Safety profile for PIQRAY® + fulvestrant from the SOLAR-1 Phase 3 clinical trial.
If you would like to discuss management of your patients on PIQRAY® + fulvestrant, please click here to contact a Novartis representative.
The safety profile of PIQRAY® + fulvestrant can be managed through dose reductions or interruptions or proactive treatment of adverse events (AEs)1
- Serious AEs associated with PIQRAY® include hyperglycaemia, hypersensitivity (including anaphylactic reaction), severe cutaneous reactions, pneumonitis, osteonecrosis of the jaw and diarrhoea1,2
- Hyperglycaemia is an expected, on-target effect of PI3K inhibition. Consequently, PIQRAY® should not be prescribed to Type 1 or uncontrolled Type 2 diabetes patients1–4†
†Type 1 and Type 2 diabetes defined by the Diabetes UK.
AEs occurring in the SOLAR-1 Phase 3 trial1
Median duration of exposure in the PIQRAY® arm was 5.5 months and 8.2 months for PIQRAY® and fulvestrant, respectively. Median duration of exposure in the placebo arm was 5.6 months and 5.6 months for placebo and fulvestrant, respectively.5
*No grade 4 AEs were observed
#AEs reported during post-marketing experience. These are derived from spontaneous reports for which it is not always possible to reliably establish frequency or a causal relationship to exposure to the medicinal product.
AEs were managed with additional therapy (97.5% vs 70.0% of patients),5 dose interruptions (68.6% vs 15.8%) and dose reductions (62.1% vs 4.7%) in patients treated with PIQRAY® + fulvestrant (n=169) vs placebo + fulvestrant (n=171), respectively6
- In the 190 patients with hyperglycaemia, 87.4% (166/190) were managed with antidiabetic medication, and 75.8% (144/190) of patients reported use of metformin as single agent or in combination with other antidiabetic medication (e.g. insulin, dipeptidyl peptidase-4 (DPP-4) inhibitors, SGLT2 inhibitors and sulfonylureas)1
Among the 169 patients who experienced diarrhoea, antidiarrhoeal medications (e.g. loperamide) were required to manage symptoms in 64.5% (109/169)1
- Concomitant treatment with metformin did not increase the incidence or severity of diarrhoea7
- Of the 134 patients in the PIQRAY® + fulvestrant arm who received antirash medication, corticosteroids and antihistamines were the most used (in 84.3% and 76.9%, respectively)7
Certain AEs may require dose modifications
- Dose interruptions may be required prior to dose reductions
- Among patients treated with PIQRAY® + fulvestrant, 25.0% of patients discontinued treatment due to AEs compared with 4.2% treated with placebo + fulvestrant3
†No patients discontinued placebo + fulvestrant due to these AEs.
THERAPY MANAGEMENT GUIDE
Please see the therapy management guide for more details on managing AEs with PIQRAY® + fulvestrant.
AEs, adverse events; PI3K, phosphoinositide 3-kinase.
- PIQRAY® (alpelisib) Summary of Product Characteristics. Novartis Pharma; 2020.
- PIQRAY® (alpelisib) Core Data Sheet: Version 1.0. Novartis Pharma AG; November 2018.
- André F, et al. N Engl J Med 2019;380(20):1929−1940.
- Goncalves MD, Hopkins BD, Cantley LC. N Engl J Med 2018;379(21):2052−2062.
- SOLAR-1 Clinical Study Report. Novartis data on file.
- André F, et al. N Engl J Med 2019;380(20):1929–1940. Supplementary Appendix.
- Rugo HS, et al. 324P. Presented at ESMO; 27 September−1 October 2019; Barcelona, Spain.