Simponi (Golimumab)
What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
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Product Details
Description
Simponi, also known as Golimumab, is a monoclonal antibody that targets and neutralizes tumor necrosis factor (TNF), a substance that promotes inflammation in the body. This medication falls under a class of drugs known as TNF blockers. Doctors may prescribe Simponi to treat a variety of autoimmune conditions, such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. By blocking the actions of TNF, it helps to reduce joint pain, swelling, and stiffness that patients with these conditions often experience.
Directions
When preparing to administer Simponi, follow the instructions given by a healthcare professional carefully. The drug comes in two forms: an autoinjector and prefilled syringe. The medication is given as a subcutaneous (under the skin) injection. The standard dosage is 50 mg once a month for rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). In cases of ulcerative colitis (UC), an induction dose of 200 mg is initially given, followed by 100 mg at week two, and then a maintenance dose of 100 mg every four weeks thereafter. Patients should be aware of the careful handling of needles and disposal in a sharps container following the injection. It's also important to rotate injection sites to avoid skin irritation.
Ingredients
The active ingredient in a Simponi injection is Golimumab. The medication may also contain inactive ingredients, such as L-histidine, polysorbate 80, and sorbitol.
Contraindications
There are no known contraindications listed on the FDA label. However, those with a known hypersensitivity to Golimumab or any component of the formulation should avoid the medication.
Cautions
- Before starting Simponi, tell your healthcare provider about:
- Other medications you are taking
- Other underlying health conditions you have
- All allergies
- Whether you are pregnant or planning to become pregnant
- If you are breastfeeding
- Using Simponi can increase the risk of developing serious infections. It's crucial not to start Simponi if you currently have an active infection. If you develop an infection while on Simponi, it should be closely monitored, and the medication should be discontinued if the infection becomes severe.
- Patients on Simponi who develop systemic illnesses, especially those living in or traveling to areas where fungal infections are common, should consider the possibility of a fungal infection. Empiric antifungal therapy may be necessary in these cases.
- For carriers of hepatitis B, there's a risk of the virus reactivating during and after treatment with Simponi. Regular monitoring is necessary, and if reactivation occurs, Simponi should be stopped and antiviral therapy initiated.
- There has been an observed increase in the incidence of lymphoma and other malignancies in patients receiving TNF blockers like Simponi, compared to the general population.
- Patients with heart failure should be cautious as Simponi can worsen or contribute to the onset of congestive heart failure. If new or worsening symptoms occur, the medication should be stopped.
- There's a possibility that Simponi might exacerbate or trigger the onset of demyelinating disorders. Patients should be aware of this risk and consult their healthcare provider if they have a history of such conditions.
- Some patients may develop a lupus-like syndrome while on Simponi. If this occurs, discontinuation of the medication is advised.
- Serious allergic reactions, including anaphylaxis, can occur with Simponi. In the event of a severe hypersensitivity reaction, immediate medical attention is necessary.
Side Effects
Simponi may cause various side effects. The most common Simponi side effects include upper respiratory infections, injection site reactions, and viral infections like the flu and cold sores. Serious risks include increased chances of severe infections like TB, hepatitis B reactivation in carriers, heart failure, nervous system issues, lupus-like symptoms, liver problems, low blood counts, and serious allergic reactions. Key symptoms are fever, fatigue, yellowing of skin or eyes, chest pain, and rash. Immediate medical attention should be sought for severe symptoms, and regular monitoring by a healthcare provider is recommended.
References:
- Simponi (Golimumab) Product Monograph. Horsham, PA: Janssen Biotech, Inc.; 2019.
- Simponi (Golimumab) Drug Label Information. Horsham, PA: Janssen Biotech, Inc.; 2023.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 10215
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