Alpelisib

Alpelisib Brand Name– PIQRAY

What is Alpelisib

Alpelisib is an oral phosphatidylinositol 3-kinase (PI3K) inhibitor.

It is indicated in combination with fulvestrant for the treatment of men and postmenopausal women with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

PI3K inhibition by alpelisib treatment has been shown to induce an increase in estrogen receptor (ER) transcription in breast cancer cells.

The combination of alpelisib and fulvestrant demonstrated increased anti-tumor activity compared to either treatment alone in xenograft models derived from ER-positive, PIK3CA-mutated breast cancer cell lines.

Hyperglycemia is an expected laboratory abnormality related to PI3K inhibition; the safety of alpelisib in patients with Type 1 and uncontrolled Type 2 diabetes has not been established as these patients were excluded from clinical trials.

Indications

  • breast cancer

Side Effects

  1. abdominal pain
  2. alopecia
  3. anaphylactic shock
  4. anaphylactoid reactions
  5. anemia
  6. anorexia
  7. asthenia
  8. dehydration
  9. diabetic ketoacidosis
  10. diarrhea
  11. dysgeusia
  12. dyspepsia
  13. dyspnea
  14. elevated hepatic enzymes
  15. erythema multiforme
  16. fatigue
  17. fever
  18. flushing
  19. headache
  20. hyperglycemia
  21. hypoalbuminemia
  22. hypocalcemia
  23. hypoglycemia
  24. hypokalemia
  25. hypomagnesemia
  26. infection
  27. interstitial lung disease
  28. lymphopenia
  29. maculopapular rash
  30. nausea
  31. osteonecrosis
  32. pancreatitis
  33. peripheral edema
  34. pneumonitis
  35. prolonged bleeding time
  36. pruritus
  37. rash
  38. renal failure (unspecified)
  39. Stevens-Johnson syndrome
  40. stomatitis
  41. thrombocytopenia
  42. vomiting
  43. weight loss
  44. xerosis
  45. xerostomia

Monitoring Parameters

  • blood glucose
  • glycosylated hemoglobin A1c (HbA1c)
  • pregnancy testing

Contraindications

  • breast-feeding
  • chronic lung disease (CLD)
  • contraception requirements
  • diabetes mellitus
  • diarrhea
  • hyperglycemia
  • infertility
  • interstitial lung disease
  • male-mediated teratogenicity
  • pneumonitis
  • pregnancy
  • pregnancy testing
  • reproductive risk
  • serious rash
  • type 1 diabetes mellitus

Interactions

  • Acalabrutinib
  • Amlodipine; Celecoxib
  • Apalutamide
  • Atazanavir; Cobicistat
  • Atropine; Hyoscyamine; Phenobarbital; Scopolamine
  • Belladonna Alkaloids; Ergotamine; Phenobarbital
  • Brigatinib
  • Carbamazepine
  • Celecoxib
  • Cobicistat
  • Cyclosporine
  • Daclatasvir
  • Darolutamide
  • Darunavir; Cobicistat
  • Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
  • Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
  • Elbasvir; Grazoprevir
  • Eltrombopag
  • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
  • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
  • Enzalutamide
  • Fosphenytoin
  • Fostamatinib
  • Glecaprevir; Pibrentasvir
  • Glimepiride
  • Glimepiride; Pioglitazone
  • Glimepiride; Rosiglitazone
  • Ibrutinib
  • Isoniazid, INH; Pyrazinamide, PZA; Rifampin
  • Isoniazid, INH; Rifampin
  • Itraconazole
  • Ledipasvir; Sofosbuvir
  • Leflunomide
  • Lumacaftor; Ivacaftor
  • Lumacaftor; Ivacaftor
  • Mitotane
  • Ombitasvir; Paritaprevir; Ritonavir
  • Osimertinib
  • Phenobarbital
  • Phenytoin
  • Ponatinib
  • Primidone
  • Regorafenib
  • Rifampin
  • Rolapitant
  • Safinamide
  • Sapropterin
  • Simeprevir
  • Sirolimus
  • Sofosbuvir; Velpatasvir
  • Sofosbuvir; Velpatasvir; Voxilaprevir
  • St. John’s Wort, Hypericum perforatum
  • Sulfasalazine
  • Tacrolimus
  • Tafamidis
  • Tedizolid
  • Teriflunomide
  • Tolbutamide
  • Vemurafenib
  • Warfarin
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