SIMPONI ARIA® (Golimumab)

SIMPONI ARIA®

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Important Safety Information

SIMPONI ARIA® (golimumab) is a prescription infusion medication used to treat adult patients with moderate to severe rheumatoid arthritis (RA) — when used in combination with methotrexate. It is also used to treat active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS).

While treatment with SIMPONI ARIA® is ideal for individuals for whom traditional oral medications have failed to provide relief, it may lower your immune system’s ability to fight infections — especially histoplasmosis and tuberculosis. Avoid interacting with people with infections, and tell your doctor if you have a history with recurring infections. Your medical provider will likely run a tuberculosis test prior to starting treatment.

Talk with your doctor about your entire medical history — particularly if you have a weakened immune system, diabetes, or HIV. Even if you have not been diagnosed with an infection, let your doctor know if you’ve recently been experiencing any signs of one, including:

  • Fever
  • Sweats
  • Chills
  • Muscle aches
  • Shortness of breath
  • Coughing
  • Blood in phlegm
  • Stomach pain
  • Diarrhea
  • Burning sensation when urinating
  • Unintended weight loss
  • Skin sores
  • Weakness
  • Fatigue

In addition, it may be necessary for your medical provider to monitor you through treatment to ensure you do not contract an infection. If you have tuberculosis prior to starting infusion therapy, the condition will have to be treated prior to using SIMPONI ARIA®.

SIMPONI ARIA® may not combine well with certain medications. Tell your doctor about all drugs you’re currently taking — whether they’re prescription, over-the-counter, vitamins, or herbal supplements. Specifically, be aware you should not take live vaccines while undergoing treatment with SIMPONI ARIA®. As for medications known to have a harmful interaction with SIMPONI ARIA®, these include Orencia, Kineret, Actemra, Rituxan, and tumor necrosis factor (TNF) blockers.

What is the most important information I should know about SIMPONI ARIA®?

SIMPONI ARIA® is a tumor necrosis factor (TNF) blocker. These types of medications could increase the risk of serious health conditions, including:

Heart Failure

If you have a history of heart failure, undergoing treatment with TNF blockers could worsen the condition. Tell your doctor so that you can be closely monitored during treatment. Seek emergency medical care if you experience shortness of breath, swelling of your legs and feet, and/or sudden weight gain.

Cancer

TNF blockers could cause unusual cancers in children and teenagers undergoing treatment. The risk is higher in teenagers and young adult males with Crohn’s disease, ulcerative colitis, or a history of lymphoma or other cancers.

Some patients treated with SIMPONI ARIA® have developed skin cancer. Tell your doctor immediately if you notice changes in moles or growths that appear during or after treatment. If you have a history of skin cancer, your doctor will monitor the appearance of your skin throughout the duration of treatment.

Hepatitis B

SIMPONI ARIA® may also reactivate hepatitis B in patients who are carriers of the virus. If this applies to you, your medical provider will likely run a blood test to determine whether you should proceed with treatment. Tell your doctor if you experience signs of reactivation, such as dark urine, jaundice, little to no appetite, fever, chills, clay-colored bowel movements, skin rash, stomach discomfort, and/or stomach aches.

Nervous and Immune System Problems

In rare cases, TNF blockers may increase the risk of developing multiple sclerosis, Guillain-Barre syndrome, and/or lupus. Tell your doctor if you experience vision changes, weakness in your limbs, a tingling sensation anywhere in your body, sensitivity to the sun, joint or muscle pain, fatigue, chest pain, shortness of breath, and/or swelling of the feet, ankles, or legs.

Liver and Blood Problems

SIMPONI ARIA® may increase the risk of serious liver problems. Seek emergency medical care immediately if you experience jaundice, poor appetite, vomiting, pain on the right side of your stomach, and/or are feeling extremely tired. In addition, signs of blood problems include fever, bruising, paleness, and/or bleeding easily.

Allergic Reactions

All TNF blockers may cause patients to experience allergic reactions. Seek medical care immediately if you experience chest tightness, breathing difficulties, skin rash, hives, fever, chills, and/or swelling of the face, throat, tongue, and/or lips. These reactions could be life-threatening.

Side Effects of SIMPONI ARIA®

As with any prescription medication, SIMPONI ARIA® carries the risk of side effects. The most common ones include:

  • High blood pressure
  • Skin rash
  • Upper respiratory infections
  • Abnormal liver tests
  • Viral infections
  • Bronchitis

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

SIMPONI ARIA® is used to treat moderate to severe rheumatoid arthritis (RA) — when used in combination with methotrexate. It is also used to treat active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS).

Please refer to the full prescribing information.