SimponiOneSM Safe ReturnsTM

1. What is SimponiOneSM Safe ReturnsTM?

SimponiOneSM Safe ReturnsTM is a unique monthly service offered only to people being treated with SIMPONITM. SimponiOneSM Safe ReturnsTM allows you to dispose of your used SmartJectTM autoinjectors or used prefilled syringes properly, easily, and at no additional cost—right after you use them. No more worrying what to do with them or where they might end up—they’re out of the house and off your mind. Please refer to the Instructions for Use and contact your doctor with remaining questions regarding disposal of used SmartJectTM autoinjectors or used prefilled syringes.

Once you enroll, you will be sent your first SimponiOneSM Safe ReturnsTM pack. After taking your monthly dose of SIMPONITM, follow the instructions to properly pack and mail back your used SmartJectTM autoinjector or used prefilled syringe for disposal. You’ll receive a new Safe ReturnsTM pack regularly every month. Your monthly dose of SIMPONITM is provided to you separately by your pharmacist or specialty pharmacy.

SimponiOneSM Safe ReturnsTM is approved only for the disposal of the one used SmartJectTM autoinjector or one used prefilled syringe that was used to administer SIMPONITM.

2. Does it cost anything to participate in SimponiOneSM Safe ReturnsTM?

SimponiOneSM Safe ReturnsTM is offered at no additional cost to people being treated with SIMPONITM. Shipping and disposal costs are taken care of by Centocor Ortho Biotech Inc., the manufacturer of SIMPONITM.

3. What are the regulations regarding disposal of used SmartJectTM autoinjectors or used prefilled syringes?

Used SmartJectTM autoinjectors and used prefilled syringes are often called "sharps."* Technically, they are classified as Regulated Medical Waste or biohazard waste, and they need to be disposed of according to government guidelines and U.S. postal service regulations for safe handling when returning.

Regulated Medical Waste should only be disposed of in containers specifically designed and approved by the U.S. postal service. These are usually called "sharps containers." Once filled, the sharps container is placed in a plastic bag which is then sealed and placed in a specially designed and labeled postage-paid mail-back box with liner. This mail-back box is sent to what’s called a "permitted medical waste treatment facility," where it is destroyed.

If you are not a SIMPONITM patient or enrolled in SimponiOneSM Safe ReturnsTM but you want to find out how to dispose of Regulated Medical Waste, consult your local government guidelines for the best resources in your local area.

*A "sharp" is any object that is contaminated or that may become contaminated through handling or during transportation and is also capable of cutting or penetrating skin or a packing material (eg, a used SmartJectTM autoinjector or used prefilled syringe fits into this category.)

4. How do I use the SimponiOneSM Safe ReturnsTM pack?

Open the end of the outer shipping box marked "Open Here." Inside you’ll find the following items:

  1. Safe ReturnsTM Instruction Guide
  2. Postage-paid mail-back box with liner
  3. Container tube
  4. Plastic bag
  5. Shipping documents
  6. Medication Guide with Full Prescribing Information

Read and follow the simple instructions in the Safe ReturnsTM Instruction Guide.

Remove the container tube from the plastic bag.

Place one used SmartJectTM autoinjector or one used prefilled syringe, with the injection end facing away from you, in the container tube, and then close the tube by twisting the cap to seal it securely.

Put the closed container tube back into the plastic bag, press the bag shut, and place it in the postage-paid mail-back box.

Seal the mail-back box by exposing the self-adhesive strip on the inside front flap and then press firmly to seal the adhesive. Remove the shipping documents from the plastic pouch on the outside of the mail-back box. Don’t damage the pouch—the completed forms must be reinserted. Confirm the information in Section 1 and make changes if needed. Sign where it says Generator Certificate. Remove the last copy and keep it for your records. (NJ residents keep the first copy only.) Then put the three remaining copies back into the pouch and close it.

Your package can be mailed from a U.S. mailbox, a post office, or anywhere the U.S. postal service arranges pickup. You may also give it to your mail carrier for pickup so it can be delivered to the destruction facility.

5. Where does the mail-back box go when I ship it?

Your mail-back box goes to a permitted medical waste treatment facility, which is owned and operated by Stericycle (the leading national medical waste management provider) for destruction.

6. Can I put any other syringes in the disposal container?

As outlined in the Safe ReturnsTM Instruction Guide included in your Safe ReturnsTM pack, DO NOT put anything in the container tube other than one used SmartJectTM autoinjector or one used prefilled syringe.

7. Can I receive confirmation that the last shipment was properly disposed?

Centocor Ortho Biotech Inc., the manufacturer of SIMPONITM, does not have access to the final reporting and tracking of disposal and is not liable for anything shipped via Safe ReturnsTM, but you can rest assure that SimponiOneSM Safe ReturnsTM disposes of all waste in accordance with all local, state, and federal guidelines and regulations.

8. Why is it required that I sign the shipping documents?

Your signature on the shipping documents is a mandatory step in the SimponiOneSM Safe ReturnsTM process, required by U.S. postal service regulations for proper disposal.

9. Where can I return the package to be mailed back?

Your package can be mailed from a U.S. mailbox, a post office, or anywhere the U.S. postal service arranges pickup. You may also give it to your mail carrier for pickup.

10. Is my SIMPONITM medicine shipped with SimponiOneSM Safe ReturnsTM?

No. Your monthly dose of SIMPONITM is provided separately by your pharmacist or specialty pharmacy. If you have any questions, contact your doctor or pharmacist.

11. Are shipping documents required for the shipment of Regulated Medical Waste?

Yes. Shipping documents, often called the "manifest," must accompany all shipments of Regulated Medical Waste. For people taking SIMPONITM, the shipping documents have been customized and are included in each shipment of the Safe ReturnsTM pack.

 

 

 
 
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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, including 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, including SIMPONI®, 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, including SIMPONI®. 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, skin reaction at site of injection, high blood pressure, flu, and cold sores.

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.