Product image of ORENCIA 250 mg/15mL (Abatacept) 250 mg/15mL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION supplied by GNH India

ORENCIA 250 mg/15mL

Active Ingredient:
Abatacept
Form:
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Brand:
ORENCIA
Origin:
USA

ORENCIA 250 mg/15mL (Abatacept INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION) 250 mg/15mL

Abatacept, the active ingredient in ORENCIA, is a selective T-cell costimulation modulator presented as a 250 mg/15 mL lyophilized powder for intravenous use. It is used to treat moderate-to-severe rheumatoid arthritis, juvenile idiopathic arthritis, and psoriatic arthritis in patients who have not responded to other treatments.

GNH India supplies ORENCIA as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies, and clinics worldwide.

Strength

250 mg/15mL

Pack Size

1 VIAL, SINGLE-USE in 1 CARTON (0003-2187-13) / 15 mL in 1 VIAL, SINGLE-USE

Manufacturer / TM Owner

E.R. Squibb & Sons, L.L.C.

1
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Indications & Clinical Uses

ORENCIA is a selective co-stimulation modulator used to treat autoimmune and inflammatory conditions.

  • Rheumatoid arthritis: Reduces signs and symptoms, slows joint damage, and improves joint function in adults who have not responded to other DMARDs or TNF antagonists.
  • Juvenile idiopathic arthritis: Treats moderate-to-severe active juvenile idiopathic arthritis in children aged 6 years and older who have not responded to DMARDs.
  • Psoriatic arthritis: Treats active psoriatic arthritis in adults who have had an inadequate response to other DMARDs.
  • Graft-vs-host disease: Used in combination with other medications to prevent GVHD in people who have had a stem cell transplant.

How It Works

  • Abatacept works by binding to CD80/CD86 receptors on antigen-presenting cells, blocking the CD28-mediated T-cell activation pathway. This reduces the immune response and prevents the immune system from attacking normal tissues, thereby alleviating symptoms of autoimmune and inflammatory conditions.

Side Effects

ORENCIA may cause side effects, ranging from common to serious.

Common Side Effects

  • Headache
  • Nausea
  • Upper respiratory tract infection
  • Nasopharyngitis
  • Infusion-related reactions
  • Dizziness
  • Diarrhea
  • Fatigue

Serious or Rare Side Effects

  • Increased risk of infections
  • Serious infections, including opportunistic infections
  • Hypersensitivity reactions
  • Gastrointestinal perforations
  • Blood disorders, such as lymphopenia and neutropenia
  • Increased risk of malignancies

Precautions & Warnings

ORENCIA should be used with caution and under medical supervision.

  • Inform your healthcare provider if you have any infections: ORENCIA can increase the risk of infections.
  • Avoid live vaccines: Do not receive live vaccines while using ORENCIA.
  • Monitor for signs of infection: Regularly check for symptoms of infection.
  • Use with caution in patients with chronic obstructive pulmonary disease: May increase the risk of COPD exacerbations.
  • Store at 2-8°C: Keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

ORENCIA may interact with other medications, requiring careful monitoring.

Major Interactions (Avoid)

  • Live vaccines: Avoid concurrent use due to increased risk of infections.
  • Biologic DMARDs: Avoid concurrent use with other biologic DMARDs.

Moderate Interactions (Monitor Closely)

  • Immunosuppressants: Monitor for increased risk of infections and immunosuppression.
  • Corticosteroids: Monitor for increased risk of infections and adverse effects.
  • TNF antagonists: Monitor for increased risk of infections and adverse effects.

Frequently Asked Questions

ORENCIA is used to treat moderate-to-severe rheumatoid arthritis, juvenile idiopathic arthritis, and psoriatic arthritis in patients who have not responded to other treatments. It is also used to prevent graft-vs-host disease in people who have had a stem cell transplant.

Abatacept works by binding to CD80/CD86 receptors on antigen-presenting cells, blocking the CD28-mediated T-cell activation pathway. This reduces the immune response and prevents the immune system from attacking normal tissues, thereby alleviating symptoms of autoimmune and inflammatory conditions.

The dose of ORENCIA is determined by a healthcare provider based on the patient's body weight and condition. It is typically administered as an intravenous infusion once every 2 weeks for the first 3 doses, and then once every 4 weeks thereafter.

ORENCIA is classified as a pregnancy category B drug, meaning that animal studies have not shown a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed. It is not known whether Abatacept is excreted in human milk, so caution should be exercised when using ORENCIA while breastfeeding.

To order ORENCIA from GNH India, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams across international markets and will ask the buyer to confirm trade or institutional credentials. The team will reply with pricing, availability, shipping, and the import paperwork.

ORENCIA is a selective T-cell costimulation modulator, which works differently from other DMARDs like methotrexate or TNF antagonists. It is used when other DMARDs have not been effective. The choice of DMARD depends on the patient's specific condition, response to previous treatments, and other factors determined by the healthcare provider.

ORENCIA should be stored at 2-8°C, refrigerated, protected from light, and not frozen or shaken. It should be handled with care, following the instructions provided by the healthcare provider or pharmacist.

ORENCIA is administered as an intravenous infusion by a healthcare professional, usually in a clinical setting such as a hospital clinic. The infusion takes approximately 30 minutes. The dose is based on the patient's body weight and is given according to a specific schedule determined by the healthcare provider.

The most serious risks associated with ORENCIA include increased risk of infections, serious infections (including opportunistic infections), hypersensitivity reactions, gastrointestinal perforations, and blood disorders. Patients should be monitored closely for signs of these complications.

ORENCIA should not be used by patients with known hypersensitivity to Abatacept or any of its components. It should be used with caution in patients with chronic obstructive pulmonary disease, as it may increase the risk of COPD exacerbations. Patients with active infections should not use ORENCIA until the infection is controlled.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

References

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