Generic Name: golimumab, Injectable Solution

Generic Name:

golimumab, Injectable Solution

SIMPONI ARIA,Simponi

All Brands

  • SIMPONI ARIA
  • Simponi
SECTION 1 of 4

Highlights for golimumab

Injectable Solution
1

Golimumab (Simponi) is an injectable drug used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.

2

Common side effects include injection site skin reactions, upper respiratory infections, and viral infections, such as flu and cold sores.

3

Your dose will depend on what disease you’re treating. Usual doses range between 50–100 mg injected under the skin every month.

4

Golimumab can lower the ability of your immune system to fight infections. Some people develop serious infections while taking this medication.

IMPORTANT INFORMATION

FDA Warning

This drug has a Black Box Warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients to potentially dangerous effects.

Risk of infection. Golimumab can lower the ability of your immune system to fight infections. Some people develop serious infections while taking golimumab. These may include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria.

Your doctor may test you for TB before starting golimumab. They may monitor you closely for symptoms even if you tested negative for TB.

Your doctor may check you for symptoms of any type of infection before, during, and after your treatment with golimumab. Don’t start taking the drug if you have any kind of infection without checking with your doctor first.

Risk of cancer. There have been cases of unusual cancers in people under 18 years old who have taken this type of medication.

This medication increases risk of lymphoma and other cancers. People with rheumatoid arthritis or psoriatic arthritis, especially those with very active disease, may be more likely to get lymphoma.

Rubber, latex allergy warning

Tell your doctor if you’re allergic to rubber or latex. The inner needle cover on the prefilled syringe contains latex. Don’t handle the needle cover if you’re allergic to latex.

Hepatitis B warning

If you carry the hepatitis B virus, it can become active while you use golimumab and damage your liver. Your doctor may do blood tests to check for the virus before you start treatment, while you’re taking golimumab, and for several months after you stop.

Drug Features

Golimumab (Simponi) is a prescription medication. It’s a self-injected drug that comes in these forms: prefilled autoinjector and single-dose prefilled syringe.

This drug may be used as part of a combination therapy. That means you may need to take it with other drugs.

SECTION 2 of 4

golimumab Side Effects

Injectable Solution

Most Common Side Effects

The most common side effects that occur with golimumab include:

  • upper respiratory infections. Report any symptoms of infection to your doctor, even if they’re mild. Symptoms may include:

    • runny nose
    • sore throat
    • hoarseness or laryngitis
  • viral infections, such as flu and cold sores

  • injection site reactions, such as:

    • redness
    • swelling
    • itching
    • pain
    • bruising
    • tingling

Serious Side Effects

If you experience any of these serious side effects, call your doctor right away. If your symptoms are potentially life threatening or if you think you’re experiencing a medical emergency, call 9-1-1.

  • infections. Report any symptoms of infection to your doctor, even if they’re mild. Symptoms may include:

    • cough that doesn’t go away
    • fever
    • unexplained weight loss
    • loss of body fat and muscle
  • lupus-like syndrome. Symptoms may include:

    • rash on your face and arms that gets worse in the sun
  • cancer. Certain kinds of cancer have been reported in people using golimumab. However, it isn’t known if golimumab increases your cancer risk. Symptoms of some types of cancer include:

    • fatigue
    • fever
    • weight loss
    • unusual skin growths (skin cancer)
    • changes in skin appearance (skin cancer)
Pharmacist's Advice
Healthline Pharmacist Editorial Team

Golimumab does not cause drowsiness.

Injection site reactions are common after taking this medication. These include pain, redness, or swelling of the area of your body where you inject the drug. Call your doctor right away if you have a reaction that doesn’t go away within a few days or gets worse.

Mild side effects may disappear within a few days or a couple of weeks. Talk to your doctor or pharmacist if they’re more severe or don’t go away.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
SECTION 3 of 4

golimumab May Interact with Other Medications

Injectable Solution

Golimumab can interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk to your doctor or pharmacist. 

Note: You can reduce your chances of drug interactions by having all of your prescriptions filled at the same pharmacy. That way, a pharmacist can check for possible drug interactions.

Medications That Might Interact with This Drug

Biologic drugs

Biologics are made from natural elements. They include vaccines, blood components, and gene therapy. Golimumab is a biologic drug. Others include:

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

Combining golimumab with biologic drugs increases your risk of serious infection.

