What is Piqray (alpelisib) for?
Piqray (alpelisib) is a kinase inhibitor indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CAmutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
How does Piqray (alpelisib) work?
Piqray (alpelisib) is an phosphatidylinositol-3-kinase (PI3K) inhibitor that blocks the PI3K pathway.
The PI3K pathway helps all cells — both healthy and cancer cells — get the energy they need.
When this pathway is overactivated because of a mutation in the PIK3CA gene, it can allow cancer cells to survive and grow. PI3K inhibitors block this pathway, with the goal of killing cancer cells.
Where has Piqray (alpelisib) been approved?
Piqray (alpelisib) was approved by:
- The Food and Drug Administration (FDA), USA, on May 24, 2019, for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CAmutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Piqray (alpelisib) taken?
The standard dosage is:
- 300 mg taken orally, once daily, with food.
Treatment should be continued until disease progression or unacceptable toxicity occurs. Patients should take their dose of Piqray (alpelisib) at approximately the same time each day. Swallow Piqray (alpelisib) tablets whole (tablets should not be chewed, crushed or split prior to swallowing). No tablet should be ingested if it is broken, cracked, or otherwise not intact.
When given with Piqray (alpelisib), the recommended standard dose of fulvestrant is 500 mg administered on Days 1, 15, and 29, and once monthly thereafter. Please refer to the Full Prescribing Information for fulvestrant.
Dosage for Piqray (alpelisib) may be different for special populations. Reduction in dose may be required based on symptoms and experienced side effects. Complete information about Piqray (alpelisib) dosage and administration can be found in the official prescribing information listed in our references section.
Note: Please consult with your treating doctor for personalised dosing and potential drug interactions.
Are there any known side effects or adverse reactions of Piqray (alpelisib)?
Common adverse reactions
The most common adverse reactions listed in the prescribing information include:
- laboratory abnormalities, such as glucose increased, creatinine increased, Gamma Glutamyl Transferase (GGT) increased, lymphocyte count decreased
- weight loss
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:
- severe allergic reactions
- severe skin reactions
- high blood sugar levels (hyperglycemia)
- lung problems (pneumonitis)
- acute kidney injury
- abdominal pain
Use in specific populations
Piqray (alpelisib) can cause fetal harm, it is advised to avoid pregnancies and breastfeeding. The safety and efficacy of Piqray (alpelisib) in pediatric patients have not been established.
Piqray (alpelisib) is used in combination with fulvestrant. Refer to the full prescribing information of fulvestrant for information on the use in specific population for that medicine.