Highlights for golimumab

  1. Golimumab subcutaneous injectable solution is available as a brand-name drug. It’s not available as a generic drug. Brand name: Simponi.
  2. Golimumab comes in two injectable forms: a subcutaneous solution and an intravenous (IV) solution.
  3. Golimumab subcutaneous injectable solution is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.

Important warnings

FDA warnings

  • This drug has black box warnings. These are the most serious warnings from the Food and Drug Administration (FDA). Black box warnings alert doctors and patients about drug effects that may be dangerous.
  • Infection warning: This drug can decrease 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 this drug. 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 this drug. Don’t start taking this drug if you have any kind of infection without checking with your doctor first.
  • Cancer warning: 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.

Other warnings

  • Low blood cell count warning: This drug can reduce the number of several different types of blood cells in your body. This can lead to serious health problems including anemia, bleeding problems, and serious infections. If you’ve had blood cell count problems in the past, tell your doctor before starting golimumab.
  • Rubber and 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 this drug and damage your liver. Your doctor may do blood tests to check for the virus before you start treatment, while you’re taking this drug, and for several months after you stop.
  • Heart failure warning: This drug could cause or worsen heart failure. If you already have heart failure, talk to your doctor about whether golimumab is safe for you.

What is golimumab?

Golimumab subcutaneous injectable solution is a prescription medication. It’s a self-injected drug that comes in a prefilled autoinjector and in a 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.

Why it’s used

Golimumab subcutaneous injectable solution is used to treat:

How it works

The conditions that golimumab treats are called autoimmune diseases. With these conditions, your immune system, which fights infection, mistakes a part of your body for a foreign invader and attacks it.

Golimumab works by weakening your immune system. That helps reduce the symptoms caused when your immune system attacks your body.

Injection site reactions

  • 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.

Golimumab side effects

Golimumab subcutaneous injectable solution doesn’t cause drowsiness, but it can cause other side effects.

More common side effects

The more common side effects that can occur with golimumab include:

  • Upper respiratory infections. Report any symptoms of infection to your doctor, even if they’re mild. Symptoms can include:
    • runny nose
    • sore throat
    • hoarseness or laryngitis
  • Viral infections, such as flu and cold sores
  • Injection site reactions. Symptoms can include:
    • redness
    • swelling
    • itching
    • pain
    • bruising
    • tingling

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • Infections. Symptoms can include:
    • cough that doesn’t go away
    • fever
    • unexplained weight loss
    • loss of body fat and muscle
  • Lupus-like syndrome. Symptoms can include:
    • a 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
    • changes in skin appearance
    • flesh-colored or bluish-red lumps, often on your face, head, or neck
  • Heart failure. Symptoms can include:
    • shortness of breath
    • fatigue
    • weight gain
    • fluid buildup in your legs
  • Immunogenicity (the ability of this drug to provoke an immune response in your body). Symptoms can include:
    • allergic reactions
    • symptoms of your disease getting worse despite treatment

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.

Golimumab may interact with other medications

Golimumab subcutaneous injectable solution can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Examples of drugs that can cause interactions with golimumab are listed below.

Biologic drugs

Biologics are made from natural elements. They include vaccines, blood components, and gene therapy. Golimumab is a biologic drug. Combining golimumab with biologic drugs increases your risk of serious infection. Other examples of biologic drugs include:

  • abatacept
  • anakinra
  • rituximab

Live vaccines

Don’t receive a live vaccine while taking golimumab. The vaccine may not fully protect you from disease. Examples of live vaccines include:

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

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.

Golimumab warnings

This drug comes with several warnings.

Allergy warning

This drug can cause a severe allergic reaction. Symptoms may include:

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

If you develop these symptoms, call 911 or go to the nearest emergency room.

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

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.

Warnings for people with certain health conditions

For 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 this drug.

For people with tuberculosis: This drug 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 and during treatment with this drug.

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

For 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, or sudden weight gain.

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

For people with a history of blood cell count problems: This drug can reduce the number of several different types of blood cells in your body. This can lead to serious health problems including anemia, bleeding problems, and serious infections. If you’ve had blood cell count problems in the past, tell your doctor before starting golimumab.

Warnings for other groups

For pregnant women: There is not enough information on the use of golimumab during pregnancy to determine risk to a fetus. Tell your doctor if you’re pregnant or plan to become pregnant. This drug should be used during pregnancy only if the potential benefit justifies the potential risk.

