Simponi Injection

DRUG DESCRIPTION

SIMPONI (golimumab) is a human IgG1? monoclonal antibody specific for human tumor necrosis factor alpha (TNF?) that exhibits multiple glycoforms with molecular masses of approximately 150 to 151 kilodaltons. SIMPONI (golimumab injection) was created using genetically engineered mice immunized with human TNF, resulting in an antibody with human-derived antibody variable and constant regions. SIMPONI (golimumab injection) is produced by a recombinant cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses.

The SIMPONI drug product is a sterile solution of the golimumab antibody supplied as either a single dose prefilled syringe (with a passive needle safety guard) or a single dose prefilled autoinjector. The Type 1 glass syringe has a coated stopper. The fixed stainless steel needle (5 bevel, 27G, half-inch) is covered with a needle shield to prevent leakage of the solution through the needle and to protect the needle during handling prior to administration. The needle shield is made of a dry natural rubber containing latex.

SIMPONI (golimumab injection) does not contain preservatives. The solution is clear to slightly opalescent, colorless to light yellow with a pH of approximately 5.5. SIMPONI is provided in one strength: 50 mg of the golimumab antibody in 0.5 mL of solution. Each 0.5 mL of SIMPONI contains 50 mg of the golimumab antibody, 0.44 mg of L-histidine and L-histidine monohydrochloride monohydrate, 20.5 mg of sorbitol, 0.08 mg of polysorbate 80, and Water for Injection.

What are the possible side effects of golimumab (Simponi, Simponi SmartJect)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with golimumab. Stop using golimumab and call your doctor right away if you have signs of infection such as:

  • fever, sweating, chills, tired feeling;
  • chest pain, feeling short of breath;
  • cough, sore throat, coughing up bloody mucus;
  • flu symptoms, stomach...

Read All Potential Side Effects and See Pictures of Simponi Injection

What are the precautions when taking golimumab injection (Simponi Injection)?

See also Warnings section.

Before using golimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: an active infection, TB infection, fungal infections (such as histoplasmosis, coccidioidomycosis), heart disease (congestive heart failure), lupus, recurrent infections, hepatitis B infection, decreased bone marrow function, seizures, certain brain/spinal cord disorders (such as multiple sclerosis), history of cancer (such as lymphoma), scheduled...

Read All Potential Precautions of Simponi Injection


Simponi Injection Consumer (continued)

SIDE EFFECTS: Redness, itching, pain, or swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/irregular/pounding heartbeat, stomach pain, blood in the stools, mental/mood changes, severe headache, easy bruising/bleeding, dark urine, yellowing eyes/skin, leg pain/swelling, numbness/tingling of the hands/feet, unsteadiness, unexplained muscle weakness, vision changes, extreme fatigue, joint pain, butterfly-shaped rash on the nose and cheeks.

Seek immediate medical attention if any of these rare but very serious side effects occur: seizures, chest pain.

Tell your doctor immediately if you develop signs of infection while using this drug, such as: fever, chills, persistent sore throat, persistent cough, night sweats, trouble breathing, painful/frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warnings section.

Before using golimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: an active infection, TB infection, fungal infections (such as histoplasmosis, coccidioidomycosis), heart disease (congestive heart failure), lupus, recurrent infections, hepatitis B infection, decreased bone marrow function, seizures, certain brain/spinal cord disorders (such as multiple sclerosis), history of cancer (such as lymphoma), scheduled surgery.

Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine. Consult your doctor about the risks of exposure to chickenpox and other infections.

Older adults may be more sensitive to the effects of this drug, especially the risk of infections.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Because of the potential risk to the infant, consult your doctor before breast-feeding.


Simponi Injection Patient Information Including Side Effects

Brand Names: Simponi, Simponi SmartJect

Generic Name: golimumab (Pronunciation: goe LIM ue mab)

  • What is golimumab (Simponi Injection)?
  • What are the possible side effects of golimumab (Simponi Injection)?
  • What is the most important information I should know about golimumab (Simponi Injection)?
  • What should I discuss with my healthcare provider before using golimumab (Simponi Injection)?
  • How should I use golimumab (Simponi Injection)?
  • What happens if I miss a dose (Simponi Injection)?
  • What happens if I overdose (Simponi Injection)?
  • What should I avoid while using golimumab (Simponi Injection)?
  • What other drugs will affect golimumab (Simponi Injection)?
  • Where can I get more information?

What is golimumab (Simponi Injection)?

Golimumab is a tumor necrosis factor (TNF) blocker. It works by reducing the effects of a substance in the body that can cause inflammation.

Golimumab is used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Golimumab is sometimes used with another medication called methotrexate (Rheumatrex, Trexall).

Golimumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of golimumab (Simponi Injection)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with golimumab. Stop using golimumab and call your doctor right away if you have signs of infection such as:

  • fever, sweating, chills, tired feeling;
  • chest pain, feeling short of breath;
  • cough, sore throat, coughing up bloody mucus;
  • flu symptoms, stomach pain, diarrhea;
  • muscle aches, weight loss.

Call your doctor at once if you have any of these other serious side effects:

  • shortness of breath with swelling of your ankles or feet;
  • chest pain, ongoing cough, coughing up blood;
  • easy bruising or bleeding, pale skin, unusual weakness;
  • cold sores;
  • vision changes;
  • numbness or tingly feeling, weakness in your legs;
  • loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, chest pain, unusual thoughts or behavior, and/or seizure (convulsions); or
  • patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).

Less serious side effects may include:

  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • dizziness; or
  • redness where you injected the medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about golimumab (Simponi Injection)?

You should not use this medication if you are allergic to golimumab, or if you are already using adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), or infliximab (Remicade).

Before using golimumab, tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, if you have recently been vaccinated with BCG, or if you have recently traveled to an area where tuberculosis is common.

Tell your doctor about all of your medical conditions, especially if you have hepatitis, congestive heart failure, lupus, diabetes, cancer, HIV or a weak immune system, or multiple sclerosis.

Before you start treatment with golimumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Golimumab can lower the blood cells that help your body fight infections. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Serious and sometimes fatal infections may occur during treatment with golimumab. Contact your doctor right away if you have signs of infection such as: fever, sweating, chills, tired feeling, chest pain, feeling short of breath, cough, sore throat, coughing up bloody mucus;, flu symptoms, stomach pain, diarrhea, muscle aches, or weight loss.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

Do not receive a "live" vaccine while you are being treated with golimumab.

Using golimumab may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes) or autoimmune disorders (such as a lupus-like syndrome). This risk may be greater in children and young adults. Talk to your doctor about your specific risk.

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