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 diarrhoea^1,2
• Hyperglycaemia is an expected, on-target effect of PI3K inhibition. Consequently, PIQRAY^® should not be prescribed to Type 1 or uncontrolled Type 2 diabetes patients^1–4†

^†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.

View resources 

AEs, adverse events; PI3K, phosphoinositide 3-kinase.

References   

1. PIQRAY^® (alpelisib) Summary of Product Characteristics. Novartis Pharma; 2020.     
2. PIQRAY^® (alpelisib) Core Data Sheet: Version 1.0. Novartis Pharma AG; November 2018.     
3. André F, et al. N Engl J Med 2019;380(20):1929−1940.     
4. Goncalves MD, Hopkins BD, Cantley LC. N Engl J Med 2018;379(21):2052−2062.     
5. SOLAR-1 Clinical Study Report. Novartis data on file.     
6. André F, et al. N Engl J Med 2019;380(20):1929–1940. Supplementary Appendix.     
7. Rugo HS, et al. 324P. Presented at ESMO; 27 September−1 October 2019; Barcelona, Spain.