What to Know About Orencia (Abatacept)

Orencia (abatacept) is an injectable biologic drug that slows joint damage and reduces pain in rheumatoid arthritis and other autoimmune diseases. It's in a class of medications called immunomodulators or selective costimulation modulators.

Orencia works by blocking an immune cell in your body, called a T-cell, that causes swelling and joint damage in arthritis via a process called the autoimmune assault. This means Orencia is different from common, older biologics like Enbrel (etanercept ) and Humira (adalimumab), which suppress an inflammatory protein called tumor necrosis factor (TNF).

Abatacept is not available in a generic or biosimilar form; Orencia is the only brand name the drug is sold under.

Uses

Orencia is approved by the U.S. Food and Drug Administration (FDA) for the treatment of:

• Moderate to severe active rheumatoid arthritis (RA) in adults
• Psoriatic arthritis (PsA)
• Moderate to severe juvenile idiopathic arthritis (JIA)

Off-Label Uses

Orencia is sometimes prescribed off-label (meaning without FDA-approval) for:

• Lupus
• Ankylosing spondylitis
• Other autoimmune conditions

Before Taking

Orencia is usually not considered a first-line treatment option, meaning you'll typically need to try other types of drugs first.

For RA, your healthcare provider likely won't consider Orencia as a treatment unless you've been unsuccessful with one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate, or other biologics, such as Enbrel or Humira. An exception may be made for some people with early active rheumatoid arthritis.

For PsA, you may start treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or prednisone before progressing to DMARDs and, finally, biologics if earlier treatments are unsuccessful.

Similarly, JIA drug therapy typically begins with NSAIDs or corticosteroids, then progresses to DMARDs, then to biologics.

Some people end up on a combination of Orencia and other DMARDs, but this drug shouldn't be combined with other biologics or TNF suppressants.

Precautions and Contraindications

Orencia helps prevent the immune system from attacking its own tissue, specifically the tissues of the joint. To do this, it needs to shut down facets of your immune system. That leaves you open to infections your body could otherwise defeat. The most common of these include:

• Respiratory tract infections, including pneumonia
• Septic arthritis
• Skin and soft tissue infections
• Urinary tract infections (UTIs)

In clinical trials, people with chronic obstructive pulmonary disease (COPD) experienced a higher rate of COPD exacerbations while on Orencia, including a persistent cough, shortness of breath, and wheezing.

For this reason, if you have COPD, you and your healthcare provider should carefully weigh the benefits against the possible consequences of this drug. If you begin taking Orencia, your practitioner will likely want to monitor you closely to see if your COPD begins to worsen. If your COPD symptoms do get worse, you may need to go off of Orencia.

People on Orencia are at an increased risk of tuberculosis (TB), including reactivation in people who've previously had the disease. Research suggests the increase may be as much as four-fold. Before starting Orencia, you'll need to be screened for TB. If you have an active TB infection, you'll have to be successfully treated for it before you can take any biologic drug.

If you're a carrier of the hepatitis B virus, Orencia may cause the virus to become active.

Some types of cancer have been reported in people taking Orencia, but it's not known whether the drug increases your risk of getting any kind of cancer.

It's unknown whether Orencia is safe to take during pregnancy. If you're pregnant or trying to become pregnant, make sure to discuss this with your healthcare provider. You may need to switch medications. If you took this drug during pregnancy, talk to your pediatrician about when it's safe for your baby to be vaccinated.

It's unknown whether Orencia can pass to a baby through breastmilk.

While taking Orencia, you'll need to avoid live attenuated vaccines. Those are vaccines containing live, weakened viruses (as opposed to inactivated vaccines, which use "killed" viruses). Because Orencia weakens your immune system, there's a chance that a live vaccine can cause the very disease it aims to prevent.

If you're prescribed Orencia, you're advised to avoid live vaccines for a period of time before you start treatment, during treatment, and for three months after going off the drug. Children prescribed this drug should be brought up to date on immunizations before taking it.

Live attenuated vaccines include:

• Nasal influenza spray (FluMist)
• Shingles vaccine
• Varicella (chickenpox) vaccine
• Measles-mumps-rubella (MMR) vaccine
• Rotavirus vaccine
• Yellow fever vaccine
• Typhoid vaccine

Check with your healthcare provider before you're given any vaccine to be sure it's a safe one for you.

