Orencia (Abatacept)

How does Orencia (Abatacept) work?

Orencia belongs to a drug class called T-cell costimulatory blocking agents. Orencia works by binding to two different proteins, CD80 and CD86. These proteins are found on specific immune cells’ surfaces and activate T-cells that fight infection. T-cells mistakenly attack normal cells and tissues in conditions such as rheumatoid arthritis, causing inflammation, swelling, and joint damage. By blocking these proteins, Orencia decreases inflammation within the body and reduces symptoms associated with rheumatoid arthritis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis.

How it’s Used?

Storage

Orencia should be stored at room temperature between 68°F to 77°F (20°C to 25°C).

Usage

Orencia comes in a once-weekly injectable pen and an IV solution. The ClickJect Autoinjector pen is given once weekly and should be injected subcutaneously into the stomach, thigh, or upper arm. Orencia should be administered on the same day each week at a consistent time. Injection sites should be rotated with each use. The autoinjector contains a single dose and should be discarded after use.

Orencia is also available in an IV form that is delivered into the vein and is usually given at your doctor’s office. Sometimes your doctor will recommend receiving an IV dose of Orencia before continuing with once-weekly injections at home.

Dosage

Orencia is available in 125mg/ml single-dose auto-injector and 250mg powder in a single-dose vial for IV infusion that requires reconstitution.

Dosing for Adults

Rheumatoid Arthritis

The recommended starting dose of Orencia for rheumatoid arthritis is 125mg subcutaneously once weekly. Your doctor may recommend receiving an IV dose before continuing with weekly subcutaneous injections. IV doses are as follows

• < 60kg: 500mg IV once
• 60-100kg: 750mg IV once
• >100kg: 1000mg IV once

If your doctor recommends IV-only dosing, the recommendations are as follows

• < 60kg: 500mg IV initially, at 2 and 4 weeks, and every four weeks thereafter.
• 60-100kg: 750mg IV initially, at 2 and 4 weeks, and every four weeks thereafter.
• >100kg: 1000mg IV initially, at 2 and 4 weeks, and every four weeks thereafter.

Psoriatic Arthritis

The recommended starting dose of Orencia for psoriatic arthritis is 125mg subcutaneously once weekly.

If your doctor recommends IV-only dosing, the recommendations are as follows for children and adults six years of age and older:

• < 75kg: 10mg/kg IV initially, at 2 and 4 weeks, and every four weeks after that.
• 75-100kg: 750mg IV initially, at 2 and 4 weeks, and every four weeks after that.
• >100kg: 1000mg IV initially, at 2 and 4 weeks, and every four weeks after that.
  • The maximum dose is 1000mg

Dosing for Children

Polyarticular Course Juvenile Idiopathic Arthritis

The recommended starting dose of Orencia for polyarticular course juvenile idiopathic arthritis for children aged two and older are as follows

• 10-25kg: 50mg subcutaneously once a week
• 25-50kg: 87.5 subcutaneously once a week
• >50kg: 125mg subcutaneously once a week

If your doctor recommends IV-only dosing, the recommendations are as follows for children and adults six years of age and older:

• < 75kg: 10mg/kg IV initially, at 2 and 4 weeks, and every four weeks after that.
• 75-100kg: 750mg IV initially, at 2 and 4 weeks, and every four weeks after that.
• >100kg: 1000mg IV initially, at 2 and 4 weeks, and every four weeks after that.
  • The maximum dose is 1000mg

IV Dosing to Prevent Graft vs. Host Disease

The recommended dose for treating graft vs. host disease in patients 6 years of age and older is 10mg/kg, administered over 60 minutes on the day before transplantation. Followed by a subsequent dose on days 5, 14, and 28 after the transplant.

The recommended dose for children aged 2-6 for preventing graft vs. host disease is 15mg/kg, administered over 60 minutes on the day before transplantation. Followed by a 12mg/kg dose administered over 60 minutes on days 5, 14, and 28 after the transplant.

Missed Dose

If you miss a dose of Orencia, call your doctor for instructions.

Overdose

Taking too much Orencia can lead to serious side effects. If you suspect an overdose, seek emergency medical attention or call the poison control helpline at 1-800-222-1222.

Side Effects

If you experience signs and symptoms of an allergic reaction, such as hives, rash, itching, difficulty breathing, or swelling of the face, mouth, or throat, seek medical attention immediately.

The most common side effects of Orencia include:

• Fever
• Nausea
• Diarrhea
• Stomach pain
• Headache
• Cold symptoms include a stuffy nose, sneezing, cough, or sore throat.

