Why is this medication prescribed

Alpelisib is prescribed primarily for the treatment of certain types of cancer. It’s specifically used for:

• Breast Cancer: It’s often prescribed for patients with hormone receptor-positive, HER2-negative breast cancer that has spread to other parts of the body (metastatic breast cancer). It is typically used in combination with another medication called letrozole.
• PIK3CA-Mutant Cancers: Alpelisib targets cancers with mutations in the PIK3CA gene, which can be involved in tumor growth. This makes it an important treatment option for cancers with this specific genetic alteration.

It works by inhibiting a specific protein (PI3K alpha) that is involved in cancer cell growth and survival. This helps to slow down or stop the growth of cancer cells.

How should this medicine be used?

Alpelisib is typically used according to the following guidelines:

• Dosage: The standard dose is usually 300 mg taken orally once daily. It’s important to follow your healthcare provider’s specific instructions regarding dosage, as it can vary based on individual factors.
• Administration: Alpelisib is taken by mouth in the form of tablets. It should be taken with food to reduce the risk of gastrointestinal side effects.
• Consistency: Try to take the medication at the same time each day to help remember and maintain even levels of the drug in your system.
• Monitoring: Regular monitoring by your healthcare provider is necessary to check for side effects and to assess how well the medication is working. This might include blood tests and other evaluations.
• Avoiding Certain Foods and Medications: Your healthcare provider may advise you to avoid certain foods or medications that can interact with alpelisib. For instance, grapefruit and grapefruit juice should generally be avoided, as they can interfere with the drug’s metabolism.
• Side Effects: Be aware of possible side effects, such as high blood sugar, rash, diarrhea, and fatigue. Report any severe or concerning side effects to your healthcare provider promptly.

Always follow the specific instructions provided by your healthcare provider or pharmacist, as they will tailor the advice to your individual needs and circumstances.

Other uses for this medicine

While alpelisib is primarily prescribed for hormone receptor-positive, HER2-negative breast cancer with PIK3CA mutations, it may also be considered for other cancers with PIK3CA mutations or alterations. Research is ongoing to explore its effectiveness in various cancer types beyond breast cancer.

What special precautions should I follow?

Special Precautions for Alpelisib:

• Blood Sugar Levels: Alpelisib can cause high blood sugar (hyperglycemia). Regularly monitor your blood sugar levels, especially if you have diabetes or are at risk for diabetes. Your healthcare provider may adjust your diabetes medication or recommend lifestyle changes to manage blood sugar.
• Liver Function: Monitor liver function regularly, as alpelisib can affect the liver. Report any symptoms of liver problems, such as jaundice (yellowing of the skin or eyes), dark urine, or severe abdominal pain.
• Skin Reactions: Watch for and report any severe skin rashes or lesions. Alpelisib can cause skin issues, and your healthcare provider may need to adjust your treatment.
• Infections: Alpelisib may weaken the immune system, increasing the risk of infections. Practice good hygiene and report any signs of infection, such as fever, chills, or persistent cough.
• Diarrhea: Alpelisib can cause gastrointestinal issues, including diarrhea. Stay hydrated and notify your healthcare provider if diarrhea becomes severe or persistent.
• Pregnancy and Breastfeeding: Alpelisib is not recommended during pregnancy or breastfeeding due to potential harm to the fetus or infant. Use effective contraception during treatment and discuss any plans for pregnancy with your healthcare provider.
• Drug Interactions: Inform your healthcare provider about all medications and supplements you are taking, as alpelisib can interact with other drugs. This includes over-the-counter medications, herbal supplements, and vitamins.
• Pre-existing Conditions: Inform your healthcare provider of any pre-existing conditions, especially those related to the heart, liver, or kidneys, as these may affect how you respond to the medication.

Always follow your healthcare provider’s advice and instructions regarding alpelisib to ensure its safe and effective use.

What special dietary instructions should I follow?

• Food Intake: Alpelisib should be taken with food to help reduce gastrointestinal side effects.
• Avoid Grapefruit: Grapefruit and grapefruit juice can interact with alpelisib and affect how the drug is metabolized. Avoid these foods while on alpelisib.
• Balanced Diet: Maintaining a balanced diet can help manage side effects and support overall health during treatment.

