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MEDICATION GUIDE

SIMPONI®
(SIM-po-nee)
(golimumab)

Read the Medication Guide that comes with SIMPONI (golimumab injection) before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. It is important to remain under your doctor's care while using SIMPONI (golimumab injection) .

What is the most important information I should know about SIMPONI (golimumab injection) ?

SIMPONI (golimumab injection) is a medicine that affects your immune system. SIMPONI (golimumab injection) can lower the ability of your immune system to fight infections. Some people have serious infections while taking SIMPONI (golimumab injection) , including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that spread throughout their body. Some people have died from these serious infections.

• Your doctor should test you for TB before starting SIMPONI (golimumab injection) .
• Your doctor should monitor you closely for signs and symptoms of TB during treatment with SIMPONI (golimumab injection) .

You should not start taking SIMPONI (golimumab injection) if you have any kind of infection unless your doctor says it is okay.

Before starting SIMPONI (golimumab injection) , tell your doctor if you:

• think you have an infection or have symptoms of an infection such as:
  • fever, sweat, or chills
  • warm, red, or painful skin or sores on your body
  • muscle aches 
  • diarrhea or stomach pain
  • cough 
  • burning when you urinate or urinate more often than normal
  • shortness of breath
  • feel very tired
  • blood in phlegm
  • weight loss
• are being treated for an infection
• get a lot of infections or have infections that keep coming back
• have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
• have TB, or have been in close contact with someone with TB
• live, have lived, or traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, blastomycosis). These infections may happen or become more severe if you use SIMPONI (golimumab injection) . Ask your doctor, if you do not know if you have lived in an area where these infections are common.
• have or have had hepatitis B
• use the medicine Orencia (abatacept), Kineret (anakinra), or Rituxan (rituximab)

After starting SIMPONI (golimumab injection) , call your doctor right away if you have any symptoms of an infection. SIMPONI (golimumab injection) can make you more likely to get infections or make worse any infection that you have.

Cancer

• There have been cases of unusual cancers in children and teenage patients taking TNF-blocking agents.
• For children and adults taking TNF-blocker medicines, including SIMPONI (golimumab injection) , the chances of getting lymphoma or other cancers may increase.
• People with inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, especially those with very active disease, may be more likely to get lymphoma.

What is SIMPONI (golimumab injection) ?

SIMPONI (golimumab injection) is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker. SIMPONI (golimumab injection) is used in adults:

• with the medicine methotrexate to treat moderately to severely active rheumatoid arthritis (RA)
• to treat active psoriatic arthritis (PsA) alone or with methotrexate
• to treat active ankylosing spondylitis (AS)

You may continue to use other medicines that help treat your condition while taking SIMPONI (golimumab injection) , such as non-steroidal anti-inflammatory drugs (NSAIDs) and prescription steroids, as recommended by your doctor.

What should I tell my doctor before starting treatment with SIMPONI (golimumab injection) ?

SIMPONI (golimumab injection) may not be right for you. Before starting SIMPONI (golimumab injection) , tell your doctor about all your medical conditions, including if you:

• have an infection (see "What is the most important information I should know about SIMPONI (golimumab injection) ?").
• have or have had lymphoma or any other type of cancer.
• have or had heart failure.
• have or have had a condition that affects your nervous system, such as multiple sclerosis.
• have recently received or are scheduled to receive a vaccine. People taking SIMPONI (golimumab injection) should not receive live vaccines. People taking SIMPONI (golimumab injection) can receive non-live vaccines.
• are allergic to rubber or latex. The needle cover on the prefilled syringe and SmartJect autoinjector contains dry natural rubber.
• are pregnant or planning to become pregnant. It is not known if SIMPONI (golimumab injection) will harm your unborn baby.
• are breastfeeding. You and your doctor should decide if you will take SIMPONI (golimumab injection) or breastfeed. You should not do both without talking to your doctor first.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially, tell your doctor if you use:

• ORENCIA (abatacept), KINERET (anakinra), or RITUXAN (rituximab). You should not take SIMPONI (golimumab injection) while you are also taking ORENCIA or KINERET. Your doctor may not want to give you SIMPONI (golimumab injection) if you have received RITUXAN recently.
• Another TNF-blocker medicine. You should not take SIMPONI (golimumab injection) while you are also taking REMICADE (infliximab), HUMIRA (adalimumab), ENBREL (etanercept), or CIMZIA (certolizumab pegol).

Ask your doctor if you are not sure if your medicine is one listed above.

