What You Need to Know About Simponi

Simponi (golimumab) is a type of drug known as a TNF-alpha (tumor necrosis factor alpha) blocker. It has been discovered that TNF plays a role in the development of inflammatory bowel disease (IBD). TNF is found in higher amounts in the colons of people with ulcerative colitis and Crohn's disease than it is in people who do not have any form of IBD. Simponi, like other immune modulator drugs used to treat IBD, binds to TNF-alpha and prevents it from being used by the body. This drug is manufactured by Janssen Biotech.

Researchers think that TNF-alpha has a role in IBD and the gastrointestinal system. IBD is an inflammatory condition, and TNF-alpha is a chemical messenger known as a cytokine. Cytokines not only deliver "messages" between cells in the body, but they also play a role in promoting the inflammatory process.

How Is Simponi Taken?

Simponi is given as an injection under the skin. After being trained by a healthcare professional, patients can give themselves the Simponi injection at home. The injections will come with detailed instructions on their use, and the prescribing physician will provide any other special instructions that patients should follow. To begin Simponi, there are two injections to start. Next, one injection is given two weeks later. And then, for maintenance, a Simponi injection is given every four weeks.

Uses

Simponi is approved to treat moderate-to-severe ulcerative colitis in cases that have not responded to more conventional medications (it is not used as a first line of treatment for the condition). Simponi is also approved to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

Simponi works to prevent inflammation by bonding to TNF-alpha. When TNF-alpha is no longer available to cause inflammation, IBD may enter a period of remission (when disease activity and symptoms are quiescent).

Who Should Not Take Simponi?

Tell your doctor if you are being treated for an infection, if you are a carrier of the hepatitis B virus, have recently received a live vaccine, or have ever had an allergic reaction to Simponi.

Side Effects

Common adverse effects of Simponi include upper respiratory tract infection, injection site reaction (such as redness or swelling), and viral infections such as the flu and cold sores. Tell your doctor if any side effects are bothersome or don't go away. These side effects should be reported to your physician immediately.

Other Warnings on Adverse Effects

Simponi and other TNF-blocker medications have been associated with certain types of infection, including tuberculosis. Any exposure to a person who has tuberculosis should be reported to the prescribing physician. Patients undergoing therapy with Simponi should be tested for tuberculosis (including the dormant form of the disease), and undergo treatment if necessary. While taking this drug, patients should also be monitored for signs or symptoms of tuberculosis, such as:

• Chest pain
• Cough
• Fever
• Loss of appetite
• Night sweats
• Weight loss

Other types of infections are also possible, as this medication lowers the body's resistance to infectious agents. Patients who have traveled to an area with a high incidence of fungal infections or who have any current infection should report these conditions to the doctor prescribing Simponi.

TNF blockers have been associated with the development of certain types of cancers. Lymphoma has been reported in people taking TNF blockers. Specifically, the risk of developing hepatosplenic T-cell lymphoma is increased, especially in young men.

Simponi has been associated with the development of skin cancer. People taking Simponi should be aware of any changes in their skin, such as new growths or moles that change in color or shape.

People who are carriers of the hepatitis B virus are at risk for a reactivation of the virus when taking anti-TNF medications. Patients who take Simponi should be tested for hepatitis B and should also be vigilant for signs and symptoms of hepatitis B such as:

• Chills
• Clay-colored bowel movements
• Darkened urine
• Extreme fatigue
• Fevers
• Lack of appetite
• Muscle aches
• Skin rashes
• Stomach discomfort
• Vomiting
• Yellow skin or eyes

A low blood count has been observed in some patients taking anti-TNF drugs. This is a special concern for people with IBD, who are already at risk for low levels of red blood cells. Your physician will monitor your blood at regular intervals to look for anemia.

Other problems that can occur while undergoing anti-TNF therapy include heart failure, multiple sclerosis, Guillain-Barré syndrome, liver disease, psoriasis, and lupus-like symptoms.

Food and Drug Interactions

Simponi is often taken in conjunction with other drugs used to treat IBD such as corticosteroids. Medications that could interact with Simponi include:

• Kineret (anakinra)
• Orencia (abatacept)
• Rituxan (rituximab)
• Live vaccines

There are no known food interactions.

Safety During Pregnancy

The FDA has classified Simponi as a type B drug. The effect that Simponi has on an unborn child has not been studied extensively. Simponi should only be used during pregnancy if clearly needed. Notify the prescribing doctor if you become pregnant while taking Simponi. It is not known if Simponi passes into breast milk, however other similar substances have been shown to pass into breast milk. The potential for serious side effects in an infant should be weighed against the usefulness of the medication to the mother. Another option is to discontinue breastfeeding before administering Simponi.