About SIMPONI™

SIMPONI™ is the first monthly self-injectable anti–TNF-alpha therapy approved to treat adults with:

  • Moderate to severe rheumatoid arthritis (RA) with the medicine methotrexate

  • Active psoriatic arthritis (PsA) alone or with the medicine methotrexate

  • Active ankylosing spondylitis (AS)

  • Once you and your doctor are comfortable with the self-injection process, you will inject SIMPONI™ once a month under the skin.

Just one dose of SIMPONI™, monthly, works to relieve:

  • Pain, stiffness, and swelling of RA and PsA
  • Pain and stiffness of AS
  • Results may not be the same for everyone.

Once you and your doctor are comfortable with the self-injection process, you will inject SIMPONI™ once a month under the skin. This means that there are only 12 self-injections of SIMPONI™ a year to effectively control your signs and symptoms of RA, PsA, and AS. Each 50 mg dose contains a low volume of medicine (0.5 mL). And the amount of time devoted to administering the SIMPONI™ medication will be just a few minutes every month.

Key Points About SIMPONI™

  • For some people, SIMPONI™ can start to relieve the signs and symptoms of RA, PsA, and AS in as little as four weeks from the start of therapy. Results may not be the same for everyone

  • SIMPONI™ offers the simplicity of monthly dosing
  • Only need to administer 12 self-injections of SIMPONI™ a year to effectively control signs and symptoms of RA, PsA, and AS
  • Time devoted to taking your SIMPONI™ medication will be just a few minutes once a month
  • Only a small amount of medicine is required (0.5 mL) to deliver the 50-mg dose

  • SIMPONI™ has been extensively studied in clinical trials with more than 2200 people with RA, PsA, and AS

  • With SimponiOneSM Support, you can get the tools and support that can help you succeed in managing your condition. For example:
  • SimponiOneSM Cost Support provides assistance with out-of-pocket expenses for those with private insurance and who meet the program eligibility requirements
  • Cost support for uninsured or underinsured people with financial need; SimponiOneSM can refer you to a patient assistance program (www.access2wellness.com) or help you identify other sources of funding to help pay for your medication

SIMPONI™ is not for everyone; only your doctor can decide if SIMPONI™ is right for you. SIMPONI™, like other medicines that affect your immune system, is a strong medicine that can cause serious side effects. Please read the Important Safety Information below and the Medication Guide for SIMPONI™ and discuss any questions or symptoms with your doctor. Two Ways to Take SIMPONI™

SIMPONI™ gives you a choice about how you want to take your medication. You can choose the single dose SmartJect™ autoinjector or the single dose prefilled syringe. Both allow you to give yourself injections at home after training and approval by a healthcare professional. Once your doctor decides SIMPONI™ is right for you, and once you and your doctor are comfortable with the self-injection process, you have the choice of 2 injection options. Either way, you don’t have to travel to your doctor’s office to receive treatment. So the amount of time you need to devote to your therapy with SIMPONI™ is reduced to just a few minutes a month.

Remember, you can always call your doctor with questions about your treatment.

Please read the Medication Guide and Instructions for Use and discuss any questions you may have with your doctor.

The SmartJect™ Autoinjector

The SmartJect™ autoinjector lets you (or your caregiver) inject quickly. And SmartJect™ is designed so you don't ever have to see the needle. It has an activation button on the side, so it takes just a simple squeeze of the palm to inject. The easy-to-grip, oval-shaped body fits comfortably in your hand. And it has a safety sleeve to make sure you inject your medicine only when the safety sleeve is firmly pressed against your skin.Video textVideo text

Video text

Video text
The Prefilled Syringe.

For those who prefer to use a prefilled syringe, SIMPONI™ gives you that choice too. As with the SmartJect™ autoinjector, the first time you use it should be in your doctor's office with the help of your doctor or nurse. It too provides the convenience of injecting on your own, in your own home, once a month. Once you and your doctor are comfortable with the self-injection process, you will inject SIMPONI™ once a month under the skin. Once-monthly dosing. Two choices of self-injecting. SIMPONI™ provides a convenient way to treat.