Live vaccines

Examples are: 

  • live flu vaccine
  • measles, mumps, rubella vaccine
  • chickenpox (varicella) vaccine
  • herpes zoster vaccine

Don’t receive a live vaccine while taking golimumab and for at least 3 months after stopping the medication. The vaccine may not fully protect you from disease.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

People with infections

Tell your doctor if you have any kind of infection, even if it’s small, such as an open cut or sore that looks infected. Your body may have a harder time fighting off the infection while you’re taking golimumab.

People with tuberculosis

Golimumab affects your immune system and may make it easier for you to get tuberculosis (TB). Your doctor may test you for TB. If you’re at risk for TB, you may be treated for it before you begin and during treatment with golimumab.

People with hepatitis B virus infection

If you carry the hepatitis B virus, it can become active while you use golimumab and damage your liver. Your doctor may do blood tests to check for the virus before you start treatment, while you’re taking golimumab, and for several months after you stop taking it.

People with heart failure

This medication may make symptoms of heart failure worse. Call your doctor right away if you get symptoms of worsening heart failure, such as shortness of breath, swelling of your ankles or feet, and sudden weight gain.

People with nervous system disorders

Though it’s rare, this type of medication may make nervous system disorders worse. These include multiple sclerosis and Guillain-Barre syndrome.

Pregnant women

Golimumab is a pregnancy category B drug. That means two things:

  1. Studies of the drug in pregnant animals have not shown risk to the fetus.
  2. There aren’t enough studies done in pregnant women to show the drug poses a risk to the fetus.

Tell your doctor if you’re pregnant or plan to become pregnant. Golimumab should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Women who are nursing

Golimumab passes through breast milk in small amounts. It isn’t known what effect this will have on a breastfeeding baby. You and your doctor may need to decide whether you’ll take golimumab or breastfeed.

For Seniors

If you’re age 65 or older, you may be at higher risk for serious infections or certain types of cancers while taking golimumab.

For Children

The safety and effectiveness of golimumab haven’t been established in people younger than 18 year old.

When to call the doctor

Call your doctor right away if you:

  • have an infection
  • have recently received or are scheduled to receive a vaccine

Allergies

Golimumab can cause a severe allergic reaction. Symptoms may include:

  • trouble breathing
  • swelling of your throat or tongue
  • hives

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal.

Tell your doctor if you’re allergic to rubber or latex. The inner needle cover on the prefilled syringe and autoinjector contains dry natural rubber. Don’t handle the needle cover if you’re allergic to latex.

SECTION 4 of 4

How to Take golimumab (Dosage)

Injectable Solution

All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

What Are You Taking This Medication For?

Rheumatoid arthritis
Form: Prefilled autoinjector
Strengths: 50 mg/0.5 mL and 100 mg/1 mL
Form: Single-dose prefilled syringe
Strengths: 50 mg/0.5 mL and 100 mg/1 mL
Adult Dosage (ages 18 years and older)
  • The dose is 50 mg injected under your skin once per month.
  • For people with rheumatoid arthritis, golimumab should be given in combination with the drug methotrexate.
Child Dosage (ages 0-17 years)

A safe and effective dose hasn’t been established for this age group.

Psoriatic arthritis
Form: Prefilled autoinjector
Strengths: 50 mg/0.5 mL and 100 mg/1 mL
Form: Single-dose prefilled syringe
Strengths: 50 mg/0.5 mL and 100 mg/1 mL
Adult Dosage (ages 18 years and older)
  • The dose is 50 mg injected under your skin once per month.
  • For people with psoriatic arthritis, golimumab may be given with or without the drug methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs).
Child Dosage (ages 0-17 years)

A safe and effective dose hasn’t been established for this age group.

Ankylosing spondylitis
Form: Prefilled autoinjector
Strengths: 50 mg/0.5 mL and 100 mg/1 mL
Form: Single-dose prefilled syringe
Strengths: 50 mg/0.5 mL and 100 mg/1 mL
Adult Dosage (ages 18 years and older)
  • The dose is 50 mg injected under your skin once per month.
  • For people with ankylosing spondylitis, golimumab may be given with or without the drug methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs).
Child Dosage (ages 0-17 years)

A safe and effective dose hasn’t been established for this age group.

