Orencia

(Abatacept)

The active ingredient in Orencia is abatacept, which is considered a disease-modifying anti-rheumatic medication (DMARD). It reduces inflammation by blocking specific proteins and cellular functions. By doing this, certain forms of arthritis are kept from getting worse. Orencia is often prescribed after failure of a disease-modifying anti-rheumatic agent (DMARD), like methotrexate but it can be used as first-line therapy.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Orencia. However, the following is a synopsis of the general guidelines for the use of Orencia:

• Initially administered as an intravenous infusion, Orencia can also be self-administered at home as a subcutaneous injection, depending on your situation. Your first dose will be administered by a healthcare professional, who may also instruct you on how to take the medication correctly on your own.
• Orencia is given to children aged 2 to 6 via subcutaneous injection.
• Orencia is available for home usage as a prefilled ClickJect autoinjector or pre-filled syringe.
• Your healthcare provider will instruct you or your carer on how to properly prepare and inject Orencia if you choose to self-administer the medication. Wait until you have been instructed on how to inject it before attempting to do so.
• Your healthcare provider will advise you of the dose.

The most common side effects of Orencia include:

• Back pain.
• Headaches.
• Sore throat, runny nose, or other cold-like symptoms.
• Dizziness.
• Upset stomach.
• Urinary tract infection or pain while urinating.

Some individuals may experience serious side effects while using Orencia. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe infections: fever, exhaustion, chills, coughing, and difficulty breathing.
• Allergic reaction: hives, rash, blisters, reddening of the skin, swelling of the lips or tongue, and trouble breathing.

These are not all of the possible side effects of Orencia. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Orencia, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Any type of infection, regardless matter how minor it is (like an open wound or sore) or how widespread it is (like the flu).
• A serious infection, weak immune system, an illness that recurs, or an infection-induced inflammation of the liver (viral hepatitis).
• Had a tuberculosis (TB) lung infection, a positive TB skin test, or you have recently had close contact with someone who has had TB. TB symptoms can include persistent coughing, fever, weight loss, and night sweats.
• A history of cytomegalovirus (CMV) or Epstein-Barr virus (EBV) if you are getting Orencia from an unrelated donor as a prophylactic medication for aGVHD during HSCT.
• Either recently had a live vaccine or have one coming up.
• A history of chronic obstructive pulmonary disease (COPD), a respiratory condition.
• A personal or family history of skin cancer, or if you notice any skin growths or changes while undergoing therapy.
• New or worsening psoriasis.
• Contains maltose, a type of sugar, that can give false high blood sugar levels with certain types of blood glucose monitors on the day of Orencia infusion.

There are no contraindications listed for Orencia by the manufacturer.

In RA clinical trials, patients who took intravenous Orencia, occasionally in combination with other RA drugs, generally began to feel better within three to six months. However, as everyone reacts to drugs differently, Orencia may work more or less quickly for you. If you're unsure whether Orencia is alleviating your symptoms, speak with your doctor.

When Orencia is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Adalimumab.
• Infliximab (Remicade).
• Anakinra.
• Certolizumab.
• Etanercept.
• Golimumab.
• Hepatitis B vaccine.
• Rituximab.

-Tocilizumab.

• Simponi.
• Immunosuppressants such as Janus kinase (JAK) inhibitors or biologic disease-modifying antirheumatic drugs (bDMARDs)

Orencia (abatacept) Dosing

For Rheumatoid and Psoriatic Arthritis (Adults):

IV: Dose based on body weight, usually 500-1,000 mg every 2 weeks for the first 3 doses, then monthly.

Injection: 125 mg under the skin once a week.

For Juvenile Idiopathic Arthritis:

IV: Dose based on body weight, typically 10 mg/kg every 2 weeks for 2 doses, then monthly. Children with 75 kg or more get the adult dose.

Injection: Dose based on weight:

10-25 kg: 50 mg

25-50 kg: 87.5 mg

50 kg or more: 125 mg

For Graft-versus-Host Disease Prevention:

Dose based on body weight and age, typically 10-15 mg/kg IV on the day before transplant, then on Days 5, 14, and 28 after transplant.

Store your Orencia at room temperature and keep out of reach of children.

Bristol-Myers Squibb Company is the pharmaceutical company that manufactures Orencia.

There are no generic versions available of Orencia.

Never stop taking Orencia (abatacept) without first talking to your doctor because doing so may make your disease worse and raise your chance of relapsing.

It is not known if Orencia is safe to use while pregnant. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you. It is not yet known if this medication passes into the breast milk.