Orencia is the brand name for an injectable biologic medication called abatacept. It is used to treat psoriatic arthritis (PsA), rheumatoid arthritis (RA), and polyarticular juvenile idiopathic arthritis (pJIA). These conditions occur as a result of abnormal attacks of your body’s immune cells (specifically T-cells) on healthy cells or tissues. This prescription medication belongs to a class of drugs called immunomodulators. It was approved by the FDA on December 5, 2005.
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Orencia (abatacept) comes in a vial, a single-dose prefilled syringe, and as an autoinjector. It can be administered intravenously or subcutaneously under the supervision of a healthcare provider.
Is There a Generic for Orencia?
No, there is no generic biosimilar of Orencia available. The medication may be expensive even with insurance as it is currently brand name only.
What Is Orencia Used To Treat?
Orencia is a biologic therapy used to treat the following arthritis conditions in adults and juveniles (children 2 years or older):
Rheumatoid Arthritis (RA)
RA is a type of arthritis that causes pain, swelling, and stiffness in the joints. It occurs due to an abnormal attack of T-cells on healthy tissues and results in inflammation in the joints and surrounding tissues.
Orencia is indicated to reduce symptoms in adult patients suffering from moderate-to-severe RA or who have not responded well to other treatments, such as NSAIDs and DMARDs.
Psoriatic Arthritis (PsA)
PsA is a progressive skin condition that is characterized by red, scaly patches. Orencia is indicated for use alone or as a combination treatment with other PsA treatments in adults.
Polyarticular Juvenile Idiopathic Arthritis (pJIA)
pJIA is a type of juvenile idiopathic arthritis (JIA) and is characterized by inflammation in one or more joints, causing pain, swelling, and stiffness in children 2 to 6 years of age and older.
Orencia is indicated to reduce symptoms in children suffering from moderate-to-severe pJIA. This medication can be used alone or in combination with methotrexate.
How Does Orencia Work?
Orencia works as a T-cell costimulation modulator. It blocks or enhances specific signaling pathways of the immune system involved in T-cell activation to reduce inflammation.
Orencia mainly works by blocking the activity of two T-cell co-stimulatory proteins, CD80 and CD86. Typically, these two proteins are present on the surface of T cells, and the binding of these two proteins with other proteins results in the activation of T-cells to help your body fight off infections.
In conditions such as RA, pJIA, and PsA, T-cells mistakenly start attacking the healthy tissues and thereby cause inflammation, pain, and joint damage.
Mechanism of Action
Orencia is a protein designed to block the activity of CD80 and CD86 proteins. By blocking the activity of these proteins, Orencia helps to reduce inflammation and joint damage to relieve the symptoms, such as joint pain, swelling, and stiffness.
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Orencia Dosage Form and Strength
Orencia is available as an infusion through the vein or an injection under the skin in the following strengths:
For Intravenous (IV) Administration
The medication comes in a single-dose vial containing 250 mg/ml of Orencia that is mixed with sterile water.
For Subcutaneous Administration
Orencia is available in two forms:
- As a single-dose prefilled glass syringe in strengths 50 mg/0.4ml, 87.5mg/0.5ml, and 125 mg/ml.
- As a single-dose prefilled ClickJect autoinjector, containing 125 mg/ml.
Orencia Dosing Information
The dose of Orencia is adjusted according to the weight of the patient, regardless of whether it is administered intravenously or subcutaneously.
For Adult Patients With RA
IV dosing regimen:
- The recommended IV dose for patients who weigh less than 60 kg is 500 mg (2 vials of abatacept).
- Patients who weigh 60 – 100 kg require a 750 mg (3 vials of abatacept) dose.
- Patients whose weight is more than 100 kg require a 1,000 mg (4 vials of abatacept) dose.
Subcutaneous dosing regimen:
Before administering Orencia subcutaneously, an optional weight-based loading dose may be administered as a single IV infusion over 30 mins.
After receiving the loading dose, patients will receive a 125 mg of subcutaneous injection within 1 day. Injections are then given once weekly thereafter.
For Adult Patients With PsA
IV dosing regimen:
- The recommended IV dose for patients who weigh less than 60 kg is 500 mg (2 vials of abatacept).
- Patients who weigh 60 – 100 kg require a 750 mg (3 vials of abatacept) dose.
- Patients whose weight is more than 100 kg require a 1,000 mg (4 vials of abatacept) dose.
Subcutaneous dosing regimen:
An intravenous loading dose is not administered for PsA patients. PsA patients will directly receive a 125 mg of subcutaneous injection once a week.
