abatacept: clinical use

Prescribing considerations

• Initiate and supervise through an experienced specialist service.
• Assess active, recurrent and opportunistic infection risk and review vaccination status before treatment.
• Screen for latent tuberculosis and viral hepatitis before initiation.
• Avoid concurrent TNF inhibitors; carefully assess any other biological immunosuppressive combination.
• Use additional caution in older people, patients predisposed to infection and those with chronic obstructive pulmonary disease.
• Record the product name and batch number for biological-medicine traceability.

Contraindications and cautions

• Hypersensitivity to abatacept or a formulation excipient.
• Severe and uncontrolled infection, including sepsis or opportunistic infection.

Monitoring

• Monitor closely for new infections and interrupt treatment if a serious infection develops.
• Review clinical response and ongoing need for treatment.
• Investigate new neurological, psychiatric or cognitive symptoms promptly for possible progressive multifocal leukoencephalopathy.
• Consider periodic skin examination, particularly where skin-cancer risk factors are present.
• Use local laboratory monitoring protocols and account for monitoring required by concomitant disease-modifying treatments.

Clinical pharmacology

Abatacept is a recombinant CTLA-4–IgG1 fusion protein that binds CD80 and CD86 and selectively modulates the CD28-mediated costimulatory signal needed for full T-cell activation.

Formulation and product differences

• The pre-filled syringe is a ready-to-use, single-use subcutaneous formulation that may be administered by a trained patient or caregiver.
• The intravenous formulation is a powder requiring aseptic reconstitution and dilution by healthcare professionals, administration through an appropriate low-protein-binding filter, and silicone-free preparation equipment.
• Both selected formulations require refrigerated storage and protection from light; the pre-filled syringe must not be frozen or shaken.

Solution for infusion

Route: Intravenous

Strengths: 250 mg

Injection

Route: Parenteral

Strengths: 50 mg, 87.5 mg, 125 mg