Orencia (abatacept) is a prescription brand-name medication. It’s approved by the Food and Drug Administration (FDA) to treat certain forms of:
- rheumatoid arthritis in adults
- polyarticular juvenile idiopathic arthritis in children ages 2 years and older
- psoriatic arthritis in adults
It’s also approved to help prevent acute (sudden) graft-versus-host disease that can occur with hematopoietic stem cell transplantation. For this purpose, Orencia can be given to adults and children ages 2 years and older. And it’s given with certain other drugs.
Here are some fast facts about Orencia:
- Active ingredient: abatacept, which is a
- Drug class: immunomodulator
- Drug forms:
- single-dose vial for IV infusion
- single-dose prefilled syringe for subcutaneous injection
- single-dose prefilled ClickJect autoinjector for subcutaneous injection
Like other drugs, Orencia can cause side effects. Read on to learn about potential common, mild, and serious side effects. For a general overview of Orencia, including details about its uses, see this article.
Orencia can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
These are just a few of the more common side effects reported by people who took Orencia in clinical studies:
* For more information about this side effect, see “Side effect specifics” below.
Mild side effects can occur with Orencia use. This list doesn’t include all the possible mild side effects of the drug. For more information, you can refer to Orencia’s prescribing information.
Mild side effects that have been reported with Orencia include:
- upper respiratory infection*
- sore throat
- injection site reaction, such as itchiness or skin that’s red or otherwise discolored †
These side effects may be temporary, lasting a few days to weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while using Orencia and want to tell the FDA about it, visit MedWatch.
* For more information about this side effects, see “Side effect specifics” below.
† This side effect was reported only in people who received Orencia by subcutaneous injection.
Orencia may cause serious side effects. The list below may not include all the possible serious side effects of the drug. For more information, you can refer to Orencia’s prescribing information.
If you develop serious side effects while using Orencia, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Serious side effects* that have been reported with Orencia include:
- possible risk of certain cancers
- serious infection
- Epstein-Barr virus or cytomegalovirus, or reactivation of either virus, in certain people
- infusion reaction
- allergic reaction
* For more information about the side effects in this list, see “Side effect specifics” below.
Orencia may cause several side effects. Here are some frequently asked questions about the drug’s side effects, and their answers.
Does Orencia cause different side effects when it’s given as an infusion or an injection?
When Orencia is given as an infusion, it may cause infusion reactions, such as dizziness. These are side effects that appear after infusions. For details, see “Infusion reactions” in “Side effect specifics” below.
When Orencia is given as a subcutaneous injection, you may have mild injection site reactions, such as itchiness or red or discolored skin.
If you have additional questions about how Orencia infusions and subcutaneous injections are alike and different, talk with your doctor or pharmacist.
Is weight gain a side effect of Orencia treatment?
No. People using Orencia in clinical studies didn’t report weight gain as a side effect.
Weight gain can be a side effect of certain medications that treat some of the same conditions as Orencia.
For example, corticosteroids, such as prednisone, and Trexall (methotrexate) can cause weight gain. Both corticosteroids and methotrexate are used to treat rheumatoid arthritis (RA) and psoriatic arthritis (PsA). And your doctor might prescribe methotrexate in combination with Orencia, depending on why you’re taking Orencia.
If you have concerns about your weight, talk with your doctor. They can recommend ways to help you maintain a moderate weight.
Can hair loss be a side effect of Orencia?
People using Orencia in clinical studies didn’t note hair loss as a side effect.
In rare cases, hair loss can be a symptom of RA, which Orencia is used to treat.
Also, other medications that treat some of the same conditions as Orencia may cause hair loss. For example, hair loss is a known side effect of Trexall (methotrexate). Orencia may be used in combination with methotrexate for acute (sudden) graft-versus-host disease prevention, and for polyarticular juvenile idiopathic arthritis (pJIA).
If you’re concerned about hair loss, talk with your doctor or pharmacist. They may be able to see whether other medications you take could be the cause and suggest treatments.
Does Orencia cause neurological side effects?
No, people using Orencia in clinical studies didn’t report neurological side effects.
Neurological side effects affect your brain or nervous system. RA, which Orencia is used to treat, can cause neurological symptoms. These symptoms include peripheral neuropathy (nerve damage that causes numbness, weakness, and pain in your arms or legs).
Some medications that treat conditions Orencia is used for can cause neurological side effects. For example, methotrexate can cause dizziness, drowsiness, and mood changes. Remicade (infliximab) is known to cause seizures in very rare cases. Both methotrexate and infliximab are used to treat RA and PsA. Methotrexate may be used in combination with Orencia for certain children with pJIA.
If you have concerns about neurological side effects of your medications, talk with your doctor or pharmacist. They can review potential side effects of the drugs.
Could depression be a side effect of Orencia?
Some medications used for conditions that Orencia is prescribed to treat can affect mood. For example, corticosteroids (such as prednisone) are known to cause mood changes and depression. Corticosteroids are prescribed to treat RA and PsA.