 

About SIMPONI™

SIMPONI™ is the first monthly self-injectable anti–TNF-alpha therapy approved to treat adults with:

  • Moderate to severe rheumatoid arthritis (RA) with the medicine methotrexate
  • Active psoriatic arthritis (PsA) alone or with the medicine methotrexate
  • Active ankylosing spondylitis (AS)
  • Once you and your doctor are comfortable with the self-injection process, you will inject SIMPONI™ once a month under the skin.

Just one dose of SIMPONI™, monthly, works to relieve:

  • Pain, stiffness, and swelling of RA and PsA
  • Pain and stiffness of AS
  • Results may not be the same for everyone.

Once you and your doctor are comfortable with the self-injection process, you will inject SIMPONI™ once a month under the skin. This means that there are only 12 self-injections of SIMPONI™ a year to effectively control your signs and symptoms of RA, PsA, and AS. Each 50 mg dose contains a low volume of medicine (0.5 mL). And the amount of time devoted to administering the SIMPONI™ medication will be just a few minutes every month.

Key Points About SIMPONI™

  • For some people, SIMPONI™ can start to relieve the signs and symptoms of RA, PsA, and AS in as little as four weeks from the start of therapy. Results may not be the same for everyone
  • SIMPONI™ offers the simplicity of monthly dosing
  • Only need to administer 12 self-injections of SIMPONI™ a year to effectively control signs and symptoms of RA, PsA, and AS
  • Time devoted to taking your SIMPONI™ medication will be just a few minutes once a month
  • Only a small amount of medicine is required (0.5 mL) to deliver the 50-mg dose
  • SIMPONI™ has been extensively studied in clinical trials with more than 2200 people with RA, PsA, and AS
  • With SimponiOneSM Support, you can get the tools and support that can help you succeed in managing your condition. For example:
  • SimponiOneSM Cost Support provides assistance with out-of-pocket expenses for those with private insurance and who meet the program eligibility requirements
  • Cost support for uninsured or underinsured people with financial need; SimponiOneSM can refer you to a patient assistance program (www.access2wellness.com) or help you identify other sources of funding to help pay for your medication

SIMPONI™ is not for everyone; only your doctor can decide if SIMPONI™ is right for you. SIMPONI™, like other medicines that affect your immune system, is a strong medicine that can cause serious side effects. Please read the Important Safety Information below and the Medication Guide for SIMPONI™ and discuss any questions or symptoms with your doctor.

Guide to SIMPONI™

Learn more about the benefits of SIMPONI™ for the treatment of moderate to severe rheumatoid arthritis (RA); active psoriatic arthritis (PsA); and active anky losing spondylitis(AS)

Click here to download the PDF*

 

* Requires Adobe® Reader®. Click here to download.

Two Ways to Take SIMPONI™

SIMPONI™ gives you a choice about how you want to take your medication. You can choose the single dose SmartJect™ autoinjector or the single dose prefilled syringe. Both allow you to give yourself injections at home after training and approval by a healthcare professional. Once your doctor decides SIMPONI™ is right for you, and once you and your doctor are comfortable with the self-injection process, you have the choice of 2 injection options. Either way, you don’t have to travel to your doctor’s office to receive treatment. So the amount of time you need to devote to your therapy with SIMPONI™ is reduced to just a few minutes a month.

Remember, you can always call your doctor with questions about your treatment.

Please read the Medication Guide and Instructions for Use and discuss any questions you may have with your doctor.

The SmartJect™ Autoinjector

The SmartJect™ autoinjector lets you (or your caregiver) inject quickly. And SmartJect™ is designed so you don't ever have to see the needle. It has an activation button on the side, so it takes just a simple squeeze of the palm to inject. The easy-to-grip, oval-shaped body fits comfortably in your hand. And it has a safety sleeve to make sure you inject your medicine only when the safety sleeve is firmly pressed against your skin.

The SmartJect™ Autoinjector

SmartJect™ Autoinjector Guides

Single-use Trainer for SmartJect™ Autoinjector

Use the trainer instructions to help you practice with your trainer before injecting with your SmartJect™ autoinjector with your SIMPONI™ medication.

Click here to download the PDF*

Reusable Trainer for SmartJect™ Autoinjector

Use these trainer instructions to help you practice with your reusable trainer before injecting with your SmartJect™ autoinjector with your SIMPONI™ medication.

