Orencia is a brand-name prescription medication that’s used for:

  • Rheumatoid arthritis (RA). Orencia is approved for use in adults with moderate to severe active RA. It can be taken alone or in combination with other drugs also used to treat RA.
  • Psoriatic arthritis (PsA). Orencia is approved for use in adults with PsA. It can be taken alone or in combination with other drugs also used to treat PsA.
  • Polyarticular juvenile idiopathic arthritis (pJIA). Orencia is approved for use in children ages 2 years and older with moderate to severe active pJIA. For this condition, Orencia can be used alone or in combination with another drug called methotrexate.
  • Prevention of acute (sudden) graft-versus-host disease (GVHD). Orencia is approved for use in adults and children ages 2 years and older who are having hematopoietic stem cell transplantation. GHVD occurs when the transplanted cells attack other cells. To help prevent this, Orencia is used with methotrexate and another type of drug called a calcineurin inhibitor.

Orencia contains the drug abatacept, which is a biologic drug. Biologics are made from living cells (such as those from plants or animals) rather than from chemicals.

Orencia comes in two forms: a liquid form and a powder form. You can take the medication by either of these ways:

  • IV infusion. The powder form of Orencia is used to make a solution, which is infused into a vein by a healthcare professional. This form of Orencia is available in one strength: 250 milligrams (mg).
  • Subcutaneous injection. The liquid form of Orencia is injected under your skin. This form of Orencia is available in one strength: 125 milligrams per milliliter (mg/mL).

Effectiveness

In clinical studies, Orencia was effective in treating moderate to severe RA. When taken together with methotrexate, Orencia worked well in improving symptoms of the disease. In these studies, ACR scores (named after the American College of Rheumatology) were used to measure people’s response to treatment. Having an ACR score of 20 meant that the people’s RA symptoms had improved by 20%.

Of people taking Orencia in combination with methotrexate, 62% reached an ACR score of 20 after 3 months. Of people taking methotrexate with a placebo (treatment with no active drug), 37% had the same result.

Orencia also worked well in people taking Orencia alone, without methotrexate. Of those taking Orencia alone, 53% reached an ACR score of 20 after 3 months. Of people who did not receive treatment with Orencia or methotrexate but who took a placebo, 31% had the same result.

Orencia has also been found to help prevent acute GVHD in certain adults and children.

For more information on the effectiveness of Orencia for other conditions, please see the “Orencia uses” section below.

Orencia is available only as a brand-name medication. It’s not currently available in biosimilar form.

A biosimilar drug is roughly comparable to a generic drug. A generic drug is a copy of a regular drug (one that’s made from chemicals). A biosimilar drug is made to be similar to a biologic drug (one that’s made from living cells).

Both generics and biosimilars have similar safety and effectiveness as the drug they’re made to copy. Also, they tend to cost less than brand-name drugs.

Orencia can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Orencia. These lists do not include all possible side effects.

For more information on the possible side effects of Orencia, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

More common side effects

The more common side effects of Orencia can include:

  • upper respiratory infections, such as the common cold or a sinus infection
  • headache
  • nausea

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

Serious side effects

Serious side effects from Orencia aren’t common, but they can occur. 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, which are discussed below in “Side effect details,” can include the following:

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on several of the side effects this drug may or may not cause.

Serious infections

You may have a higher risk of serious infections while you’re taking Orencia. This is because the drug makes your immune system less able to protect you from infections.

In clinical studies, 54% of people taking Orencia had infections. Infections were considered serious in 3% of people taking Orencia in the studies. Of those who took a placebo (treatment with no active drug), 48% had infections. Infections were considered serious in 1.9% of people who took the placebo. The most common serious infections affected people’s lungs, skin, urinary tract, colon, and kidneys.

Symptoms of an infection can vary, depending on which part of your body is affected. They may include:

  • fever
  • feeling very tired
  • cough
  • flu-like symptoms
  • warm, red, or painful areas on your skin

Let your doctor know if you have symptoms of an infection. They may recommend certain tests to see what kind of infection you have. If needed, they’ll also prescribe medications to treat your infection.

In some cases, it may be hard to treat serious infections while you’re taking Orencia. If you have an infection, your doctor may recommend that you stop taking Orencia until your infection is gone.

Also, your doctor will want to make sure that you don’t have either a hepatitis B or tuberculosis (TB) infection before you start taking Orencia. The hepatitis B virus affects your liver, and TB affects your lungs. These viruses may or may not cause symptoms. When they don’t, you may not know you have the infection. Knowing if you have hepatitis B or TB will help your doctors determine whether Orencia is safe for you to use. See “Orencia precautions” below for details.

Epstein-Barr virus or cytomegalovirus

In people receiving Orencia to help prevent acute (sudden) graft-versus-host disease, the drug may cause infection with cytomegalovirus or Epstein-Barr virus. These are serious viral infections.

Also, if you’ve had either infection in the past, Orencia can cause the virus to become active again and start causing symptoms.

To prevent graft-versus-host disease, Orencia is typically given with other medications to help prevent the two infections. Your doctor will monitor you for signs of these and other infections during and after your Orencia treatment.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Orencia. In clinical studies, less than 1% of people taking Orencia had an allergic reaction. Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Orencia. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Cancer

You may have an increased risk of cancer if you take Orencia. This drug can affect the way your cells function and may increase how quickly your cells grow and multiply (make more cells). These effects can cause cancer.

In clinical studies, 1.3% of people taking Orencia developed cancer. Of those not taking Orencia, but who took a placebo (treatment with no active drug), 1.1% had the same result. In most cases, the cancer occurred in people’s lungs and blood.

It’s not known if the cancer was caused by using Orencia. It’s possible that other factors played a role in its development.

Symptoms of cancer can vary depending on the area of your body that’s affected. Symptoms may include:

  • neurological changes (such as headaches, seizures, vision or hearing problems, or being paralyzed in your face)
  • bleeding or bruising more easily than usual
  • cough
  • fatigue (lack of energy)
  • fever
  • swelling
  • lumps
  • weight gain or weight loss

Tell your doctor if you have any symptoms of cancer. They’ll recommend certain tests to see if you’ve developed cancer. If you have cancer, they’ll recommend treatment for it. They’ll also discuss with you whether it’s still safe for you to take Orencia.

