golimumab Subcutaneous

goe-LIM-ue-mab

Subcutaneous route(Solution)

Tuberculosis, invasive fungal infections, and other opportunistic infections, some fatal, have been observed in patients receiving golimumab. Patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection prior to initiating golimumab and during therapy. Treatment of latent tuberculosis infection should be initiated prior to therapy with golimumab. Monitor patients receiving golimumab for signs and symptoms of infection including tuberculosis in patients who tested negative for latent tuberculosis infection. Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with tumor necrosis factor (TNF) blockers, of which golimumab is a member .

Commonly used brand name(s)

In the U.S.

• Simponi

Available Dosage Forms:

• Solution

Therapeutic Class: Immune Modulator

Pharmacologic Class: Tumor Necrosis Factor Inhibitor

Uses For golimumab

Golimumab injection is used 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. Psoriatic arthritis usually occurs with a skin condition called psoriasis. Golimumab may be used alone or in combination with other arthritis medicines, such as methotrexate (Rheumatrex®, Trexall®), sulfasalazine (Azulfidine®), hydroxychloroquine (Plaquenil®), corticosteroids (cortisone-like medicines), or nonsteroidal antiinflammatory drugs (NSAIDs).

golimumab is available only with your doctor's prescription.

Before Using golimumab

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 golimumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to golimumab 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.

Pediatric

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.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

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.

Interactions with Medicines

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 golimumab, 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 golimumab 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


• Anakinra


• Bacillus of Calmette and Guerin Vaccine, Live


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Poliovirus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

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 Problems

The presence of other medical problems may affect the use of golimumab. 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 (e.g., 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 number of 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 number of platelets)—Use with caution. May make these conditions worse.

• Cancer, active or history of or


• Chronic obstructive pulmonary disease (COPD) (a lung disease) or


• Diabetes or


• Hepatitis B, history of or


• Immune system problem or


• Tuberculosis, history of or


• Wegener's 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.

Proper Use of golimumab

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

golimumab comes with a Medication Guide and a Patient Information Insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you use golimumab 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.

golimumab 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 golimumab.

To use the 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 golimumab.


• 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 golimumab in any other way.


• Do not remove the needle cover on 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 1-800-JANSSEN (1-800-526-7736) for help.


• If the liquid is clear, place it on the clean, flat surface. Do not shake the medicine.


• Choose an injection site on your body (e.g., 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.
  
  


• 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.

Dosing

The dose of golimumab 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 golimumab. 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.
    
    
  
  

Missed Dose

If you miss a dose of golimumab, 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.

Storage

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

Precautions While Using golimumab

If you will be using golimumab for a long time, it is very important that your doctor check you at regular visits. This will allow your doctor to see if the medicine is working properly and to decide whether you should continue to use it. Blood tests may be needed to check for unwanted effects.

golimumab may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using golimumab and 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 golimumab.

You will need to have a skin test for tuberculosis before you start using golimumab. 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 golimumab may increase your chance of having serious side effects.

Check with your doctor right away if you have more than one of these symptoms: fever or chills; a general feeling of discomfort, illness, or weakness; light-colored stools; nausea and vomiting; dark brown-colored urine; right-sided stomach pain; or yellow eyes and skin. These may be signs of serious liver problems.

Stop using golimumab and 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 with breathing; weight gain; or wheezing. 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; forgetful; 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).

A small number of people (including children and teenagers) who have used this type of medicine have developed certain types of cancer (e.g., leukemia). Some patients also developed a rare type of cancer called lymphoma. Talk with your doctor if you have unusual bleeding, bruising, or weakness; swollen lymph nodes in the neck, underarms, or groin; or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.

golimumab Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Body aches or pain


• chills


• cough


• difficulty with breathing


• ear congestion


• fever


• headache


• loss of voice


• muscle aches


• sneezing


• sore throat


• stuffy or runny nose


• unusual tiredness or weakness

Less common

• Blurred vision


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• congestion


• cough producing mucus


• diarrhea


• dizziness


• general feeling of discomfort or illness


• hoarseness


• joint pain


• loss of appetite


• muscle aches and pains


• nausea


• nervousness


• pain or tenderness around the eyes and cheekbones


• painful cold sores or blisters on the lips


• pounding in the ears


• shivering


• shortness of breath or troubled breathing


• slow or fast heartbeat


• sweating


• tender, swollen glands in the neck


• tightness of the chest or wheezing


• trouble with sleeping


• trouble with swallowing


• voice changes


• vomiting

Rare

• Bone pain


• frequent or painful urination


• pain and inflammation at the joints


• redness, soreness, or itching skin


• severe abdominal or stomach pain


• sores, welting, or blisters


• yellow eyes or skin

Incidence not known

• Hives


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• red, scaling, or crusted skin


• skin rash


• swelling of the face, throat, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site


• burning or stinging of the skin


• difficulty having a bowel movement (stool)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: golimumab Subcutaneous side effects (in more detail)

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More golimumab Subcutaneous resources

• Golimumab Subcutaneous Side Effects (in more detail)
• Golimumab Subcutaneous Use in Pregnancy & Breastfeeding
• Golimumab Subcutaneous Drug Interactions
• Golimumab Subcutaneous Support Group
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