What should I do if I forget a dose?

• If You Miss a Dose: If you miss a dose of alpelisib, take it as soon as you remember if it’s within 6 hours of the scheduled time.
• Skip If Late: If it’s been more than 6 hours since the missed dose, skip it and take your next dose at the regular scheduled time. Do not take two doses at once to make up for a missed dose.
• Consult Your Healthcare Provider: Always check with your healthcare provider for specific instructions regarding missed doses, as they might have tailored recommendations based on your treatment plan.

What side effects can this medication cause?

Alpelisib can cause a range of side effects. Some of the common and serious side effects include:

Common Side Effects:

• Hyperglycemia (High Blood Sugar): Elevated blood sugar levels are a frequent side effect. Symptoms can include increased thirst, frequent urination, and fatigue.
• Diarrhea: This can be mild to severe. Staying hydrated and reporting persistent symptoms to your healthcare provider is important.
• Nausea and Vomiting: Gastrointestinal symptoms are common but can often be managed with medications and dietary adjustments.
• Rash: Skin rashes or other dermatological reactions can occur. Monitor for any changes in your skin and report severe cases to your healthcare provider.
• Fatigue: Feeling unusually tired or weak can be a side effect of the medication.

Serious Side Effects:

• Elevated Liver Enzymes: Alpelisib can affect liver function, leading to elevated liver enzymes. Symptoms of liver issues include jaundice, dark urine, and severe abdominal pain.
• Infections: A weakened immune system can increase susceptibility to infections. Watch for signs of infection such as fever, chills, or persistent cough.
• Severe Skin Reactions: Severe skin issues, such as significant rash, blisters, or peeling, should be reported immediately.
• Hyperglycemic Crises: Severe high blood sugar can lead to diabetic ketoacidosis or hyperosmolar hyperglycemic state. These conditions require immediate medical attention.
• Pneumonitis: Inflammation of the lungs can occur, leading to symptoms such as cough, difficulty breathing, or chest pain.
• Regular Monitoring: Frequent blood tests and check-ups are important to monitor side effects and adjust treatment as needed.
• Report Symptoms: Always inform your healthcare provider of any new or worsening symptoms.
• Follow Instructions: Adhere to dietary and lifestyle recommendations to manage side effects like hyperglycemia and gastrointestinal issues.

If you experience any severe side effects or symptoms that concern you, seek medical attention promptly.

What should I know about storage and disposal of this medication?

Storage and Disposal of Alpelisib:

Storage:

• Store alpelisib tablets at room temperature, typically between 68°F and 77°F (20°C and 25°C).
• Keep the medication in its original container, tightly closed, to protect it from moisture and light.
• Store alpelisib out of reach of children and pets.

Disposal:

• Do not flush alpelisib down the toilet or pour it into a drain. Instead, use a drug take-back program or follow local disposal guidelines.
• Many communities offer programs for safely disposing of unused medications. Check with your pharmacist or local waste disposal facility for options.

In case of emergency/overdose

• Contact Emergency Services: If you experience severe side effects or symptoms, seek emergency medical attention immediately. This includes symptoms such as severe rash, high fever, difficulty breathing, or signs of a severe allergic reaction.
• Call Poison Control: Contact your local poison control center or emergency medical services right away if you suspect an overdose.
• Symptoms of Overdose: Symptoms may include severe nausea, vomiting, dizziness, or confusion. Report these symptoms to a healthcare provider promptly.

What other information should I know?

• Medication Interaction: Be aware of potential interactions with other medications, supplements, and herbal products. Always inform your healthcare provider about all the substances you are taking.
• Regular Monitoring: Regular visits to your healthcare provider for monitoring and lab tests are important to assess your response to the medication and manage side effects.
• Lifestyle Adjustments: Adopting a healthy lifestyle, including a balanced diet and regular exercise, can help manage some side effects and improve overall well-being during treatment.
• Communication: Maintain open communication with your healthcare provider about any concerns or changes in your condition. They can provide guidance and adjust your treatment plan as needed.

Always follow the instructions provided by your healthcare provider and the medication’s labeling to ensure safe and effective use of alpelisib.