Skin rash

In clinical studies, skin rash wasn’t a serious side effect in people taking Orencia. Of people with RA who took Orencia, 4% had a rash during studies. Of those who took placebo (treatment with no active drug), 3% had a rash. A mild skin rash can also occur in the area of your body where Orencia is injected.

In some cases, a skin rash can be a symptom of an allergic reaction. (See the “Allergic reaction” section above.)

If you have a skin rash that doesn’t go away while you’re using Orencia, tell your doctor. They’ll talk with you about what may be causing your skin rash. They may ask if you have symptoms of a serious allergic reaction. If you’re having an allergic reaction, your doctor will prescribe medications to reduce your allergy symptoms, and they may have you stop using Orencia.

Weight gain (not a side effect)

During clinical studies, weight gain wasn’t a side effect in people taking Orencia.

If you’re concerned about weight gain while you’re using Orencia, talk with your doctor.

Hair loss (not a side effect)

In clinical studies, hair loss wasn’t a side effect in people taking Orencia. But hair loss may occur in people with certain forms of arthritis, including those that Orencia may be used to treat.

Let your doctor know if you’re concerned about hair loss, or if you have hair loss while you’re using Orencia. They may recommend tests to try to figure out why it’s happening and offer ways to help you cope with the side effect.

Fatigue (not a side effect)

Fatigue (lack of energy) wasn’t a side effect in people taking Orencia during clinical studies. But some people with different forms of arthritis (such as those that Orencia is used to treat) may experience fatigue.

Tell your doctor if you have fatigue that doesn’t go away while you’re using Orencia. They’ll recommend certain tests to help figure out the cause of your fatigue. If needed, they may also prescribe medications to help relieve your fatigue.

The Orencia dosage your doctor prescribes will depend on several factors. These include:

  • the type and severity of the condition you’re using Orencia to treat
  • your weight
  • the form of Orencia you take

Typically, your doctor will start you on the usual dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Orencia comes in two forms: powder and liquid. These forms have different strengths.

Powder form

The powder form:

  • is available in one strength: 250 mg (milligrams)
  • is mixed with liquid to make a solution that’s given to you as an IV infusion (an injection into your vein, given over time)

Liquid form

The liquid form:

  • is available in one strength: 125 mg/mL (milligrams per milliliter)
  • is given to you as a subcutaneous injection (an injection under your skin)
  • comes in prefilled glass syringes that hold 0.4 mL, 0.7 mL, and 1.0 mL of liquid
  • also comes in a 1-mL vial that’s placed into a device called a ClickJect autoinjector

Dosage for rheumatoid arthritis

The dosage of Orencia for rheumatoid arthritis (RA) typically depends on how you’re taking the drug. Dosages for IV infusion and subcutaneous injection are described below.

IV infusion

The dosage of Orencia for each IV infusion will depend on your body weight. The typical dosage of Orencia is:

  • 500 mg for people weighing less than 60 kilograms (kg)* (about 132 pounds [lb])
  • 750 mg for people weighing 60 to 100 kg (about 132 to 220 lb)
  • 1,000 mg for people weighing more than 100 kg (about 220 lb)

Each IV infusion will last about 30 minutes.

After your first dose of Orencia, you’ll be given two more doses every 2 weeks. After that, each dose is given every 4 weeks.

* One kg is equal to about 2.2 lb.

Subcutaneous injection

The typical dosage of Orencia for subcutaneous injection is: 125 mg once each week.

Your first subcutaneous injection may or may not be given after you’ve had a previous dose of Orencia through an IV infusion. If you’ve had an IV infusion of Orencia, you’ll typically take your first subcutaneous injection of the drug on the day following your IV treatment.

Dosage for psoriatic arthritis

The dosage of Orencia for psoriatic arthritis (PsA) typically depends on how you’re taking the drug. Dosages for IV infusion and subcutaneous injections are reviewed below.

IV infusion

The dosage of Orencia for each IV infusion will depend on your body weight. The typical dosage of Orencia is:

  • 500 mg for those weighing less than 60 kg (about 132 lb)
  • 750 mg for those weighing 60 to 100 kg (about 132 to 220 lb)
  • 1,000 mg for those weighing more than 100 kg (about 220 lb)

Each IV infusion will last about 30 minutes.

After your first dose of Orencia, you’ll be given two more doses every 2 weeks. After that, each dose is given every 4 weeks.

Subcutaneous injection

The typical dosage of Orencia for subcutaneous injection is 125 mg once each week.

Dosage for polyarticular juvenile idiopathic arthritis

The dosage of Orencia for polyarticular juvenile idiopathic arthritis (pJIA) typically depends on how you’re taking the drug. Dosages for IV infusions and subcutaneous injections are reviewed below.

IV infusion

The dosage of Orencia for each IV infusion may depend on your or your child’s body weight. The typical dosage of Orencia in children ages 6 years and older with pJIA is:

  • 10 mg/kg (mg of drug per kg of body weight) for those weighing less than 75 kg (about 165 lb)
  • 750 mg for those weighing 75 kg and 100 kg (about 165 pounds to 220 lb)
  • 1,000 mg for those weighing more than 100 kg (about 220 lb)

For example, a person who weighs 50 kg (about 110 lb) will take 500 mg of Orencia. This is 10 milligrams of drug for each kilogram of their body weight.

After your or your child’s first dose of Orencia, two more doses will be given every 2 weeks. After that, each dose is given every 4 weeks.

IV administration of Orencia is not recommended in children who are younger than 6 years of age.

Subcutaneous injection

The dosage of Orencia for subcutaneous injection will depend on your or your child’s body weight. The typical dosage of Orencia in children ages 2 years and older with pJIA is:

  • 50 mg for those weighing 10 kg to less than 25 kilograms (about 22 pounds to less than about 55 lb)
  • 87.5 mg for those weighing 25 kg to less than 50 kilograms (about 55 pounds to less than about 110 lb)
  • 125 mg for those weighing 50 kg or more (about 110 lb or more)

In people ages 6 years and older, their first injection of Orencia may or may not be given after they’ve had an IV infusion of the drug. If an IV infusion of Orencia has already been given, the first subcutaneous injection of the drug is typically given on the day following the IV infusion.

Dosage for acute graft-versus-host disease prevention

To help prevent acute (sudden) graft-versus-host disease, Orencia is given as an IV infusion. The typical dosage for this use is:

  • 10 mg/kg (mg of drug per kg of body weight) for adults and in children ages 6 years and older.
  • 15 mg/kg for the first dose in children ages 2 to less than 6 years, followed by 12 mg/kg on days 5, 14, and 28 of treatment.

