Safety profile

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
• Severe hyperglycaemia, in some cases associated with hyperglycaemic hyperosmolar nonketotic syndrome (HHNKS) or ketoacidosis, has been observed in patients treated with Piqray. Some cases of ketoacidosis with fatal outcome have been reported in the post-marketing setting.¹

^†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; 2021.     
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.