Voclosporin Application Scope

Marketed under the brand name Lupkynis, is indicated for the treatment of adult patients with active lupus nephritis, in combination with a background immunosuppressive regimen.

Characteristics

Ingredients: The active ingredient is voclosporin, a calcineurin inhibitor; inactive ingredients include standard excipients used in capsule formulations.
Properties: Voclosporin is a novel calcineurin inhibitor with enhanced action against calcineurin and greater metabolic stability compared to cyclosporine.
Specification: Available as oral capsules, each containing 7.9 mg of voclosporin.
Packaging Specification: Supplied in bottles containing 60 capsules.
Storage: Store at room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
Expiry Date: Refer to the expiration date printed on the packaging.
Executive Standard: Complies with FDA-approved standards for prescription medications.
Approval Number: FDA NDA #214487 (approved January 2021).
Date of Revision: Refer to the latest revision date on the prescribing information.
Manufacturer: Aurinia Pharmaceuticals Inc.

Guidelines for the Use of Voclosporin

Dosage and Administration: The recommended starting dose is 23.7 mg orally twice daily, in combination with mycophenolate mofetil and corticosteroids. Dosage adjustments may be necessary based on clinical response and tolerability.
Adverse Reactions: Common adverse reactions (≥3%) include decreased glomerular filtration rate, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain, dyspepsia, alopecia, renal impairment, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.
Contraindications: Contraindicated in patients with a baseline eGFR ≤45 mL/min/1.73 m² unless the benefits outweigh the risks. Not recommended for use during pregnancy or breastfeeding.
Precautions: Monitor renal function and blood pressure regularly. Avoid live attenuated vaccines during treatment. Use caution when co-administering with drugs that are substrates, inhibitors, or inducers of CYP3A4.

Interactions

Drug Interactions: Co-administration with strong CYP3A4 inhibitors (e.g., ketoconazole) can increase voclosporin exposure; dose adjustments may be necessary. Avoid concomitant use with strong CYP3A4 inducers (e.g., rifampin) as they may decrease voclosporin efficacy.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.