Simponi contains the active ingredient golimumab, which is a human IgG1κ monoclonal antibody targeting tumor necrosis factor alpha (TNFα). It is available as a preservative-free injection, provided in single-dose prefilled syringes and autoinjectors, with strengths of 50 mg in 0.5 mL and 100 mg in 1 mL. Key inactive ingredients include L-histidine, polysorbate 80, and sorbitol. This formulation is intended for subcutaneous administration.

How should I use this medication?

This medication is injected into a vein or under the skin. It is usually given by your care team in a hospital or clinic setting. It may also be given at home.

If you get this medication at home, you will be taught how to prepare and give it. Use exactly as directed. Take it as directed on the prescription label at the same time every day. Keep taking it unless your care team tells you to stop.

It is important that you put your used injectors, needles, and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. If you get this medication in a hospital or clinic setting, a special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you get this medication at the hospital or clinic: It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

If you give yourself this medication at home: If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Call your care team with questions.

Where should I keep my medication?

Infusions will be given in a hospital or clinic. They will not be stored at home.

Storage for syringes or injectors given under the skin and stored at home:

Keep out of the reach of children and pets.

Refrigeration (preferred): Store in the refrigerator. Do not freeze. Do not shake. Keep this medication in the original container. Protect from light. Get rid of any unused medication after the expiration date.

Room Temperature: This medication may be stored at room temperature between 20 and 25 degrees C (68 and 77 degrees F) for up to 30 days. Do not put the medication back in the refrigerator after it reaches room temperature. Keep this medication in the original container. Protect from light. Do not freeze. Do not shake. If it is stored at room temperature, get rid any unused medication after 30 days or after it expires, whichever comes first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Aplastic anemia—unusual weakness or fatigue, dizziness, headache, trouble breathing, increased bleeding or bruising
• Body pain, tingling, or numbness
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Lupus-like syndrome—joint pain, swelling, or stiffness, butterfly-shaped rash on the face, rashes that get worse in the sun, fever, unusual weakness or fatigue
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Dizziness
• Fever
• Increase in blood pressure
• Runny or stuffy nose
• Sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Cancer
• Diabetes
• Guillain-Barre syndrome
• Heart failure
• Hepatitis B or history of hepatitis B infection
• Immune system problems
• Infection or history of infections
• Low blood counts, such as low white cell, platelet, or red cell counts
• Multiple sclerosis
• Psoriasis
• Recently received or scheduled to receive a vaccine
• Tuberculosis, a positive skin test for tuberculosis, or recent close contact with someone who has tuberculosis
• An unusual or allergic reaction to golimumab, other medications, latex, rubber, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Abatacept
• Adalimumab
• Anakinra
• Certolizumab
• Etanercept
• Infliximab
• Live virus vaccines
• Rilonacept
• Rituximab
• Tocilizumab

This medication may also interact with the following:

• Cyclosporine
• Theophylline
• Vaccines
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You will be tested for tuberculosis (TB) before you start this medication. If your care team prescribes any medication for TB, you should start taking the TB medication before starting this medication. Make sure to finish the full course of TB medication.

This medication may increase your risk of getting an infection. Call you care team if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancers if you take this medication.

What are the most serious risks of this medication?

Taking this medicine can increase the risk of getting cancer.

This medicine can lower your body’s ability to fight infections. You may get more infections while taking this medicine. Any infection you get could become serious and even deadly.