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Manufactured by various FDA-approved generic manufacturers.

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alpelisib Uses, Side Effects, Interactions, Warnings & Dosing

What dosages is alpelisib available in?

What dosages is alpelisib available in?

alpelisib is available as a 50 mg, 125 mg, and 200 mg oral tablet.

What is alpelisib used for?

What is alpelisib used for?

alpelisib is a kinase inhibitor that is used to treat PIK3CA-related overgrowth spectrum (PROS).

How does alpelisib work?

How does alpelisib work?

alpelisib is a kinase inhibitor. It works by preventing PI3K (a protein that signals your cells to grow) from working properly. People with PROS have abnormal PI3K proteins that cause uncontrollable cell growth, which lead to complications of the condition. By blocking PI3K from working properly, it helps stop your cells from growing too quickly.

How do I take alpelisib?

How do I take alpelisib?

alpelisib is dosed as follows:

  • Adults 18 years of age and older: The typical dose is 250 mg by mouth once per day
  • Children ages 2 to 18 years old: The typical starting dose is 50 mg by mouth once per day. If your child is at least 6 years old and isn’t responding well to the medication, your child’s provider might raise the dose to 125 mg once per day
Is it safe for me to take alpelisib?

Is it safe for me to take alpelisib?

alpelisib is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

alpelisib Common Side Effects

alpelisib Common Side Effects

Common side effects of alpelisib:

  • Diarrhea
  • Inflammation and sores in mouth
  • High blood sugar
  • Eczema
  • Dry skin
  • Hair loss
alpelisib Serious Side Effects

alpelisib Serious Side Effects

Serious side effects are rare with alpelisib. Contact your healthcare provider immediately if you experience any of the following.

  • Severe allergic reaction: hives; swelling of the lips, tongue, or face; difficulty breathing
  • Severe skin reactions: red or purple skin rash, blisters on skin, peeling skin, fever
  • Dangerously high blood sugar: frequently thirsty, needing to urinate often, difficulty breathing, rapid heartbeat, fruity breath, dry mouth, confusion
  • Lung inflammation: cough, shortness of breath, chest pain
  • Dehydration: dry mouth, not urinating as much, lightheadedness, dizziness
Effects of other drugs, drug classes and over-the-counter products on alpelisib

Effects of other drugs, drug classes and over-the-counter products on alpelisib

The following medications may interact with alpelisib:

  • CYP3A4 Inducers: Avoid coadministration of alpelisib with a strong CYP3A4 inducer
  • Breast Cancer Resistance Protein (BCRP) Inhibitors: Avoid the use of BCRP inhibitors in patients treated with alpelisib. If unable to use alternative drugs, closely monitor for increased adverse reactions.
  • CYP2C9 Substrates: Closely monitor when alpelisib is coadministered with CYP2C9 substrates where decreases in the plasma concentration of these drugs may reduce activity
Who makes alpelisib?

Who makes alpelisib?

Various FDA-approved generic manufacturers

Is alpelisib safe in pregnancy?

Is alpelisib safe in pregnancy?

alpelisib can harm your unborn baby.

Females who are able to become pregnant:

  • Your healthcare provider will check to see if you are pregnant before you start treatment with alpelisib
  • You should use effective birth control during treatment with alpelisib and for 1 week after the last dose. Talk to
    your healthcare provider about birth control methods that may be right for you during this time
  • If you become pregnant or think you are pregnant, tell your healthcare provider right away
  • Males with female partners who are able to become pregnant should use condoms and effective birth control during treatment with alpelisib and for 1 week after the last dose. If your female partner becomes pregnant, tell your healthcare provider right away

What to do if you missed your alpelisib dose

The FDA's medical product safety reporting program for health professionals, patients and consumers.

Learn more about reporting side effects
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Medical Disclaimer

NowPatient has taken all reasonable steps to ensure that all material is factually accurate, complete, and current. However, the knowledge and experience of a qualified healthcare professional should always be sought after instead of using the information on this page. Before taking any drug, you should always speak to your doctor or another qualified healthcare provider.

The information provided here about medications is subject to change and is not meant to include all uses, precautions, warnings, directions, drug interactions, allergic reactions, or negative effects. The absence of warnings or other information for a particular medication does not imply that the medication or medication combination is appropriate for all patients or for all possible purposes.

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