Alpelisib

English

Approved Treatment Indication:

Breast Neoplasms, Male, Breast Neoplasms

Listen

Share

Summary

What conditions is Alpelisib used for?
Alpelisib is used to treat certain types of breast cancer in adults. It's also used to treat a genetic condition called PIK3CA Related Overgrowth Spectrum (PROS) in adults and children over 2 years old.
How does Alpelisib work in the body?
Alpelisib is a kinase inhibitor. It works by blocking signals that cause cancer cells to multiply and spread, helping to control the growth of cancer cells and reduce overgrowth in conditions like PROS.
What are the usual dosages and routes of administration for Alpelisib?
For adults, the usual daily dose of Alpelisib is 300 mg, taken as two 150 mg tablets once daily with food. For children over 2 years old with certain conditions, the dose may vary, and a healthcare provider should determine the appropriate dosage.
What are the most commonly observed adverse effects of Alpelisib?
Common side effects of Alpelisib include increased blood glucose, diarrhea, rash, nausea, fatigue, and decreased appetite. Serious adverse effects include severe hypersensitivity reactions, severe cutaneous adverse reactions, hyperglycemia, pneumonitis, and diarrhea or colitis.
What are the important safety warnings and contraindications for Alpelisib?
Alpelisib should not be used in patients with severe hypersensitivity to it or any of its components. It's also important to avoid using Alpelisib during pregnancy and breastfeeding due to potential harm to the fetus or infant.

Government Approvals

US(FDA), UK(BNF)

WHO Essential Medicine

NO

Known Teratogen

NO

Pharmaceutical Class

NA

Controlled Drug Substance

NO

Video Thumbnail

Drug Ingredient

Alpelisib

Learn more about this brand -

Summary

What conditions is Alpelisib used for?
Alpelisib is used to treat certain types of breast cancer in adults. It's also used to treat a genetic condition called PIK3CA Related Overgrowth Spectrum (PROS) in adults and children over 2 years old.
How does Alpelisib work in the body?
Alpelisib is a kinase inhibitor. It works by blocking signals that cause cancer cells to multiply and spread, helping to control the growth of cancer cells and reduce overgrowth in conditions like PROS.
What are the usual dosages and routes of administration for Alpelisib?
For adults, the usual daily dose of Alpelisib is 300 mg, taken as two 150 mg tablets once daily with food. For children over 2 years old with certain conditions, the dose may vary, and a healthcare provider should determine the appropriate dosage.
What are the most commonly observed adverse effects of Alpelisib?
Common side effects of Alpelisib include increased blood glucose, diarrhea, rash, nausea, fatigue, and decreased appetite. Serious adverse effects include severe hypersensitivity reactions, severe cutaneous adverse reactions, hyperglycemia, pneumonitis, and diarrhea or colitis.
What are the important safety warnings and contraindications for Alpelisib?
Alpelisib should not be used in patients with severe hypersensitivity to it or any of its components. It's also important to avoid using Alpelisib during pregnancy and breastfeeding due to potential harm to the fetus or infant.

Indications and Purpose

How does Alpelisib work?

Alpelisib works by inhibiting the PI3K pathway, specifically targeting the PI3Kα enzyme. This pathway is involved in cell growth and survival. By blocking this enzyme, Alpelisib reduces the proliferation of cancer cells and helps control the overgrowth of affected tissues.

How does one know if Alpelisib is working?

The benefit of Alpelisib is evaluated through regular medical check-ups and laboratory tests ordered by your doctor. These tests monitor the body's response to the medication, including blood glucose levels and tumor progression. Regular follow-ups help ensure the treatment is effective and allows for timely adjustments if needed.

Is Alpelisib effective?

Alpelisib has been shown to be effective in treating certain types of breast cancer with PIK3CA mutations, as demonstrated in clinical trials like SOLAR-1. Patients receiving Alpelisib plus fulvestrant showed improved progression-free survival compared to those receiving placebo plus fulvestrant. This evidence supports its use in managing advanced or metastatic breast cancer with specific genetic mutations.

What is Alpelisib?

Alpelisib is used to treat certain types of breast cancer with PIK3CA mutations and PIK3CA Related Overgrowth Spectrum (PROS) in adults and children. It works by inhibiting the PI3K pathway, which is involved in cell growth and survival, thereby reducing cancer cell proliferation and overgrowth in affected tissues.

What is Alpelisib used for?

Alpelisib is indicated for the treatment of hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer in adults. It is also used to treat PIK3CA Related Overgrowth Spectrum (PROS) in adults and children aged 2 years and older, a genetic condition causing tissue overgrowth and abnormalities.

Directions for Use

For how long do I take Alpelisib?

Alpelisib is typically used for as long as it is effective and tolerated by the patient. Treatment continues until disease progression or unacceptable toxicity occurs. Always follow your doctor's guidance on the duration of use.

How do I take Alpelisib?

Take Alpelisib once daily with food, at the same time each day. Swallow the tablets whole without chewing, crushing, or splitting them. There are no specific food restrictions, but it's important to follow your doctor's dietary recommendations to manage any side effects.

How should I store Alpelisib?

Store Alpelisib in its original container, tightly closed, at room temperature between 68°F to 77°F (20°C to 25°C). Keep it away from excess heat and moisture, and out of reach of children. Do not store it in the bathroom. Proper storage ensures the medication remains effective and safe to use.

What is the usual dose of Alpelisib?

For adults, the usual dose of Alpelisib is 300 mg taken orally once daily with food. For children aged 2 years and older with PIK3CA Related Overgrowth Spectrum (PROS), the dose may vary based on the specific condition and doctor's recommendation. Always follow the healthcare provider's instructions for dosing.

Warnings and Precautions

Can Alpelisib be taken safely while breastfeeding?

Women are advised not to breastfeed during treatment with Alpelisib and for 1 week after the last dose due to the potential for serious adverse reactions in the breastfed child. Consult your doctor for personalized advice on feeding your baby during treatment.

Can Alpelisib be taken safely while pregnant?

Alpelisib can cause fetal harm when administered to a pregnant woman. Women of reproductive potential should use effective contraception during treatment and for 1 week after the last dose. If pregnancy occurs, inform your doctor immediately. There is no strong evidence from human studies, but animal studies have shown adverse developmental outcomes.

Can I take Alpelisib with other prescription drugs?

Alpelisib may interact with strong CYP3A4 inducers, which can decrease its effectiveness. It's important to avoid using these inducers, such as rifampin, while on Alpelisib. Additionally, breast cancer resistance protein (BCRP) inhibitors may increase Alpelisib concentration, raising the risk of side effects. Always inform your doctor about all medications you are taking to avoid interactions.

Is Alpelisib safe for the elderly?

Elderly patients, especially those aged 75 and older, may experience a higher incidence of certain side effects, such as hyperglycemia. It's important for elderly patients to be closely monitored by their healthcare provider while taking Alpelisib. Dose adjustments may be necessary based on individual tolerance and response.

Who should avoid taking Alpelisib?

Important warnings for Alpelisib include the risk of severe hypersensitivity reactions, severe cutaneous adverse reactions, hyperglycemia, and pneumonitis. Patients with a history of severe skin reactions or uncontrolled diabetes should use Alpelisib with caution. It's contraindicated in patients with severe hypersensitivity to the drug or its components. Always consult your doctor for personalized advice.