Simponi

What is Simponi?

Simponi can be used to treat certain autoimmune diseases (conditions where the immune system attacks healthy body parts and causes swelling and pain), including:

• Adults with rheumatoid arthritis (a condition in which the body attacks itself, causing swelling and pain) can take methotrexate along with other medications (Rasuvo, Trexall, and Otrexup).
• Ankylosing Spondylitis in Adults (a condition where the body attacks joints in the spine, causing joint damage and pain)
• Psoriatic arthritis is a condition that results in joint swelling, pain, and scaling of the skin. It can be treated with methotrexate alone or in combination in adults.
• When other treatments and medications have not helped or were not tolerated, ulcerative colitis is prescribed.

Simponi is also given in conjunction with steroid medications to treat some symptoms and control ulcerative colitis. It can also improve the appearance of the large intestine lining during a colonoscopy. Simponi may be safe and effective for children younger than 18 years old, but this is unknown.

Warnings

Simponi should not be used if abatacept or anakinra are also being taken. Simponi can affect your immune system. You could get more serious infections, including fatal ones. Contact your doctor if there are any of the following symptoms: fever, chills and aches, fatigue, skin sores or ulcers, diarrhoea, or burning in the urination.

Simponi can cause serious and even fatal infections, especially if your immune system is already weakened by other medications. Before you begin using Simponi, you should have your condition tested.

Simponi users have been diagnosed with a rare, fast-growing form of lymphoma, which can affect the liver, spleen, and bone marrow. It is fatal. It has mostly affected teenage boys and young males who use Simponi.

Before you take this drug

Simponi should not be used if you have an allergy to latex or rubber.

Tell your doctor about any of the following to ensure Simponi will be safe for you:

• Is a chronic or active
• A disorder of the nerves and muscles, such as multiple sclerosis;
• Lymphoma or cancer?
• Congestive heart failure;
• Psoriasis;
• Recently received or scheduled for a live vaccination

Inform your doctor of any travel plans or exposure to tuberculosis. You may have been exposed to certain infections while travelling. Simponi can increase your risk of other cancers. This is something you should discuss with your doctor.

Golimumab is not known to harm an unborn child. Inform your physician if you are pregnant or plan to become pregnant. Inform your doctor about using Simponi while pregnant. This could have an impact on your baby’s vaccination schedule in the first six months of their life. Ask your doctor if you can safely breastfeed when using Simponi.

What is Simponi, and how should I use it?

Uae Simponi, as prescribed by your physician. Read all the instructions on the prescription label. Before you begin taking this medication, you should be tested to see if you have a history of tuberculosis and hepatitis. During treatment, your doctor may monitor you for symptoms and signs. Simponi can also be injected into the skin every 2 to 4 weeks. This injection may be given to you.

You will be shown by your healthcare provider where to inject Simponi. Don't inject Simponi in the same area twice.If you need assistance injecting an injection, reach out to either your pharmacist or doctor for advice. Only prepare an injection when you are prepared to administer it. If the medication is cloudy or has changed colour, call your pharmacist.

Simponi can deteriorate your immune system. You will need to test your blood often. Do not freeze. Store the medicine in its original packaging in the refrigerator. Keep away from the light. Heat the medicine using only cool, tap water or the microwave; allow it to come down to room temperature before using it.  Never warm up the medicine in hot water, sunlight, or the microwave.

Once used, discard prefilled syringes or auto-injectors even if they contain medication left inside them. Never reuse a syringe or needle. Dispose of all sharps according to local or state regulations. A puncture-proof container should be used. Keep away from children and pets.

Details on dosage

Adult dose of Simponi:

Subcutaneous: 50mg once a week.

Adult dose of Simponi used for ulcerative colitis:

Initial dose: 200mg subcutaneously in week 0, then 100mg at week 2.
Maintenance dose: 100 mg subcutaneously every four weeks
Comments:
Testing for hepatitis B virus infection should be done before treatment.
Before starting treatment, evaluate patients for active tuberculosis.
The safety and effectiveness of switching from subcutaneous to IV formulations have not been proven.
Use: To treat patients with moderate-to-severe ulcerative colitis who have shown corticosteroid dependency, have not tolerated oral corticosteroids or aminosalicylates, have an insufficient response, or have failed to tolerate azathioprine or 6-mercaptopurine.
Inducing and maintaining a clinical response
improving the endoscopic appearance during induction
Inducing clinical remission
achieving and maintaining clinical remission among induction responders

Adult dose of Simponi used for rheumatoid arthritis:

Subcutaneous: 50mg once a week.
Use: To treat patients with moderately active to severely active rheumatoid arthritis

Adult dose of Simponi:

Subcutaneous: 50 mg every month.
Comments:
This drug can be used with or without methotrexate or any other nonbiologic disease-modifying antirheumatic (DMARD) drugs.
Corticosteroids (nsaids), analgesics, and/or nonsteroidal antiinflammatory drugs can be taken during the course of treatment.
Testing for hepatitis B virus infection should be done before treatment.
Before starting treatment, evaluate patients for active tuberculosis.
The safety and effectiveness of switching from subcutaneous to IV formulations have not been proven.
Use: To treat patients with active ankylosing spondylitis.

What happens if I miss the dose?

In case you miss a dose, immediately contact your physician to obtain instructions.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

You could get a serious infection if you receive a live vaccine. Live vaccines are measles (MMR), rubella, rotavirus (typhoid), yellow fever, and varicella (chickenpox).

Side effects of Simponi

If you experience any of the following symptoms of an allergic reaction: difficulty breathing, hives, swelling in your lips, face, throat, or tongue, seek emergency medical attention.

If you notice signs of an infection, such as:

• Feeling very tired; fever, chills, and sweating;
• Cough, bloody mucus, and shortness of breath
• Weight loss;
• Painful skin sores or warmth
• Diarrhoea, stomach pain,
• Burning or increased urination.

Call your doctor immediately if you:

• Skin growth or changes to the skin's appearance
• Swelling in your lower legs;
• Vision changes
• You may feel a tingling or numbness in your arms and legs.
• Heart problem: rapid weight gain and a feeling of shortness of breath.
• Low blood cell counts: a fever, chills, and tiredness; mouth sores or skin sores Easy bruising. Unusual bleeding. Pale skin. Cold hands and feet. Feeling light-headed.
• Liver disorders: fatigue, nausea, dark urine, and clay-coloured stools. Jaundice: yellowing of the skin, eyes, or lips.
• New or worsening lupus symptoms: joint pain and a skin reaction on your arms or cheeks that gets worse in the sun;
• Signs of Psoriasis: red or scaly skin patches, flaking, pus

Side effects of Simponi may include:

• Cold symptoms like a stuffy nose and sneezing, sore neck
• Abnormal liver function tests
• High blood pressure
• Skin rash;
• Low blood cell count;
• Pain, itching, or redness where the medicine has been injected.

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Interaction with other drug

It is sometimes not safe to take certain medications at the same time. Some drugs may affect the blood levels of drugs that you are taking, which can increase side effects and make them less effective.

Tell your doctor about your other medications, including:

• Anakinra;
• Abatacept, etanercept,
• Adalimumab, certolizumab, infliximab, rituximab, or tocilizumab.

This list is incomplete. Golimumab may interact with other drugs, such as prescription and over-the-counter medicines, vitamins, and herbal products. This list does not include all possible drug interactions.