Methotrexate is also known to cause mood changes. Methotrexate may be prescribed in combination with Orencia for certain children with pJIA, and to help prevent acute (sudden) graft-versus-host disease.
In addition, not knowing when RA will flare up could lead to depression. You may also be more likely to develop depression if you have PsA.
If you’d like to learn more about depression and your medications, talk with your doctor or pharmacist. They can review the possible side effects of the drugs.
Are there any long-term side effects of Orencia?
Treatment with Orencia could cause long-term side effects, but this isn’t common. Long-term side effects may include:
These side effects, including Orencia’s possible link to certain cancers, are discussed in “Side effect specifics” below.
If you have additional questions about potential long-term side effects of Orencia, talk with your doctor or pharmacist.
Learn more about some of the side effects that Orencia may cause.
Treatment with Orencia may increase the risk of a serious infection, such as pneumonia. It may also increase the risk of sepsis (a dangerous reaction to an infection). In rare cases, these side effects can be life threatening. This is because Orencia can make your immune system less able to protect you from infections.
A serious infection was a more rare side effect in clinical studies. Most serious infections occurred in people using other medications that weakened their immune system.
Symptoms of an infection can include:
Note: Certain other infections are also possible if you’re receiving Orencia for graft-versus-host disease prevention. See the “Epstein-Barr virus and cytomegalovirus” section just below for details.
Certain people may have a higher risk of serious infections than usual if they use Orencia. For details, see “Precautions for Orencia” below.
What you can do
To help prevent infection, talk with your doctor about whether you need any vaccines before starting Orencia treatment.
If you develop symptoms of an infection while using Orencia, talk with your doctor right away. If your infection is serious, they’ll likely have you stop using Orencia until your infection clears.
Before you begin treatment with Orencia, your doctor will test you for tuberculosis (TB). This is an infection that affects your lungs. TB doesn’t always cause symptoms, so you may not know if you have it. Knowing whether you have TB will help your doctor determine if Orencia is safe for you.
Epstein-Barr virus and cytomegalovirus
If you’ve had either infection in the past, Orencia can cause the virus to reactivate (cause symptoms). Symptoms may include:
- reduced appetite
- swollen lymph nodes
What you can do
Your doctor will likely prescribe drugs with Orencia to help prevent these infections, if you’re taking the drug for graft-versus-host disease. They’ll also monitor you for symptoms of any infection.
It’s possible that Orencia can increase the risk of developing certain cancers, such as skin cancer and lymphoma (a type of blood cancer). These cancers were very rarely reported in clinical studies by people using Orencia for rheumatoid arthritis (RA). But it’s not known for certain whether the cancer was due to Orencia or other factors.
It’s important to note that people with RA are known to have an increased risk of developing lymphoma.
Symptoms of skin cancer and lymphoma
Here are some possible symptoms of skin cancer and lymphoma.
Symptoms of skin cancer can include:
- new moles or skin growths
- skin sores that don’t heal
- changes in skin growths or moles
- skin lesions that change, bleed all of a sudden, or don’t heal
Lymphoma often doesn’t cause symptoms. But in some people it can cause:
What you can do
While you use Orencia, your doctor will usually check you for skin cancer from time to time. You should talk with them right away if you notice any of the symptoms of skin cancer or lymphoma mentioned above. Your doctor will likely want to see you to check your symptoms and order any tests that they think will be useful.
Upper respiratory infection
An upper respiratory infection is a possible side effect of Orencia. This is expected because the drug makes your immune system less able to protect you from infections. This was one of the most common side effects in clinical studies of Orencia.
- discomfort, congestion, or swelling in your nose and sinuses
- mild fever
- producing more mucus than usual
- scratchy or sore throat
What you can do
If you develop symptoms of an upper respiratory infection while using Orencia, talk with your doctor. Because the drug can increase your risk of serious infections, they’ll likely want to examine you in person. Then your doctor can determine the best way to treat your infection.
If Orencia is given as an IV infusion, infusion reactions may occur. These are side effects that appear after you receive an infusion.
Infusion reactions were common in clinical studies of Orencia IV infusions. Examples include:
In most people, these reactions were mild or moderate. But there were rare reports of more serious reactions, including anaphylaxis (a severe and potentially life threatening allergic reaction).
What you can do
A healthcare professional will monitor you while you receive your Orencia infusions. If you develop symptoms of an infusion reaction, they’ll have treatments ready to give you. Depending on the severity of your reaction, your doctor may recommend that you stop Orencia treatment.
When an allergic reaction occurs, the symptoms can be mild or serious and can include:
- skin rash
- swelling under your skin, typically in your lips, eyelids, feet, or hands
- swelling of your mouth, tongue, or throat, which can make it hard to breathe
What you can do
For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep using Orencia. But if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Orencia is approved to treat polyarticular juvenile idiopathic arthritis in children ages 2 years and older. It’s also approved to help prevent acute (sudden) graft-versus-host disease in certain children ages 2 years and older.
