Simponi

(Golimumab)

The active ingredient in Simponi is golimumab. It is a biologic disease-modifying antirheumatic medication (DMARD) that is categorized as a tumor necrosis factor (TNF) blocker (or inhibitor). The body produces a protein called TNF, which is essential for inflammation. Simponi reduces inflammation in the body by blocking TNF, which helps with autoimmune condition-related joint and intestinal discomfort and edema.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-approved product Labeling, Instructions for Use, and Medication Guide, before using Simponi. However, the following is a synopsis of the general guidelines for the use of Simponi:

• Once every two to four weeks, Simponi is injected beneath the skin in the front of the thighs or lower abdomen (at least 2 inches away from your belly button). It's possible that you could administer this shot to yourself with a pre-filled syringe autoinjector.
• Simponi can exacerbate or cause a recurrence of TB or hepatitis B if you have ever had one of these illnesses. Before taking this medication, you should be evaluated for these conditions. Throughout therapy, your doctor might need to keep an eye out for any symptoms.
• Don't prepare an injection until you're ready to administer it. If the medication appears hazy, has changed colour, or contains particles, give your chemist a call.

The most common side effects of Simponi include:

• Increased risk of infections, including viral infections, fungal infections, upper respiratory tract infections, and bronchitis.
• Higher liver enzymes.
• Injection site reactions.
• High blood pressure.
• Low blood cell count.

Some individuals may experience serious side effects while using Simponi. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Serious infections, with symptoms such as fever, shortness of breath, coughing, weakness, chills, sweating, diarrhea, sore throat, stomach discomfort, burning when urinating, and increased frequency of urination.
• Shortness of breath, edema in the legs, ankles, or feet, an irregular heartbeat, fatigue, and weakness are all signs of heart failure.
• Loss of appetite, exhaustion, skin lumps, enlarged lymph nodes in the neck, armpits, or groin, weight loss, and nosebleeds are all possible indicators of cancer.
• Hives, itching, facial or tongue swelling, and trouble breathing are examples of allergic reactions.
• This medicine may increase your risk of having a lupus-like syndrome. Check with your doctor right away if you have chest pain, fever, or chills.

These are not all of the possible side effects of Simponi. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Simponi, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• An active or chronic infection.
• Liver problems.
• A nervous system disorder, such as multiple sclerosis or Guillain-Barré syndrome.
• Cancer or lymphoma.
• Congestive heart failure.
• Psoriasis.
• Recently received or scheduled to receive a live vaccine.
• Allergy to rubber or latex.
• Had or have been exposed to tuberculosis, or if you have recently traveled, let your doctor know. You might have been exposed while traveling, and some infections are more prevalent in particular regions of the world.
• Skin cancer.
• Recently received or scheduled to receive a live vaccine.

Boxed Warning

If a patient has a serious infection, stop taking Simponi. Patients older than 65 years of age may be at greater risk. Active TB, including reactivation of latent TB, is one of the reported infections with TNF blockers, of which Simponi is a member. Lymphoma and other malignancies, some fatal, have also been reported in children and adolescents treated with anti-TNF medications.

There are no specific contraindications listed by the drug manufacturer.

Typically, it takes three to four months for SImponi to work, but each person will experience this differently.

When Simponi is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Anakinra.
• Abatacept, etanercept.
• Adalimumab, certolizumab, infliximab, rituximab, or tocilizumab.
• Corticosteroids.
• DMARDS (disease-modifying antirheumatic drugs).
• Azathioprine.
• NSAIDs.

Simponi (golimumab) is administered subcutaneously (SQ) in the lower abdomen (at least 2 inches from the belly button) or in the front of the thighs.

The usual dose for ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis is 50 mg administered subcutaneously once per month.

For ulcerative colitis, a single intradermal injection of 200 mg is the recommended first dosage. Another one-time dose of 100 mg should be injected beneath the skin after two weeks. The usual maintenance dose is 100 mg injected every 4 weeks.

Do not freeze this medication; instead, keep it in the refrigerator in its original container. Keep out of the light.

Before using, remove the medication from the refrigerator and allow it to come to room temperature for half an hour. Avoid heating the medication in a microwave, hot water, or the sun.

Janssen Biotech is the manufacturer of Simponi.

There are no generic versions available of Simponi.

If you are planning surgery or exhibit any symptoms of an infection, such as fever, coughing, or red or sore skin, don't forget to call your doctor. Golimumab may need to be stopped when receiving treatment for an infection or if you have a scheduled surgery.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.