Pivikto 150mg alpelisib film coated tablets

[Product Name] Alpelisib Tablets

[English Name] Alpelisib Tablets

[Specification] 150 mg × 28 tablets/box

[Manufacturer] Sandoz Pvt Ltd (a subsidiary of Novartis, Switzerland)

Alpelisib tablets are a targeted therapy medication developed by Novartis, Switzerland. This specific product is the original innovator drug from Novartis. To differentiate pricing for the Indian market, Novartis has listed its subsidiary, Sandoz, as the manufacturer for this product; however, the actual product is a Novartis product, and its therapeutic efficacy is identical to that of products explicitly labeled under the Novartis brand. Alpelisib tablets are primarily indicated for the treatment of patients with advanced or metastatic breast cancer that is hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), and harbors a *PIK3CA* gene mutation. It is typically used in combination with fulvestrant and is indicated for patients whose disease has progressed following prior endocrine therapy.

[Indications]

HR+/HER2- Breast Cancer: Indicated for patients with breast cancer that is hormone receptor-positive and HER2-negative.

*PIK3CA* Gene Mutation: Indicated for patients confirmed via genetic testing to harbor a *PIK3CA* mutation.

Advanced or Metastatic Breast Cancer: Used for patients with advanced or metastatic breast cancer, particularly those who have developed resistance to endocrine therapy.

[Conditions for Use]

Alpelisib is primarily indicated for patients whose tumor tissue has been confirmed—using an FDA-approved testing method—to harbor a *PIK3CA* gene mutation.

It is particularly suitable for cases of endocrine resistance—specifically, when a patient's cancer continues to progress following prior endocrine therapy.

[Background of Use]

*PIK3CA* mutations are among the most common genetic alterations found in breast cancer. These mutations can lead to the abnormal activation of the PI3K/AKT/mTOR signaling pathway, which, in turn, promotes the growth and survival of cancer cells.

Alpelisib works by specifically inhibiting the PI3Kα isoform, thereby blocking this signaling pathway and helping to control tumor progression.

[Dosage and Administration]

Recommended Dosage

Standard Adult Dose: 300 mg once daily (consisting of two 150 mg tablets). Combination Therapy: Typically used in combination with fulvestrant. The recommended regimen for fulvestrant involves a 500 mg injection administered on Days 1, 15, and 29, followed by a single injection once monthly thereafter.

Administration

Oral Administration: Take with food to minimize gastrointestinal discomfort.

Swallow Whole: Do not chew, crush, or split the tablets.

Consistent Timing: Take the medication at the same time each day to ensure stable drug concentrations.

Dosage Adjustment

Management of Adverse Reactions: If severe side effects occur (e.g., hyperglycemia, rash, diarrhea, etc.), the physician may adjust the dosage or temporarily suspend treatment.

First Dose Reduction: Reduce the dose to 250 mg (one 150 mg tablet + one 100 mg tablet).

Second Dose Reduction: Reduce the dose to 200 mg (two 100 mg tablets).

If the medication remains intolerable, discontinuation of treatment may be required.

Missed Doses

If a dose is missed, take the regular prescribed dose at the scheduled time for the next dose; do not take a double dose.

[Mechanism of Action]

Alpelisib is a PI3K inhibitor. It exerts its therapeutic effect by inhibiting the activity of the PI3Kα subunit, thereby blocking the PI3K/AKT/mTOR signaling pathway and inhibiting the growth and proliferation of tumor cells.

[Precautions]

Prior to use, genetic testing must be performed to confirm the *PIK3CA* mutation status.

Common side effects include hyperglycemia, rash, diarrhea, etc.; blood glucose levels must be closely monitored, and appropriate management measures should be implemented.

The medication should be administered under the guidance of a physician, with periodic assessments of efficacy and safety. Product Specifications

Product Name: Alpelisib 150mg * 28 Tablets/Box (Pivikto 150mg)

Generic Name: Alpelisib Tablets

Active Ingredient: Alpelisib

Dosage Form: Tablets

Specification: 150mg * 28 tablets/box

Manufacturer: Sandoz Pvt Ltd (a subsidiary of Novartis, Switzerland)

Indications: In combination with fulvestrant: Alpelisib is approved for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer in postmenopausal women and men whose cancer has progressed following an endocrine-based regimen and who have a *PIK3CA* gene mutation.

Applicability Criteria

Alpelisib is primarily indicated for patients whose tumor tissue has been confirmed to harbor a *PIK3CA* gene mutation using an FDA-approved diagnostic test.

It is particularly suitable for cases of endocrine resistance—specifically, when a patient's cancer continues to progress despite having previously undergone endocrine therapy.

Dosage and Administration:

Administration

Oral Use: Alpelisib tablets should be swallowed whole and may be taken with food. It is recommended to take the medication at a fixed time each day to maintain stable blood drug concentrations.

Do Not Chew, Crush, or Split Tablets: Unless the tablet is clearly marked to indicate that this is permissible, it must be swallowed whole.

Dosage

Recommended Dose: The standard recommended starting dose is 300 mg once daily. This dosage is established based on usage patterns observed in the majority of clinical studies.

Combination Therapy: Alpelisib is typically used in combination with fulvestrant. The standard dosage for fulvestrant involves a 28-day cycle, administered as a 500 mg intramuscular injection on Days 1 and 15.

Dosage Adjustment

In the event of adverse reactions, a physician may recommend reducing the dosage or temporarily interrupting treatment until symptoms subside. Depending on the severity of the reaction, the Alpelisib dosage may be reduced from 250 mg to 200 mg, or even lower.

For patients experiencing hyperglycemia or other manageable side effects, adjustments to diet, increased monitoring frequency, or the use of additional medications may be required to control these adverse effects. Precautions

It is crucial to monitor blood glucose levels regularly—both before initiating treatment and throughout the course of therapy—as Alpelisib may cause elevated blood sugar.

It is equally important to monitor the patient's skin condition, as skin rash is another common side effect.

Patients should inform their healthcare provider of any new or worsening symptoms so that the treatment plan can be adjusted in a timely manner.