Prescribing information

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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.

 

Screenshot from the video: Professor Caroline Robert discusses the landmark 5-year data with Tafinlar + Mekinist

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.
HCP20-C003 September 2020.
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at http://www.report.novartis.com/
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]