Golimumab, Injection

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KEY POINTS

• This medicine is given by injection to treat certain kinds of arthritis or ulcerative colitis. Use it exactly as directed
• You may get serious or life-threatening infections when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause lupus-like syndrome, or cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: monoclonal antibody for tumor necrosis factor (TNF)

Generic and brand names: golimumab, injection; Simponi; Simponi Aria

What is this medicine used for?

Simponi is given by subcutaneous injection (just under the skin) to treat:

• Ankylosing spondylitis
• Psoriatic arthritis
• Rheumatoid arthritis (RA)
• Ulcerative colitis

This medicine may be used alone or along with another medicine.

Simponi Aria is given by IV (slow drip through a needle into a large vein) along with another medicine to treat moderate to severe active rheumatoid arthritis.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine, or to latex or rubber
• A blood disorder
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Diabetes
• High blood pressure
• Heart failure
• Hepatitis B or other liver problems
• Lung disease
• Lupus or other autoimmune diseases
• Lymphoma or other cancer
• Multiple sclerosis, Guillain-Barré syndrome, neuropathy, or any condition that causes numbness or tingling
• Seizures
• Tuberculosis (TB), a positive skin test for TB, or close contact with someone who has TB (your healthcare provider may give you a skin test to check for this).

You should NOT receive shots of this medicine if you have any kind of infection. Tell your healthcare provider if you:

• Currently have an infection
• Have any open cuts or sores
• Often have infections or infections come back
• Are scheduled to receive any vaccines
• Are scheduled to have major surgery

Some infections are more likely in certain parts of the country. Tell your provider where you have lived or recently traveled or where you plan to travel to during treatment.

Tell your provider if you take any other medicines for RA or JIA, especially anakinra (Kineret), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), adalimumab (Humira), rituximab (Rituxan), infliximab (Remicade), or tocilizumab (Actemra).

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

If you have a baby and you were using his medicine during your pregnancy, tell your baby's healthcare provider before your baby receives any vaccine. Your baby may have an increased chance of getting an infection for up to 6 months after birth.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Simponi Aria is given by your healthcare provider. Keep all appointments.

Simponi comes in a single-use prefilled syringe or a single-use autoinjector. The shots are given just under the skin. If your healthcare provider is giving you the shots, keep all your appointments. Sometimes you can give yourself these shots or have someone at home give them to you. Check the label on the medicine for directions about your specific dose. Be sure you know how and when to have shots and how much medicine to use. If you are not sure of how to give yourself the shots, ask your healthcare provider or pharmacist for help.

Carefully read and follow the directions that come in the package of medicine for preparing and giving the shots. Wash your hands before using this medicine.

Let the medicine warm to room temperature outside the carton for 30 minutes before you inject it. The shots should not be given into areas where the skin is tender, bruised, or red, or where you have scars or stretch marks.

Use each prefilled syringe or pen only once and dispose of them safely, following your healthcare provider's instructions. Do not use the medicine if it looks cloudy or contains particles.

Do not stop using this medicine without your healthcare provider's approval.

What if I miss a dose?

Simponi: If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

If you miss an infusion, contact your healthcare provider for another appointment as soon as possible.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine increases your risk for serious or life-threatening infections. Stay away from people with colds, flu, or other infections. Contact your healthcare provider right away if you develop a fever or ANY other symptoms of infection. Also, do not have any vaccines without getting your healthcare provider's approval first.

This medicine may increase your risk for lymphoma, leukemia, melanoma, and other cancers. Talk to your healthcare provider about this.

Your healthcare provider will check you regularly to see how this medicine affects you. Keep all appointments.

This medicine may cause or worsen heart failure. Contact your healthcare provider right away if you have new or worse symptoms of heart failure such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.

Rarely, this medicine causes a condition called lupus-like syndrome. Its symptoms include a rash on your face or other parts of your body, chest pain or discomfort that doesn’t go away, new joint pain, shortness of breath, and sensitivity to sunlight. Talk to your healthcare provider about this.

This medicine may also increase the risk of developing psoriasis or worsen psoriasis. Contact your provider if you notice red scaly patches or raised bumps on the skin that are filled with pus.

This medicine may make you dizzy or cause vision changes. Do not drive or operate machinery unless you are fully alert and can see clearly.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Lupus-like syndrome (new joint pain, rash, sensitivity to sunlight, chest pain); seizures; fever; cough; sore throat; trouble breathing; pain while urinating or urinating more often than usual; unexplained bleeding or bruising; unusually pale skin; yellowing of the eyes and skin; dark urine; severe nausea or vomiting; severe stomach pain; light-colored bowel movements; unexplained loss of appetite; numbness or tingling in any part of your body; trouble walking; vision changes; severe dizziness; blood in vomit, bowel movement, or urine; unexplained swelling in your ankles or feet; increased shortness of breath; unusual tiredness or weakness; new or worsening skin sores, red scaly patches, raised bumps that may be filled with pus, or other skin changes; pain, redness, or swelling around the injection site that doesn’t go away or gets worse.

Other: Headache; runny nose; mild dizziness; itching, redness, or pain at the injection site.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking any other medicines.

• Echinacea
• Fingolimod (Gilenya)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as abatacept (Orencia), adalimumab (Humira), anakinra (Kineret), belimumab (Benlysta), canakinumab (Ilaris), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), leflunomide (Arava), rituximab (Rituxan), tocilizumab (Actemra), and tofacitinib (Xeljanz)
• Mercaptopurine (Purinethol)
• Natalizumab (Tysabri)
• Rilonacept (Arcalyst)
• Theophylline
• Vaccines
• Vedolizumab (Entyvio)
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the original carton in the refrigerator. Do not let it freeze. Do not shake the medicine. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.