Simponi

Generic Name: golimumab (goe LIM ue mab)

What is Simponi?

Simponi (golimumab) is a tumor necrosis factor (TNF) blocker. It works by reducing the effects of a substance in the body that can cause inflammation.

Simponi is used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Golimumab is sometimes used with another medication called methotrexate (Rheumatrex, Trexall).

Simponi may also be used for other purposes not listed in this medication guide.

Important information about Simponi

You should not use Simponi if you are allergic to golimumab, or if you are already using adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), or infliximab (Remicade).

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

Tell your doctor about all of your medical conditions, especially if you have hepatitis, congestive heart failure, lupus, diabetes, cancer, HIV or a weak immune system, or multiple sclerosis.

Before you start treatment with Simponi, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Simponi can lower the blood cells that help your body fight infections. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Serious and sometimes fatal infections may occur during treatment with Simponi. Contact your doctor right away if you have signs of infection such as: fever, sweating, chills, tired feeling, chest pain, feeling short of breath, cough, sore throat, coughing up bloody mucus;, flu symptoms, stomach pain, diarrhea, muscle aches, or weight loss.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

Do not receive a “live” vaccine while you are being treated with Simponi.

Using Simponi may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes) or autoimmune disorders (such as a lupus-like syndrome). This risk may be greater in children and young adults. Talk to your doctor about your specific risk.

Before using Simponi

You should not use Simponi if you are allergic to golimumab, or if you are already using adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), or infliximab (Remicade).

Before using 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.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use Simponi:

an active or recent infection;

hepatitis B;

congestive heart failure;

lupus;

diabetes;

cancer, HIV, or a weak immune system;

an allergy to latex rubber;

a disease that affects the nerves or muscles, such as multiple sclerosis;

if you have recently been vaccinated with BCG (Bacille Calmette-Guerin); or

if you are scheduled to receive any vaccines.

FDA pregnancy category B. Simponi is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether golimumab passes into breast milk. Do not use Simponi without first talking to your doctor if you are breast-feeding a baby.

Using Simponi may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes) or autoimmune disorders (such as a lupus-like syndrome). This risk may be greater in children and young adults.Talk with your doctor about your specific risk.

How should I use Simponi?

Before you start treatment with Simponi, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Simponi is usually given once per month. Follow the instructions on your prescription label.

Simponi comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Simponi is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Do not shake the Simponi prefilled syringe. Vigorous shaking can ruin the medicine. Do not use the medication if it has changed colors, is cloudy, or has any particles in it. Call your doctor for a new prescription.

Use a different place on your thigh, stomach, or upper arm each time you give yourself an injection. Your care provider will show you the places on your body where you can safely inject the medication. Do not inject into the same place two times in a row.

Each single-use pre-filled syringe of Simponi is for one use only. Throw away the auto-injector after one use, even if there is still some medicine left in it after injecting your dose.

Throw away used needles and syringes in a puncture-proof container. If your medicine does not come with such a container, ask your pharmacist where you can get one. Keep this container out of the reach of children and pets. Your pharmacist can tell you how to properly dispose of the container.

Simponi can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop using Simponi.

Store Simponi in the refrigerator but do not allow it to freeze. Keep the medication in its original carton and protect from light. You may take the prefilled syringe or autoinjector 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.

What happens if I miss a dose?

Use the medication 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 if you think you have used too much of this medicine. An overdose of Simponi is not expected to produce life-threatening symptoms.

What should I avoid while using Simponi?

Do not receive a “live” vaccine while you are being treated with Simponi.

Avoid injecting Simponi into skin that is scarred, bruised, red, tender, or hard.

Simponi side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Simponi: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Serious and sometimes fatal infections may occur during treatment with Simponi. Stop using it and call your doctor right away if you have signs of infection such as:

fever, sweating, chills, tired feeling;

chest pain, feeling short of breath;

cough, sore throat, coughing up bloody mucus;

flu symptoms, stomach pain, diarrhea;

muscle aches, weight loss.

Call your doctor at once if you have any of these other serious side effects while taking Simponi:

shortness of breath with swelling of your ankles or feet;

chest pain, ongoing cough, coughing up blood;

easy bruising or bleeding, pale skin, unusual weakness;

cold sores;

vision changes;

numbness or tingly feeling, weakness in your legs;

loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, chest pain, unusual thoughts or behavior, and/or seizure (convulsions); or

patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).

Less serious Simponi side effects may include:

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

dizziness; or

redness where you injected the medication.

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.

What other drugs will affect Simponi?

Tell your doctor about all other medications you use, especially:

abatacept (Orencia);

anakinra (Kineret);

rituximab (Rituxan);

a blood thinner such as warfarin (Coumadin);

cyclosporine (Gengraf, Neoral, Sandimmune);

digoxin (digitalis, Lanoxin, Lanoxicaps);

theophylline (Elixophyllin, Theo-24, Uniphyl);

seizure medication such as carbamazepine (Carbatrol, Tegretol), divalproex (Depakote), phenytoin (Dilantin), or valproic acid (Depakene); or

a heart rhythm medication such as disopyramide (Norpace), procainamide (Procan, Pronestyl), or quinidine (Quinidex, Quin-Release Quin-G).

This list is not complete and there may be other drugs that can interact with Simponi. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.