For example, an adult who weighs 75 kg (about 165 lb) will receive 750 mg of Orencia per infusion. This is 10 mg of drug for each kg of their body weight.

Orencia is given on the day before hematopoietic stem cell transplantation and on days 5, 14, and 28 after the transplant. Each IV infusion will last about 60 minutes.

To prevent the disease, Orencia is given in combination with methotrexate and another type of drug called a calcineurin inhibitor. Your doctor may have you start taking these drugs before you begin the Orencia treatment, and you might continue taking them after your transplant.

Pediatric dosage

The typical recommended dosage of Orencia varies depending on how it’s taken and the body weight of the person taking it. For more information about the dosage in children, see the “Dosage for polyarticular juvenile idiopathic arthritis” and “Dosage for acute graft-versus-host disease prevention” sections above.

What if I miss a dose?

What you’ll do for a missed dose depends on how you take Orencia. But for both cases, medication reminders can help make sure that you don’t miss a dose.

IV infusion

If you missed an appointment for your infusion of Orencia, call your healthcare clinic right away. They’ll schedule a new appointment for you to receive your Orencia IV treatment.

Subcutaneous injection

If you missed a subcutaneous injection of Orencia, call your doctor right away. They’ll help you create a new dosage schedule to follow.

Will I need to use this drug long term?

Possibly, if you’re taking it for arthritis. The forms of arthritis that Orencia is used to treat are chronic (long-term) diseases. Orencia may be used long term for treatment if you and your doctor feel that the drug is safe and effective for you.

If you’re receiving Orencia to help prevent graft-versus-host disease, you might only take the drug for about a month.

The Food and Drug Administration (FDA) approves prescription drugs such as Orencia to treat certain conditions. Orencia is FDA-approved to treat three different types of arthritis: rheumatoid arthritis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis. It’s also approved to help prevent acute (sudden) graft-versus-host disease in certain situations.

Orencia for rheumatoid arthritis

Orencia is FDA-approved to treat moderate to severe active rheumatoid arthritis (RA) in adults. It’s used mostly in adults who have ongoing symptoms of the disease.

RA is an autoimmune disease that causes damage in your joints. Symptoms of RA can include pain, swelling, and stiffness throughout your body.

Orencia is recommended by experts as a treatment for RA. Your doctor may want you to use it alone or in combination with other drugs, including methotrexate. These other drugs are sometimes called disease-modifying antirheumatic drugs (DMARDs).

Effectiveness for rheumatoid arthritis

In one clinical study, Orencia was given with methotrexate to 424 people with moderate to severe RA. Orencia was given by IV infusion. Of those taking Orencia, 62% of people had at least a 20% reduction in their RA symptoms after 3 months of treatment. Of those taking a placebo (treatment with no active drug) with methotrexate, 37% had the same result.

Another clinical study looked at Orencia treatment in people with RA. People were given both Orencia and methotrexate. But in this study, the combination of medications was given by subcutaneous injection to one group. And another group was given the medications by IV infusion.

After 3 months of treatment, 68% of people taking the medications by subcutaneous injection had at least a 20% reduction in their RA symptoms. This is compared to 69% of people who took the medications by IV infusion.

Orencia for psoriatic arthritis

Orencia is FDA-approved to treat adults with psoriatic arthritis (PsA). It’s used mostly in people with ongoing symptoms of the disease. In fact, current recommendations by experts suggest using Orencia in these people.

PsA is a type of arthritis that occurs in people with psoriasis. Symptoms of the condition generally include red, scaly skin patches, and sore, swollen joints.

Effectiveness for psoriatic arthritis

In one clinical study, Orencia was given to 40 people with PsA using IV infusion. After 24 weeks of treatment, 47.5% of people taking Orencia had at least a 20% reduction in their PsA symptoms. Of those taking a placebo (treatment with no active drug), 19% had the same result.

In another clinical study, Orencia was given to 213 people with PsA using subcutaneous injection (an injection under their skin). After 24 weeks of treatment, 39.4% of those who took Orencia had at least a 20% reduction in their PsA symptoms. Of those taking a placebo (treatment with no active drug), 22.3% had the same result.

Orencia for polyarticular juvenile idiopathic arthritis

Orencia is FDA-approved to treat moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA). This condition is the most common form of arthritis in children. It causes joint pain, swelling, and stiffness in 5 or more joints.

Orencia should be used in children where JIA affects many of their body parts. It’s approved for use in children ages 2 years and older.

Experts currently recommend using Orencia in these people. The drug can be used alone or in combination with methotrexate.

Effectiveness for polyarticular juvenile idiopathic arthritis

In one clinical study, Orencia was given to 190 children with pJIA who were ages 6 to 17 years. The children received Orencia through an IV infusion. Most of the children also received methotrexate. By the end of the study, 65% of children taking Orencia had at least a 30% reduction in their JIA symptoms.

In another clinical study, Orencia was given as a subcutaneous injection to 205 children with JIA. The children had previously received other drugs to treat their JIA, but they still had symptoms of the condition. By the end of the study, Orencia was effective in reducing the symptoms of JIA. The results of this study were similar to the results of the IV infusion study.

Orencia for acute graft-versus-host disease prevention

Orencia is FDA-approved to help prevent acute (sudden) graft-versus-host disease caused by hematopoietic stem cell transplantation. It can be used for this purpose in adults and in children ages 2 years and older, along with certain other medications.

In someone with this condition, the transplanted cells attack other cells. This can cause a variety of symptoms, including stomach and digestive problems, skin problems, weight loss, and fatigue. The disease can be life- threatening in some cases.

The risk of this condition depends partly on how close the match is between your cells and your donor’s cells. Orencia can be used in people who had a matched donor or a 1-allele mismatched donor (a donor whose cells didn’t match yours in a certain way).

For graft-versus-host disease prevention, Orencia is given in combination with methotrexate and another type of drug called a calcineurin inhibitor.

Effectiveness for acute graft-versus-host disease prevention

In clinical studies, Orencia was found to be effective for preventing this condition in adults and children ages 2 years and older, when given with methotrexate and a calcineurin inhibitor.

Orencia for other conditions

You may wonder if Orencia is used for other conditions. Below are conditions that Orencia may sometimes be used off-label to treat. Off-label use means that the drug is used to treat a condition even though it’s not FDA-approved to do so.

