"Nov. 9, 2010 (Atlanta) -- People who take drugs called TNF blockers for rheumatoid arthritis may potentially reduce their odds of developing Alzheimer's disease, preliminary research suggests.
The use of TNF blockers was associated with"...
Read the Medication Guide that comes with SIMPONI 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.
What is the most important information I should know about SIMPONI?
SIMPONI is a medicine that affects your immune system. SIMPONI can lower the ability of your immune system to fight infections. Some people have serious infections while taking SIMPONI, 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 and hepatitis B before starting SIMPONI.
- Your doctor should monitor you closely for signs and symptoms of TB during treatment with SIMPONI.
You should not start taking SIMPONI if you have any kind of infection unless your doctor says it is okay.
Before starting SIMPONI, 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
- 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. 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), ACTEMRA (tocilizumab) or RITUXAN (rituximab)
After starting SIMPONI, call your doctor right away if you have any symptoms of an infection. SIMPONI can make you more likely to get infections or make worse any infection that you have.
- For children and adults taking TNF-blocker medicines, including SIMPONI, the chances of getting cancer may increase.
- There have been cases of unusual cancers in children and teenage patients taking TNF-blocking agents.
- 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.
- Some people treated with SIMPONI have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with SIMPONI, tell your doctor.
- Some people receiving medicines that are like SIMPONI, called TNF-blockers, developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn's disease or ulcerative colitis with a TNF-blocker and another medicine called IMURAN® (azathioprine) or PURINETHOL® (6-mercaptopurine, 6-MP).
What is SIMPONI?
SIMPONI is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker. SIMPONI 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)
- with moderate to severe active ulcerative colitis (UC) when certain other UC medicines have not worked well enough OR cannot be tolerated, OR if it is necessary to continue taking steroid medicines:
You may continue to use other medicines that help treat your condition while taking SIMPONI, 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?
SIMPONI may not be right for you. Before starting SIMPONI, 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?”).
- 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 or Guillain-Barré syndrome.
- have recently received or are scheduled to receive a vaccine. People taking SIMPONI should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer). People taking SIMPONI can receive non-live vaccines.
- have a baby and you were using SIMPONI during your pregnancy. Tell your baby's doctor before your baby receives any vaccine. Your baby may have an increased chance of getting an infection for up to 6 months after birth.
- 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 will harm your unborn baby.
- are breastfeeding. You and your doctor should decide if you will take SIMPONI 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 nonprescription medicines, vitamins, and herbal supplements. Especially, tell your doctor if you:
- use ORENCIA (abatacept) or KINERET (anakinra). You should not take SIMPONI while you are also taking ORENCIA (abatacept) or KINERET (anakinra).
- use other TNF-blocker medicines, including REMICADE (infliximab), HUMIRA (adalimumab), ENBREL (etanercept), or CIMZIA (certolizumab pegol).
- receive RITUXAN (rituximab) or ACTEMRA (tocilizumab).
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?
- SIMPONI is given as an injection under the skin (subcutaneous injection).
- If your doctor decides that you or a caregiver may be able to give your injections of SIMPONI at home, you should receive training on the right way to prepare and inject SIMPONI. Do not try to inject SIMPONI yourself until you have been shown the right way to give the injections by your doctor or nurse.
- Use SIMPONI exactly as prescribed by your doctor. Your doctor will tell you how much SIMPONI to inject and when to inject it depending on your medical condition.
- SIMPONI comes in a prefilled syringe or SmartJect autoinjector. Your doctor will prescribe the type that is best for you.
- See the detailed Instructions for Use that comes with your SIMPONI for information about the right way to prepare and give your SIMPONI injections at home.
- Do not miss any doses of SIMPONI. If you forget to use SIMPONI, 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, call your doctor or pharmacist.
What are the possible side effects with SIMPONI?
SIMPONI can cause serious side effects, including: See “What is the most important information I should know about SIMPONI?”