Click here to download the PDF*

Single dose SmartJect™ Autoinjector

Use this guide for reviewing the steps for injecting your SIMPONI™ medicine using the SmartJect™ autoinjector. Remember, this guide is not intended to replace the Instructions for Use that come with your SIMPONI™ medication. Please thoroughly review those instructions prior to injecting your SIMPONI™ medication.

Click here to download the PDF*

 

* Requires Adobe® Reader®. Click here to download.

Watch the video to review the steps for injecting your SIMPONI™ MEDICINE medicine using the easy-to-use SmartJect™ autoinjector. Remember, this guide is not intended to replace the Instructions for Use that come with your SIMPONI™ medication. Please thoroughly review those instructions prior to injecting your SIMPONI™ medication.

 

Please read the Important Safety Information for SIMPONI™ and the Medication Guide below and discuss any questions you have with your doctor.

The Prefilled Syringe.

For those who prefer to use a prefilled syringe, SIMPONI™ gives you that choice too. As with the SmartJect™ autoinjector, the first time you use it should be in your doctor's office with the help of your doctor or nurse. It too provides the convenience of injecting on your own, in your own home, once a month. Once you and your doctor are comfortable with the self-injection process, you will inject SIMPONI™ once a month under the skin.

SIMPONI™ Prefilled Syringe

Use this guide for reviewing the steps for injecting your SIMPONI™ medication using the prefilled syringe. Remember, this guide is not intended to replace the Instructions for Use that come with your SIMPONI™ medication. Please thoroughly review those instructions prior to injecting your SIMPONI™ medication.

Click here to download the PDF*

 

* Requires Adobe® Reader®. Click here to download.

Once-monthly dosing. Two choices of self-injecting. SIMPONI™ provides a convenient way to treat.

 
 

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The SmartJect™ Autoinjector

Designed with the SIMPONI™ patient in mind

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IMPORTANT SAFETY INFORMATION

SIMPONI™ (golimumab) is a prescription medicine. SIMPONI™ can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI™ and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.

You should not start SIMPONI™ if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:

  • fever, sweat, or chills
  • muscle aches
  • cough
  • shortness of breath
  • blood in phlegm
  • weight loss
  • warm, red, or painful skin
    or sores on your body
  • diarrhea or stomach pain
  • burning when you urinate
    or urinate more than normal
  • feel very tired

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults taking TNF blockers, including SIMPONI™, the chances for getting lymphoma or other cancers may increase. You should tell your doctor if you have had or develop lymphoma or other cancers.

Tell your doctor about all the medications you take including ORENCIA (abatacept), KINERET (anakinra), RITUXAN (rituximab) or another TNF blocker, or if you are scheduled to or recently received a vaccine. People taking SIMPONI™ should not receive live vaccines.

Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF-blocker medicines, such as SIMPONI™. Some of these cases have been fatal. Your doctor may do blood tests before and after you start treatment with SIMPONI™. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as:

  • feel very tired
  • skin or eyes look yellow
  • little or no appetite
  • vomiting
  • muscle aches
  • dark urine
  • clay-colored bowel movements
  • fevers
  • chills
  • stomach discomfort
  • skin rash

Heart failure can occur or get worse in people who use TNF blockers like SIMPONI™. Your doctor will closely monitor you if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath or swelling of your lower legs or feet.

Rarely, people using TNF blockers can have nervous system problems such as multiple sclerosis. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.

Liver problems can happen in people using TNF blockers. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.

Low blood counts have been seen with people using TNF blockers. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.

Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, swelling of the feet, ankles, and/or legs.

New or worse psoriasis symptoms may occur. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus.

Tell your doctor if you are allergic to rubber or latex. The needle cover contains dry natural rubber.

Tell your doctor if you have any symptoms of an allergic reaction while taking SIMPONI™ such as hives, swollen face, breathing trouble, chest pain.

Common side effects of SIMPONI™ include: upper respiratory tract infection, nausea, abnormal liver tests, redness at site of injection, high blood pressure, bronchitis, dizziness, sinus infection, flu, runny nose, fever, cold sores, numbness, or tingling.

Please read the Medication Guide for SIMPONI™ and discuss any questions you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.