Abatacept

From Drugs Prescribing Information
Jump to: navigation, search

Click on "►" to expand:

Contents

[edit] BRAND NAMES

[edit] MECHANISM OF ACTION

Abatacept is a protein that lessens the immune system's attack on normal tissues by interfering with the immune cells (called T lymphocytes) that contribute to the development of rheumatoid arthritis and polyarticular juvenile idiopathic arthritis.

T cells must be ‘activated’ before they work. This happens when some signal molecules attach to receptors on the surface of the T cells. Abatacept selectively modulates the activation of T cells by attaching to two of these signal molecules called CD80 and CD86. This stops them activating the T cells, helping to reduce the inflammation.

Abatacept is produced by recombinant DNA technology: it is made by a cell that has received a gene (DNA), which makes it able to produce abatacept.

[edit] INDICATIONS

Orencia is used to treat the following diseases:

  • moderate to severe active rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints) in adults (aged 18 years or over) who have not had an adequate response to other medicines including methotrexate or a ‘tumour necrosis factor (TNF) blocker’.Abatacept may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists
  • moderate to severe active polyarticular juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints) in adolescents and children from six years of age who have not had a sufficient response to other medicines including one TNF blocker. Abatacept may be used as monotherapy or concomitantly with methotrexate

Important Limitations of Use: Abatacept should not be given concomitantly with anakinra or TNF antagonists

[edit] DOSAGE

Intravenous Administration for Adult Rheumatoid Arthritis.

Infusion should last 30 minutes. The dose to use depends on the patient’s weight. It is given every 2 and 4 weeks after the first infusion and every 4 weeks thereafter.. If there is no response within six months, the doctor should consider whether treatment should continue or not.

Body Weight of Patient
Dose
Number of Vials
Less than 60 kg
500 mg
2
60 to 100 kg
750 mg
3
More than 100 kg
1000 mg
4


Subcutaneous Administration for Adult Rheumatoid Arthritis

  • Administer by subcutaneous injection once weekly with or without an intravenous loading dose. For patients initiating therapy with an intravenous loading dose, administer a single intravenous infusion (as per body weight categories above), followed by the first 125 mg subcutaneous injection given within a day of the intravenous infusion.
  • Patients transitioning from Abatacept intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.


Juvenile Idiopathic Arthritis

  • Pediatric patients 6 to 17 years of age with juvenile idiopathic arthritis who weigh less than 75 kg is 10 mg/kg intravenously calculated based on the patient’s body weight at each administration. Pediatric patients weighing 75 kg or more should be administered Abatacept following the adult intravenous dosing regimen, not to exceed a maximum dose of 1000 mg.



General Dosing Information for Intravenous Administration

  • Administer as a 30-minute intravenous infusion
  • Following initial dose, give at 2 and 4 weeks, then every 4 weeks
  • Prepare Abatacept using only the silicone-free disposable syringe
  • Use only sterile water to reconstitute the powder
  • The reconstituted product must be administered using a filter

[edit] CONTRAINDICATIONS

  • Hypersensitivity to the active substance or to any of the excipients listed in section.
  • Severe and uncontrolled infections such as sepsis and opportunistic infections

[edit] WARNINGS AND PRECAUTIONS

  • Concomitant use with a TNF antagonist can increase the risk of infections and serious infections
  • Hypersensitivity, anaphylaxis, and anaphylactoid reactions
  • Patients with a history of recurrent infections or underlying conditions predisposing to infections may experience more infections
  • Discontinue if a serious infection develops
  • Screen for latent TB infection prior to initiating therapy. Patients testing positive should be treated prior to initiating Abatacept
  • Live vaccines should not be given concurrently or within 3 months of discontinuation
  • Patients with juvenile idiopathic arthritis should be brought up to date with all immunizations prior to Abatacept therapy
  • Based on its mechanism of action, Abatacept may blunt the effectiveness of some immunizations
  • Chronic Obstructive Pulmonary Disease patients may develop more frequent respiratory adverse events
  • Antirheumatic therapies have been associated with hepatitis B reactivation. Therefore, screening for viral hepatitis should be performed before starting therapy with Abatacept

[edit] PREGNANCY AND LACTATION

  • Pregnancy Category C (US): Abatacept has been shown to cross the placenta in animals, and in animal reproduction studies alterations in immune function occurred. Abatacept should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
  • Nursing Mothers: It is not known whether Abatacept is excreted into human milk or absorbed systemically after ingestion by a nursing infant. However, abatacept was excreted in rat milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Abatacept, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

[edit] SIDE EFFECTS

Most common adverse events (≥10%) are headache, upper respiratory tract infection, nasopharyngitis, and nausea

[edit] RELATED LINKS

Novel Treatments for Rheumatoid Arthritis

[edit] BIBLIOGRAPHY

[edit] REFERENCES