Some serious side effects can also occur; call your doctor or seek immediate medical attention if you experience any of the following symptoms:

• Fever, chills, night sweats, and weight loss
• Dry cough and sore throat
• Warmth, pain, or redness of the skin
• Trouble breathing
• Stabbing chest pain, wheezing, cough with yellow/green mucous
• Pain/burning with urination

Warnings & Precautions

Children

Orencia is approved for children two and older for the management of polyarticular course juvenile idiopathic arthritis and children six years and older for the management of psoriatic arthritis. It can also be used in children aged 2 and older to prevent graft vs. host disease.

Pregnancy and Breastfeeding

Orencia is not recommended for use in pregnancy or while breastfeeding. The safety and efficacy have not been studied in these patients.

Use with TNF Antagonists

Patients who receive IV Orencia and TNF Antagonists together experience an increased rate of infections, some serious. It is not recommended to use Orencia with TNF antagonists. Patients should be closely monitored for infection if transitioning from TNF antagonists to Orencia.

Serious Infections

Patients who take Orencia have an increased risk of developing severe infections, including sepsis and pneumonia, that may lead to hospitalization or death. Caution should be used in patients with a history of recurrent infections or conditions that may predispose them to infections. Patients who develop a new infection while taking Orencia should be monitored closely. If a serious infection occurs, Orencia should be discontinued.

Viral Reactivation

Cases of hepatitis B reactivation have been reported with the use of Orencia. Patients should be screened for viral hepatitis before starting treatment with Orencia.

Vaccines

Vaccinations should not be given concurrently with Orencia or three months after discontinuation. It is recommended that pediatric patients receive all vaccines before starting Orencia.

COPD

Patients with COPD who have been treated with Orencia experience more adverse effects than those taking a placebo. These patients experienced more frequent COPD exacerbations, cough, rhonchi, and shortness of breath. Caution should be used in these patients for worsening of their respiratory status.

Cancers

In clinical trials, some patients taking Orencia developed lung cancer and lymphoma. Patients with rheumatoid arthritis are already at increased risk of lymphoma. Other malignancies reported while taking Orencia include skin, breast, bile duct, bladder, cervical, endometrial, lymphoma, melanoma, myelodysplastic syndrome, ovarian, prostate, renal, thyroid, and uterine cancers. The potential that Orencia increases the development of these cancers is unknown.

Drug Interactions

This is not a complete list of potential drug interactions. Before taking Orencia, tell your doctor if you take any medications, herbal supplements, or vitamins.

TNF Antagonists

When used in conjunction with Orencia, TNF antagonists can lead to an increased risk of infections. It is not recommended to use Orencia with TNF antagonists. Patients should be closely monitored for infection if transitioning from TNF antagonists to Orencia.

Other Biologic RA Therapy

There is not enough evidence to assess the safety of Orencia when used with other biologic rheumatoid arthritis therapies such as anakinra. Use together is not recommended.

Blood Glucose Testing

Orencia may interfere with fasting blood glucose readings when administered intravenously, resulting in falsely elevated readings. When receiving IV Orencia, it is recommended to delay blood glucose monitoring if possible. Subcutaneous Orencia does not interfere with blood sugar readings, so no modification is needed.

Alternative Medications

Other drugs are available to treat rheumatoid arthritis, psoriatic arthritis, and polyarticular course juvenile idiopathic arthritis. It is important to note that this is not a complete list of alternative treatments; speak to your doctor to discuss other medications.

Hydroxychloroquine (Plaquenil)

Hydroxychloroquine belongs to a class of medications called antimalarials. It works to treat rheumatoid arthritis by decreasing the activity of the immune system.

Sulfasalazine (Azulfidine)

Sulfasalazine belongs to a class of medications called anti-inflammatory drugs. It works to treat rheumatoid arthritis and polyarticular juvenile idiopathic arthritis by reducing inflammation within the body.

Leflunomide (Arava)

Leflunomide belongs to a class of medications called disease-modifying antirheumatic drugs (DMARDs). It treats rheumatoid arthritis by decreasing inflammations and slowing disease progression. Other medicines used to treat rheumatoid arthritis in this class include azathioprine (Imuran).

Tumor Necrosis Factor Inhibitors (TNF)

TNF inhibitors work by blocking TNF production, a protein produced by the body that causes inflammation. Available TNF blockers include etanercept (Enbrel), adalimumab (Humira), and infliximab (Remicade).

B-cell Depleting Agents

Rituximab (Rituxan) is a B-cell depleting agent that works by lowering the number of B-cells to reduce inflammation, pain, swelling, and joint damage in patients with rheumatoid arthritis.

Interleukin-1 (IL-1) Receptor Antagonist Therapy

Anakinra (Kineret) is an interleukin-1 (IL-1) receptor antagonist used to treat rheumatoid arthritis. It works by blocking the activity of interleukin, which causes inflammation in the body.

Immunomodulators (Abatacept)

Abatacept is in a class of medications called selective costimulation modulators (immunomodulators). It works by blocking the activity of T-cells, a type of immune cell in the body that causes swelling and joint damage in people who have arthritis.

Frequently Asked Questions