Alpelisib (al-pe-LIS-ib)

Treats breast cancer. Also treats a rare condition called PIK3CA-related overgrowth spectrum (PROS).

Brand Name(s):

Piqray 200MG Daily Dose, Piqray 250MG Daily Dose, Piqray 300MG Daily Dose, Vijoice, Vijoice 250MG Daily Dose

When This Medicine Should Not Be Used:

How to Use This Medicine:

Granule, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take the medicine with food at about the same time each day.
• Swallow the tablet whole. Do not crush, break, or chew it. Do not take this medicine if it is broken, cracked, or damaged.
• If you cannot swallow Vijoice® tablets:
  • Mix the tablets into a glass with 2 to 4 ounces of water and let it stand for at least 5 minutes. Use water only.
  • Crush the tablets with a spoon and stir to dissolve. The mixture will be cloudy and you may still see some tablet pieces.
  • Swallow the mixture right away.
  • Add 2 to 3 tablespoons of water to the same glass and stir with the same spoon. Swallow the entire contents of the glass to make sure you get the full dose. Repeat this step if needed.
• If you are using the Vijoice® oral granules:
  • Each packet is for single use only. Do not use the packet if the packet seal is broken.
  • Do not use multiple packets of the oral granules or part of a packet to prepare a dose. Do not combine the tablet with the granules.
  • Hold the packet of granules with the cut line on top. Shake the packet gently to make sure the granules are in the lower part of the packet. Open the packet along the cut line using scissors.
  • You may take the granules in one of the following ways:
    • Option 1: Pour the granules directly onto the tongue by tapping the side and top of the packet swallow it with about 4 to 8 tablespoons (2 to 4 ounces) of water. If there is any medicine remaining in the mouth, rinse the mouth with additional water and swallow to make sure the entire dose is taken.
    • Option 2: Pour the granules into a cup by tapping the side and top of the packet. Add 1 to 3 teaspoons (0.5 ounces) of liquid (including water, milk, or apple juice) or soft food (applesauce or yogurt). Take the mixture right away. Rinse the cup with up to 4 tablespoons (2 ounces) of water, milk or apple juice. Take the mixture right away. Repeat this step until there is no medicine left in the cup to make sure the entire dose is taken. Throw away any mixture that is not taken within 2 hours after preparing.
• You may also receive medicines to help prevent nausea and vomiting.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose of this medicine and it is within 9 hours after the usual time, take it as soon as you can. Then go back to your regular schedule. If you miss a dose and it is more than 9 hours since your usual time, skip the missed dose and go back to your regular dosing schedule.
• If you vomit after taking a dose, take the next dose at the regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Throw away any unused mixture of Vijoice® after 60 minutes of mixing it.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how alpelisib works. Tell your doctor if you are using efavirenz, ketoconazole, ranitidine, rifampin, or warfarin.

Warnings While Using This Medicine:

• Pregnancy after menopause is not likely, but if you think you could be pregnant, tell your doctor. This medicine could harm an unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Women should use an effective form of birth control during treatment and for 1 week after the last dose. Male patients who have female partners should use effective birth control during treatment and for 1 week after the last dose.
• Do not breastfeed during treatment with this medicine and for 1 week after the last dose.
• Tell your doctor if you have kidney disease, lung disease or breathing problems, or diabetes.
• This medicine may cause the following problems:
  • Serious skin reactions, including Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Lung or breathing problems (including pneumonitis, interstitial lung disease)
• This medicine may cause a high blood sugar level. Your doctor may give you metformin before starting treatment with this medicine.
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Increased thirst, hunger, or urination, weight loss
• Severe diarrhea, stomach pain, dry mouth, red or black stools
• Trouble breathing, chest tightness, cough

If you notice these less serious side effects, talk with your doctor:

• Decreased appetite, change in taste
• Dry skin
• Hair loss or thinning of hair
• Headache
• Nausea, vomiting
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088