Keep a list of all your medications with you to show your doctor and pharmacist each time you get a new medicine.

How should I use SIMPONI (golimumab injection) ?

• SIMPONI (golimumab injection) is given as an injection under the skin (subcutaneous injection or SC).
• SIMPONI (golimumab injection) should be injected one time each month.
• If your doctor decides that you or a caregiver may be able to give your inj ections of SIMPONI (golimumab injection) at home, you should receive training on the right way to prepare and inject SIMPONI (golimumab injection) . Do not try to inject SIMPONI (golimumab injection) yourself until you have been shown the right way to give the injections by your doctor or nurse.
• Use SIMPONI (golimumab injection) exactly as prescribed by your doctor.
• SIMPONI (golimumab injection) comes in a prefilled syringe or SmartJect™ autoinjector. Your doctor will prescribe the type that is best for you.
• See the detailed Patient Instructions for Use at the end of this Medication Guide for instructions about the right way to prepare and give your SIMPONI (golimumab injection) injections at home.
• Do not miss any doses of SIMPONI (golimumab injection) . If you forget to use SIMPONI (golimumab injection) , inject your dose as soon as you remember. Then, take your next dose at your regular scheduled time. In case you are not sure when to inject SIMPONI (golimumab injection) , call your doctor or pharmacist.

What are the possible side effects with SIMPONI (golimumab injection) ?

SIMPONI (golimumab injection) can cause serious side effects, including:

See "What is the most important information I should know about SIMPONI (golimumab injection) ?"

Serious Infections

Hepatitis B infection in people who carry the virus in their blood.

• If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use SIMPONI (golimumab injection) . Your doctor may do blood tests before you start treatment with SIMPONI (golimumab injection) and while you are using SIMPONI (golimumab injection) . Tell your doctor if you have any of the following symptoms of a possible hepatitis B infection:

Heart failure, including new heart failure or worsening of heart failure that you already have. New or worse heart failure can happen in people who use TNF-blocker medicines like SIMPONI (golimumab injection) .

• If you have heart failure, your condition should be watched closely while you take SIMPONI (golimumab injection) .
• Call your doctor right away if you get new or worsening symptoms of heart failure while taking SIMPONI (golimumab injection) (such as shortness of breath or swelling of your lower legs or feet).

Nervous System Problems

Rarely, people using TNF-blocker medicines, including SIMPONI (golimumab injection) , have nervous system problems such as multiple sclerosis.

• Tell your doctor right away if you get any of these symptoms:
  • vision changes
  • weakness in your arms or legs
  • numbness or tingling in any part of your body

Liver Problems

Liver problems can happen in people who use TNF-blocker medicines, including SIMPONI (golimumab injection) . These problems can lead to liver failure and death. Call your doctor right away if you have any of these symptoms:

• feel very tired
• skin or eyes look yellow
• poor appetite or vomiting
• pain on the right side of your stomach (abdomen)

Blood Problems

Low blood counts have been seen with other TNF-blockers. Your body may not make enough blood cells that help fight infections or help stop bleeding. Symptoms include fever, bruising or bleeding easily, or looking pale. Your doctor will check your blood counts before and during treatment with SIMPONI (golimumab injection) .

Other side effects with SIMPONI (golimumab injection) include:

• Immune System Problems. Rarely, people using TNF-blocker medicines have developed symptoms that are like the symptoms of Lupus. Tell your doctor if you have any of these symptoms:
  • a rash on your cheeks or other parts of the body
  • sensitivity to the sun
  • new joint or muscle pains
  • becoming very tired
  • chest pain or shortness of breath
  • swelling of the feet, ankles, and/or legs
• Psoriasis. Some people using SIMPONI (golimumab injection) had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with SIMPONI (golimumab injection) .
• Allergic Reactions. Allergic reactions can happen in people who use TNF-blocker medicines. Call your doctor right away if you have any of these symptoms of an allergic reaction:
  • hives
  • swollen face
  • breathing trouble
  • chest pain

These are not all of the side effects with SIMPONI (golimumab injection) . Tell your doctor about any side effect that bothers you or does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How do I store SIMPONI (golimumab injection) ?

• Refrigerate SIMPONI (golimumab injection) at 36°F to 46°F (2°C to 8°C).
• Do not freeze SIMPONI (golimumab injection) .
• Keep SIMPONI (golimumab injection) in the carton to protect it from light when not being used.
• Do not shake SIMPONI (golimumab injection) .

Keep SIMPONI (golimumab injection) and all medicines out of the reach of children.

