Proper Use

Drug information provided by: Micromedex

A nurse or other trained health professional will give you Simponi® Aria™ (together with methotrexate) in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 30 minutes.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Simponi® is given as a shot under your skin. It may sometimes be given at home to patients who do not need to be in a hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

If you use Simponi® at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.

Simponi® is available in 2 forms. You may use a prefilled syringe or a prefilled SmartJect® autoinjector.

The needle covers of the prefilled syringe and SmartJect® autoinjector contain dry natural rubber (a derivative of latex). This may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.

To use Simponi® injection:

  • First, gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.
  • Wash your hands with soap and water before and after using this medicine.
  • Remove the carton with the syringe or autoinjector from the refrigerator and place it on the clean cloth.
  • Allow 30 minutes for the syringe to warm up to room temperature. Do not warm this medicine in any other way.
  • Do not remove the needle cover on the prefilled syringe or the autoinjector cap while allowing the medicine to reach room temperature. Remove these immediately before use.
  • Check the liquid in the syringe or autoinjector using the viewing window. It should be clear and colorless or slightly yellow in color. The liquid may have small white particles or an air bubble. If it is cloudy, discolored, or contains large particles, do not use the syringe or autoinjector. Call your doctor, pharmacist, or the company for help (1-800-526-7736).
  • If the liquid is clear, place it on the clean, flat surface. Do not shake the medicine.
  • Choose an injection site on your body (eg, middle thigh, lower abdomen or stomach area, or upper arm). Clean the injection site with a fresh alcohol wipe, and let it dry.
  • Remove the cap or needle cover when you are ready to inject. Inject the medicine within 5 minutes after the cap or cover has been removed.
  • For the SmartJect® autoinjector:
    • Hold the autoinjector in your hand.
    • Push the open end of the autoinjector firmly against your skin at a 90-degree angle.
    • Use your free hand to pinch and hold the skin at the injection site.
    • Press the button with your fingers or thumb to inject the medicine.
    • Do not pull the autoinjector away from the skin until you hear 2 loud "click" sounds. It usually takes up to 15 seconds for you to hear the second "click" sound. This means that the injection is finished and the needle has pulled back into the autoinjector.
    • Lift the autoinjector from the injector site. Check the viewing window on the autoinjector for a yellow indicator. The yellow indicator means the autoinjector worked properly.
  • For the prefilled syringe:
    • Hold the syringe with one hand between the thumb and index fingers.
    • Use your free hand to pinch and hold the skin at the injection site.
    • Inject the medicine in a dart-like motion into the pinched skin at a 45-degree angle.
    • Use your thumb to push the plunger and inject the full dose of the medicine. Pull the needle out of the skin.
  • You might have a small amount of blood or liquid at the injection site. Press and hold a dry, clean cotton ball on the injection site for 10 seconds, but do not rub it.
  • Throw away used syringes or autoinjectors in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage form (prefilled syringe or autoinjector):
    • For rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis:
      • Adults—50 milligrams (mg) injected under the skin once a month.
      • Children—Use and dose must be determined by your doctor.
    • For ulcerative colitis:
      • Adults—At first, 200 milligrams (mg) injected under the skin. A second dose of 100 mg is given 2 weeks later. The long-term dose is 100 mg every 4 weeks.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Protect Simponi® from direct light. Keep the medicine in the original package until you are ready to use it.