Posted on December 21st, 2015 by

Class: Tumor necrosis factor (TNF)-alpha inhibitor

Generic Name: Golimumab

Trade Name: Simponi®

For which conditions is this drug approved? Simponi is approved for use with the medicine methotrexate to treat adults with moderately to severely active rheumatoid arthritis (RA). Simponi is also approved for patients with active psoriatic arthritis, alone or with methotrexate, and for patients with active ankylosing spondylitis.

What is the mechanism of action? Simponi works by blocking the inflammatory effects of a protein called tumor necrosis factor alpha (TNF alpha) in RA and other conditions associated with inflammation. The body produces TNF when there is inflammation. In RA, untreated inflammation can lead to joint damage.

How is Simponi typically given (administered)? Simponi is given as an injection under the skin (subcutaneous injection) one time each month. The injections come in a prefilled syringe or SmartJect® autoinjector. Your doctor may decide you can give the injections to yourself at home of have a caregiver give them. Your doctor will provide training in how to administer home injections.

How are patients typically monitored? Simponi affects your immune system and can lower its ability to fight infections, so your doctor will watch you for signs of infection during treatment, including invasive fungal infections. If you carry the hepatitis B virus, your doctor will monitor you for reactivation of the virus (a risk during treatment with Simponi). Your doctor will also watch for: serious allergic reaction and hypersensitivity, lymphoma and other types of cancer, heart failure, and damage to the protective covering (myelin sheath) surrounding the nervous system.

What are some of the side effects of treatment with Simponi (occur in 10% to 29% of patients)?

  • Upper respiratory infection

 This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
  • Be especially sure to tell your doctor if you use the RA medicines Orencia® (abatacept) or Kineret® (anakinra). You should not receive Simponi while you’re also taking Orencia or Kineret.
  • Tell you doctor if you use other TNF-blocker medicines, including Remicade® (infiiximab), Humira® (adalimumab), Enbrel® (etanercept), or Cimzia® (certolizumab pegol). Also tell your doctor if you receive RA treatment with Rltuxan® (rituximab) or Actemra® (tocilizumab).
  • Keep a list of all your medications to show your doctor and pharmacist each time you get a new medicine.
  • Do not try to give yourself Simponi injections until your doctor or nurse has shown you how to do it correctly and safely.
  • Try not to miss any doses of Simponi. If you do miss a dose, inject that dose as soon as you remember. Take your next dose at your regular scheduled time.
  • Tell you doctor if you are allergic to rubber or latex. The needle cover on the prefilled syringe and SmartJect autoinjector contains dry natural rubber.

Are there any special precautions patients should be aware of before starting treatment?

  • Simponi can raise your risk of serious infections. These include tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that spread throughout your body. Your doctor should test you for TB and hepatitis B before you start treatment.
  • In most cases, you should not take Simponi if you have signs of an infection of any kind, unless your doctor determines that it’s safe.
  • Tell your doctor if you have the following signs of an infection: fever, sweat, or chills; warm, red, or painful skin or sores on your body; muscle aches; diarrhea or stomach pain; cough; burning when you urinate or urinating more often; shortness of breath; blood in your phlegm; feeling very tired; or weight loss.
  • Tell your doctor if you are currently being treated for an infection, tend to get a lot of infections, or have infections that keep coming back.
  • Tell you doctor if you have diabetes, HIV, or a weak immune system. These conditions raise your risk of getting infections.
  • Tell your doctor if you have TB or have been in close contact with someone with TB.
  • Tell your doctor if you live, have lived, or traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fugal infections (histoplasmosis, coccidioidomycosis, blastomycosis).
  • Tell you doctor if you have or have had hepatitis B. The virus can become active again during treatment with Simponi. Your doctor should test you for hepatitis B before you start taking Simponi.
  • Tell your doctor if you have had lymphoma or any type of cancer.
  • Tell you doctor if you have or had heart failure.
  • Tell you doctor if you have or have had a condition that affects your nervous system, such as multiple sclerosis or Guillain-Barré syndrome.
  • Tell your doctor if you have recently received or are scheduled to receive a vaccine. You should not receive live vaccines while you’re taking Simponi.
  • If you’ve had a baby and were using Simponi during your pregnancy, tell your baby’s doctor before your baby receives any vaccines. He or she may have an increased chance of getting an infection for up to six months after birth.
  • Tell your doctor if you are pregnant or planning to become pregnant. It is not known if Simponi will harm your unborn baby.
  • Tell your doctor if you are breastfeeding. You and your doctor should decide if you will breastfeed or take Simponi. Do not do both without first talking to your doctor.

When should patients notify their physician?

  • Tell your doctor right away if you have any of the following symptoms of a possible hepatitis B infection:
    • Feel very tired
    • Clay-colored bowel movements
    • Dark urine
    • Fevers
    • Skin or eyes look yellow
    • Chills
    • Little or no appetite
    • Stomach discomfort
    • Vomiting
    • Skin rash
    • Muscle aches
  • Tell your doctor right away if you have new or worsening symptoms of heart failure while taking Simponi. This includes shortness of breath or swelling of your lower legs or feet.
  • Tell your doctor right away if you have any of the following signs of a nervous system problem: vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.
  • Tell your doctor right away if you have the following signs of a liver problem: feel very tired, your skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach (abdomen).
  • Tell your doctor right away if you have the following signs of low blood counts: fever, bruising or bleeding easily, or looking pale.
  • Tell your doctor right away if you have the following signs of an allergic reaction: hives, swollen face, breathing trouble, or chest pain.
  • Tell your doctor right away if you have symptoms similar to those of lupus. These include: a rash on your cheeks or other parts of the body; sensitivity to the sun; new joint or muscle pains; unusual tiredness; chest pain or shortness of breath; swelling of the feet, ankles, or legs.
  • Tell your doctor if you have new psoriasis or if psoriasis you already have gets worse. Symptoms of psoriasis include red scaly patches on your skin or raised bumps that are filled with pus.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated: 12/15

Tags: Drug Dictionary, Other, RA, S

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