What is Simponi Aria?

QUICK LINKS

• Blackbox Warning
• Overview
• Proper Use
• Dosing
• Missed Dose
• Use & Storage
• Before Using
• Allergies
• Pediatric
• Geriatric
• Pregnancy
• Breast Feeding
• Drug Interactions
• Other Interactions
• Other Medical Problems
• Precautions

Blackbox WarningTOP

OverviewTOP

Golimumab injection is used alone or together with other medicines (eg, methotrexate) to treat the symptoms of moderate to severe rheumatoid arthritis and ankylosing spondylitis (arthritis in the spine or backbone). It is also used to treat psoriatic arthritis, which is a type of arthritis that causes pain and swelling in the joints along with patches of scaly skin on some areas of the body.

Golimumab injection is used to treat moderate to severe ulcerative colitis in patients who have been treated with other medicines that did not work well.

This medicine is available only with your doctor's prescription.

Proper UseTOP

A nurse or other trained health professional will give you Simponi® Aria™ (together with methotrexate) in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 30 minutes.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Simponi® is given as a shot under your skin. It may sometimes be given at home to patients who do not need to be in a hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand exactly how to use the medicine.

If you use Simponi® at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.

Simponi® is available in 2 forms. You may use a prefilled syringe or a prefilled SmartJect® autoinjector.

The needle covers of the prefilled syringe and SmartJect® autoinjector contain dry natural rubber (a derivative of latex). This may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.

To use Simponi® injection:

• First, gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.
• Wash your hands with soap and water before and after using this medicine.
• Remove the carton with the syringe or autoinjector from the refrigerator and place it on the clean cloth.
• Allow 30 minutes for the syringe to warm up to room temperature. Do not warm this medicine in any other way.
• Do not remove the needle cover from the prefilled syringe or the autoinjector cap while allowing the medicine to reach room temperature. Remove these immediately before use.
• Check the liquid in the syringe or autoinjector using the viewing window. It should be clear and colorless or slightly yellow in color. The liquid may have small white particles or an air bubble. If it is cloudy, discolored, or contains large particles, do not use the syringe or autoinjector. Call your doctor, pharmacist, or the company for help (1-800-526-7736).
• If the liquid is clear, place it on the clean, flat surface. Do not shake the medicine.
• Choose an injection site on your body (eg, middle thigh, lower abdomen or stomach area, or upper arm). Clean the injection site with a fresh alcohol wipe, and let it dry.
• Remove the cap or needle cover when you are ready to inject. Inject the medicine within 5 minutes after the cap or cover has been removed.
• For the SmartJect® autoinjector:
  • Hold the autoinjector in your hand.
  • Push the open end of the autoinjector firmly against your skin at a 90-degree angle.
  • Use your free hand to pinch and hold the skin at the injection site.
  • Press the button with your fingers or thumb to inject the medicine.
  • Do not pull the autoinjector away from the skin until you hear 2 loud "click" sounds. It usually takes up to 15 seconds for you to hear the second "click" sound. This means that the injection is finished and the needle has pulled back into the autoinjector.
  • Lift the autoinjector from the injector site. Check the viewing window on the autoinjector for a yellow indicator. The yellow indicator means the autoinjector worked properly.
• For the prefilled syringe:
  • Hold the syringe with one hand between the thumb and index fingers.
  • Use your free hand to pinch and hold the skin at the injection site.
  • Inject the medicine in a dart-like motion into the pinched skin at a 45-degree angle.
  • Use your thumb to push the plunger and inject the full dose of the medicine. Pull the needle out of the skin.
• Do not inject into skin areas that are red, bruised, tender, or hard, or have scars or stretch marks.
• You might have a small amount of blood or liquid at the injection site. Press and hold a dry, clean cotton ball on the injection site for 10 seconds, but do not rub it.
• Throw away used syringes or autoinjectors in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

DosingTOP

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (prefilled syringe or autoinjector):
  • For rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis:
    • Adults—50 milligrams (mg) injected under the skin once a month.
    • Children—Use and dose must be determined by your doctor.
  • For ulcerative colitis:
    • Adults—At first, 200 milligrams (mg) injected under the skin. A second dose of 100 mg is given 2 weeks later. Then, a maintenance dose of 100 mg is given every 4 weeks.
    • Children—Use and dose must be determined by your doctor.