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.
Your doctor should do blood tests before you start treatment with SIMPONI and
while you are using SIMPONI. Tell your doctor if you have any of the following
symptoms of a possible hepatitis B infection:
- feel very tired
- clay-colored bowel movements
- dark urine
- skin or eyes look yellow
- little or no appetite
- stomach discomfort
- skin rash
- muscle aches
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 including SIMPONI.
- If you have heart failure, your condition should be watched closely while you take SIMPONI.
- Call your doctor right away if you get new or worsening symptoms of heart failure while taking SIMPONI (such as shortness of breath or swelling of your lower legs or feet).
Nervous System Problems
Rarely, people using TNF-blocker medicines, including SIMPONI, have nervous system problems such as multiple sclerosis or Guillain-Barré syndrome.
- Tell your doctor right away if you get any of these
- vision changes
- weakness in your arms or legs
- numbness or tingling in any part of your body
Liver problems can happen in people who use TNF-blocker medicines, including SIMPONI. 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)
Low blood counts have been seen with TNF-blockers, including SIMPONI. 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.
Common side effects with SIMPONI include:
- upper respiratory infection (runny nose, sore throat, and hoarseness or laryngitis)
- reaction at the site of injection (redness, swelling, itching, pain, bruising, or tingling)
- viral infections such as flu and oral cold sores
Other side effects with SIMPONI 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, or legs
- Psoriasis. Some people using SIMPONI 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.
- Allergic Reactions. Allergic reactions can happen
in people who use TNF-blocker medicines including SIMPONI. Some reactions may
be serious and can be life-threatening. Some of these reactions can happen
after receiving your first dose of SIMPONI. Call your doctor right away if you
have any of these symptoms of an allergic reaction:
- swollen face
- breathing trouble
- chest pain
These are not all of the side effects with SIMPONI. 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 should I store SIMPONI?
- Refrigerate SIMPONI at 36°F to 46°F (2°C to 8°C).
- Do not freeze SIMPONI.
- Keep SIMPONI in the carton to protect it from light when not being used.
- Do not shake SIMPONI.
Keep SIMPONI and all medicines out of the reach of children.
General Information about SIMPONI
- Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not use SIMPONI for a condition for which it was not prescribed.
- Do not give SIMPONI 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. If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about SIMPONI that is written for health professionals. For more information go to www.simponi.com or call 1-800-JANSSEN (1-800-5267736).
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 does not contain preservatives.
Instructions for Use
(golimumab) SmartJect® autoinjector
If your doctor decides that you or a caregiver may be able to give your SIMPONI injections at home, you should receive training on the right way to prepare and inject SIMPONI using SmartJect.
Do not try to inject SIMPONI yourself until you have been shown the right way to give the injections by your doctor or nurse.
Please read this Instructions for Use before using SIMPONI SmartJect and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.
Store in refrigerator at 36° to 46°F (2° to 8°C).
Keep SIMPONI SmartJect and all medicines out of reach of children.
Do not shake SmartJect at any time.
Call your doctor to talk about any questions you may have. For additional assistance or to share your feedback call 800-JANSSEN (800-526-7736).
Your SmartJect at-a-glance
Prepare for your injection
Take out Smart Ject
Take Smart Ject out of the refrigerator and remove it from the carton. Place on a flat surface out of reach of children.
Smart Ject should sit at room temperature for 30 minutes to ensure proper injection.
Do not warm any other way.
Do not remove the cap yet.
Inspect Smart Ject
Check the expiration date ('EXP') on the back of SmartJect.
Do not use SIMPONI SmartJect if the expiration date has passed-. Call your doctor or pharmacist for a refill.
Check the security seal on the cap.
Do not inject if the seal is broken.
While SmartJect sits at room temperature for 30 minutes, gather your supplies:
- 1 Alcohol swab
- 1 Cotton ball -or gauze pad
- 1 Sharps container
(See Step 3).
