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- What is Simponi (golimumab)? How does it work (mechanism of action)?
- What is Simponi used for?
- What are the side effects of Simponi?
- What is the dosage for golimumab?
- Which drugs or supplements interact with golimumab?
- Is golimumab safe to use during pregnancy or while breastfeeding?
- What else should you know about golimumab?
What is Simponi (golimumab)? How does it work (mechanism of action)?
Golimumab is an injectable synthetic (man-made) protein that binds to tumor necrosis factor alpha (TNFα) in the body and blocks the effects of TNFα in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis. As a result, the inflammation caused by these diseases and its consequences are reduced. Adalimumab (Humira), certolizumab (Cimzia) and etanercept (Enbrel) are two other injectable drugs that block TNFα.
Inflammation is the body's reaction to injury and is a necessary process for the repair of injury. TNF is a protein that the body produces when there is inflammation. TNF promotes inflammation and the signs of inflammation, which, in the case of arthritis, include fever as well as pain, tenderness, and swelling of joints. The unchecked inflammation of rheumatoid and psoriatic arthritis as well as ankylosing spondylitis eventually leads to destruction of the joints. Golimumab binds to TNF in the body and thereby blocks the effects of TNF. As a result, inflammation and its inflammatory consequences in joints are reduced, and the progressive destruction of the joints is slowed or prevented.
- The FDA approved golimumab in April 2009.
- Simponi and Simponi Aria are the brand names for golimumab.
- Simponi and Simponi Aria are not available in generic form.
- You need a prescription for Simponi and Simponi Aria.
What is Simponi used for?
What are the side effects of Simponi?
Common side effects include:
- Elevated liver function test results
- Abnormal prickling, tingling, tickling, or burning sensation (paraesthesia)
Other side effects include:
- Injection site reactions (redness, swelling)
- Reduced levels of blood cells
- Reactivation of hepatitis B virus
- New onset or worsening of psoriasis
Less common side effects include:
Possible serious side effects include:
- Herpes infection
- Serious allergic reactions
- Liver toxicity
- Sepsis (bacteria in the blood)
- Fungal infections
Individuals with active infections should not be treated with golimumab. This drug may worsen or cause new diseases of the nervous system. It also may cause or worsen congestive heart failure. In studies, some patients who used golimumab or other TNFα blocking drugs developed cancer.
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What is the dosage for golimumab?
- Golimumab is injected under the skin.
- Injection sites should be rotated.
- The recommended dose is 50 mg monthly.
Which drugs or supplements interact with golimumab?
- Combining anakinra (Kineret), abatacept (Orencia), rituximab (Rituxan) with golimumab may result in a reduction of white blood cells in the blood (neutropenia), serious infections and no additional benefit.
- Golimumab may interfere with the effectiveness of vaccines. Live vaccines, including attenuated vaccines, should not be given to patients receiving this drug.
Is golimumab safe to use during pregnancy or while breastfeeding?
What else should you know about golimumab?
What preparations of golimumab are available?
- Injection (Prefilled Syringe): 50 mg/0.5 ml
How should you keep golimumab stored?
- This drug should be stored refrigerated at 2 C to 8 C (36 F to 46 F).
Golimumab (Simponi) is an injectable protein (man-made) used in the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Side effects are fever, paresthesia, and elevated liver function tests. Drug interactions, warnings and precautions, and pregnancy and breastfeeding information should be reviewed prior to taking any medication.
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Rheumatoid Arthritis (RA)
Rheumatoid arthritis (RA) is an autoimmune disease that causes chronic inflammation of the joints, the tissue around the joints, as well as other organs in the body. Because it can affect multiple other organs of the body, rheumatoid arthritis is referred to as a systemic illness and is sometimes called rheumatoid disease. The 16 characteristic early RA signs and symptoms include the following. Anemia Both sides of the body affected (symmetric) Depression Fatigue Fever Joint deformity Joint pain Joint redness Joint stiffness Joint swelling Joint tenderness Joint warmth Limping Loss of joint function Loss of joint range of motion Many joints affected (polyarthritis)
Arthritis (Joint Inflammation)
Arthritis is inflammation of one or more joints. When joints are inflamed they can develop stiffness, warmth, swelling, redness and pain. There are over 100 types of arthritis, including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, lupus, gout, and pseudogout.
Ankylosing spondylitis is a type of arthritis that causes chronic inflammation of the spine. The tendency to develop ankylosing spondylitis is genetically inherited. Treatment incorporates medications, physical therapy, and exercise.
Pain management and treatment can be simple or complex, according to its cause. There are two basic types of pain, nociceptive pain and neuropathic pain. Some causes of neuropathic pain include: complex regional pain syndrome, interstitial cystitis, and irritable bowel syndrome. There are a variety of methods to treat chronic pain, which are dependant on the type of pain experienced.
Psoriatic arthritis is a disease that causes skin and joint inflammation. Symptoms and signs include painful, stiff, and swollen joints, tendinitis, and organ inflammation. Treatment involves anti-inflammatory medications and exercise.
Chronic pain is pain (an unpleasant sense of discomfort) that persists or progresses over a long period of time. In contrast to acute pain that arises suddenly in response to a specific injury and is usually treatable, chronic pain persists over time and is often resistant to medical treatments.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.