Big Bear APELIXDx Alpelisib 150mg

Product Information

• Product name: APELIXDx Alpelisib150mg Alpelisib 150mg
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Alpelisib
• Current strength: 150mg
• SKU: Product ID 3152
• Site category: general medicines

Product Summary

APELIXDx Alpelisib150mg Alpelisib 150mg is an AISTIKA-listed product supplied by Laos BigBear Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Alpelisib is the active ingredient used for this product page. Public prescribing information for Alpelisib was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Alpelisib is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against PI3Kα. Gain-of-function mutations in the gene encoding the catalytic α-subunit of PI3K (PIK3CA) lead to activation of PI3Kα and Akt-signaling, cellular transformation and the generation of tumors in in vitro and in vivo models. Activating mutations in PIK3CA have been found to induce a spectrum of overgrowths and malformations comprising a wide group of clinically recognizable disorders commonly known as PROS. These findings were reversed after withdrawal of alpelisib.

Reference Indications

Alpelisib is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Alpelisib is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response.

Reference Dosage and Administration

Recommended Dose: Pediatric patients (2 to less than 18 years of age): 50 mg taken orally once daily with food.

Dose conversion must be confirmed by a physician because the reference dose may vary by indication, organ function, toxicity, or interacting medicines.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

Severe Hypersensitivity : Permanently discontinue Alpelisib. Promptly initiate appropriate treatment. Interrupt Alpelisib for signs or symptoms of SCARs. Permanently discontinue Alpelisib if SCARs are confirmed. ( 2.5 , 5.2 ) Hyperglycemia : Alpelisib can cause severe hyperglycemia, in some cases associated with hyperglycemic hyperosmolar non-ketotic syndrome (HHNKS) or ketoacidosis. The safety of Alpelisib in patients with Type 1 or uncontrolled Type 2 diabetes has not been established. Before initiating treatment with Alpelisib, test fasting plasma glucose (FPG), HbA1c, and optimize blood glucose. After initiating treatment, monitor periodically. Initiate or optimize anti-hyperglycemic medications as clinically indicated. Interrupt, reduce dose, or discontinue Alpelisib if severe hyperglycemia occurs.

Common Adverse Reactions and Monitoring

Fifty-seven patients 2 years of age and older with severe or life-threatening PIK3CA-Related Overgrowth Spectrum (PROS) received Alpelisib based on age at dosages ranging from 50 mg to 250 mg orally once daily . Among patients who received Alpelisib, 95% were exposed for 6 months or longer and 79% were exposed for greater than one year. The median age of patients who received Alpelisib was 14 years (range, 2 to 50); 58% were female; 12% were White and race was not reported for 88%. Dosage interruption of Alpelisib due to an adverse reaction occurred in 11% of patients. Dose reductions of Alpelisib due to an adverse reaction occurred in 5% of patients.

Drug Interactions and Special Populations

CYP3A4 Inducers : Avoid coadministration of Alpelisib with a strong CYP3A4 inducer. Consider an alternative concomitant drug with no or minimal potential to induce CYP3A4. Breast Cancer Resistance Protein (BCRP) Inhibitors : Avoid the use of BCRP inhibitors in patients treated with Alpelisib. Alpelisib is metabolized by CYP3A4. Concomitant use of Alpelisib with a strong CYP3A4 inducer may decrease alpelisib concentration , which may decrease alpelisib activity. Breast Cancer Resistance Protein Inhibitors (BCRP) Avoid the use of BCRP inhibitors in patients treated with Alpelisib. Alpelisib is transported by BCRP. Lactation : Advise not to breastfeed. There are no available data in pregnant women to inform the drug-associated risk. Advise pregnant women of the potential risk to a fetus.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: VIJOICE public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.