Pediatric Dose for pJIA
Pediatric patients 6 years of age or older receive IV infusion doses that are weight dependent.
- Children who weigh less than 75 kg require a dose of 10 mg per kg.
- Children weighing 75 – 100 kg require a dose of 750 mg/ml.
The maximum dose should not exceed 1,000mg.
Pediatric patients 2 years of age or older receive subcutaneous injection doses that are weight dependent.
- Children whose weight is 10 kg to less than 25 kg require a dose of 50 mg subcutaneously.
- For children 25 kg to less than 50 kg, administer 87.5 mg subcutaneously.
- For children who are at least 50 kg, administer 125 mg subcutaneously.
How Often Is Orencia Given?
Orencia can be given intravenously and subcutaneously.
The initial three doses of the IV infusion are given once every 2 weeks (weeks 0, 2, and 4) and then every 4 weeks thereafter.
The prefilled autoinjector is administered once a week under the skin. Patients or their caregivers can inject at home with proper training.
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Is Orencia a Form of Chemotherapy?
No, Orencia is a biological therapy used to treat inflammatory conditions such as RA, PsA, and jPIA. It is not a form of chemotherapy.
Possible Side Effects of Orencia
As with any medication, there may be potential side effects associated with Orencia, including
- Infection
- Headache
- Allergic reactions
- Sore throat
- Nausea
- Upper respiratory infection
- Breathing problems or chest pain
Common side effects in children and adolescents include:
- Diarrhea
- Fever
- Abdominal pain
- Cough
Immediately report any side effects you experience to your doctor, as some side effects can be serious.
Orencia Precautions
You should consult with your healthcare provider or rheumatologist if you have certain medical conditions. Before starting Orencia, be sure to discuss the potential benefits and risks with your doctor, as Orencia may not be suitable for you in the following cases:
- If you are pregnant or intend to become pregnant. Avoid taking Orencia since the impact of Orencia on the fetus has not been studied yet.
- If you are breastfeeding or planning to breastfeed. Since the data on abatacept secretion in human breast milk is limited, breastfeeding is not recommended while receiving abatacept doses.
- If you have an allergy to any component of Orencia. Do not take this medication.
- If you have a history of infections coming back or have ever had a tuberculosis or a viral hepatitis infection.
- If you have chronic obstructive pulmonary disease (COPD), diabetes, or a history of skin cancer.
- If you are taking other biologic medicines, multivitamins, herbal supplements, or over-the-counter medicines.
- If you have received surgery or recently received a live vaccine.
It’s important to follow these precautions and follow your doctor’s instructions to ensure that Orencia is used safely and effectively.
Orencia Cost
The cost of Orencia for an intravenous powder of 250 mg is $1,428.48. The cost of this medication can vary and may depend on the pharmacy you visit.
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REFERENCES:
- US Food and Drug administration. Orencia (abatacept) prescribing information.https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125118s171lbl.pd
- Todd, D. J., Costenbader, K. H., & Weinblatt, M. E. (2007). Abatacept in the treatment of rheumatoid arthritis. International Journal of Clinical Practice, 61(3), 494–500. https://doi.org/10.1111/j.1742-1241.2007.01289.x
- ORENCIA® (abatacept) | Official Patient Website. (n.d.). ORENCIA® (Abatacept) Patient Site. https://www.orencia.com/
- Nash, P., Nayiager, S., Genovese, M. C., Kivitz, A. J., Oelke, K., Ludivico, C., Palmer, W., Rodriguez, C., Delaet, I., Elegbe, A., & Corbo, M. (2013). Immunogenicity, Safety, and Efficacy of Abatacept Administered Subcutaneously With or Without Background Methotrexate in Patients With Rheumatoid Arthritis: Results From a Phase III, International, Multicenter, Parallel-Arm, Open-Label Study. Arthritis Care &Amp; Research, 65(5), 718–728. https://doi.org/10.1002/acr.21876
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Dr. Christine Leduc, PharmD, was born and raised in Irvine, CA. She attended college at Midwestern University, where she graduated cum laude. The most rewarding part of her job is suggesting lifestyle changes, educating patients on how their medication works, and precepting future pharmacists. Her areas of expertise are customer service and knowledge of specialty medication. Having worked in the service industry in the past, she has gained the customer service skills necessary to understand the needs of her patients. Dr. Leduc is currently precepting students from Marshall B. Ketchum University, University of Kansas, and Midwestern University. In her free time, she enjoys traveling, baking, and gardening.