Orencia for lupus (off-label use)

Orencia isn’t FDA-approved to treat lupus, but sometimes it’s used off-label for this condition.

Some experts believe that Orencia can be helpful in reducing the symptoms of lupus. But recent clinical studies haven’t been able to show how well Orencia improves this condition. More information is needed to know for sure if Orencia is safe and effective to use in people with lupus.

Talk with your doctor if you have lupus and you’re interested in taking Orencia. They’ll discuss your treatment options with you and prescribe a medication that’s safe and effective for you.

Orencia for ankylosing spondylitis (not a recognized treatment)

Orencia isn’t FDA-approved to treat ankylosing spondylitis (AS). Also, experts don’t recommend using the drug to treat this disease.

Talk with your doctor if you have AS. They’ll discuss your treatment history and recommend the best medication for you.

Orencia for children

Orencia is FDA-approved for use in children with moderate to severe polyarticular juvenile idiopathic arthritis (pJIA). It’s also approved to help prevent acute (sudden) graft-versus-host disease in children. For more information, see the “Orencia for polyarticular juvenile idiopathic arthritis” and “Orencia for acute graft-versus-host disease prevention” sections above.

Orencia can be used alone or in combination with other drugs. Your doctor will recommend if you need to take other medications with Orencia to treat your condition. This is more likely in people with rheumatoid arthritis or polyarticular juvenile idiopathic arthritis, and in people receiving Orencia for prevention of acute (sudden) graft-versus-host disease.

Orencia with other drugs for rheumatoid arthritis

Orencia is FDA-approved to treat adults with moderate to severe active rheumatoid arthritis (RA). The drug can be used alone or in combination with other medications. However, if it’s used with other drugs, those drugs shouldn’t belong to the group of drugs called anti-TNFs. (See the “Orencia interactions” section below for more details.)

In clinical studies, Orencia worked well when it was taken with other drugs by adults with moderate to severe RA. The most common drugs given with Orencia were disease-modifying antirheumatic drugs (DMARDs), including methotrexate.

Orencia with other drugs for polyarticular juvenile idiopathic arthritis

Orencia is FDA-approved to treat children with polyarticular juvenile idiopathic arthritis (pJIA). The drug is approved for use alone or in combination with methotrexate.

In clinical studies, Orencia worked well to treat JIA in children when the drug was given with methotrexate. As a result, experts currently recommend that Orencia be used with methotrexate rather than alone to treat JIA.

Orencia with other drugs for acute graft-versus-host disease prevention

Orencia is FDA-approved for use in adults and children ages 2 years and older who are having hematopoietic stem cell transplantation. In this case, it is approved to help prevent acute (sudden) graft-versus-host disease. The drug is given in combination with methotrexate and another type of drug called a calcineurin inhibitor (such as cyclosporine or tacrolimus). In clinical studies, Orencia was found to be effective for this purpose when given with these other drugs.

Your doctor may also prescribe antiviral drugs to help prevent serious viral infections. These infections include Epstein-Barr virus and cytomegalovirus. Examples of antiviral medications that may be used include acyclovir, valacyclovir, and ganciclovir.

Other drugs are available that can treat your condition. Some may be better suited for you than others. If you’re interested in finding an alternative to Orencia, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions.

Alternatives for rheumatoid arthritis

Examples of other drugs that may be used to treat rheumatoid arthritis (RA) include:

Alternatives for psoriatic arthritis

Examples of other drugs that may be used to treat psoriatic arthritis (PsA) include:

  • methotrexate (Otrexup, Rasuvo, Trexall, Xatmep)
  • sulfasalazine (Azulfidine, Azulfidine EN)
  • cyclosporine (Gengraf, Neoral, Sandimmune)
  • apremilast (Otezla)
  • adalimumab (Humira)
  • certolizumab pegol (Cimzia)
  • etanercept (Enbrel)
  • golimumab (Simponi)
  • infliximab (Remicade, Inflectra, Renflexis)
  • ustekinumab (Stelara)
  • secukinumab (Cosentyx)
  • ixekizumab (Taltz)
  • brodalumab (Siliq)
  • tofacitinib (Xeljanz)

Alternatives for polyarticular juvenile idiopathic arthritis

Examples of other drugs that may be used to treat polyarticular juvenile idiopathic arthritis (pJIA) include:

  • methotrexate (Otrexup, Rasuvo, Trexall, Xatmep)
  • adalimumab (Humira)
  • etanercept (Enbrel)
  • golimumab (Simponi Aria)
  • infliximab (Remicade, Inflectra, Renflexis)
  • tocilizumab (Actemra)

Alternatives for acute graft-versus-host disease prevention

Examples of other drugs that may be used to help prevent acute (sudden) graft-versus-host disease caused by hematopoietic stem cell transplantation include:

  • corticosteroids, such as prednisone and prednisolone
  • methotrexate (Otrexup, Rasuvo, Trexall, Xatmep)
  • cyclosporine (Gengraf, Neoral, Sandimmune)

Note: While the drugs above are commonly used to help prevent this disease, each represents an off-label use. Orencia is the only drug approved by the Food and Drug Administration (FDA) for prevention of acute graft-versus-host disease. (Off-label use means that the drug is used to treat a condition even though it’s not FDA-approved to do so.)

Orencia is approved to treat certain autoimmune diseases, and to help prevent acute (sudden) graft-versus-host disease.

To learn more about Orencia’s mechanism of action (how the drug works in your body), see this article.

There aren’t any known interactions between Orencia and alcohol. But drinking too much alcohol may worsen both your arthritis symptoms and the progression of the disease. Also, alcohol may interact with other drugs you’re taking.

If you drink alcohol, talk with your doctor about how much is safe for you to drink during Orencia treatment. They’ll discuss your current arthritis treatment and advise if alcohol is safe for you to consume.

Here are answers to some frequently asked questions about Orencia.

Can I take Orencia if I have COPD?

You may be able to.

If you have chronic obstructive pulmonary disease (COPD), taking Orencia can increase your risk of having certain side effects. In fact, it can increase your risk of having serious trouble breathing. Orencia is also sometimes used to help prevent acute (sudden) graft-versus-host disease in people with COPD. If you have COPD and you’re using this drug, your doctor may monitor you closely to make sure Orencia is safe for you.

Tell your doctor if you have COPD and have any trouble breathing while you’re taking Orencia. (See the “Orencia precautions” section below for more information.) Your doctor can recommend if Orencia is safe for you to use. If it’s not safe, they’ll prescribe other medications that are safer for you.

