Uses

This medication is used to treat certain types of breast cancer. Alpelisib may also be used to treat a certain overgrowth disorder, PIK3CA-Related Overgrowth Spectrum (PROS). Alpelisib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of certain abnormal cells that can cause cancer or PROS.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start taking alpelisib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Different brands of this medication have different uses and directions. Do not change brands of this medication unless directed by your doctor.

Take this medication by mouth with food as directed by your doctor, usually once daily. Do not take tablets that look damaged, or are broken or cracked.

If you are using the brand used for treating cancer, swallow the tablets whole. Do not chew, crush, or split the tablets.

If you are using the brand used for treating PROS, swallow the tablets whole. Do not chew or split the tablets. If you have trouble swallowing these tablets, you may mix them with water to make a suspension. Use only water to make the suspension. Place the tablet(s) in a glass with 2 to 4 ounces (60 to 120 milliliters) of water and let it stand for about 5 minutes. Crush the tablets with a spoon and stir well. The mixture will be cloudy and you may see tablet pieces. Swallow the mixture right away. To make sure you take all of the dose, add another 2 to 3 tablespoonfuls (60 to 90 milliliters) of water to the glass. Stir well and drink all of it. Repeat if any medicine remains in the glass. Throw any mixture that is not taken within 60 minutes.

The dosage is based on your medical condition, age, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

If you vomit after taking a dose, do not take another dose on the same day. Wait until the next day to take your dose at the regular time.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Side Effects

Nausea, vomiting, tiredness, change in how food tastes, loss of appetite, decreased weight, or dry skin may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Diarrhea commonly occurs. Severe diarrhea can lead to dehydration and kidney problems. If you have diarrhea, tell your doctor right away. Drink enough fluids to prevent dehydration and ask your doctor or pharmacist about medicines to treat diarrhea.

Pain or sores in the mouth and throat may occur. Brush your teeth carefully/gently, avoid using mouthwash that contains alcohol, and rinse your mouth often with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• symptoms of lung problems (such as shortness of breath, cough, chest pain)
• abdominal pain
• blood/mucus in stool

This medication may make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar, such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• flu-like symptoms (such as fever, body aches)
• swollen lymph nodes
• peeling skin
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice any other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking alpelisib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• diabetes
• liver disease
• history of severe skin reactions (such as Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially increased blood sugar.

This medication can affect fertility in both males and females. Ask your doctor for more details.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using alpelisib. Alpelisib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Men and women using this medication should ask about reliable forms of birth control during treatment and for 1 week after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 1 week after the last dose. Consult your doctor before breastfeeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of alpelisib from your body, which may affect how alpelisib works. Examples include rifamycins (such as rifampin), among others.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, blood sugar, kidney/liver function) should be done while you are taking this medication. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, take it as soon as you remember if it is within 9 hours after the usual time. If it has been longer than 9 hours, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store in the original container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.