Missed DoseTOP

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Use & StorageTOP

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Protect Simponi® from direct light. Keep the medicine in the original package until you are ready to use it.

Before UsingTOP

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

AllergiesTOP

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

PediatricTOP

Appropriate studies have not been performed on the relationship of age to the effects of golimumab injection in the pediatric population. Safety and efficacy have not been established.

GeriatricTOP

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of golimumab injection in the elderly. However, elderly patients are more likely to have serious infections, which may require caution in patients receiving golimumab injection.

PregnancyTOP

Breast FeedingTOP

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug InteractionsTOP

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept
• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Alfentanil
• Aminophylline
• Anakinra
• Artemether
• Astemizole
• Bacillus of Calmette and Guerin Vaccine, Live
• Carbamazepine
• Cisapride
• Cyclosporine
• Dihydroergotamine
• Ergotamine
• Fentanyl
• Fosphenytoin
• Iloperidone
• Influenza Virus Vaccine, Live
• Lumefantrine
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Paclitaxel
• Phenytoin
• Pimozide
• Poliovirus Vaccine, Live
• Quinidine
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Sirolimus
• Smallpox Vaccine
• Tacrolimus
• Terfenadine
• Theophylline
• Typhoid Vaccine
• Varicella Virus Vaccine
• Warfarin
• Yellow Fever Vaccine

Other InteractionsTOP

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical ProblemsTOP

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Aspergillosis (fungus infection), history of or
• Blastomycosis (fungus infection), history of or
• Blood or bone marrow problems (eg, aplastic anemia, cytopenia, pancytopenia), history of or
• Candidiasis (fungus infection), history of or
• Coccidioidomycosis (fungus infection), history of or
• Congestive heart failure or
• Guillain-Barré syndrome (nervous system disorder), history of or
• Histoplasmosis (fungus infection), history of or
• Legionellosis (bacterial infection), history of or
• Leukopenia or neutropenia (low white blood cells) or
• Listeriosis (bacterial infection), history of or
• Multiple sclerosis, history of or
• Optic neuritis (eye problem) or
• Pneumocystosis (fungus infection), history of or
• Polyneuropathy (nerve problem) or
• Psoriasis or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

• Cancer (eg, colon, lymphoma, skin), active or history of or
• Chronic obstructive pulmonary disease (COPD) or
• Diabetes or
• Hepatitis B, history of or
• Immune system problem or
• Primary sclerosing cholangitis (bile duct disease) or
• Tuberculosis, history of or
• Wegener granulomatosis (blood vessels are inflamed)—May increase chance for side effects.

• Infection, active or not completely going away or
• Tuberculosis, active—Should not be used in patients with these conditions.

PrecautionsTOP

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this medicine.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

Golimumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Do not have any live vaccines (immunizations) while you are being treated with golimumab. Check with your doctor before having any vaccines.

Do not take other medicines for arthritis unless you talk to your doctor. This includes abatacept (Orencia®), anakinra (Kineret®), adalimumab (Humira®), certolizumab (Cimzia®), etanercept (Enbrel®), infliximab (Remicade®), rituximab (Rituxan®), or tocilizumab (Actemra®). Using any of these together with this medicine may increase your chance of having serious side effects.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor right away if you have more than one of these symptoms: chest pain, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, shortness of breath, swelling of the face, fingers, feet, or lower legs, tightness in the chest, trouble breathing, or weight gain. These may be signs of a heart condition called congestive heart failure (CHF).

Check with your doctor right away if you have more than one of these symptoms: blurred vision, difficulty controlling your bladder or bowels, difficulty with walking, feeling sad or depressed, forgetfulness, muscle cramps, numbness or tingling in your arms, legs, or face, slurred speech or problems with swallowing, or unusual tiredness or weakness. These may be signs of a nervous system disease called multiple sclerosis (MS).

This medicine may increase your risk of getting certain types of cancer, including lymphoma, leukemia, skin cancer, and colon cancer. Some teenagers and young adults with Crohn's disease or ulcerative colitis developed a rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL). Check with your doctor right away if you have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, or unexplained weight loss.

This medicine may increase your risk of having a lupus-like syndrome. Check with your doctor right away if you have chest pain, fever or chills, a general feeling of discomfort, illness, or weakness, joint pain, a rash on the cheeks or arms that is worse in the sun, or severe tiredness.

This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.