For women who are breastfeeding: This drug may pass through breast milk in small amounts. It isn’t known what effect this would have on a breastfeeding child. You and your doctor may need to decide whether you’ll take this drug 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 this drug.

For children: The safety and effectiveness of this drug haven’t been established in children younger than 18 years.

When to call the doctor

  • Call your doctor right away if you have an infection or have recently received or are scheduled to receive a vaccine.

How to take golimumab

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

Drug forms and strengths

Brand: Simponi

  • 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

Dosage for rheumatoid arthritis (RA)

Adult dosage (ages 18 years and older)

  • Typical dosage: 50 mg injected under your skin once per month.
  • Use with other drugs: For people with RA, golimumab should be given in combination with the drug methotrexate.

Child dosage (ages 0–17 years)

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

Dosage for psoriatic arthritis

Adult dosage (ages 18 years and older)

  • Typical dosage: 50 mg injected under your skin once per month.
  • Use with other drugs: For people with psoriatic arthritis, golimumab may be given with or without the drug methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

Child dosage (ages 0–17 years)

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

Dosage for ankylosing spondylitis

Adult dosage (ages 18 years and older)

  • Typical dosage: 50 mg injected under your skin once per month.
  • Use with other drugs: For people with ankylosing spondylitis, golimumab may be given with or without the drug methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

Child dosage (ages 0–17 years)

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

Dosage for ulcerative colitis

Adult dosage (ages 18 years and older)

  • Typical starting dosage: 200 mg injected under the skin, followed by 100 mg injected under the skin 2 weeks later.
  • Typical maintenance dosage: 100 mg injected under the skin every 4 weeks.

Child dosage (ages 0–17 years)

A safe and effective dosage 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 speak with your doctor or pharmacist about dosages that are right for you.

Take as directed

Golimumab subcutaneous injectable solution is used for long-term treatment. It 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 this drug 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 dangerous side effects.

How to tell if the drug is working: For arthritis: You should have less joint pain and are able to move better.

For ulcerative colitis: You should have less diarrhea, bloody stools, and stomach pain.

Important considerations for taking golimumab

Keep these considerations in mind if your doctor prescribes golimumab for you.

Storage

  • This drug needs to be refrigerated. Store it in the refrigerator at a temperature between 36°F and 46°F (2°C and 8°C).
  • Once the syringe has been stored at room temperature, it shouldn’t be placed back into the refrigerator.
  • Don’t freeze this drug. Don’t use if it’s been frozen, even if it’s thawed.
  • Keep this drug in its original carton to protect it from light.
  • Keep this drug away from extreme heat or cold.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

  • Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
  • Carry this drug’s prefilled syringes with you in a travel cooler at a temperature between 36°F and 46°F (2°C and 8°C).
  • Don’t worry about airport X-ray machines. They can’t harm your medication.
  • You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
  • Needles and syringes need to be used to take this medication. Check for special rules about traveling with medication, needles, and syringes.
  • Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Self-management

At first, you’ll likely receive this drug under the supervision of a healthcare provider. You may start to self-inject this drug if your doctor decides that it’s okay. If so, your doctor will give you directions on how to take golimumab. Here are a few tips:

  • 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. Keep the cover or cap on the needle or autoinjector, removing it right before injection.
  • Before injecting the drug, look for particles and discoloration in the solution through the viewing window. This drug 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.
  • When you inject, don’t pull the autoinjector away from your skin until you hear two “click” sounds. This usually takes about 3 to 6 seconds, but it may take up to 15 seconds for you to hear the second click after the first one. If you pull the autoinjector away from your skin before the injection is completed, you may not receive a full dose of this drug.
  • 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.
  • Be sure to rotate your injection sites. You can give the injection in the front of your middle thighs and lower part of your 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 medication. Don’t throw needles in trash cans 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 a program for disposing needles and syringes. If you’re putting the container in the trash, label it “do not recycle.”

Clinical monitoring

Your doctor may do certain tests before and during your treatment with golimumab. These tests will help keep you safe while you take this drug. They may include:

  • 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 this drug, and for several months after you stop.

Availability

Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it.

Hidden costs

Besides the medication, you’ll need to buy:

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

You may also have certain tests done. The cost of these tests will depend on your insurance coverage.

Prior authorization

Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

Are there any alternatives?

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

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.