Nurses Compass
Drug Guide
Voclosporin
Classification
Therapeutic: Immunosuppressant for autoimmune diseases, especially lupus nephritis
Pharmacological: Calcineurin inhibitor
FDA Approved Indications
- Treatment of active lupus nephritis in adult patients
Mechanism of Action
Voclosporin inhibits calcineurin, leading to decreased T-cell activation and cytokine production, thereby suppressing the immune response involved in lupus nephritis.
Dosage and Administration
Adult: Starting dose of 23.7 mg twice daily, adjusted based on response and tolerability.
Pediatric: Not FDA-approved for pediatric use.
Geriatric: Use with caution; no specific dosage adjustment recommended but monitor closely.
Renal Impairment: Adjust dose as necessary; renal function should be monitored.
Hepatic Impairment: No specific adjustment provided; monitor liver function.
Pharmacokinetics
Absorption: Rapidly absorbed with peak concentrations in approximately 1-2 hours.
Distribution: Bound extensively to plasma proteins.
Metabolism: Primarily metabolized by CYP3A4 enzyme.
Excretion: Excreted mainly in feces; minor renal excretion.
Half Life: Approximately 12 hours.
Contraindications
- Allergy to voclosporin or other calcineurin inhibitors.
- Use with potent CYP3A4 inhibitors without dose adjustments.
Precautions
- Monitor blood pressure, renal function, and signs of infection; avoid live vaccines; use with caution in patients with hepatic impairment.
Adverse Reactions - Common
- Nephrotoxicity (Common)
- Hypertension (Common)
- Headache (Common)
- Diarrhea (Common)
Adverse Reactions - Serious
- Serious infections (Less common)
- Malignancies (e.g., lymphoma, skin cancer) (Less common)
- Neurotoxicity (Uncommon)
- Liver injury (Uncommon)
Drug-Drug Interactions
- Potent CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) increase voclosporin levels.
Drug-Food Interactions
- Grapefruit juice may increase levels by inhibiting CYP3A4.
Drug-Herb Interactions
- St. John's Wort may decrease efficacy by inducing CYP3A4.
Nursing Implications
Assessment: Monitor renal function, liver function, blood pressure, and signs of infection.
Diagnoses:
- Risk for infection related to immunosuppression.
- Risk for renal impairment.
Implementation: Administer as prescribed; monitor labs regularly; counsel patient on infection prevention.
Evaluation: Assess response to therapy and adverse effects periodically.
Patient/Family Teaching
- Take medication exactly as prescribed.
- Report signs of infection, unusual bleeding, or side effects.
- Avoid live vaccines during treatment.
- Maintain regular follow-up appointments.
Special Considerations
Black Box Warnings:
- Increased risk of infections and lymphoma due to immunosuppression.
Genetic Factors: Genetic variations in CYP3A4 may affect drug metabolism.
Lab Test Interference: May interfere with certain lab tests; inform laboratory personnel of medication use.
Overdose Management
Signs/Symptoms: Severe immunosuppression, bleeding, kidney or liver dysfunction, neurotoxicity.
Treatment: Supportive care, discontinuation of drug, and symptomatic management.
Storage and Handling
Storage: Store at room temperature away from moisture and heat.
Stability: Stable for up to the period specified in the package insert when stored properly.