Can I get vaccines while I’m using Orencia?

You may be able to get certain vaccines during Orencia treatment. However, you shouldn’t receive 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. While you’re taking Orencia, your immune system isn’t able to fight off infections as well as it normally does. If you get a live vaccine while you’re taking Orencia, you may get the infection that the vaccine is meant to protect you from.

If you get a non-live vaccine during Orencia treatment, it may not work as well to protect you from the infection that it’s meant to. But you’re still allowed to get these types of vaccines during treatment.

Make sure all your or your child’s vaccines are up-to-date before beginning Orencia treatment. If you have any questions about which vaccines are needed, talk with your doctor. They’ll recommend if vaccination can be postponed.

If I get an infection while using Orencia, can I take an antibiotic?

Yes. There aren’t any known interactions between Orencia and antibiotics.

If you get a new infection while you’re taking Orencia, ask your doctor if you need to take an antibiotic. They can prescribe an antibiotic that works well when taken with Orencia.

Can I take Orencia at home?

It depends on how your doctor recommends that you take Orencia.

Your doctor may want you to receive Orencia as an IV infusion (an injection into a vein that’s given over time). This means a healthcare professional will place a needle in your vein, and you’ll receive the drug through the needle as an infusion. In this case, you can’t take Orencia at home. You’ll need to visit a healthcare clinic for your treatments.

Otherwise, your doctor may want you to take Orencia through a subcutaneous injection. In this case, Orencia will be injected with a needle under your skin. The first injection should be done at a healthcare clinic by medical staff. But after this, you’ll likely be able to self-inject Orencia at home.

Can I use Orencia if I have diabetes?

Yes, but you’ll need to be careful if you receive Orencia as an IV infusion.

The form of Orencia used for IV infusions contains maltose. This substance doesn’t work in your body to treat your condition, but it affects how some devices measure your blood sugar levels. When exposed to maltose, some glucose (blood sugar) monitors may show that you have higher levels of blood sugar than you actually do.

Let your doctor know if you have diabetes and you’re taking Orencia through IV infusions. They’ll recommend the best way for you to measure your blood sugar levels during treatment.

Can Orencia help with hair loss?

Orencia hasn’t proved to be effective in stopping hair loss. Although one clinical study evaluated its use for hair loss, the study was small and only included 15 people.

Talk to your doctor if you are concerned about hair loss. They’ll advise you on how to cope with it and may prescribe medication to control it.

Can I travel if I am taking Orencia?

Yes, you can travel, but you should make sure that you don’t miss any of your Orencia doses.

If you’re receiving Orencia at a healthcare clinic, talk with a healthcare professional about your travel plans. They’ll make sure your dosage schedule doesn’t interfere with your travel.

If you’re self-injecting Orencia, make sure you’re able to take the medication with you if you’ll need your dose while you’re away from home. Ask your doctor or pharmacist about how to pack and store Orencia while you’re traveling.

Do I need a prior authorization to get Orencia?

It depends on your insurance plan. Many insurance plans request a prior authorization before you’ll have any insurance coverage for Orencia.

To request prior authorization, your doctor will fill out paperwork for your insurance company. The insurance company will then review this paperwork and let you know if your plan will cover Orencia.

There aren’t enough studies in humans to know for sure if Orencia is safe to use during pregnancy. Animal studies suggest that Orencia may affect a fetus if used during pregnancy. But studies in animals don’t always predict what happens in humans.

Let your doctor know if you’re planning a pregnancy or if you become pregnant while you’re using Orencia. They’ll discuss your treatment options and recommend if using Orencia is safe for you to do during pregnancy.

It’s not known if Orencia is safe to take during pregnancy. If you or your sexual partner can become pregnant, talk with your doctor about your birth control needs while you’re taking Orencia.

No studies in humans have looked into the safety of Orencia use while breastfeeding. Studies in animals have shown that Orencia passes into the breast milk of animals who are given the drug. But it isn’t known if the drug affects animals who consume that breast milk.

Keep in mind that studies in animals don’t always predict what happens in humans.

Tell your doctor if you’re breastfeeding or planning to breastfeed while you’re taking Orencia. They’ll recommend the safest way for you to feed your child.

You may wonder how Orencia compares to other medications that are prescribed for similar uses. Here we look at how Orencia and Humira are alike and different.

General

Orencia contains the drug abatacept. Humira contains the drug adalimumab. These drugs work differently in your body, and they belong to different groups of drugs.

Uses

Orencia and Humira are both approved by the Food and Drug Administration (FDA) to treat moderate to severe rheumatoid arthritis (RA) and psoriatic arthritis (PsA) in adults. These drugs are also approved to treat polyarticular juvenile idiopathic arthritis (pJIA) in children ages 2 years and older.

Orencia is also FDA-approved to help prevent acute (sudden) graft-versus-host disease caused by hematopoietic stem cell transplantation. For this purpose, it’s used in adults and children ages 2 years and older.

Humira is also FDA-approved to treat the following conditions:

Drug forms and administration

Orencia comes in two forms, which have different strengths. These forms are as follows:

  • powder form
    • is available in one strength: 250 mg (milligrams)
    • is mixed with liquid to make a solution that’s given to you as an IV infusion
  • liquid form
    • is available in one strength: 125 mg/mL (milligrams per milliliter)
    • is given to you as a subcutaneous injection
    • comes in prefilled glass syringes that hold 0.4 mL, 0.7 mL, and 1.0 mL of liquid
    • also comes in a 1-mL vial that’s placed into a device called a ClickJect autoinjector

Humira comes as a solution that’s given by subcutaneous injection. It’s available in the following two strengths:

  • 100 mg/mL: comes in vials that hold 0.8 mL, 0.4 mL, 0.2 mL, and 0.1 mL of solution
  • 50 mg/mL: comes in vials that hold 0.8 mL, 0.4 mL, and 0.2 mL of solution

Side effects and risks

Orencia and Humira contain different drugs. But both medications affect the way your immune system works. Therefore, both medications can cause very similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Orencia, with Humira, or with both drugs (when taken individually).

  • Can occur with Orencia:
    • nausea
  • Can occur with Humira:
    • skin reaction in the area around your injection site
    • skin rash
  • Can occur with both Orencia and Humira:
    • upper respiratory infections, such as the common cold or a sinus infection
    • headache

Serious side effects

These lists contain examples of serious side effects that can occur with Orencia, with Humira, or with both drugs (when taken individually).

