This section is intended for UK healthcare professionals. If you are a member of the public click here. If you have been prescribed Ninlaro click here.

Special Populations

Using NINLARO in special patient populations1

Elderly

  • No dose adjustment of NINLARO is required for patients over 65 years of age
  • Discontinuations in patients less than 75 years of age were reported in 13 patients (28%) in the NINLARO regimen and 10 patients (16%) in the placebo regimen
  • Discontinuations in patients over 75 years of age were observed in 10 patients (21%) in the NINLARO regimen and 9 patients (15%) in the placebo regimen

Paediatric population

  • NINLARO in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with MM who have received at least one prior therapy
  • The safety and efficacy of NINLARO in children below 18 years of age have not been established - no data are available

Hepatic impairment

  • No dose adjustment of NINLARO is required for patients with mild hepatic impairment (total bilirubin ≤ ULN and AST > ULN or total bilirubin >1 to 1.5 x ULN and any AST)
  • A lower starting dose of 3 mg is recommended for patients with moderate (total bilirubin >1.5 to 3 x ULN) or severe (total bilirubin >3 x ULN) hepatic impairment

Renal impairment

  • No dose adjustment of NINLARO is required for patients with mild or moderate renal impairment (creatinine clearance ≥30 mL/min)
  • A lower starting dose of 3 mg is recommended for patients with severe renal impairment (creatinine clearance <30 mL/min) or end-stage renal disease requiring dialysis
  • NINLARO is not dialysable and therefore can be administered without regard to the timing of dialysis
  • Refer to the lenalidomide SmPC for dosing recommendations in patients with renal impairment

NINLARO Patient Support Programme (PSP)

This NINLARO Patient Support Programme (PSP) has been designed to help patients familiarise themselves with the NINLARO based triplet regimen. The programme is intended for patients that are currently receiving or are about to initiate treatment with the NINLARO regimen.

To download a copy of the booklet, which provides further information on the programme for Healthcare Professional click here

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