General Information about SIMPONI (golimumab injection)

• Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not use SIMPONI (golimumab injection) for a condition for which it was not prescribed.
• Do not give SIMPONI (golimumab injection) to other people, even if they have the same condition that you have. It may harm them.
• This Medication Guide summarizes the most important information about SIMPONI (golimumab injection) . If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about SIMPONI (golimumab injection) that is written for health professionals. For more information go to www.simponi (golimumab injection) .com or call 1-800-457-6399.

What are the ingredients in SIMPONI?

Active ingredient: golimumab.

Inactive ingredients: L-histidine, L-histidine monohydrochloride monohydrate, sorbitol, polysorbate 80, and water for injection. SIMPONI (golimumab injection) does not contain preservatives.

Patient Instructions for Use

SIMPONI^®
(SIM-po-nee)
(golimumab) SmartJect™ autoinjector

If your doctor decides that you or a caregiver may be able to give your injections of SIMPONI (golimumab injection) at home, you should receive training on the right way to prepare and inject SIMPONI (golimumab injection) . Do not try to inject SIMPONI (golimumab injection) yourself until you have been shown the right way to give the injections by your doctor or nurse.

It is important to read, understand, and follow these instructions so that you inject SIMPONI (golimumab injection) the right way. Call your doctor if you or your caregiver has any questions about the right way to inject SIMPONI (golimumab injection) .

Important information about your SmartJect autoinjector:

• When the button on the SmartJect autoinjector is pressed to give the dose of SIMPONI (golimumab injection) you will hear a loud 'click' sound. It is very important that you practice injecting SIMPONI (golimumab injection) with your doctor or nurse so that you are not startled by this click when you start giving the injections to yourself at home.
• If you pull the SmartJect autoinjector away from the skin before the injection is completed, you may not get your full dose of medicine and may lose some of the medicine.

Do not:

• shake the SmartJect autoinjector at any time
• remove the SmartJect autoinjector cap until you get to that step

Step 1: Gather and inspect the supplies for your injection

You will need these supplies for an injection of SIMPONI (golimumab injection) . See Figure 1.

• 1 alcohol swab
• 1 cotton ball or gauze
• 1 SIMPONI (golimumab injection) prefilled SmartJect autoinjector
• sharps container for autoinjector disposal

Figure 1

The figure below shows what the SmartJect autoinjector looks like. See Figure 2.

Figure 2

1.1 Check Expiration Date

• Check the expiration date ("EXP") on the SmartJect autoinjector.
• You can also check the expiration date printed on the carton.
• If the expiration date has passed, do not use the SmartJect autoinjector. Call your doctor or pharmacist, or call 1-800-457-6399 for help.

1.2 Check Security Seal

• Check the security seal around the cap of the SmartJect autoinjector. If the security seal is broken, do not use the SmartJect autoinjector.

1.3 Wait 30 minutes

• To ensure proper injection, allow the autoinjector to sit at room temperature outside the carton for 30 minutes and out of the reach of children.

Do not warm the SmartJect autoinjector in any other way (For example, do not warm it in a microwave or in hot water).

Do not remove the SmartJect autoinjector cap while allowing it to reach room temperature.

1.4 Check the Liquid in the SmartJect autoinjector

• Look through the viewing window of the SmartJect autoinjector. See Figure 3. Make sure that the liquid in the prefilled syringe is clear and colorless to slightly yellow in color. You may see a small amount of tiny particles that are white, or that you can see through. Do not inject the liquid if it is cloudy or discolored, or has large particles in it.

• You may also notice an air bubble. This is normal. See Figure 3.

Figure 3

Step 2: Choose and prepare the injection site

2.1 Choose the Injection Site

• The recommended injection site is the front of your middle thighs. See Figure 4.

Figure 4

• You can also use the lower part of the abdomen below the navel (belly button), except for the two-inch area directly around the navel. See Figure 5.

Figure 5

• If a caregiver is giving you the injection, the outer area of the upper arms may also be used. See Figure 5.
• Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks.

2.2 Prepare the Injection Site

• Wash your hands well with soap and warm water.
• Wipe the injection site with an alcohol swab.
• Do not touch this area again before giving the injection. Allow the skin to dry before injecting.
• Do not fan or blow on the clean area.

Step 3: Injecting SIMPONI (golimumab injection) using the single dose SmartJect autoinjector

3.1 Remove the Cap

• Do not remove the cap until you are ready to inject SIMPONI (golimumab injection) . Inject SIMPONI (golimumab injection) within 5 minutes after the cap has been removed.
• When you are ready to inject, twist the cap slightly to break the security seal. See Figure 6.

