Simponi

Simponi is a prescription medication for the treatment of ulcerative colitis, moderately to severely active rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

Simponi belongs to class of medications called DMARDs, or disease modifying antirheumatic drugs. These medications work by blocking tumor necrosis factors (TNFs), factors partly responsible for over-inflammation in certain diseases.

This medication comes in a once-monthly, self-injectable form to be injected under the skin (subcutaneous injection). It also comes as an injection to be given through the vein (IV) by a healthcare provider.

Common side effects include upper respiratory infection and redness at the site of injection.

Simponi is a prescription medication for the treatment of ulcerative colitis, moderately to severely active rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Janssen Biotech, Inc.

Serious side effects have been reported with Simponi. See “Drug Precautions” section.

Common side effects with Simponi include:

• upper respiratory infection (runny nose, sore throat, and hoarseness or laryngitis)
• reaction at the site of injection (redness, swelling, itching, pain, bruising, or tingling)
• viral infections such as flu and oral cold sores

Other side effects with Simponi include:

• Immune System Problems. Rarely, people using TNF-blocker medicines have developed symptoms that are like the symptoms of Lupus. Tell your doctor if you have any of these symptoms:
  • a rash on your cheeks or other parts of the body
  • sensitivity to the sun
  • new joint or muscle pains
  • becoming very tired
  • chest pain or shortness of breath
  • swelling of the feet, ankles, or legs
• Psoriasis. Some people using Simponi had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with Simponi.
• Allergic Reactions. Allergic reactions can happen in people who use TNF-blocker medicines including Simponi. Some reactions may be serious and can be life-threatening. Some of these reactions can happen after receiving your first dose of Simponi. Call your doctor right away if you have any of these symptoms of an allergic reaction:
  • hives
  • swollen face
  • breathing trouble
  • chest pain

This is not a complete list of Simponi side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• anakinra (Kineret)
• rituximab (Rituxan)
• abatacept (Orencia)
• tocilizumab (Actemra)
• infliximab (Remicade)
• adalimumab (Humira)
• etanercept (Enbrel)
• certolizumab (Cimzia)
• live vaccines such vaccines for MMR, rotavirus, typhoid, smallpox, and for influenza (nasal spray form)

This is not a complete list of Simponi drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Simponi including:

Simponi is a medicine that affects your immune system. Simponi can lower the ability of your immune system to fight infections. Some people have serious infections while taking Simponi, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that spread throughout their body. Some people have died from these serious infections.

• Your doctor should test you for TB and hepatitis B before starting Simponi.
• Your doctor should monitor you closely for signs and symptoms of TB during treatment with Simponi.

You should not start taking Simponi if you have any kind of infection unless your doctor says it is okay.

Before starting Simponi, tell your doctor if you:

• think you have an infection or have symptoms of an infection such as:
  • fever, sweat, or chills
  • muscle aches
  • cough
  • shortness of breath
  • blood in phlegm
  • weight loss
  • warm, red, or painful skin or sores on your body
  • diarrhea or stomach pain
  • burning when you urinate or urinate more often than normal
  • feel very tired
• are being treated for an infection
• get a lot of infections or have infections that keep coming back
• have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
• have TB, or have been in close contact with someone with TB
• 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 fungal infections (histoplasmosis, coccidioidomycosis, blastomycosis). These infections may happen or become more severe if you use Simponi. Ask your doctor if you do not know if you have lived in an area where these infections are common.
• have or have had hepatitis B
• use the medicine Orencia (abatacept), Kineret (anakinra), Actemra (tocilizumab) or Rituxan (rituximab)

After starting Simponi, call your doctor right away if you have any symptoms of an infection. Simponi can make you more likely to get infections or make worse any infection that you have.

Cancer

• For children and adults taking TNF-blocker medicines, including Simponi, the chances of getting cancer may increase.
• There have been cases of unusual cancers in children and teenage patients taking TNF-blocking agents.
• People with inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, especially those with very active disease, may be more likely to get lymphoma.
• Some people treated with Simponi have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with Simponi, tell your doctor.
• Some people receiving medicines that are like Simponi, called TNF-blockers, developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn's disease or ulcerative colitis with a TNF-blocker and another medicine called Imuran (azathioprine) or Purinethol (6-mercaptopurine, 6-MP).

Hepatitis B infection in people who carry the virus in their blood.

If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use Simponi. Your doctor should do blood tests before you start treatment with Simponi and while you are using Simponi. Tell your doctor if you have any of the following symptoms of a possible hepatitis B infection:

• feel very tired
• dark urine
• skin or eyes look yellow
• little or no appetite
• vomiting
• muscle aches
• clay-colored bowel movements
• fevers
• chills
• stomach discomfort
• skin rash

Congestive heart failure (CHF): may worsen current CHF or may cause CHF

• Simponi should be used with caution in patients with CHF.
• Patients with CHF and also taking Simponi should be closely monitored during therapy.
• Simponi should be discontinued if new or worsening symptoms of CHF appear.
• Symptoms of CHF include shortness of breath, swelling in arms or legs, and general weakness and fatigue.

New onset or worsening of demyelinating disorders (disorder of the nervous system), including multiple sclerosis or Guillain-Barré syndrome

• Rare cases of this complication have been reported in patients treated with Simponi.
• Discontinuation of Simponi should be considered if this condition occurs.  

