Abatacept (orencia) - Uses, Dose, MOA, Side effects, Brands

Abatacept (Orencia) is a novel drug recently approved in the United States and European countries for the treatment of autoimmune rheumatic diseases like Rheumatoid Arthritis.

Abatacept drug class:

It belongs to the class of medicine that inhibits the activation of T cells by binding to CD 80 and CD 86 present on the APC (antigen-presenting cells). It is a selective costimulation modulator

(Abatacept) Orencia indications:

  • It may be used as a monotherapy or in combination with other anti-rheumatic drugs in patients  Rheumatoid arthritis.
  • Abatacept should not be used along with TNF-blocking agents (like adalimumab, etanercept, and infliximab, etc) and anakinra.
  • It can also be used alone or in conjunction with methotrexate to treat mild to severe juvenile idiopathic arthritis.

Abatacept in Psoriatic arthritis:

  • The FDA has approved abatacept for treating psoriatic arthritis. NSAIDs, Methotrexate, Sulfasalazine, cyclosporin, and leflunomide are effective in the treating peripheral arthritis in patients with psoriasis.
  • However, none of these drugs have proven roles in modifying disease progression and halting joint destruction.
  • Abatacept in clinical trials was found effective in 39% of the patients compared to placebo (22%).
  • It has also been found effective in patients with axial involvement in psoriatic arthritis, enthesitis, and dactylitis. 

Abatacept in Juvenile idiopathic arthritis:

  • Additionally, it has been licenced for use in children with moderately to highly active juvenile idiopathic arthritis as a monotherapy or in combination with methotrexate.

(Abatacept) Orencia dose:

Abatacept (Orencia) should be administered via an intravenous infusion initially

Adult patients with upto 60 kg body weight:

Dose via intravenous infusion:

  • 3 doses of 500 mg every 15 days
  • 500 mg every month by intravenous infusion

Otherwise it can be infused by a subcutaneous injection:

  • 125 mg once a week, with the first dosage administered subcutaneously one day after the intravenous loading dose;
  • Patients who are unable to get an intravenous infusion may begin subcutaneous abatacept treatment without first receiving an intravenous loading dose.

Adult patients with a body-weight of 60 – 100 kgs:

  • A Loading Dose via an intravenous infusion:
    • 750 mg every 15 days for 3 doses
    • followed by intravenous infusions 750 mg monthly.

Alternatively by subcutaneous injection:

  • 125 mg once weekly, the first subcutaneous dose should be given within 1 day of the intravenous loading dose;
  • (patients who are unable to receive an infusion may initiate subcutaneous abatacept without receiving an intravenous loading dose)

101 kg and above weighing adults:

Loading dose via intravenous infusion: 3 doses of 1000mg for 15 days 

  • 1000 mg every month by intravenous infusion

Alternatively by subcutaneous injection:

  • The first subcutaneous dose of 125 mg once weekly should be administered one day after the intravenous loading dose; 
  • (patients who are unable to receive an infusion may initiate subcutaneous abatacept without receiving an intravenous loading dose).

Intravenous Dose of Orencia (Abatacept) in Children:

Children 6 years of age or older and weighing less than 75 kgs:

  • 10 mg/kg
  • The dose is repeated at 2 weeks and 4 weeks after the initial dose and every 4 weeks thereafter

Children 6 years or older and weighing more than 75 kgs:

  • Follow the Usual adult dosing with a maximum dose of up to 1000 mg
  • Following the initial dose, the dose is repeated at 2 weeks, 4 weeks, and then every 4 weeks after that. 

Dose in Kidney disease:

  • The manufacturer has not provided any dose adjustment in patients with kidney disease. 

Dose in Liver Disease:

  • The manufacturer has not provided any dose adjustment in patients with liver disease.

How to administer Abatacept (Orencia)?

Intravenous infusion of Orencia:

  • Infuse for 30 minutes.
  • Inject using 0.2-1.2 micron low protein-binding filter

Subcutaneous administration of Orencia:

  • Before injecting, let the prefilled syringe warm at room temperature for 30 to 60 minutes.
  • Preferably inject into front thigh, or the abdomen but not close to the navel (keep a distance of about three fingers from the navel), or the outer upper arms (the least preferred site).
  • Do not inject into an inflamed area i.e. tender, bruised, red, or hard skin.
  • Always rotate the injection sites

Pregnancy Risk Category: C

It may be used if benefits outweigh the risks

  • Pregnancy Implications  Pregnant females have not been tested with Abatacept. Animal studies have not shown any teratogenic effects.
  • Lactation It is not known if abatacept is found in breast milk.

Considerations for Breastfeeding

  • Breastfeeding is not recommended due to the adverse effects on the developing immune system

Side effects of Abatacept:

Abatacept is contraindicated in patients allergic to it, HIV, and immunocompromised patients who are at risk of infection and sepsis.

  • Hypersensitivity reactions:

    • Hypersensitivity reactions may involve anaphylactic reactions resulting in hypotension that may occur during the infusion and within 24 hours of the infusion.
    • Epinephrine, fluids, and steroids must be available while infusing the medicine.
  • Infections:

    • Patients are also at risk of developing serious infections such as the reactivation of tuberculosis, pneumocystis pneumonia, and other bacterial and viral infections.
    • Screening must be done for hepatitis B infections and immunized prior to initiating the treatment in patients. 
  • Malignancies:

    • The risks of malignancies such as lymphoma and lung cancer have been associated with its use.
    • However, these cancers are more common in patients with rheumatoid arthritis and the data is scarce regarding the associations of cancers with abatacept use.

Common side effects of Abatacept (Orencia): 

  • Abdominal pain
  • Vomiting
  • Nausea
  • Flushing
  • Conjunctivitis
  • Infection
  • Cough
  • Stomatitis
  • Fatigue 
  • Paraesthesia
  • Headache
  • Diarrhea
  • Pain in extremities
  • Dizziness
  • Hypertension
  • Dyspepsia
  • Fatigue

Uncommon adverse effects of Orencia:

  • Psoriasis
  • Weight gain
  • Dyspnoea
  • Gastritis
  • Palpitation
  • Alopecia
  • Bradycardia
  • Hypotension
  • Anxiety
  • Dry eye
  • Visual disturbance
  • Tachycardia
  • Arthralgia
  • Thrombocytopenia
  • Basal and squamous cell carcinoma
  • Dry skin
  • Skin papilloma
  • Depression 
  • Bronchospasm
  • Hypertension
  • Sleep disorder
  • Bruising
  • Depression
  • Hyperhidrosis
  • Menstrual disturbances

Rare side effects of Abatacept:​​​​​​​

Mechanism of Action (MOA) of Orencia (Abatacept):

  • The drug abatacept modulates costimulation. It binds to CD80 on antigen-presenting cells to prevent T-cell (T-lymphocyte) activation (APC).

  • This prevents the necessary CD28 interaction between T cells and APCs. T cells that have been activated are present in the synovium of rheumatoid arthritis patients.

Pharmacodynamics/Kinetics of Orencia:

  • Half-life elimination: 8-25 days

Monitoring Parameters

  • Signs and symptoms that indicate infection. It is recommended that you screen for TB and hepatitis before starting therapy.

International Brand Names of Abatacept:

  • Orencia

Currently, it is not available in Pakistan. 

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