simponi

Simponi (golimumab) reduces the effects of a substance in the body that can cause inflammation.

Simponi is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or ulcerative colitis.

Simponi is sometimes used with another medicine called methotrexate (Rheumatrex, Trexall).

Important information

You should not use Simponi if you are also using abatacept or anakinra.

Before you start treatment with Simponi, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

Serious and sometimes fatal infections may occur during treatment with Simponi, especially if you also use other medications that can weaken your immune system.

Stop using Simponi and call your doctor right away if you have signs of infection such as: fever, chills, muscle aches, feeling very tired, cough, shortness of breath, sweating, skin sores, diarrhea, stomach pain, weight loss, increased urination, or burning when you urinate.

If you have ever had tuberculosis or hepatitis B, Simponi can cause these conditions to come back or get worse. You should be tested for these conditions before you start using Simponi.

Some people using Simponi have developed a rare fast-growing type of lymphoma (cancer) that affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mostly in teenage boys and young men using Simponi.

Before taking this medicine

You should not use Simponi if you are allergic to golimumab.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where certain infections are common (Ohio River Valley, Mississippi River Valley, and the Southwest).

To make sure Simponi is safe for you, tell your doctor if you have:

• an active or recent infection, or chronic infections that come and go;

• hepatitis B (or if you are a carrier of the virus);

• diabetes;

• HIV or AIDS;

• a weak immune system;

• a nerve-muscle disease such as multiple sclerosis or Guillain-Barre syndrome;

• a history of cancer or lymphoma;

• a history of congestive heart failure;

• an allergy to latex rubber;

• if you are also using abatacept (Orencia) or anakinra (Kineret); or

• if you are scheduled to receive any vaccine.

Using Simponi may increase your risk of developing cancer or autoimmune disorders. Talk with your doctor about your specific risk.

Some people using Simponi have developed a rare fast-growing type of lymphoma (cancer) that affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mostly in teenage boys and young men using Simponi or similar medicines to treat Crohn"s disease or ulcerative colitis. However, people with autoimmune disorders (including rheumatoid arthritis, Crohn"s disease, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma.

Simponi is not expected to harm an unborn baby. However, a newborn baby may have an increased risk of infection for up to 6 months if the mother uses Simponi during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether golimumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medication to anyone under 18 years old without medical advice.

How should I use Simponi?

Use Simponi exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

If you have ever had tuberculosis or hepatitis B, Simponi can cause these conditions to come back or get worse. You should be tested for these conditions before you start using Simponi.

Simponi is sometimes injected into a vein through an IV. A healthcare provider will give you this type of injection once every 4 to 8 weeks.

Simponi may also be injected under the skin once every 2 to 4 weeks. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Your care provider will show you the best places on your body to inject Simponi. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Each single-use prefilled syringe or auto-injector device is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Store in the refrigerator, do not freeze. Protect from light. Keep the medication in its original carton until you are ready to give an injection.

Take the prefilled syringe or auto-injector out of the refrigerator and place it at room temperature for 30 minutes before giving your injection. Do not warm the medication with water or heat.

Simponi can weaken your immune system. Your blood will need to be tested often.

Simponi dosing information

Usual Adult Dose for Ankylosing Spondylitis:

Initial dose: 50 mg subcutaneously once a month

Comments:
-Psoriatic arthritis or ankylosing spondylitis: May be administered with or without methotrexate or other non-biologic Disease Modifying Antirheumatic Drugs (DMARDs).
-RA, PsA or AS: Corticosteroids, non-biologic DMARDs, and/or Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) may be continued during treatment with this drug.

Usual Adult Dose for Psoriatic Arthritis:

Initial dose: 50 mg subcutaneously once a month

Comments:
-Psoriatic arthritis or ankylosing spondylitis: May be administered with or without methotrexate or other non-biologic Disease Modifying Antirheumatic Drugs (DMARDs).
-RA, PsA or AS: Corticosteroids, non-biologic DMARDs, and/or Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) may be continued during treatment with this drug.

Usual Adult Dose for Ulcerative Colitis:

Initial dose: 200 mg subcutaneously at week 0, followed by 100 mg at week 2.
Maintenance dose: 100 mg subcutaneously every 4 weeks.

Usual Adult Dose for Rheumatoid Arthritis:

Initial dose: 50 mg subcutaneously (SC) once a month or 2 mg per kg intravenous (IV) infusion over 30 minutes at weeks 0 and 4, then every 8 weeks thereafter.

Comments: It should be given in combination with methotrexate. Corticosteroids, non-biologic Disease Modifying Antirheumatic Drugs (DMARDs), analgesics and/or Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) may be continued during treatment with this drug.

What happens if I miss a dose?

Use the missed dose as soon as you remember, and then go back to your regular injection schedule. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Simponi?

Do not receive a "live" vaccine while using Simponi, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

If you use Simponi during pregnancy, your baby should not receive a live vaccine for the first 6 months after birth.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Simponi side effects

Get emergency medical help if you have signs of an allergic reaction to Simponi: hives; chest pain, difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with Simponi. Stop using this medicine and call your doctor right away if you have signs of infection such as:

• fever, chills, muscle aches, feeling very tired;

• cough, shortness of breath;

• sweating, skin sores;

• diarrhea, stomach pain, weight loss;

• increased urination, or burning when you urinate.

Call your doctor at once if you have any of these other side effects:

• skin growths or changes in skin appearance;

• shortness of breath with swelling of your ankles or feet;

• pale skin, easy bruising or bleeding;

• vision changes, neck stiffness, seizure;

• numbness or tingly feeling, weakness in your arms or legs;

• liver problems--upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• lupus-like syndrome--muscle or joint pain, chest pain, patchy skin color, skin rash over your cheeks and nose (worsens in sunlight); or

• signs of psoriasis--red or scaly patches of skin, flaking, pus.

Common Simponi side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;

• flu symptoms, cold sores; or

• pain, itching, redness, or swelling where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Simponi?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• any other medicines to treat rheumatoid arthritis, such as adalimumab, certolizumab, etanercept, infliximab, rituximab, or tocilizumab.

This list is not complete. Other drugs may interact with golimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.