Figure 6

• Pull the cap off and throw it in the trash right away. See Figure 7.
• Do not put the cap back on because it may damage the needle inside the SmartJect autoinjector.
• Do not use your SmartJect autoinjector if it is dropped without the cap in place.

3.2 Push the SmartJect autoinjector against the skin

• Hold the SmartJect autoinjector comfortably in your hand.
• Do not press the button. Push the open end of the SmartJect autoinjector firmly against the skin at 90-degree angle. See Figure 8.

Figure 8

• Use your free hand to pinch and hold the skin at the injection site. This may make injecting easier.

3.3 Press button to inject

• Continue to hold the SmartJect autoinjector firmly against the skin, and press the button with your fingers (see Figure 9) or thumb (see Figure 10). You will not be able to push in the button unless the SmartJect autoinjector is pushed firmly against your skin.
• After the button is pressed, it will stay pressed in so you do not need to keep pressure on it. See Figure 11.

Figure 11

• You will hear a loud 'click' sound. This means that the injection has started. Do not pull the SmartJect autoinjector away from your skin. If you pull the SmartJect autoinjector away from the skin, you may not get your full dose of medicine. See Figure 12.

• Do not lift the SmartJect autoinjector yet.

3.4 Wait for Second "Click"

• Keep holding the SmartJect autoinjector against your skin until you hear the second 'click' sound. It usually takes about 3 to 6 seconds, but may take up to 15 seconds for you to hear the second 'click' sound. See Figure 13.
• The second 'click' sound means that the injection is finished and the needle has pulled back (retracted) into the SmartJect autoinjector.
• Lift the SmartJect autoinjector from the injection site. See Figure 14.
• If you have hearing problems, count for 15 seconds from the time you pressed the button and then lift the SmartJect autoinjector from the injection site.

Step 4: After the injection 4.1 Check the Viewing Window

• After you finish injecting, check the viewing window to see the yellow indicator. See Figure 15. This means the SmartJect autoinjector has worked the right way.

Figure 15

• If you do not see the yellow indicator in the viewing window, call 1-800-457-6399 for help.

4.2 Dispose of the used SmartJect autoinjector

• Place the used SmartJect autoinjector into a closable puncture-resistant container. You may use a sharps container (such as a red biohazard container), a hard plastic container (such as a detergent bottle), or a metal container (such as an empty coffee can). See Figure 16.
• Ask your doctor for instructions on the right way to throw away (dispose of) the container. There may be local or state laws about how you should throw away used needles and syringes.
• • Do not throw away your used SmartJect autoinjector in household trash. Do not recycle.

4.3 Use Cotton Ball or Gauze

• There may be a small amount of blood or liquid at the injection site, which is normal.
• You can press a cotton ball or gauze over the injection site for 10 seconds. Do not rub the injection site.
• You may cover the injection site with a small adhesive bandage, if needed.

Patient Instructions for Use

SIMPON®
Prefilled Syringe

If your doctor decides that you or a caregiver may be able to give your injections of SIMPONI (golimumab injection) at home, you should receive training on the right way to prepare and inject SIMPONI (golimumab injection) . Do not try to inject SIMPONI (golimumab injection) yourself until you have been shown the right way to give the injections by your doctor or nurse.

It is important to read, understand, and follow these instructions so that you inject SIMPONI (golimumab injection) the right way. Call your doctor if you or your caregiver has any questions about the right way to inject SIMPONI (golimumab injection) .

Important information about your prefilled syringe:

• Always hold the prefilled syringe by the body of the syringe.

Do not:

• pull back on the plunger at any time.
• shake the SIMPONI (golimumab injection) prefilled syringe. This may damage the medicine.
• remove the needle cover from the prefilled syringe until you get to that step.
• touch the needle guard activation clips to prevent covering the needle with the needle guard too soon (See Figure 2).
• use SIMPONI (golimumab injection) if it has been frozen or if it has been kept at a room temperature that is too warm. See the Medication Guide section: "How should I store SIMPONI (golimumab injection) ?"
• use your SIMPONI (golimumab injection) prefilled syringe if it looks damaged.

Step 1: Gather the supplies for your injection

You will need these supplies for an injection of SIMPONI (golimumab injection) . See Figure 1.