Ulcerative colitis
Form: Prefilled autoinjector
Strengths: 50 mg/0.5 mL and 100 mg/1 mL
Form: Single-dose prefilled syringe
Strengths: 50 mg/0.5 mL and 100 mg/1 mL
Adult Dosage (ages 18 years and older)
  • The starting dose is 200 mg injected under the skin followed by 100 mg injected under the skin a week later.
  • For maintenance, the dose is 100 mg injected under the skin every 4 weeks.
Child Dosage (ages 0-17 years)

A safe and effective dose hasn’t been established for this age group.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.
Pharmacist's Advice
Healthline Pharmacist Editorial Team

Golimumab comes with risks if you don’t take it as prescribed.

If You Don’t Take It at All

The conditions this medication is approved to treat are progressive. This means they can get worse over time, especially when left untreated. Receiving your medications as directed by your doctor, even when you’re feeling well, will give you the best chance of managing your disease and improving your quality of life.

If You Stop or Miss Doses

If you stop taking golimumab or miss doses, your condition may get worse.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you can. Never try to catch up by giving two injections at the same time. This could result in toxic side effects.

How to Tell If the Drug Is Working

You may be able to tell if this medication is working for arthritis if you experience less joint pain and are able to move better.

You may be able to tell if it’s working for ulcerative colitis if you have less diarrhea, bloody stools, and stomach pain.

This is a long-term medication.

This drug needs to be refrigerated

Store golimumab in the refrigerator from 36–46°F (2.2–7.7°C). Once the syringe has been stored at room temperature, it shouldn’t be placed back into the refrigerator. Don’t freeze golimumab. Don’t use it if’s been frozen, even if it’s thawed.

Keep it in its original carton to protect it from light. Keep it away from extreme heat or cold.

Travel

When traveling with your medication:

  • Always carry it with you or in your carry-on bag.
  • Carry golimumab prefilled syringes with you in a travel cooler at a temperature of 36–46°F (2.2–7.7°C).
  • Don’t worry about airport X-ray machines. They can’t hurt this medication.
  • You may need to show your pharmacy’s preprinted label to identify the medication. Keep the original prescription-labeled box with you when traveling.
  • Needles and syringes need to be used to take this medicine. Check for special rules about traveling with medicine, needles, and syringes.

Self-Management

At first, you’ll likely receive golimumab under the supervision of a healthcare provider. You may start to self-inject golimumab if your doctor decides that it’s okay. Your doctor will give you directions on how to take golimumab.

  • To ensure proper use, leave the prefilled syringe or autoinjector at room temperature outside of the carton for 30 minutes. Don’t warm it up in a different way.
  • Before injecting it, look for particles and discoloration in the solution through the viewing window. Golimumab is clear and colorless to light yellow. Don’t use it if the solution is discolored or cloudy, or if there are foreign particles in it.
  • After you give the injection, don’t use any leftover drug that stays in the prefilled syringe or prefilled autoinjector.
  • When you take the dose, if you need multiple injections, do the injections in different places on your body.
  • Make sure to rotate your injection sites. You can give the injection in the front of your middle thighs and lower part of abdomen below the belly button, avoiding the two-inch area around the belly button. Never give injections in skin that’s tender, bruised, red, or hard.

You’ll need these additional supplies:

  • alcohol wipes
  • dry sterile gauze or tissue
  • a puncture-resistant needle disposal container

Syringes and needles are used to inject this medicine. Don’t throw needles in trashcans or recycling bins, and never flush them down the toilet. Ask your pharmacist for a needle clipper and safe container for disposing used needles and syringes. Your community may have program for disposing needles and syringes. If you’re putting the container in the trash, label it “do not recycle”.

Clinical Monitoring

Tuberculosis (TB) test: Your doctor might test you for TB before you start this drug. They might also check you closely for signs and symptoms of TB during your treatment.

Hepatitis B virus infection test: If you carry the hepatitis B virus, your doctor might do blood tests before you start treatment, while you’re using golimumab, and for several months after you stop.

Hidden Costs

Besides the medicine, you’ll need to buy:

  • sterile alcohol wipes
  • gauze
  • a container for throwing away your needles and syringes

Insurance

Many insurance companies require a prior authorization before they approve the prescription and pay for golimumab.

Are There Any Alternatives?

There are other drugs available to treat your condition. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.


Show Sources

Content developed in collaboration with University of Illinois-Chicago, Drug Information Group

Medically reviewed by Creighton University, Center for Drug Information and Evidence-Based Practice on May 21, 2015

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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