Voclosporin

LUPKYNIS

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Pronunciation: VOE-kloe-spor-in (loop-KYE-nis)

Voclosporin ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Voclosporin ballicule

Voclosporin LUPKYNIS mascot mnemonic cartoon — Visual mnemonic: Voclosporin mascot
**“Lupine spore vocalist”**

What it isCalcineurin inhibitor; lupus nephritis with mycophenolate and steroids.

Why this oneIt achieves renal response faster than standard therapy, and unlike cyclosporine it needs no level monitoring.

What limits itNephrotoxicity and hypertension as for the class. CYP3A4-dependent; QT prolongation.

Voclosporin molecular structure (skeletal formula) — Molecular structure: Voclosporin

FDA-approved for

lupus nephritis (2021)

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Increased risk of malignancies and serious infections with immunosuppressants (may lead to hospitalization or death)

FDA dosing	Population	Start	Target	Max
Lupus nephritis (with MMF + corticosteroids)	adult	23.7 mg BID	23.7 mg BID	23.7 mg BID

Renal Not recommended if baseline eGFR ≤45 unless benefit exceeds risk; reduced dose in severe renal impairment; modify dose per eGFR changes

Hepatic Mild-moderate: dose reduction required; severe: avoid

If dose missed by >4 h, skip it; maintain at least 8 h between doses

Instructions

Swallow whole on an empty stomach
Dose ~12 h apart, at least 8 h between doses
Avoid grapefruit and grapefruit juice
Missed dose: take within 4 h, otherwise skip; do not double
Avoid live vaccines

Available strengths

cap 7.9 mg

Contraindications

Concomitant strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) — nephrotoxicity risk

Cautions

Nephrotoxicity
Hypertension
Neurotoxicity (incl. PRES)
Hyperkalemia
QT prolongation
Hypersensitivity reactions
Avoid live vaccines
Pure red cell aplasia

Adverse reactions

Decreased GFR
Hypertension
Diarrhea
Headache
Anemia

Pregnancy Avoid (alcohol content; used with MMF, which can cause fetal harm)

Lactation Small amounts in human milk; data insufficient

Cost

Voclosporin (LUPKYNIS)

Strength		#/mo	generic $/mo	CostPlus
7.9 mg	cap	60 BID		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Voclosporin is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2037 est.

⚠ BOXED WARNING

Malignancies and serious infections

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades2 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilitySerious infection, cytopenias, hepatic injury and malignancy risk require laboratory and clinical monitoring.

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Memory aids: interaction avatars

CYP3A4 substrate

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