• 1 alcohol swab
• 1 cotton ball or gauze
• 1 SIMPONI (golimumab injection) prefilled syringe
• sharps container for syringe disposal

Figure 1

The diagram below shows what the prefilled syringe looks like. See Figure 2.

Figure 2

Step 2: Get ready to use your prefilled syringe

2.1 Check the Expiration Date

• Look for the expiration date printed on the back panel of the SIMPONI (golimumab injection) carton.
• If the expiration date has passed, do not use the prefilled syringe. Call your doctor or pharmacist or call 1-800-457-6399 for help.

2.2 Wait 30 minutes

• To ensure proper injection, allow the prefilled syringe to sit at room temperature outside of the carton for 30 minutes and out of the reach of children.
• Do not warm the prefilled syringe in any other way (For example, Do not warm it in a microwave or in hot water).
• Do not remove the prefilled syringe needle cover while allowing it to reach room temperature.

2.3 Check the Liquid in the Prefilled Syringe

• Hold your SIMPONI (golimumab injection) prefilled syringe by the body with the covered needle pointing down. See Figure 3.
• Look at the liquid through the viewing window of the prefilled syringe. Make sure that the liquid in the prefilled syringe is clear and colorless to slightly yellow in color. You may see a small amount of tiny particles that are white, or that you can see through. Do not inject the liquid if it is cloudy or discolored, or has large particles in it.
• You may also see an air bubble. This is normal.

Step 3: Choose and prepare the injection site

3.1 Choose the Injection Site

• The recommended injection site is the front of your middle thighs. See Figure 4.

Figure 4

• You can also use the lower part of the abdomen below the navel (belly button), except for the two-inch area directly around the navel. See Figure 5.
• If a caregiver is giving you the injection, the outer area of the upper arms may also be used. See Figure 5.

Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks.

3.2 Prepare the Injection Site

• Wash your hands well with soap and warm water.
• Wipe the injection site with an alcohol swab.
• Do not touch this area again before giving the injection. Let your skin dry before injecting.
• Do not fan or blow on the clean area.

Step 4: Inject SIMPONI (golimumab injection)

Do not remove the needle cover until you are ready to inject SIMPONI (golimumab injection) . Inject SIMPONI (golimumab injection) within 5 minutes after you remove the needle cover.

4.1 Remove the Needle Cover

• Do not touch the plunger while removing the needle cover.
• Hold the body of the prefilled syringe with one hand, and pull the needle cover straight off. See Figure 6.

Figure 6

• Put the needle cover in the trash.
• You may see an air bubble in the prefilled syringe. This is normal.
• You may also see a drop of liquid at the end of the needle. This is normal.
• Do not touch the needle or let it touch any surface.
• Do not use the prefilled syringe if it is dropped without the needle cover in place.

4.2 Position the prefilled syringe and inject SIMPONI (golimumab injection)

• Hold the body of the prefilled syringe in one hand between the thumb and index fingers. See Figure 7.

Figure 7

• Do not pull back on the plunger at any time.
• Use the other hand to gently pinch the area of skin that you previously cleaned. Hold firmly.
• Use a quick, dart-like motion to insert the needle into the pinched skin at about a 45-degree angle. See Figure 8 .

Figure 8

• Inject all of the medicine by using your thumb to push in the plunger until the plunger head is completely between the needle guard wings. See Figure 9.
• When the plunger is pushed as far as it will go, keep pressure on the plunger head. Take the needle out of the skin and let go of the skin.
• Slowly take your thumb off the plunger head. This will let the empty syringe move up until the entire needle is covered by the needle guard. See Figure 10.

Figure 10

Step 5: After the injection

5.1 Dispose of the used prefilled syringe

• Place the used prefilled syringe in a closable puncture-resistant container. You may use a sharps container (such as a red biohazard container), a hard plastic container (such as a detergent bottle), or a metal container (such as an empty coffee can). For the safety and health of you and others, needles and used syringes must never be re-used. See Figure 11.

Figure 11

• Ask your doctor for instructions on the right way to throw away (dispose of) the container. There may be local or state laws about how you should throw away used needles and syringes.

• Do not throw away your used prefilled syringe in household trash. Do not recycle.

5.2 Use Cotton Ball or Gauze

• There may be a small amount of blood or liquid at the injection site, which is normal.
• You can press a cotton ball or gauze over the injection site and hold for 10 seconds. Do not rub the injection site.
• You may cover the injection site with a small adhesive bandage, if needed.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 7/2010

Last reviewed on RxList: 9/13/2010
This monograph has been modified to include the generic and brand name in many instances.