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Alpelisib is available as a 50 mg, 150 mg, and 200 mg oral tablet.

Alpelisib is an anticancer agent and is used to treat metastatic or advanced breast cancer that’s hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, with PIK3CA mutations (in females who’ve gone through menopause and in males).

Alpelisib is a kinase inhibitor. It targets proteins made by the PIK3CA gene. Typically, these proteins send signals to help cells grow and divide. In people with certain types of breast cancer, there are changes to their PIK3CA gene (mutations). These mutations cause the proteins made by the PIK3CA gene to send too many signals. This leads to the cancer cells growing and dividing very fast. Alpelisib blocks the PIK3CA proteins from sending too many signals to cancer cells. With less signals to grow, the cancer cells won’t be able to grow as fast.

Alpelisib is typically taken as 300 mg by mouth once daily.

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.

Common side effects of Alpelisib:

• High blood sugar
• Higher creatinine levels
• Diarrhea
• Low white blood cell count
• Higher liver enzyme levels
• Rash
• Nausea
• Tiredness
• Low red blood cell count
• Loss of appetite
• Painful sores in the mouth and throat
• Vomiting
• Weight loss
• Lower calcium, potassium, and magnesium levels
• Longer activated partial thromboplastin time
• Hair loss

Serious side effects are rare with Alpelisib. Contact your healthcare provider immediately if you experience any of the following. Dangerously high blood sugar: dry mouth, feeling thirsty, confusion, headache, nausea or vomiting, fruity breath, dry or flushed skin, fast breathing, urinating more often, experiencing weight loss while feeling more hungry
Serious lung problems: trouble breathing, dry cough, feeling very tired or weak, not feeling hungry, chest pain and discomfort Severe allergic reaction: hives, difficulty breathing, swelling of the lips, tongue, or face Severe skin reactions: skin rash, blisters on skin, peeling skin, fever

The following medications may interact with Alpelisib:

• CYP3A4 Inducers: Avoid coadministration of Alpelisib with a strong
• CYP3A4 inducer. Consider an alternative concomitant drug with no or minimal potential to induce CYP3A4.
• 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.

Various FDA-approved generic manufacturers

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 (contraception) 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:

• You 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.

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