Home Drug Guide Belatacept

Drug Guide

Generic Name

Belatacept

Brand Names Nulojix

Classification

Therapeutic: Immunosuppressant

Pharmacological: Fusion protein, T-cell costimulation blocker

FDA Approved Indications

Prophylaxis of organ rejection in adult kidney transplant recipients

Mechanism of Action

Belatacept selectively inhibits T-cell activation by binding to CD80 and CD86 on antigen-presenting cells, preventing costimulatory signals necessary for T-cell activation, thereby reducing immune response against transplanted organs.

Dosage and Administration

Adult: Initial dose of 10 mg/kg IV infusion on days 1, 5, and 15, then every 4 weeks; doses adjusted based on patient response and immunosuppression protocols.

Pediatric: Not approved/not established; limited data available.

Geriatric: No specific dose adjustments recommended; monitor closely due to potential increased risk of infections.

Renal Impairment: Use with caution; no specific adjustments provided.

Hepatic Impairment: No specific data; use caution and monitor accordingly.

Pharmacokinetics

Absorption: Administered IV, so absorption is immediate.

Distribution: Widely distributed; volume of distribution approximately 8-11 liters.

Metabolism: Metabolized via proteolytic enzymes; not via cytochrome P450 system.

Excretion: Replaced mainly as peptides/metabolites in urine and feces.

Half Life: Approximately 8-10 days.

Contraindications

History of active or latent tuberculosis; hypersensitivity to belatacept or its components.

Precautions

Risk of serious infections, including opportunistic infections and progressive multifocal leukoencephalopathy (PML).
Screen for latent infections prior to treatment.
Assess for potential latent or active infections before initiation.

Adverse Reactions - Common

Infections (e.g., respiratory, urinary) (Common)
Anemia (Common)
Peripheral edema (Common)

Adverse Reactions - Serious

Progressive multifocal leukoencephalopathy (PML) (Rare)
Serious infections (Serious)
Liver function abnormalities (Uncommon)

Drug-Drug Interactions

Other immunosuppressants, corticosteroids, live vaccines.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for signs of infections, neurologic symptoms suggestive of PML, and liver function.

Diagnoses:

Risk for infection related to immunosuppression.
Impaired skin integrity.

Implementation: Administer IV as scheduled, monitor vital signs and labs, educate patient on infection risk.

Evaluation: Assess for signs of rejection, adverse reactions, and infections.

Patient/Family Teaching

Inform about increased risk of infections and importance of reporting symptoms such as fever or neurologic changes.
Emphasize adherence to scheduled infusions.
Advise on avoiding live vaccines and practicing good hygiene.

Special Considerations

Black Box Warnings:

Risk of progressive multifocal leukoencephalopathy (PML).

Genetic Factors: Efficacy may be reduced in Epstein-Barr virus (EBV) seronegative patients.

Lab Test Interference: Can cause lymphopenia, anemia, and other hematologic changes; monitor accordingly.

Overdose Management

Signs/Symptoms: Severe immunosuppression leading to increased risk of infections.

Treatment: Supportive care, discontinue drug, monitor closely, treat infections aggressively.

Storage and Handling

Storage: Refrigerate at 2-8°C (36-46°F); protect from light.

Stability: Stable until the expiration date on the label if stored properly.