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Alpelisib (Oral)

Generic Name: alpelisib (al-pe-LIS-ib)

Medically reviewed by Drugs.com. Last updated on July 13, 2020.

Commonly used brand name(s)

In the U.S.

  • Piqray 200MG Daily Dose
  • Piqray 250MG Daily Dose
  • Piqray 300MG Daily Dose

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antineoplastic Agent

Uses for alpelisib

Alpelisib is used together with other medicines (eg, fulvestrant) to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA­mutated, advanced or metastatic (cancer that has spread) breast cancer in men and in women who have already stopped menstruating (postmenopausal). Your doctor will test for the presence of the mutation.

Alpelisib interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor.

Alpelisib is available only with your doctor's prescription.

Before using alpelisib

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For alpelisib, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to alpelisib or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of alpelisib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alpelisib in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking alpelisib, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using alpelisib with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Apalutamide
  • Carbamazepine
  • Eltrombopag
  • Enzalutamide
  • Fosphenytoin
  • Lumacaftor
  • Mitotane
  • Phenytoin
  • Rifampin
  • St John's Wort
  • Velpatasvir
  • Voxilaprevir

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of alpelisib. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diabetes or
  • Lung disease or breathing problems—Use with caution. May make these conditions worse.

Proper use of alpelisib

Medicines used to treat cancer are very strong and can have many side effects. Before using alpelisib, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take alpelisib exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Alpelisib comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not crush, break, or chew it. Take it with food.

Do not take alpelisib if it is broken, cracked, or damaged.

Dosing

The dose of alpelisib will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of alpelisib. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For breast cancer:
      • Adults—300 milligrams (mg) (two 150 mg tablets) once a day.
      • Children—Use and dose must be determined by your doctor.

Missed dose

DRUG: GENERAL, MISS, STANDARD

If you miss a dose of alpelisib 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 you take alpelisib, do not take another dose the same day. Wait and take your next dose when you normally would.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using alpelisib

It is very important that your doctor check your progress at regular visits to make sure alpelisib is working properly. Blood tests may be needed to check for unwanted effects.

It is unlikely that a postmenopausal woman may become pregnant. But, using alpelisib while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using alpelisib to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment and for 1 week after your last dose. Male patients who have female partners should use effective birth control during treatment and for 1 week after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Alpelisib may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using alpelisib.

Serious skin reactions can occur with alpelisib. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with alpelisib.

Alpelisib may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.

Alpelisib may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to the symptoms from lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.

Alpelisib may cause diarrhea, and in some cases it can be severe. Your doctor may give you medicine to treat diarrhea. Drink plenty of fluids to prevent dehydration. If you have any questions about this or if mild diarrhea continues, or gets worse, check with your doctor.

If you plan to have children, talk with your doctor before using alpelisib. Some men and women using alpelisib have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Alpelisib side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  • Bladder pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • blurred vision
  • diarrhea
  • difficult, burning, or painful urination
  • dry mouth
  • fever
  • flushed, dry skin
  • frequent urge to urinate
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • lower back or side pain
  • nausea
  • rapid weight gain
  • stomach pain
  • sweating
  • tingling of the hands or feet
  • troubled breathing
  • unexplained weight loss
  • unusual tiredness of weakness
  • unusual weight gain or loss
  • vomiting

Less common

  • Pale skin
  • troubled breathing with exertion
  • unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Belching
  • decreased weight
  • dry skin or mouth
  • hair loss or thinning of hair
  • headache
  • heartburn
  • indigestion
  • loss or change in taste
  • stomach discomfort or upset
  • swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.