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 with moderately to severely active Rheumatoid arthritis.

Abatacept should not be used in combination with TNF-blocking agents (like adalimumab, etanercept, and infliximab, etc) and anakinra.

It can also be used in moderate or severe juvenile idiopathic arthritis as monotherapy or in combination with methotrexate.

Abatacept in Psoriatic arthritis:

The FDA has approved abatacept in the treatment of psoriatic arthritis. NSAIDs, Methotrexate, Sulfasalazine, cyclosporin, and leflunomide have all been found to be effective in the treatment of 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 enthesitis, dactylitis, and axial involvement in psoriatic arthritis.

Abatacept in Juvenile idiopathic arthritis:

It has also been approved as monotherapy or in combination with methotrexate in patients with moderately to severely active juvenile idiopathic arthritis. 

(Abatacept) Orencia dose:

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


Adult patients with body weight up to 60 kg:

Loading Dose via intravenous infusion:

500 mg every 15 days for 3 doses,

Then by intravenous infusion 500 mg every month,

Alternatively, it can be administered by a subcutaneous injection:

125 mg once a week, the first subcutaneous dose should be given within one day of the intravenous loading dose;

(patients who are unable to receive an intravenous infusion may initiate subcutaneous abatacept without 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)


Adult patients with a bodyweight of 101 kg and above:

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

Then by intravenous infusion 1000 mg every month,

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).

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
    • The dose is repeated at 2 weeks and 4 weeks after the initial dose and every 4 weeks thereafter.

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 over at least 30 minutes.

Administer through a 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 the front of the thigh, or the abdomen but not close to the navel (keep a distance of about three fingers from the navel), or the outer area of the upper arms (the least preferred site).

Do not administer 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 potential 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.

Patients should be screened for hepatitis B infections and immunized prior to initiating the treatment.

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
    • conjunctivitis
    • cough
    • diarrhea
    • dizziness
    • dyspepsia
    • fatigue
    • flushing
    • headache
    • hypertension
    • infection
    • leucopenia
    • nausea
    • pain in extremities
    • paraesthesia
    • stomatitis
    • vomiting.

Uncommon adverse effects of Orencia:

    • Psoriasis
    • alopecia
    • anxiety
    • arthralgia
    • basal and squamous cell carcinoma
    • bradycardia
    • bronchospasm
    • bruising
    • depression
    • dry eye
    • dry skin
    • dyspnoea
    • gastritis
    • hyperhidrosis
    • hypotension
    • menstrual disturbances
    • palpitation
    • skin papilloma
    • sleep disorder
    • tachycardia
    • thrombocytopenia
    • visual disturbance
    • weight gain

Rare side effects of Abatacept:

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

Abatacept acts as a costimulation modulator. It blocks the activation of T-cells (T-lymphocytes) by binding to CD80 on the antigen-presenting cells (APC).

This blocks the CD28 interaction required between T cells and APCs. Patients with rheumatoid arthritis have synovium containing activated T lymphocytes.

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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