Liver Problems

Liver problems can happen in people who use TNF-blocker medicines, including Simponi. These problems can lead to liver failure and death. Call your doctor right away if you have any of these symptoms:

• feel very tired
• skin or eyes look yellow
• poor appetite or vomiting
• pain on the right side of your stomach (abdomen)

Blood Problems

Low blood counts have been seen with TNF-blockers, including Simponi. Your body may not make enough blood cells that help fight infections or help stop bleeding. Symptoms include fever, bruising or bleeding easily, or looking pale. Your doctor will check your blood counts before and during treatment with Simponi.                         

Simponi may cause dizziness. Do not drive or operate heavy machinery until you know how Simponi affects you.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Simponi, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Simponi, tell your doctor about all of your medical conditions. Especially tell your doctor if you...

• have a history an infection
• have a history of any type of cancer
• have a history of heart failure
• have or have had a condition that affects your nervous system (e.g., multiple sclerosis or Guillain-Barré syndrome)
• have recently received or are planning to receive a vaccine
• have a baby and you were using Simponi during your pregnancy. Let your baby's doctor know before your baby receives any vaccine. Your baby may have an increased chance of getting an infection, particularly within 6 months after birth.
• are allergic to rubber or latex, as the needle cover on the syringe and autoinjector is made with dry natural rubber
• are pregnant, planning to become pregnant, or are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Simponi falls into category B. There are no well-controlled studies of Simponi in pregnant women, and so it is unknown whether Simponi can cause fetal harm when administered to a pregnant woman. Simponi should be used during pregnancy only if clearly needed.

In addition, you should let your baby's doctor know before your baby is given any vaccine. There may be an increased risk of infection with your newborn, particularly within 6 months after birth.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is unknown whether Simponi can pass into human breast milk. Because many drugs are able to pass into human milk, and because of the potential for adverse effects in nursing infants while using Simponi, a decision should be made whether to stop nursing or the use of Simponi between you and your doctor.

Self-Injectable Simponi 

Simponi is meant for use under the supervision of a physician. After proper training in injection technique, a patient may self inject with Simponi if a physician determines that it is appropriate.

Simponi comes in a liquid form meant for injection directly underneath the skin (subcutaneous injection). It is given once per month.

If self-injecting Simponi at home, allow the prefilled syringe or autoinjector to rest at room temperature outside the carton for 30 minutes before injection. Do not warm Simponi in any other way.

Visually inspect the solution for particles and discoloration through the viewing window before use. Simponi should be clear and colorless or light yellow in color. The solution should not be used if discolored, cloudy, or if particles are visible. Any leftover product remaining in the prefilled syringe or prefilled autoinjector should not be used.

Sites for injection should be done at a different spot from the last injection. Injections should never be given into areas where the skin is tender, bruised, red, hard, or damaged in any way.

For a complete list of instructions on how to use Simponi, refer to your doctor or a pharmacist for more information.

Simponi to be given through the vein

• Simponi is prepared and given by a healthcare provider through a needle placed in your vein (infusion). The infusion is usually given in your arm and should take 30 minutes.
• Your doctor will decide how much Simponi you will receive based on your weight. Your usual schedule for receiving Simponi after your first treatment should be:
  • 4 weeks after your first treatment
  • every 8 weeks after that
• If you forget or miss an appointment to receive Simponi, make another appointment as soon as possible.
• You may continue to use other medicines for your treatment while taking Simponi, such as non-steroidal anti-inflammatory drugs (NSAIDs), prescription steroids, and pain relief medicines.

Self-Injection Simponi 

Simponi is meant for use under the supervision of a physician. After proper training in injection technique, a patient may self inject with Simponi if a physician determines that it is appropriate.

A 50 mg injection of Simponi is administered once every month.

For rheumatoid arthritis: Simponi should be prescribed with methotrexate.

For psoriatic arthritis or ankylosing spondylitis: Simponi may be given with or without methotrexate or other disease modifying antirheumatic drugs (DMARDs).

For ulcerative colitis:  The recommended dosage regimen is a 200 mg injection at Week 0, followed by 100 mg at Week 2 and then maintenance therapy with 100 mg every 4 weeks.

Simponi to be given through the vein

The Simponi dosage regimen is 2 mg per kg given as an intravenous (IV) infusion over 30 minutes at weeks 0 and 4, then every 8 weeks thereafter.

Simponi should be given in combination with methotrexate. Other non-biologic DMARDs, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with Simponi.

The efficacy and safety of switching between intravenous and subcutaneous formulations and routes of administration have not been established.

If you inject too much of this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Self-Injectable Simponi:

• Keep Simponi refrigerated at 36°F to 46°F (2°C to 8°C).
• Do not keep Simponi in a freezer.
• Keep Simponi in the carton to protect it from light when not in use.
• Do not shake Simponi.
• Keep this and all medicines out of the reach of children.

Intravenous Simponi:

Simponi must be refrigerated at 2ºC to 8ºC (36ºF to 46ºF) and protected from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake. Do not use Simponi beyond the expiration date (EXP) on the vial label.

WARNINGS: SERIOUS INFECTIONS and MALIGNANCY