  • Can occur with Orencia:
    • no unique serious side effects
  • Can occur with Humira:
    • problems with your nervous system (numbness or tingling, changes in your vision, weakness in your arms or legs, or dizziness)
    • low levels of certain blood cells, such as white blood cells and platelets
    • heart problems, such as heart failure
    • liver problems, such as liver failure
  • Can occur with both Orencia and Humira:

* Humira has a boxed warning from the FDA regarding the risks of both serious infections and cancer. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

Both Orencia and Humira are FDA-approved to treat rheumatoid arthritis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis. The effectiveness of both drugs in treating these conditions is compared below.

Effectiveness in treating rheumatoid arthritis

Orencia and Humira have been directly compared in a clinical study as treatment options for rheumatoid arthritis (RA).

In this study, 646 adults with moderate to severe RA were taking either Orencia or Humira: 318 people took Orencia, while 328 people took Humira. Both groups of people also took methotrexate. After 2 years of treatment, both drugs were equally effective in treating RA.

Of those taking Orencia, 59.7% of people had at least a 20% reduction in their RA symptoms. Of people taking Humira, 60.1% had the same result.

Effectiveness in treating psoriatic arthritis

Orencia and Humira haven’t been directly compared in clinical trials as treatment options for psoriatic arthritis (PsA). But separate studies have found that both drugs are effective to treat the condition.

Effectiveness in treating polyarticular juvenile idiopathic arthritis

Orencia and Humira were compared in a review of studies as treatment options for polyarticular juvenile idiopathic arthritis (pJIA). After this review, experts found that both drugs had similar safety and effectiveness.

Costs

Orencia and Humira are both brand-name drugs. There are currently no biosimilar forms of Orencia available. A biosimilar drug is roughly comparable to a generic drug. A generic drug is a copy of a regular drug (one that’s made from chemicals). A biosimilar drug is made to be similar to a biologic drug (one that’s made from living cells).

A biosimilar drug to Humira is available in a form that’s given by IV infusion. Experts recommend using biosimilars to treat RA, PsA, and JIA when it’s safe and effective for your condition. Talk with your doctor to find out if a biosimilar is right for you.

Brand-name medications usually cost more than biosimilar drugs cost.

The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

You may wonder how Orencia compares to other medications that are prescribed for similar uses. Here we look at how Orencia and Enbrel are alike and different.

General

Orencia contains the drug abatacept. Enbrel contains the drug etanercept. These drugs belong to different classes of medications, and they work differently in your body.

Uses

Orencia and Enbrel are approved by the Food and Drug Administration (FDA) to treat rheumatoid arthritis (RA) and psoriatic arthritis (PsA) in adults. Both drugs are also approved to treat polyarticular juvenile idiopathic arthritis (pJIA) in children ages 2 years and older.

Orencia is also FDA-approved to help prevent acute (sudden) graft-versus-host disease caused by hematopoietic stem cell transplantation. For this purpose, it’s used in adults and children ages 2 years and older.

Enbrel is also FDA-approved to treat two other conditions:

Drug forms and administration

Orencia comes in two forms, which have different strengths. These forms are as follows:

  • powder form
    • is available in one strength: 250 mg (milligrams)
    • is mixed with liquid to make a solution that’s given to you as an IV infusion
  • liquid form
    • is available in one strength: 125 mg/mL (milligrams per milliliter)
    • is given to you as a subcutaneous injection
    • comes in prefilled glass syringes that hold 0.4 mL, 0.7 mL, and 1.0 mL of liquid
    • also comes in a 1-mL vial that’s placed into a device called a ClickJect autoinjector

Enbrel is given through subcutaneous injection. It comes in the following forms:

  • powder form
    • is available in one strength: 25 mg
    • is mixed with liquid to form a solution
  • liquid form
    • is available in one strength: 50 mg/mL
    • comes in vials that hold 0.5 mL and 1.0 mL of liquid

Side effects and risks

Orencia and Enbrel contain different drugs. But both of these drugs work on your immune system. Therefore, both medications can cause very similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Orencia or with Enbrel.

  • Can occur with Orencia:
    • infections, such as the common cold or a sinus infection
    • headache
    • nausea
  • Can occur with Enbrel:
    • skin reaction in the area around your injection site
  • Can occur with both Orencia and Enbrel:
    • no shared common side effects

Serious side effects

These lists contain examples of serious side effects that can occur with Orencia, with Enbrel, or with both drugs (when taken individually).

  • Can occur with Orencia:
    • no unique serious side effects
  • Can occur with Enbrel:
    • problems with your nervous systems (multiple sclerosis, seizures, inflammation of nerves)
    • low levels of certain blood cells, such as white blood cells and platelets
    • heart problems, such as heart failure
    • liver problems, such as liver failure
    • serious infections, such as tuberculosis (TB)*
  • Can occur with both Orencia and Enbrel:

* Enbrel has a boxed warning from the FDA regarding the risks of both serious infections and cancer. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

Both Orencia and Enbrel are FDA-approved to treat rheumatoid arthritis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis. The effectiveness of both drugs in treating these conditions is compared below.

Effectiveness in treating rheumatoid arthritis

These drugs haven’t been directly compared in clinical trials. But separate studies have found that both Orencia and Enbrel are effective in treating rheumatoid arthritis (RA).

Effectiveness in treating psoriatic arthritis

These drugs haven’t been directly compared in clinical trials. But separate studies have found that both Orencia and Enbrel are effective in treating psoriatic arthritis (PsA).

Effectiveness in treating polyarticular juvenile idiopathic arthritis

A review of studies looked at how well Orencia and Enbrel work to treat polyarticular juvenile idiopathic arthritis (pJIA) in children. At the end of the review, experts agreed that both drugs have similar safety and effectiveness in treating the condition.

Costs

Orencia and Enbrel are both brand-name drugs. There are currently no biosimilar forms of Orencia available. A biosimilar drug is roughly comparable to a generic drug. A generic drug is a copy of a regular drug (one that’s made from chemicals). A biosimilar drug is made to be similar to a biologic drug (one that’s made from living cells).

A biosimilar drug to Enbrel is available in a form that’s given by IV infusion. Experts recommend using biosimilars to treat RA, PsA, and JIA when it’s safe and effective for your condition. Talk with your doctor to find out if a biosimilar is right for you.

