Piqray chemical name: alpelisib is approved to be used in combination with the hormonal therapy Faslodex chemical name: fulvestrant to treat advanced-stage or metastatic hormone-receptor-positive, HER2-negative breast cancer with a PIK3CA mutation that has grown after treatment with hormonal therapy in postmenopausal women and men. 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. There are several isoforms of PI3; one of them is the alpha isoform. Piqray specifically targets the alpha isoform. Piqray is prescribed with the hormonal therapy Faslodex to treat postmenopausal women and men diagnosed with advanced-stage or metastatic hormone-receptor-positive, HER2-negative breast cancer with a PIK3CA mutation that has grown after treatment with hormonal therapy. The cancer must be tested to make sure the mutation is present.
Drug type: Alpelisib is an anti-cancer "antineoplastic" chemotherapy drug. This medication is classified as a "phosphatidylinositol 3-kinase inhibitor". For more detail, see "How Alpelisib works" below.
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What Alpelisib Is Used For:
Medically reviewed by Judith Stewart, BPharm. Last updated on Nov 2, Piqray alpelisib is a prescription medicine used in men and postmenopausal women with HR-positive, HER2-negative breast cancer that is advanced or has spread to other parts of the body metastatic. Your doctor will test you for this gene. Piqray is given in combination with fulvestrant Faslodex. Do not take Piqray if you have had a severe allergic reaction to alpelisib or are allergic to any of the ingredients in this medicine. Although, Piqray is for use only in women who can no longer get pregnant, you may need to have a negative pregnancy test before starting this treatment. Tell your doctor if you think you may be pregnant. Alpelisib and fulvestrant both can harm an unborn baby or cause birth defects if the mother or the father is using these medicines.
Approval was based on SOLAR-1 NCT , a phase 3, randomized, double-blind, placebo-controlled trial of alpelisib plus fulvestrant versus placebo plus fulvestrant in patients including postmenopausal women, and men, with HR-positive, HER2-negative, advanced or metastatic breast cancer whose disease had progressed or on or after receiving an aromatase inhibitor. The estimated median PFS by investigator assessment in the alpelisib plus fulvestrant arm was Overall survival data were not mature at the time of analysis. The most common adverse reactions including laboratory abnormalities on the alpelisib plus fulvestrant arm were increased glucose, increased creatinine, diarrhea, rash, decreased lymphocyte count, increased gamma glutamyl transferase, nausea, increased alanine aminotransferase, fatigue, decreased hemoglobin, increased lipase, decreased appetite, stomatitis, vomiting, decreased weight, decreased calcium, decreased glucose, prolonged activated partial thromboplastin time aPTT , and alopecia. The recommended alpelisib dose is mg two mg film-coated tablets taken orally, once daily, with food. When given with alpelisib, the recommended dose of fulvestrant is mg administered intramuscularly on days 1, 15, and 29, and once monthly thereafter. This application also used the Assessment Aid AAid. FDA granted this application priority review.