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Simponi Aria 50mg/4mL Injection
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Indications & Clinical Uses
- Simponi Aria (golimumab) 50 mg/4 mL is the same active substance as Simponi but formulated as an intravenous infusion given only in a clinic or infusion centre, not self-injected at home.
- It is approved in the United States for moderately to severely active rheumatoid arthritis in adults, given with methotrexate; active psoriatic arthritis and active ankylosing spondylitis in adults; and active polyarticular juvenile idiopathic arthritis and psoriatic arthritis in children 2 years of age and older.
- Unlike subcutaneous Simponi, Simponi Aria's US label does not cover ulcerative colitis.
- Each infusion is calculated by body weight - 2 mg/kg in adults, 80 mg/m squared body-surface area in children - and given over 30 minutes through an in-line filter, initially at weeks 0 and 4, then every 8 weeks thereafter.
- Because the two golimumab products differ in strength, route, dosing interval and approved uses, Simponi Aria and subcutaneous Simponi are not interchangeable formulations of the same product.
Side Effects
- Common Simponi Aria side effects, reported in 3% or more of patients, include upper respiratory tract infection, raised liver enzymes (ALT/AST), viral infections, a drop in neutrophil (white blood cell) count, bronchitis, high blood pressure and rash; infusion reactions such as flushing, itching, chest discomfort or a change in blood pressure can occur during or shortly after the infusion, which is why you are monitored throughout.
- Simponi Aria carries a boxed warning for serious, sometimes fatal, infections, including tuberculosis and invasive fungal infections such as histoplasmosis and aspergillosis, and for lymphoma and other malignancies, including rare hepatosplenic T-cell lymphoma reported mainly in young males, usually with concurrent azathioprine or mercaptopurine.
- Tell the infusion team immediately about breathing difficulty, chest tightness, dizziness, fever, persistent cough or unusual bruising during or after your infusion.
Precautions & Warnings
- Before your first Simponi Aria infusion you will be tested for latent tuberculosis and screened for hepatitis B, since both can reactivate during treatment; infusions are not given during an active infection.
- Simponi Aria should not be combined with other biologic TNF blockers, abatacept or anakinra.
- Use caution if you have congestive heart failure or a history of a demyelinating condition such as multiple sclerosis, and tell the infusion team about any history of cancer or blood disorders.
- Live vaccines should not be given during treatment; discuss vaccination timing with your healthcare provider, particularly for children.
- This medicine is given only by a healthcare professional in a facility equipped to manage infusion reactions, so there is no home-storage or self-administration step for the patient.
- Discuss pregnancy and breastfeeding plans with your provider, since golimumab crosses the placenta.
Avoid Interactions
- Tell the prescribing team about every other medicine you or your child takes.
- Simponi Aria is contraindicated with abatacept or anakinra and should not be combined with other TNF blockers or biologic disease-modifying drugs because of a higher risk of serious infection without added benefit.
- Methotrexate slightly reduces golimumab clearance and is commonly used together in rheumatoid arthritis; this combination is intentional and monitored.
- Live or live-attenuated vaccines should be avoided during treatment and for a period beforehand in infants exposed in utero.
- Report any recent or planned surgery, since infection risk can be higher around that time, and mention azathioprine or mercaptopurine use given the rare lymphoma signal reported with thiopurines and TNF blockers combined.
References
Frequently Asked Questions
Simponi Aria (golimumab) is an infused biologic medicine for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in adults, and juvenile arthritis in children 2 and older. It's the same drug as Simponi but given as an IV infusion instead of a self-injection.
You receive a Simponi Aria infusion over 30 minutes at a clinic, at week 0, again at week 4, then every 8 weeks afterward. Your dose is calculated from your body weight, so it's given only by trained healthcare staff, never at home.
A nurse gives Simponi Aria through a vein over about 30 minutes using an in-line filter, while monitoring you for infusion reactions like flushing, itching, chest tightness or blood pressure changes. Tell the infusion team right away if you feel unwell during or after.
Simponi Aria carries a boxed warning for serious infections, including tuberculosis and fungal infections, which can be fatal, and for lymphoma and other cancers, including a rare lymphoma seen mostly in young men. You're tested for TB and hepatitis B before your first infusion.
Avoid live vaccines during treatment, and don't combine Simponi Aria with abatacept, anakinra or another TNF-blocker biologic, since this raises infection risk. Tell your care team about any infection, planned surgery, or history of heart failure or multiple sclerosis before your next infusion.
No. Both contain golimumab, but Simponi Aria is a 50 mg/4 mL solution given as a clinic IV infusion every 8 weeks, while Simponi is a 50 mg/0.5 mL dose self-injected under the skin, usually monthly. They are not interchangeable.
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