Brand-name medications usually cost more than biosimilar drugs cost.

The actual price you’ll pay for either drug will depend on your insurance plan, your location, and the pharmacy you use.

Orencia can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Orencia and other medications

Below are lists of medications that can interact with Orencia. These lists do not contain all the drugs that may interact with Orencia.

Before taking Orencia, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Anti-TNFs

Anti-TNFs are a group of drugs commonly used to treat rheumatoid arthritis (RA), psoriatic arthritis (PsA), and polyarticular juvenile idiopathic arthritis (pJIA). These drugs work by attaching to and blocking the action of a protein called tumor necrosis factor (TNF).

Examples of anti-TNF drugs include:

Both Orencia and anti-TNFs lower the ability of your body to fight new or existing infections. Taking these drugs together can further increase your risk of getting new infections and reduce your ability to fight off infections that are already inside of your body.

Talk with your doctor if you’re taking or planning to start taking an anti-TNF drug while you’re using Orencia. Your doctor can discuss your treatment needs and recommend medications that are safe for you to take.

Other rheumatic medications

Both Orencia and other rheumatic medications, including Xeljanz, affect your immune system. These drugs reduce your immune system’s ability to fight infections. Taking Orencia with other rheumatic drugs may lower your immune system’s ability too much. This can increase your risk of infections.

Tell your doctor if you’re taking any other rheumatic medications besides Orencia. Your doctor can order tests to check how well your immune system is working and recommend the best treatment plan for you.

Orencia and herbs and supplements

There aren’t any herbs or supplements that have known interactions with Orencia. However, you should still check with your doctor or pharmacist before using any supplements while you’re taking Orencia.

As with all medications, the cost of Orencia can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance

If you need financial support to pay for Orencia, or if you need help understanding your insurance coverage, assistance is available.

A financial support program called Orencia On Call is available. For more information and to find out if you’re eligible for support, call 800-ORENCIA (800-673-6242) or visit the program’s website.

You should take Orencia according to your doctor or another healthcare professional’s instructions.

Orencia by IV infusion

In some cases, your doctor may recommend that you receive Orencia as an IV infusion. This is an injection into a vein that’s given over time.

In this case, you’ll need to schedule an appointment at your healthcare clinic. Once you’re at the clinic for your infusion, medical staff will take you to a comfortable room. They’ll insert a needle into your vein and connect the needle to a bag filled with liquid that contains Orencia.

For rheumatoid arthritis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis, each infusion will take about 30 minutes. For prevention of acute (sudden) graft-versus-host disease, each infusion will take about 60 minutes.

During the infusion, the Orencia solution will move from the IV bag, through the needle, and into your vein.

After you’ve received your entire dose, the needle will be removed from your vein. Your doctor may want to monitor you for a while before you leave the clinic. This is done to make sure that you don’t have any serious side effects after you’ve received Orencia.

Orencia taken by subcutaneous injection

Your doctor may recommend that you receive Orencia through a subcutaneous injection (an injection under your skin).

Initially, your healthcare professional may want to give you your Orencia injection. This allows them to explain the injection process and show you exactly how to do it. After showing you how to do Orencia injections, they may ask you to start giving yourself injections of the drug.

Each Orencia injection can be done through two different devices: a prefilled syringe or a prefilled ClickJect autoinjector. Each device will come with the exact amount of Orencia that your doctor prescribed. You won’t have to measure out your dose of Orencia for each injection. Your healthcare professional will give you step-by-step instructions on how to use the device you’re given.

Ask your doctor if you’re unsure about how to self-inject Orencia. They’ll review the process with you. You can also visit the Orencia website to read more about how to self-inject the drug.

When to take

Once you start taking Orencia for the first time, you’ll receive a dosing schedule. You should take Orencia according to that schedule.

Medication reminders can help make sure that you follow your dosing schedule.

Before taking Orencia, talk with your doctor about your health history. Orencia may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Use of anti-tumor necrosis factor (TNF) drugs. If you’re taking anti-TNF drugs (which include Humira, Enbrel, and Remicade) with Orencia, the ability of your immune system to fight infections can be significantly reduced. This increases your risk of harmful, and sometimes life-threatening, infections. Talk with your doctor about all the medications you’re taking before starting Orencia.
  • History of recurrent or latent infections, such as hepatitis B or tuberculosis (TB). If you have recurrent infections (infections that come back often), taking Orencia may increase your risk of more frequent recurrences. If you have any latent infections (infections without any symptoms), taking Orencia can increase your risk of having a flare-up of the infection. Common latent infections include TB and hepatitis B virus. Talk to your doctor about your history of infections before starting Orencia.
  • History of cytomegalovirus or Epstein-Barr virus, in certain people. If you’re receiving Orencia to help prevent graft-versus-host disease and you’ve had either of the two infections in the past, Orencia can reactivate these viruses, which can start causing symptoms again. Your doctor will monitor you for signs of any infection during and after Orencia treatment. Be sure to tell them about any past infections you’ve had.
  • Need for vaccinations. If you receive vaccinations while you’re taking Orencia, the vaccines may not work properly in your body. You also shouldn’t receive live vaccines while you’re taking Orencia or for 3 months after your last dose. Talk with your doctor about any vaccines you may need before you start taking Orencia.
  • Immunosuppression (reduced activity of the immune system). Orencia works by reducing certain functions of your immune system. If you already have immunosuppression, you might have an even higher risk of infections with Orencia, and these can be serious. Be sure to talk with your doctor about whether Orencia is safe for you.
  • Increased risk of skin cancer. Orencia may increase your risk of cancer, including skin cancer. Be sure to talk with your doctor about your risk. People taking Orencia typically have regular skin exams during their treatment. If you have risk factors that make you more likely to develop skin cancer, your doctor might monitor you more often than usual for any symptoms.
  • Chronic obstructive pulmonary disease (COPD). If you have COPD, taking Orencia may worsen your COPD symptoms. Because of this, you may need close monitoring if you take this drug. If you have a history of COPD, talk with your doctor before you start taking Orencia.
  • Severe allergic reaction to Orencia. You shouldn’t take Orencia if you’ve had a severe allergic reaction to the drug in the past. If you’re unsure of whether you’ve had a severe allergic reaction, talk with your doctor before starting Orencia.
  • Pregnancy. Orencia use during pregnancy hasn’t been studied in humans. Talk to your doctor about whether Orencia is safe to use during pregnancy. For more information, see the “Orencia and pregnancy” section above.
  • Breastfeeding. It’s not known for sure if Orencia is safe to take while breastfeeding. For more information, please see the “Orencia and breastfeeding” section above.

