaction.
• Heart failure: Swelling in the ankles or feet, trouble breathing, sudden weight gain, and unusual tiredness are signs of new or worsening heart failure, which can be fatal unless promptly treated.
• Liver damage: Dark urine, persistent nausea or vomiting, stomach or abdominal pain, and yellow eyes or skin are signs of liver damage.
• Hepatitis B infection: Dark urine, yellow eyes or skin, reduced appetite, vomiting, muscle aches, clay-colored stools, skin rash, fever, and chills, are signs of hepatitis B infection, which must be treated right away.
• Nervous system problems: Weakness, numbness, vision changes, and tingling of the arms or legs are signs of nervous system problems, such as multiple sclerosis or Guillain-Barré syndrome.
• Psoriasis: Red scaly patches, blisters, or pus-filled bumps on the skin are signs of new or worsening psoriasis.

Get immediate medical attention if you notice any of these serious side effects.

Warnings

Simponi carries a boxed warning from the U.S. Food and Drug Administration (FDA), which is the most serious warning issued by the agency. It alerts healthcare providers and patients to potentially serious side effects that can lead to injury and death.

This medication comes with several important warnings:

• Allergic reactions: Let your healthcare provider know if you are allergic to latex or rubber because the cover for the needle used for injection contains dry natural rubber.
• Pregnancy: Tell your healthcare provider if you are pregnant, are planning on becoming pregnant, or breastfeeding.
• Infections: Let your provider know if you have an infection or if you're being treated for symptoms of infection, such as a fever, fatigue, or diarrhea. Your body will have a more difficult time combatting the infection while on Simponi.
• Tuberculosis (TB): While on this medication, it's easier for you to contract TB, and there is an increased risk of reactivation of a prior TB infection that is dormant (not active) in the body.
• Hepatitis B: This infection can be activated if you're carrying the virus while you are taking this drug. Let your practitioner know if you have hepatitis B symptoms.
• Heart failure: This drug can cause or worsen heart failure. If you develop signs of heart failure, get immediate medical attention. You may need to be hospitalized.
• Cancer: Taking Simponi may put you at greater risk for developing various cancers, such as melanoma, leukemia, and lymphoma, among others.
• Anemia: Simponi can lower the number of blood cells in your body, resulting in anemia or serious bleeding problems.
• Additional warnings: If you have a history of multiple sclerosis, liver problems, or issues with your blood count, notify your healthcare provider before you start taking this drug.

Interactions

Simponi can interact with other medications you may be taking, which can decrease the drug's efficacy or increase your risk of developing serious side effects.

Before starting treatment with Simponi, let your healthcare provider know about any other medications, supplements, or vitamins you might be taking. Also, keep your medical team updated if you start any new medication during the course of your Simponi treatment.

A higher rate of infections has also occurred in people who take other biologic drugs, like those commonly used for rheumatoid arthritis, while taking Simponi. Also, people taking Simponi should avoid getting live vaccines because they can cause infections if your immune system is suppressed.

Therapeutic agents used in the treatment of cancer may interact with Simponi.

Summary

Simponi (golimumab) is an immunosuppressive drug used to treat several medical conditions, including ulcerative colitis and rheumatoid arthritis. People who use Simponi have an increased risk of infections. The drug also comes with a black box warning of serious and potentially-life threatening side effects, including liver damage, heart failure, and cancer. If you develop any unusual or concerning symptoms while using Simponi, call your healthcare provider right away.