Most side effects in children who received the drug in clinical studies were the same as those reported in adults treated for other conditions. But a few additional side effects in children weren’t reported (or weren’t common) in adults. These included:
If you have questions about Orencia’s side effects in children, talk with your doctor or pharmacist.
Be sure to talk with your doctor about your health history before you use Orencia. This drug may not be the right treatment if you have certain medical conditions or other factors that affect your health. The conditions and factors to consider include:
Chronic obstructive pulmonary disease. In clinical studies, people with chronic obstructive pulmonary disease (COPD) were more likely to have certain side effects of Orencia than people without COPD. Examples include cough and abnormal breath sounds. If you have COPD, your doctor can help determine if Orencia is safe for you to use. If they recommend the drug, your doctor will likely want to monitor you more closely than usual during the treatment.
Current or past infection, or a weakened immune system. Orencia can weaken your immune system and make you more likely to develop infections. If you have a current infection, using Orencia may make it harder to treat. Your doctor will likely want to treat your current infection before you start treatment with Orencia.
History of cytomegalovirus or Epstein-Barr virus, in certain people. If you’re receiving Orencia for graft-versus-host disease prevention, and you’ve had cytomegalovirus or Epstein-Barr virus in the past, Orencia can cause these viruses to become active (cause symptoms) again. Your doctor will monitor you for symptoms during and after your Orencia treatment. Be sure to tell your doctor about any past infections you’ve had before you start it.
In some cases, you may have a higher risk of serious infections than usual if you use Orencia. Your risk is increased if you have a weakened immune system or had infections that kept coming back. You can talk with your doctor about any past infections and whether Orencia is right for you.
Need for vaccines. If you receive any vaccines while you’re taking Orencia, they might not work correctly. Also, you should not get any live vaccines while you’re taking Orencia, or for 3 months after your last dose. (Live vaccines contain a weakened form of a virus or bacteria.) Talk with your doctor about any vaccinations you may need before you start Orencia treatment.
History of hepatitis B. If you have had an infection called hepatitis B, using Orencia may make the virus that causes hepatitis B become active again. If the virus is active, it can cause hepatitis B symptoms to return. People who had the hepatitis B virus weren’t included in clinical studies of Orencia.
Your doctor will likely want to check you for the virus before you begin using Orencia. If you have the virus, they’ll usually want to treat it before you start using Orencia.
History of tuberculosis. Using Orencia may cause a flare-up of a latent infection, such as tuberculosis (TB). A latent infection doesn’t cause symptoms but is still present in your body. Your doctor will likely screen you for TB before you begin using Orencia. If you do have TB, they can help determine the best treatment. It’s not known if Orencia is safe for people with latent TB.
Personal or family history of skin cancer. It’s possible that Orencia can increase your risk of skin cancer. If you have a personal or family history of skin cancer, you may have a higher risk than usual. And your doctor will likely want to monitor you closely if they decide that Orencia is safe for you.
Allergic reaction. If you’ve ever had an allergic reaction to Orencia or any of its ingredients, your doctor will likely not prescribe Orencia. Talk with your doctor about which other treatments may be better choices for you.
Alcohol use with Orencia
There’s no known direct interaction between drinking alcohol and using Orencia. However, alcohol may worsen symptoms of the conditions that Orencia is used for.
If you drink, talk with your doctor about how much alcohol is safe for you while you use Orencia.
Pregnancy and breastfeeding while using Orencia
Here’s some information about pregnancy, breastfeeding, and Orencia.
Pregnancy. It’s not known whether it’s safe to use Orencia while pregnant. There haven’t been enough studies in pregnant people using the medication. If you’re pregnant or planning a pregnancy, your doctor can weigh the pros and cons of Orencia with you.
If you’re pregnant and using Orencia, your doctor may ask you to join a pregnancy registry. The registry allows doctors to collect information about the safety of Orencia for pregnant people. To find more information, call 877-311-8972 or visit the registry’s website. You can also talk with your doctor.
Breastfeeding. It’s not known whether it’s safe to breastfeed while using Orencia. Studies haven’t looked at the medication’s use in people who breastfeed or whether Orencia could cause side effects in a breastfed child. If you’re breastfeeding or plan to, you doctor can advise you about the risks and benefits of Orencia.
Treatment with Orencia can cause side effects, but they’re usually mild. Most mild side effects of the drug go away with time and don’t require medical attention. However, serious side effects are possible, as with most medications. You should talk with your doctor if you experience serious side effects while using Orencia.
You should also talk with your doctor if you become pregnant during your Orencia treatment. It’s not known if it’s safe for pregnant people to use the medication.
If you’d like to learn more about Orencia, talk with your doctor or pharmacist. They can help answer any questions you have about side effects of this drug.
In addition, you can do some research on your own. These articles might help:
- More information about Orencia. For details about other aspects of Orencia, refer to this article.
- Dosage. For information about Orencia’s dosage, see this article.
- A look at arthritis. To learn more about this condition, you can refer to our arthritis hub and these lists of rheumatology and psoriatic arthritis articles.
Disclaimer: Medical News Today 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 another 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.