Piqray

About Alpelisib 

Alpelisib tablets are prescribed 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, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. 

Strength

50 mg, 150 mg, and 200 mg film-coated tablets

Recommended Dosage:

The recommended dosage is two 150 mg Alpelisib tablets taken once a day with meals orally. 

Important: If patients experience any adverse reactions from the Alpelisib treatment, it is necessary to consult the treating doctor. 

Warnings & Precautions

• Alpelisib treatment should be discontinued permanently in cases of severe hypersensitivity. It is necessary to begin the prescribed treatment immediately.
• There have been reports of severe cutaneous responses such as Stevens-Johnson syndrome (SJS) and Erythema Multiforme (EM). If signs or symptoms of severe cutaneous responses are evident, patients must withhold the Alpelisib treatment until the cause of the reaction is confirmed by the consulting doctor. If SJS, EM, or TEN is proven, Piqray should be discontinued permanently. It is necessary to consult the treating doctor in cases of adverse reactions.
• There were reports of severe hyperglycemia, including ketoacidosis.  Piqray has not been proven safe in people with Type 1 or uncontrolled Type 2 diabetes. Before beginning Alpelisib therapy, evaluate fasting plasma glucose (FPG), HbA1c, and optimize blood glucose. After starting therapy, check in regularly. As clinically appropriate, initiate or optimize anti-hyperglycemic medicines. If severe hyperglycemia arises, interrupt, reduce, or discontinue the Alpelisib tablets. 
• There have been reports of severe instances of pneumonitis and interstitial lung disease. Keep an eye out for clinical signs or radiological abnormalities. If severe pneumonitis develops, interrupt or discontinue Alpelisib tablets.
• Severe episodes of diarrhea have been recorded, causing dehydration and severe renal damage. If diarrhea arises, it is advised that the patients should begin antidiarrheal medication, and increase oral fluids. If severe diarrhea occurs, interrupt, modify the dose, or discontinue Alpelisib treatment.
• Alpelisib treatment has the potential to damage a fetus (Embryo-Fetal Toxicity). Inform patients of the potential risk to a fetus and encourage them to utilize effective contraception. 

Common Alpelisib Side Effects

• Increased glucose
• Increased creatinine 
• Diarrhea
• Rash
• Reduced lymphocyte count
• Increased GT
• Nausea
• Increased ALT 
• Fatigue
• Reduced Hemoglobin 
• Increased lipase 
• Reduced appetite
• Stomatitis
• Vomiting
• Reduced Weight 
• Reduced Calcium
• Reduced glucose 
• Prolonged aPTT 
• Alopecia

Use in specific population 

• Piqray poses a risk of fetal harm in pregnant women, and there is insufficient data on its use in this population. Before starting th medicine inform your doctor if you are pregnant or planning to get pregnant . 
• Breastfeeding is not recommended during Piqraytreatment due to the lack of information on the presence of entrectinib or its metabolites in human milk and their impact on infants. 
• Lactating women are advised to discontinue breastfeeding during treatment and for 7 days after the final dose to mitigate potential adverse reactions in breastfed children. 
• Before starting Piqray, assess the pregnancy status of females of reproductive potential and recommend effective contraception during treatment and for at least 7 days post-final dose. 
• Male patients with female partners of reproductive potential should also use effective contraception during treatment and for 7 days after the final dose. 
• Based on animal studies, Piqray may impair fertility in males and females of reproductive potential. 
• Piqray safety and effectiveness have not been established in pediatric patients, and no dose adjustment is recommended for those with mild to moderate renal impairment.

Storage and Handling

Each carton contains two blister packs with every pack containing a 14-day supply of 28 Alpelisib tablets (150 mg). 

Store at 20ºC to 25ºC excursions permitted between 15ºC to 30ºC.