Golimumab

Golimumab

(goe LIM ue mab)

U.S. Brand Names

Simponi™

Pharmacologic Category

Antipsoriatic Agent; Antirheumatic, Disease Modifying; Monoclonal Antibody; Tumor Necrosis Factor (TNF) Blocking Agent

What key warnings should I know about before taking this medicine?

Tuberculosis has been seen in patients started on this medicine. These patients were exposed to tuberculosis in the past, but never actually developed the infection. You should be tested to see if you have been exposed to tuberculosis before starting this medicine.

Serious infections have occurred in patients who take these types of medicine.

This medicine does not mix well with many medicines. Serious reactions may occur. Check all medicines with healthcare provider.

Please read the medication guide.

Reasons not to take this medicine

• If you have an allergy to golimumab, polysorbate 80, or any other part of this medicine.

• Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.

• If you have a latex allergy, talk with healthcare provider.

• If you are breast-feeding.

What is this medicine used for?

• This medicine is used to treat arthritis. The arthritis is usually considered moderately to severely active and may not have responded to other treatments.

• This medicine is used to treat ankylosing spondylitis.

• This medicine is used to treat psoriatic arthritis.

How does it work?

• Golimumab reduces inflammation and helps reduce symptoms and protect joints from further harm.

• It decreases the body's harmful response to diseases affecting the immune system.

How is it best taken?

• This medicine is given as a shot into the fatty part of the skin.

• Your healthcare provider may teach you how to give the shot.

• Follow instructions closely if you or a family member are giving the shot at home.

• Wash hands before and after use.

• Move site where you give the shot with each shot.

• Throw syringe away after single use. Do not reuse.

• Throw away needles in needle/sharp disposal box and return box to healthcare provider when full.

What do I do if I miss a dose? (does not apply to patients in the hospital)

• Take a missed dose as soon as possible.

• Do not take a double dose or extra doses.

• Do not change dose or stop medicine. Talk with healthcare provider.

What are the precautions when taking this medicine?

• Hepatitis B testing may be suggested. Unrecognized hepatitis B infection may worsen during treatment.

• Long-term use may increase your risk of cancer.

• Serious infections have been reported with use of this medicine. If you have any infection, are taking antibiotics now or in the recent past, or have many infections, talk with healthcare provider.

• Talk with healthcare provider before receiving any vaccinations. Use with this medicine may either increase the risk of serious infection or make the vaccination less effective.

• If you have cancer, talk with healthcare provider.

• If you have diabetes, talk with healthcare provider. You may be more likely to develop infections.

• If you have heart disease, talk with healthcare provider.

• If you have multiple sclerosis or other nerve disease, talk with healthcare provider.

• Check medicines with healthcare provider. This medicine may not mix well with other medicines.

• Tell healthcare provider if you are pregnant or plan on getting pregnant.

What are some possible side effects of this medicine?

• Irritation where the shot is given.

• Risk of infection. Avoid people with infections, colds, or flu.

• Feeling dizzy. Rise slowly over several minutes from sitting or lying position. Be careful climbing.

What should I monitor?

• Change in condition being treated. Is it better, worse, or about the same?

• You will need a tuberculosis test before starting this medicine.

• Follow up with healthcare provider.

Reasons to call healthcare provider immediately

• If you suspect an overdose, call your local poison control center or emergency department immediately.

• Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat.

• Signs or symptoms of infection. These include a fever of 100.5 degrees or higher, chills, severe sore throat, ear or sinus pain, cough, increased sputum or change in color, painful urination, mouth sores, wound that will not heal, or anal itching or pain.

• Difficulty breathing.

• Severe dizziness.

• Severe headache.

• Feeling extremely tired or weak.

• Swelling of legs or belly.

• Dark urine or yellow skin or eyes.

• Not hungry.

• Numbness or tingling of hands or feet.

• Sudden change in vision.

• Any rash.

• No improvement in condition or feeling worse.

How should I store this medicine?

• Store in a refrigerator. Do not freeze.

• Protect from light.

• Do not shake.

General statements

• If you have a life-threatening allergy, wear allergy identification at all times.

• Do not share your medicine with others and do not take anyone else's medicine.

• Keep all medicine out of the reach of children and pets.

• Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).

• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.

Created: 2009-05-18 09:44:50.0

Modified: 2009-08-26 15:48:31.0

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