New drug approved by FDA on January 22 ,2021 by Aurinia Pharmaceticals

1. PRESENTED BY:
CH.BINDU MADHAVI
V/VI PHARM D
Y17PHD0805
NIRMALA COLLEGE OF PHARMACY

2. DRUG DETAILS:
DRUG NAME LUPKYNIS
ACTIVE INGREDIENT Voclosporin
COMPANY Aurinia Pharmaceuticals
APPROVED DATE January 22, 2021
CATEGORY Calcineurin Inhibitor
LUPKYNIS is a drug used to treat patients with active lupus nephritis.
Lupus nephritis (LN) is an inflammation of the kidneys that is caused by systemic lupus erythematous (SLE) - a chronic,
autoimmune disease.
LUPKYNIS is a calcineurin-inhibitor
immunosuppressant indicated in combination with
a immunosuppressive therapy regimen ( MMF and
Corticosteroids) for the treatment of adult patients
with active lupus nephritis (LN).

3. • MOL FORMULA: C63H111N11O12
• MOL WEIGHT : 1214.6 g/mole
• APPEARANCE: appears as oval,
pink/orange capsules, imprinted on one
side with VCS in white.
• PROPERTIES: voclosporin is
freely soluble in acetone,
acetonitrile, ethanol, and methanol
and is insoluble in water
STRUCTURE OF VOCLOSPORIN

4. MEACHANISM OF ACTION

5. DOSAGE FORMS AND STRENGTHS:
Usual Adult dose: 23.7mg P/O BD
• Dosage Modifications in Renal impairment-
• Modify dose based on GFR
• If used in patients with severe renal impairment at baseline, the recommended starting dose is 15.8 mg twice a day
• Dosage modifications in Hepatic impairment-
• Mild or moderate : Reduce to 15.8 mg BID
• Severe : Not recommended
GFR REDUCED FROM BASELINE DOSE ADJUSTMENT
GFR <60 mL/min/1.73 m2 >20 to <30% Reduce by 7.9 mg BID
GFR <60 mL/min/1.73 m2 GFR is still reduced from baseline by
>20%
reduce dose again by 7.9 mg BID
GFR <60 mL/min/1.73 m2 ≥30% Discontinue
GFR ≥80% of baseline Consider increasing dose by 7.9
mg BID

6. ADVERSE EFFECTS
• Glomerular filtration rate decreased
• Hypertension
• Diarrhoea
• Headache
• Anaemia
• Cough
• Urinary tract infection
• Upper abdominal pain
• Dyspepsia
• Renal Impairment
• Abdominal pain

7. INTERACTIONS:
• Voclosporin is a sensitive CYP3A4 substrate. Co-administration with strong or moderate CYP3A4
inhibitors increases voclosporin exposure and leads to increase adrs (e.g., ketoconazole, itraconazole,
clarithromycin)
• Voclosporin is a P-gp inhibitor. Co-administration of voclosporin increases exposure of P-gp
substrates. (e.g., amiodarone, erythromycin, omeprazole)
• Some products that may interact with this drug are: cyclophosphamide and drugs that may
increase potassium levels (such as potassium supplements, certain diuretics/"water pills"
including amiloride, spironolactone).
• CONTRAINDICATIONS:
• Pregnancy ( causes foetal death)
• Hypersensitivity Reactions
• Contraindicated in patients with BP greater than 165/105mm Hg or with hypertensive emergency.

8. • MONITORING PARAMETERS:
• Monitor electrolytes (specially K levels) periodically
• Monitor BP
• Monitor QT prolongation
• GENERAL CONSIDERATIONS:
• Take on an empty stomach. Take on an empty stomach, either 1 hour before or 2 hours after a
meal and as close to 12 hours between doses as possible.