Other Biologics

Orencia is the first drug classified as a selective costimulation modulator. However, it's one of many biologics, including:

• Actemra
• Cimzia (certolizumab)
• Enbrel
• Humira
• Kineret (anakinra)
• Remicade (infliximab)
• Rituxan
• Simponi (golimumab)

Dosage

Orencia is available in two formulations with different dosing schedules.

Intravenous Infusion

An intravenous (IV) infusion is when a medical professional delivers medication directly into your vein via a needle.

Infusions of Orencia take 30 minutes. Typically, you have two weeks between the first and second dose, then four weeks between doses for the rest of the time you're on the medication.

The dosage of infused Orencia is weight dependent.

IV infusions are available for adults and children over 6. They haven't been studied in younger children.

Subcutaneous Injection

Subcutaneous (under the skin) injection of Orencia is done once a week. You can give yourself the shot or have a friend, family member, or home-healthcare worker help you with it. The injection should be given in the thigh, abdomen, or (if someone else is administering it) the upper arm.

In some cases, healthcare providers prescribe an infusion for the first dosage, followed by self-injections afterward. Injectable Orencia comes in pre-filled syringes or an autoinjector that contains 125 mg of the drug.

Injected Orencia is considered safe for treating JIA in children 2 or older, but at lower dosages.

The Orencia autoinjector hasn't been studied in children.

All listed dosages are according to the drug manufacturer. Check your prescription and talk to your healthcare provider to make sure you are taking the right dose for you.

How to Inject and Store

Store Orencia syringes or autoinjectors in the refrigerator at between 36 degrees F and 46 degrees F. Do not freeze the medication. Keep it in the original packaging and out of the light. Dispose of any medications that are expired or are no longer needed.

Your healthcare provider will instruct you as to the proper procedure for injections. Be sure to follow them exactly and ask any questions you may have.

Keep the medication refrigerated until shortly before you intend to use it.

When it's time for the injection:

• Take the medication out of the refrigerator and allow it to warm up on its own for 30 minutes. (Injections of cold medicine can be painful.) Do not microwave or try to warm up the medication in any way. Leave the needle cover on.
• Wash your hands thoroughly with soap and water.
• Choose an injection site that's free of damaged skin, with no scars, stretch marks, or bruising. You should rotate injection sites, so make a note of the date and site so you can make sure to use a different one the next time.
• Clean the injection site with an alcohol swab and allow it to air dry. Don't rub, touch, or blow on the site after swabbing.

Be sure to follow the instructions that come with the syringes or the autoinjector.

Using prefilled syringes:

• Pinch the skin.
• Inject the needle at a 45-degree angle.
• Push the plunger as far as it will go, then slowly lift your thumb from the plunger; the needle guard should then cover the needle.
• Remove the syringe and stop pinching the skin.

Using autoinjectors:

• Hold the injector at a 90-degree angle to the site.
• Pinch the skin.
• Push down on the skin with the autoinjector.
• Press the button (you'll hear a click) and hold for 15 seconds to deliver the full dose; wait for the blue indicator to stop moving.
• Lift the autoinjector straight up to remove it from the skin and release the pinch.

After the injection:

• Press a cotton ball or gauze over the site if there's any bleeding. (There should be very little.)
• Cover the site with an adhesive bandage, if needed.
• Do not rub the injection site.

Then, dispose of the injector according to the instructions that come with the drug.

Side Effects

As with any drug, side effects are possible when you take Orencia.

Common

Common side effects include:

• Headache
• Sore throat
• Nausea

Children and adolescents may also experience:

• Diarrhea
• Cough
• Fever
• Abdominal pain

Severe

Severe side effects of Orencia are rare but possible. They include:

• Upper respiratory tract infection
• Bronchitis
• Herpes zoster
• Pneumonia
• Localized infection

Warnings and Interactions

To avoid dangerous interactions between Orencia and other drugs, be sure your healthcare provider knows about all medications you take, both prescription and over-the-counter, as well as any nutritional supplements.

Orencia is known to have negative interactions with:

• TNF suppressants
• Other biologic drugs

Blood Glucose Monitoring

Infusions of Orencia contain maltose, which is a type of sugar. In people with diabetes who use blood-glucose monitors, this ingredient may cause false high readings on the day of infusion. Talk to your healthcare provider about alternate ways to monitor your blood sugar on infusion days.