Check liquid in the SmartJect
After 30 minutes, check the liquid in the viewing window. It should be clear to slightly yellow and may contain tiny white or clear particles.
It is also normal to see a small air bubble.
Do not inject if the liquid is cloudy or discolored, or has large particles.
Choose injection site
Select from the following areas for your injection:
- Front of thighs (recommended)
- Lower abdomen (do not use the 2-inch area around your navel (belly-button))
- Back of upper arms (if a caregiver is giving you the injection)
Choose a different site within your preferred area for each injection.
Do not inject into skin that is tender, bruised, red, scaly or hard.
Clean injection site
Wash your hands well with soap and warm water.
Wipe your chosen injection site with an alcohol swab and allow it to dry.
Do not touch or blow on the injection site after you have cleaned it.
Inject SIMPONI using SmartJect
Twist the cap to break the security seal, then pull it straight off. Dispose of the cap right away.
It is important to inject within 5 minutes of removing the cap.
Do not put the cap back on, this may damage the hidden needle.
Do not inject if SmartJect is dropped without the cap on.
Hold SmartJect comfortably and position it straight onto your skin, as shown.
Make sure the green safety sleeve is flat against your skin and that your injection site is as flat as possible.
Do not touch or press the button while positioning the SmartJect onto your skin.
Push SmartJect firmly against your skin so the green safety sleeve slides into the clear cover.
Do not touch or press the button while pushing SmartJect against your skin.
The green safety sleeve helps prevent accidental injections.
You will not be able to press the button to start your injection until SmartJect is pushed firmly enough against your skin for the green safety sleeve to slide into the clear cover.
Press button and wait
Keep holding SmartJect firmly against your skin. Use your other hand to press the raised part of the button to start your injection.
You will hear a loud 1st 'click’ as you press the button. This is normal, the medication is just beginning to be delivered. You may or may not feel a needle prick.
Do not lift SmartJect up yet! This may result in loss of medication.
After 1 press of the button you do not need to keep pressure on the button.
Wait for the 2nd ‘click’ which means your injection is complete.
Listen for 2nd ‘click’
Keep holding SmartJect firmly against your skin until you hear the 2nd ‘click’ (3-15 seconds).
The 2nd 'click' means the injection is complete and you can lift SmartJect from your skin.
If you have trouble hearing the 'clicks,' count to 15 after pressing the button, then lift the SmartJect off your skin.
Check the viewing window
After lifting SmartJect from your skin, look for the yellow indicator in the viewing window to confirm SmartJect worked properly. The yellow indicator will fill about half of the viewing window.
If you do not see the yellow indicator, call 800-JANSSEN (800-526-7736).
Do not administer a second dose without speaking to your doctor.
After Your Injection
Dispose of your SmartJect
Put your used SmartJect in an FDA-cleared sharps disposal container right away after use.
Do not throw away (dispose of) loose needles and syringes in your household trash.
Do not recycle your used sharps disposal container.
For more information, see “Helpful tips”.
Check injection site
There may be a small amount of blood or liquid at the injection site.
Hold pressure over your skin with a cotton ball or gauze pad until any bleeding stops.
Do not rub the injection site.
If needed, cover injection site with a bandage. Your injection is now complete!
If you are having difficulty injecting:
- Make sure the cap is removed.
- Make sure SmartJect is pushed firmly against your skin.
- Make sure you are pressing the raised part of button.
- Try pressing the button a little harder.
- Try a different injection site.
If you are pinching the skin to inject:
Use 1 hand to both position SmartJect against the skin and press the button
Additional disposal information:
If you do not have a FDAcleared-sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
- upright and stable during use
- properly labeled to warn of hazardous waste inside the container
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
There may be state or local laws about how you should throw away used needles and syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: www.fda.gov/safesharpsdisp osal.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 7/13/2015
This monograph has been modified to include the generic and brand name in many instances.
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