mended human dose (MRHD) of 23.7 mg twice daily. Furthermore, animal studies have linked voclosporin doses at 0.1 to 0.3-times the MRHD in rabbits to reduced placental and fetal body weight.
mg twice daily. If at follow up visits eGFR is < 60 mL/min/1.73m2 and has decreased by 20-30% from baseline, the dose should be reduced by 7.9 mg twice a day. If the eGFR is still reduced from baseline by > 20% in two weeks There is no available data from after the initial dose reduction, humans regarding the presence reduce the dose again by 7.9 mg of voclosporin in breastmilk or twice a day. If eGFR is < 60 mL/ its effects on lactation. In animal min/1.73m2 and reduced from models, voclosporin was detected baseline by > 30%, discontinue in the milk of lactating rats, indiand reassess eGFR in two weeks. Voclosporin may be re-initiatcating it would likely be present in human milk as well. The use of ed at 7.9 mg twice daily if eGFR voclosporin is not recommended returns to > 80% of baseline, in lactating women, and breastand the dose can continue to be feeding should be avoided for at increased by 7.9 mg twice a day least 7 days after the last dose of for each eGFR measurement > voclosporin. 80% of baseline, not to exceed the initial starting dose. Dosing: The recommended starting dose for voclosporin Storage: Store in the original in patients with normal renal packaging at room temperature function is 23.7 mg (3 capsules) (20oC to 25oC); may be stored twice a day taken on an empty briefly at 15oC to 30oC. stomach. It is important to stay as consistent as possible with at Dosages and Cost: Voclosporin least 8-hours between doses. If a is available as 7.9 mg capsules dose has been missed, the patient contained within a wallet consistshould be instructed to take the ing of four individual 3 x 5 blister dose as soon as possible within strips (60 capsules) or carton 4-hours of the missed dose. If containing three wallets (180 it has been > 4 hours, omit the capsules). Cost has not yet been missed dose and continue taking established. at scheduled time. Baseline eGFR must be established prior to Summary/Use in clinical practreatment initiation and should tice be assessed every two weeks for Voclosporin in addition to backthe first month and every four ground immunosuppressive weeks thereafter. If eGFR is < 45 therapy (mycophenolate mofetil mL/min/1.73m2 at baseline, voc- plus corticosteroids) is a viable losporin is not recommended as option for treating patients with it has not been studied in these lupus nephritis. Lupus nephritis is a serious condition that withpatients. However, if used in paout appropriate treatment can tients with severe renal impairment, the recommended starting lead to permanent and irreversdose is 15.8 mg twice daily. In ible damage to the kidneys. The standard of therapy is currently patients with mild to moderate high-dose corticosteroids plus hepatic impairment (Child-Pugh either mycophenolate mofetil or A or Child-Pugh B), the recommended starting dose is also 15.8 cyclophosphamide. UnfortunatePage 17
ly, research has shown that after 6 to 12 months of therapy, only 10 to 40% of patients achieve CRR, indicating the need for a more efficient treatment regimen. Voclosporin is a next-generation calcineurin inhibitor similar to cyclosporine; however, it is more potent and is metabolized quicker, eliminating the need for drug level monitoring.
When compared to the current standard of treatment for lupus nephritis, treatment with voclosporin resulted in a higher proportion of patients reaching CRR. While an effective treatment, the use of voclosporin is associated with more adverse effects such as reduced eGFR, hypertension, and headache when compared to placebo. Prior to the initiation of voclosporin, it is important for providers to evaluate the patient’s renal function and their list of current medications. Voclosporin should not be taken concomitantly with potent CYP3A4 inhibitors, as these will increase voclosporin concentrations and the risk for adverse effects. Furthermore, it is important to counsel patients on the importance of staying consistent and separating doses by at least 8 hours and to take on an empty stomach to ensure absorption. The manufacturer suggests monitoring blood pressure every two weeks for the first month after initiating voclosporin, and as clinically indicated thereafter. If the patient experiences readings >165/105 mmHg or presents with hypertensive emergency, voclosporin should be discontinued and antihypertensive therapy initiated. Voclosporin is relatively new and the most recent findings from Arriens and colleagues have yet