Note: For more information about the potential negative effects of Orencia, see the “Orencia side effects” section above.

Using more than the recommended dosage of Orencia can lead to serious side effects. For more information on serious side effects, please see the “Orencia side effects” section above.

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

If you get Orencia from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Orencia should be stored in a refrigerator at a temperature of 36°F to 46°F (2°C to 8°C). You should keep the medication protected from light and stored inside the original packaging. You shouldn’t allow Orencia (inside either prefilled syringes or ClickJect autoinjectors) to freeze.

Disposal

If you no longer need to take Orencia and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

Orencia is a biologic drug indicated for:

  • active, moderate to severe rheumatoid arthritis (RA) in adults
  • active psoriatic arthritis (PsA) in adults
  • active, moderate to severe polyarticular juvenile idiopathic arthritis (pJIA) in children ages 2 years and older
  • acute graft-versus-host disease (GVHD) prevention in adults and in children ages 2 years and older

For RA treatment, Orencia can be used alone, or as polytherapy if combined with disease-modifying antirheumatic drugs (DMARDs). For JIA treatment, Orencia can be used alone or in combination with methotrexate. For GVHD prevention, it’s used with methotrexate and a calcineurin inhibitor.

Regardless of the condition treated, Orencia should not be co-administered with an anti-TNF medication.

Mechanism of action

Orencia binds to the cell-proteins CD80 and CD86, which are found in the cell membrane of antigen presenting cells. This binding inhibits the stimulation of the CD28 protein. CD28 is essential to activate T-lymphocytes. Activation of T-lymphocytes plays an important role in the pathogenesis of RA and PsA. Blocking this activation reduces the progression of these diseases. It also helps prevent the immune system reaction that can lead to GVHD.

In-vitro studies indicate that the binding to CD80 and CD86 has additional cellular effects. By targeting T-lymphocytes, Orencia decreases their proliferation. It also inhibits the production of key cytokines that are important for several immune reactions. These cytokines include TNF-alpha, INF-gamma, and IL-2.

Also, animal models have shown additional effects observed after Orencia administration. Studies revealed that Orencia can suppress inflammation and decrease the production of antibodies against collagen. It can also limit the production of antigens that target INF-gamma. Whether these actions are important for the clinical effectiveness of Orencia remains unknown.

Pharmacokinetics and metabolism

The pharmacokinetics and metabolism of Orencia vary based on the condition being treated. They also vary based on route of administration.

Studies in all patient populations show a trend of higher drug clearance with higher body weight. However, no significant variation in clearance is reported across use in people of different ages or gender. In studies, the use of methotrexate, anti-TNFs, NSAIDs, or corticosteroids did not cause significant variation in clearance.

RA: Intravenous administration

Multiple dosages of 10 mg/kg to patients with rheumatoid arthritis (RA) led to a peak concentration of 295 mcg/mL. Terminal half-life is observed at day 13.1, with a clearance of 0.22 mL/h/kg.

In patients with RA, Orencia has a proportional increase between dosage and peak concentration. The relationship between dosage and area under the curve (AUC) follows the same trend. Also, the volume of distribution reaches a ratio of 0.07 L/kg.

Following multiple dosages of 10 mg/kg, the steady state is observed at day 60. The steady trough concentration reached is 24 mcg/mL.

Monthly administration of Orencia does not cause systemic accumulation of the medication.

RA: Subcutaneous administration

When administrated subcutaneously, Orencia reaches minimum and peak concentrations of 32.5 mcg/mL and 48.1 mcg/mL, respectively, at day 85. If no loading dosage with intravenous administration is provided, Orencia reaches a mean trough concentration of 12.6 mcg/mL at week 2.

Systemic clearance reaches 0.28 mL/h/kg, with a volume of distribution ratio of 0.11 L/kg. The subcutaneous bioavailability is 78.6%., with a terminal half-life of 14.3 days.

PsA: Intravenous administration

Orencia shows linear pharmacokinetics at dosages between 3 mg/kg and 10 mg/kg. When administered at 10 mg/kg, Orencia reaches steady state concentrations at day 57. The geometric trough concentration is 24.3 mcg/mL at day 169.

PsA: Subcutaneous administration

Weekly subcutaneous administration of Orencia 125 mg leads to a geometric trough concentration of 25.6 mcg/mL at day 169. The steady state is reached at day 57.

JIA: Intravenous administration

In children ages 6 to 17 years, Orencia reaches minimum and peak concentrations of 11.9 mcg/mL and 217 mcg/mL, respectively, at steady state. The mean clearance is 0.4 mL/h/kg.

Pharmacokinetics studies for children under 6 years of age are not available as Orencia via intravenous infusion is not approved for use in this population.

JIA: Subcutaneous administration

In children ages 2 to 17 years, weekly subcutaneous administration of Orencia reaches the steady state at day 85.

Mean concentrations of Orencia vary based on dosage. At day 113, Orencia reaches concentrations of 44.4 mcg/mL, 46.6 mcg/mL, and 38.5 mcg/mL at dosages of 50 mg, 87.5 mg, and 125 mg, respectively.

GVHD: Intravenous administration

In children ages 6 to 17 years, Orencia reaches minimum and peak concentrations of 43 mcg/mL and 221 mcg/mL, respectively, at steady state. The mean clearance is between 0.26 to 0.32 mL/h/kg. Steady state is reached in 20 to 21 days.

Pharmacokinetic studies of children under 6 years of age were similar to results of studies with populations 6 years and older, based on pharmacokinetic modeling.

Contraindications

There are no contraindications for the use of Orencia. However, some precautions should be taken before and during its administration. For more information, see the “Orencia precautions” section above.

Storage

When provided as a vial with lyophilized powder, Orencia should be refrigerated at a temperature of 36°F to 46°F (2°C to 8°C). The vial should be kept inside its original package and protected from light to avoid degradation.

Prefilled syringes or ClickJect autoinjectors of Orencia should also be refrigerated at a temperature of 36°F to 46°F (2°C to 8°C). Temperatures should be controlled to prevent freezing of the solution. Also, these devices should be kept inside their original packaging and protected from light to avoid degradation.

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.

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