Oral NINLARO + Rd is generally well-tolerated with manageable side effects1
Adverse events were generally Grade 1 or 2 and were manageable with supportive care1
- The most frequently reported adverse events were GI, rash, thrombocytopenia, peripheral oedema, peripheral
neuropathy (PN) and back pain1
- They were generally Grade 1 and 2 and manageable with supportive care
- No CV or renal safety signals seen in the study
- Thrombocytopenia was increased in the NINLARO + Rd vs placebo + Rd arm, but did not result in an increase in bleeding events or platelet transfusions2
- The incidence of Grade ≥3 PN was 2% across both NINLARO + Rd and placebo + Rd1,2
Oral NINLARO + Rd is generally well tolerated with manageable side effects in patients who have received 2-3 prior lines of therapy1,7
All-grade AEs were consistent with the safety population1,7
- In the 2-3 prior lines subgroup, rates of Grade ≥3 peripheral neuropathy were 3% vs 1% and rash 3% and <1% for NINLARO + Rd vs placebo +Rd, respectively
Most patients were able to continue on extended oral NINLARO + Rd treatment3
Most patients were able to continue extended oral NINLARO + Rd treatment without dose modifications3
- The majority of patients (76%) continued at their starting dose of NINLARO without dose reduction3
- The median relative dose intensity of NINLARO was high and similar to placebo (97.4% and 98.8%, respectively) at 23 months' median follow-up4
- 17% of patients discontinued the NINLARO + Rd regimen because of AEs vs 14% for placebo + Rd1
The efficacy and tolerablility profile of the all-oral NINLARO + Rd regimen allowed patients' global quality of life to be sustained6
Adding oral NINLARO to Rd delivered a clinically meaningful PFS extension without negatively impacting global quality of life compared to placebo + Rd6
- The double‑blind study design adds to the clinical significance of the quality of life assessment
AEs of special interest: no safety concerns identified (≤2% difference between oral NINLARO + Rd and placebo + Rd)1
* Represents multiple MedDRA preferred terms
† Includes treatment-emergent AEs and new primary maligancies reported during follow-up period
Oral NINLARO is available in several strengths to allow for dose modifications
- 4 mg is the usual recommended starting dose
- Use the recommended starting dose of 3 mg in patients with moderate or severe haptic impairment, severe renal impairment or end-stage renal disease requiring dialysis1
- No dose adjustment is required for:1
- Body type or weight
- Elderly patients older than 65 years
- Patients with mild or moderate renal impairment *
- Patients with mild hepatic impairment +
- Moreau P, Masszi T, Grzasko N. N Engl J Med. 2016;374:1621-34.
- NINLARO (ixazomib capsules) Summary of Product Characteristics.
- Takeda Data on File - UK/DF/1611/0017.
- Takeda Data on File - UK/DF/1701/0002.
- Takeda Data on File - UK/DF/1611/0018.
- Moreau P, Masszi T, Grzasko N. N Engl J Med. 2016;374:1621-34, Supplemental Appendix. Available at http://www.nejm.org/doi/suppl/10.1056/NEJMoa1516282/suppl_file/nejmoa1516282_appendix.pdf. Accessed January 2017.
- Mateos M-V, Masszi T, Grzasko N, et al. Haematologica. 2017;102:1767-1775.
- Takeda Data on File - UK/DF/1708/0010.