Simponi (Golimumab)
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Description
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Fact Table
| Fact Table | |
|---|---|
| Generic Name | Golimumab |
| License | FDA approved |
| Bioavailability | Not available (Biological) |
| Legal Status | Prescription Drugs |
| Chemical Name | Golimumab |
| Elimination Half-Life | 14 days (approximately) |
| Dosage (Strength) | 50 mg/0.5 mL, 100 mg/1 mL (Solution for subcutaneous injection) |
| Pregnancy | Category B: No evidence of risk in humans |
| Brands | Simponi |
| Protein Binding | Not available |
| PubChem CID | Not applicable |
| MedlinePlus | a611010 |
| DrugBank | DB06674 (Golimumab) |
| KEGG | D08965 (Golimumab) |
| Routes of Administration | Subcutaneous |
Simponi, generically known as golimumab, is a human monoclonal antibody that has been engineered for the treatment of several chronic autoimmune diseases. As part of a class of drugs known as tumor necrosis factor (TNF) blockers, Simponi works by targeting and neutralizing the TNF protein, a substance in the body's immune system that can cause inflammation and lead to immune-system diseases.
Simponi is commonly prescribed for conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. It offers relief by reducing inflammation, improving physical function, and preventing further damage to joints or other affected parts of the body. Before you buy Simponi, it is crucial that you talk to your healthcare provider about potential side effects and effectiveness.
Directions
Simponi is administered as a subcutaneous injection and is typically used once a month. It is crucial to follow your healthcare provider’s instructions carefully when using Simponi. Do not shake the medication.
Ingredients
Simponi’s active ingredient is golimumab.
Cautions
Simponi injection can lower the ability of your immune system to fight infections. Do not use it if you have active infections and monitor for signs of infection during treatment.
All patients should be tested for TB before starting Simponi. If you have latent TB, treatment to prevent the TB from becoming active may be initiated by your healthcare provider.
As a TNF blocker, Simponi may increase the risk of developing certain types of cancers. Discuss any personal or family history of cancer with your healthcare provider.
Interactions
Simponi may interact with other medications, which can alter how it works or increase your risk for serious side effects. Inform your healthcare provider about all medications, supplements, or herbs you are currently taking. Key interactions include live vaccines, other TNF blockers and immunosuppressants.
Side Effects
Simponi side effects include:
- Injection site reactions such as redness, itching, swelling
- Upper respiratory infections like colds and sinus infections
- Headaches and dizziness
- Nausea
Frequently Asked Questions about Simponi (Golimumab)
How does Simponi work?
Simponi (golimumab) is a monoclonal antibody that targets and inhibits tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation and plays a role in autoimmune diseases. By blocking TNF-alpha, Simponi helps reduce inflammation and modulate the immune system's response.
What are the side effects of Simponi?
Common side effects of Simponi include:
- Upper respiratory infections
- Injection site reactions (redness, itching, pain)
- Nausea
- Dizziness
- Flu-like symptoms
- Elevated liver enzymes
Serious side effects can include:
- Increased risk of infections (e.g., tuberculosis)
- Hepatitis B reactivation
- Heart failure
- Nervous system problems
- Allergic reactions
Why is Simponi so expensive?
Simponi is expensive due to several factors:
- High research and development costs
- Manufacturing complexity
- Market exclusivity and patent protections
- Regulatory costs
- Limited competition in the biologic drug market
How is Simponi administered?
Simponi is administered via subcutaneous injection. The frequency of administration varies based on the condition being treated but is typically once a month. Simponi Aria, a related formulation, is administered as an intravenous infusion by a healthcare professional, typically every 8 weeks after initial loading doses.
How long does Simponi Aria stay in your system?
Simponi Aria has a half-life of approximately 14 days. It generally takes about 5 half-lives for a drug to be eliminated from the body, so Simponi Aria can stay in the system for about 70 days (10 weeks) after the last dose.
What is Simponi used for?
Simponi is used to treat various autoimmune conditions, including:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Ulcerative colitis
How long can Simponi be unrefrigerated?
Simponi should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). If necessary, it can be kept at room temperature (up to 25°C or 77°F) for a maximum of 30 days. If it has been unrefrigerated for more than 30 days, it should not be used.
How long does it take for Simponi to start working?
The time it takes for Simponi to start working can vary. Some patients may begin to see improvements in their symptoms within a few weeks, but it can take up to 3 to 6 months to experience the full therapeutic effects.
Is Simponi a biologic?
Yes, Simponi is a biologic medication. Biologics are drugs made from living organisms or contain components of living organisms.
Is Simponi a steroid?
No, Simponi is not a steroid. It is a biologic TNF inhibitor used to treat autoimmune diseases.
Is Simponi an immunosuppressant?
Yes, Simponi acts as an immunosuppressant by inhibiting TNF-alpha, thereby reducing the immune system's inflammatory response.
Is Simponi safe?
Simponi is considered safe for many patients when used as prescribed. However, like all medications, it carries risks, including serious infections and other side effects. Patients should be monitored regularly by their healthcare provider to manage and mitigate potential risks.
