LUPKYNIS

Lupkynis treatment should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of lupus nephritis. 9 mg soft capsules), twice daily. It is recommended that Lupkynis is administered consistently as close to a 12-hour schedule as possible and with a minimum of 8 hours between each dose.

If a dose is missed, it should be taken as soon as possible within 4 hours after missing the dose; beyond the 4-hour time frame, the next regular dose should be taken at the usual scheduled time. The next dose should not be doubled.

Lupkynis should be used in combination with mycophenolate mofetil. Physicians should evaluate the efficacy of treatment at a time point of at least 24 weeks and make an appropriate risk-benefit analysis for continuation of therapy. Dose adjustment based on eGFR It is recommended to establish a baseline estimated glomerular filtration rate (eGFR) before starting treatment with voclosporin, and assess every two weeks for the first month, and every four weeks thereafter.

73 m2. 73 m2 no dose modification is required (see table 1).

Table 1:

Recommended dose adjustments based on eGFR Confirmed eGFR decrease from baseline1 Recommendation ≥ 30 % reduction Stop administration of voclosporin. 9 mg (1 capsule) twice daily and increase as tolerated based on renal function. 9 mg (1 capsule) twice daily.

9 mg (one capsule) twice daily. ≤ 20 % reduction Maintain current dose and monitor. 73 m2 no action is required It is recommended that patients requiring a reduction in dose are reassessed for eGFR recovery within two weeks. 9 mg twice a day for each eGFR measurement that is ≥ 80 % of baseline should be considered; the starting dose should not be exceeded.

5). 8 mg twice daily. 2). 4). 73 m2. 7 mg twice daily. 73 m2) and is not recommended in these patients unless the benefit outweighs the risk. 2). Elderly Data are limited in LN patients > 65 years, and there are no data in patients aged > 75 years.

2). Paediatric population The safety and efficacy of Lupkynis in children and adolescents aged 5 to 18 years have not yet been established. No data are available. There is no relevant use of Lupkynis in children below the age of 5 years in lupus nephritis.

1 %). 9 %). 4). Tabulated list of adverse reactions Adverse reactions that occurred in patients with LN receiving the recommended dose of voclosporin with a median treatment duration of 1 year in two placebo-controlled clinical studies and/or post-marketing use are summarised in table 3.

All adverse reactions are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).

9 % in the placebo group. Infections occurring in at least 5 % of patients receiving voclosporin and at least 1 % more frequently than patients receiving placebo were urinary tract infection, viral upper respiratory tract infection, herpes zoster and gastroenteritis.

4 %). 8 % of placebo patients. 4). 2 % vs. 6 % vs. 4 % vs. 9 % vs. 8 %). 4 % of placebo patients. 7 %, placebo 0). 5 %). Following a decrease in eGFR, the median time to recovery was 49 days for patients on voclosporin with an eGFR decrease ≥ 20 %.

Similarly for patients with an eGFR decrease of ≥ 30 %, the median time to recovery was 102 days on voclosporin. 6 % of placebo patients. The incidence of hypertension was highest in the first 4 weeks of treatment with voclosporin and declined thereafter.

8 % of placebo patients. 4 % of placebo patients. Long term exposure (up to 36 months) The pattern of adverse reactions with continued treatment (from 12 to 36 months) was consistent with that seen in the first year of treatment; however, the incidences of the vast majority of events were lower in subsequent years.

0% in the placebo group. Infections occurring in at least 5 % of patients receiving voclosporin and at least 1 % more frequently than patients receiving placebo were urinary tract infection, upper respiratory tract infection, viral upper respiratory tract infection and gastroenteritis.

4. 1. 3 PHARMACEUTICAL FORM Soft capsule (capsule) Pink/orange oval soft capsules measuring approximately 13 mm × 6 mm. 1 Therapeutic indications Lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN).

2 Posology and method of administration Lupkynis treatment should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of lupus nephritis. 9 mg soft capsules), twice daily. It is recommended that Lupkynis is administered consistently as close to a 12-hour schedule as possible and with a minimum of 8 hours between each dose.

If a dose is missed, it should be taken as soon as possible within 4 hours after missing the dose; beyond the 4-hour time frame, the next regular dose should be taken at the usual scheduled time. The next dose should not be doubled.

Lupkynis should be used in combination with mycophenolate mofetil. Physicians should evaluate the efficacy of treatment at a time point of at least 24 weeks and make an appropriate risk-benefit analysis for continuation of therapy. Dose adjustment based on eGFR It is recommended to establish a baseline estimated glomerular filtration rate (eGFR) before starting treatment with voclosporin, and assess every two weeks for the first month, and every four weeks thereafter.

73 m2. 73 m2 no dose modification is required (see table 1).

Table 1:

Recommended dose adjustments based on eGFR Confirmed eGFR decrease from baseline1 Recommendation ≥ 30 % reduction Stop administration of voclosporin. 9 mg (1 capsule) twice daily and increase as tolerated based on renal function. 9 mg (1 capsule) twice daily.

9 mg (one capsule) twice daily. ≤ 20 % reduction Maintain current dose and monitor. 73 m2 no action is required It is recommended that patients requiring a reduction in dose are reassessed for eGFR recovery within two weeks. 9 mg twice a day for each eGFR measurement that is ≥ 80 % of baseline should be considered; the starting dose should not be exceeded.

1. 5).