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Alpelisib

1 INDICATIONS AND USAGE VIJOICE 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). VIJOICE 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )

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Brand NameDosage FormCompanyStrengthPrice

◎Alpesib

Tablet

Everest Pharmaceuticals Ltd.

150 mg

৳1500

per tablet

1–1 of 1 brand

Clinical Information

Indications

Alpesib is 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.

Pharmacology

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. In breast cancer cell lines, Alpelisib inhibited the phosphorylation of PI3K downstream targets, including Akt and showed activity in cell lines harboring a PIK3CA mutation. In vivo, Alpelisib inhibited the PI3K/Akt signaling pathway and reduced tumor growth in xenograft models, including models of breast cancer. 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 antitumor activity compared to either treatment alone in xenograft models derived from ER-positive, PIK3CA mutated breast cancer cell lines.

Dosage & Administration

The recommended dose of Alpelisib is 300 mg (two 150 mg film coated tablets) taken orally, once daily, with food. Continue treatment until disease progression or unacceptable toxicity occurs. Patients should take their dose of Alpelisib at approximately the same time each day. Swallow 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. If a dose of Alpelisib is missed, it can be taken with food within 9 hours after the time it is usually taken. After more than 9 hours, skip the dose for that day. The next day, take Alpelisib at the usual time. If the patient vomits after taking the dose, advise the patient not to take an additional dose on that day, and to resume the dosing schedule the next day at the usual time. When given with Alpelisib, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, and 29, and once monthly thereafter.

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Always consult a registered doctor before taking any medicine. This information is for general knowledge only.

Drug Interactions

Effect of Other Drugs on Alpesib- CYP3A4 Inducer : Coadministration of Alpesib with a strong CYP3A4 inducer may decrease Alpesib concentration, which may decrease Alpesib activity. Avoid coadministration of Alpesib with strong CYP3A4 inducers. BCRP Inhibitors : Coadministration of Alpesib with a BCRP inhibitor may increase Alpesib concentration, which may increase the risk of toxicities. Avoid the use of BCRP inhibitors in patients treated with Alpesib. If unable to use alternative drugs, when Alpesib is used in combination with BCRP inhibitors, closely monitor for increased adverse reactions. Effect of Alpesib on Other Drugs- CYP2C9 Substrates : Coadministration of Alpesib with CYP2C9 substrates (e.g., Warfarin) may reduce plasma concentration of these drugs. Closely monitor when Alpesib is used in combination with CYP2C9 substrates where decreases in the plasma concentration of CYP2C9 substrates may reduce activity of these drugs.

Precautions & Warnings

Severe Hypersensitivity : Advise patients of the signs and symptoms of severe hypersensitivity reactions. Permanently discontinue Alpesib in the event of severe hypersensitivity. Severe Cutaneous Reactions : Severe cutaneous reactions, including Stevens-Johnson Syndrome (SJS) and Erythema Multiforme (EM) were reported in patients treated with Alpesib. Advise patients of the signs and symptoms of severe cutaneous reactions (e.g., a prodrome of fever, flu-like symptoms, mucosal lesions or progressive skin rash). Hyperglycemia : Before initiating treatment with Alpesib, test FPG, HbA1c, and optimize blood glucose. After initiating treatment with Alpesib, monitor blood glucose and/or FPG at least once every week for the first 2 weeks, then at least once every 4 weeks, and as clinically indicated. Monitor HbA1c every 3 months and as clinically indicated. Based on the severity of the hyperglycemia, Alpesib may require dose interruption, reduction, or discontinuation. Pneumonitis : Permanently discontinue Alpesib in all patients with confirmed pneumonitis. Advise patients to immediately report new or worsening respiratory symptoms. Diarrhea : Advise patients to start antidiarrheal treatment, increase oral fluids, and notify their healthcare provider if diarrhea occurs while taking Alpesib. Embryo-Fetal Toxicity : Based on findings in animals and its mechanism of action, Alpesib can cause fetal harm when administered to a pregnant woman.