Simponi Aria is used to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) including:

• rheumatoid arthritis (a condition in which the body attacks its own joints causing pain, swelling, and loss of function) along with methotrexate (Otrexup, Rasuvo, Trexall) in adults,
• ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas causing pain and joint damage) in adults,
• psoriatic arthritis (PsA; a condition that causes joint pain and swelling and scales on the skin) in adults and children 2 years of age and older,
• polyarticular juvenile idiopathic arthritis (PJIA; a type of childhood arthritis that affects five or more joints during the first six months of the condition, causing pain, swelling, and loss of function) in children 2 years of age and older.

Simponi Aria is a prescription medicine called a TNF-blocker (tumor necrosis factor blocker).

It is not known if Simponi Aria is safe and effective in children with PsA and pJIA under 2 years of age or in children with conditions other than PsA and pJIA.

You should not use Simponi Aria if you are also using abatacept or anakinra.

Simponi Aria affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, skin sores, diarrhea, or burning when you urinate.

Serious and sometimes fatal infections may occur during treatment with Simponi Aria, especially if you also use other medications that can weaken your immune system.

If you have ever had tuberculosis or hepatitis B, Simponi Aria can cause these conditions to come back or get worse. You should be tested for these conditions before you start using Simponi Aria.

Some people using Simponi Aria have developed a rare fast-growing type of lymphoma (cancer) that affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mostly in teenage boys and young men using Simponi Aria.

Use Simponi Aria exactly as prescribed by your doctor Follow all directions on your prescription label and read all medication guides or instruction sheets.

If you have ever had tuberculosis or hepatitis B, Simponi Aria can cause these conditions to come back or get worse. You should be tested for these conditions before you start this medicine. Your doctor may need to monitor you for signs and symptoms during treatment. 

Simponi Aria is given as an infusion into a vein. A healthcare provider will give you this type of injection once every 4 to 8 weeks.

Simponi Aria can weaken your immune system. Your blood will need to be tested often.

Store in original container in the refrigerator, do not freeze. Protect from light.

Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before using. Do not warm the medicine with hot water, sunlight, or a microwave.

Usual Adult Dose of Simponi Aria for Psoriatic Arthritis:

IV: 2 mg/kg over 30 minutes at weeks 0 and 4, then every 8 weeks thereafter.

Usual Adult Dose of Simponi Aria for Rheumatoid Arthritis:

IV: 2 mg/kg over 30 minutes at Weeks 0 and 4, then every 8 weeks thereafter
Use: For the treatment of patients with moderately to severely active rheumatoid arthritis

Usual Adult Dose of Simponi Aria for Ankylosing Spondylitis:

IV: 2 mg/kg over 30 minutes at weeks 0 and 4, then every 8 weeks thereafter

Comments:
-This drug may be given with or without methotrexate or other nonbiologic disease modifying antirheumatic drugs (DMARDs).
-Corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during therapy.
-Patients should be tested for hepatitis B viral infection before starting treatment.
-Evaluate patients for active tuberculosis and tested for latent infection before starting treatment.
-The safety and efficacy of switching between subcutaneous and IV formulations have not been established.

Use: For the treatment of patients with active ankylosing spondylitis (AS)

Usual Pediatric Dose of Simponi Aria for Psoriatic Arthritis:

IV: 80 mg/m2 over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter

Comments:
-Dosage regimen is based on body surface area (BSA).

Use: For the treatment of active psoriatic arthritis in patients 2 years of age and older

Usual Pediatric Dose of Simponi Aria for Juvenile Idiopathic Arthritis:

IV: 80 mg/m2 over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter

Comments:
-Dosage regimen is based on body surface area (BSA).

Use: For the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older

To make sure Simponi Aria is safe for you, tell your doctor if you have ever had:

• an active or chronic infection;

• a nerve-muscle disorder such as multiple sclerosis or Guillain-Barré syndrome;

• cancer or lymphoma;

• congestive heart failure;

• psoriasis; or

• recently received or scheduled to receive a live vaccine.

Tell your doctor if you've had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

Using Simponi Aria may increase your risk of developing other cancers. Ask your doctor about this risk.

It is not known if golimumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Tell your baby's doctor if you used Simponi Aria during pregnancy. It could affect your baby's vaccination schedule during the first 6 months of life.

Ask a doctor if it is safe to breastfeed while using Simponi Aria.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid receiving a "live" vaccine, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Get emergency medical help if you have signs of an allergic reaction to Simponi Aria: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, sweating, muscle aches, feeling very tired;

• cough, bloody mucus, shortness of breath;

• weight loss;

• painful skin sores, warmth, or redness;

• diarrhea, stomach pain; or

• increased urination, or burning when you urinate.

Also call your doctor at once if you have:

• skin growths or changes in skin appearance;

• swelling in your lower legs;

• vision changes;

• numbness or tingly feeling, weakness in your arms or legs;

• heart problems - swelling, rapid weight gain, feeling short of breath;

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;

• liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• new or worsening symptoms of lupus - joint pain, and a skin rash on your cheeks or arms that worsens in sunlight; or

• signs of psoriasis - red or scaly patches of skin, flaking, pus.

Common Simponi Aria side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;

• abnormal liver function tests;

• high blood pressure;

• skin rash;

• low blood cell counts; or

• pain, itching, redness, bruising, tingling or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• anakinra;

• abatacept, etanercept; or

• adalimumab, certolizumab, infliximab, rituximab, or tocilizumab.

This list is not complete. Other drugs may interact with golimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.