Alpelisib is the generic name for the trade name drug Piqray®. In some cases, health care professionals may use the trade name Piqray® when referring to the generic drug name alpelisib.
Drug type: Alpelisib is an anti-cancer("antineoplastic") chemotherapy drug. This medication is classified as a "phosphatidylinositol 3-kinase inhibitor".(For more detail, see "How Alpelisib works" below.)
What Alpelisib Is Used For:
- Advanced or metastatic HR-positive, HER2-negative breast cancer with PIK3CA mutation in men or postmenopausal women who have already received other pharmaceutical treatments.
Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
How Alpelisib Is Given:
- Alpelisib comes as a tablet and is taken orally
- Tablets should be swallowed whole and not chewed or crushed
- Alpelisib should be taken at approximately the same time each day and given with food
- Alpelisib is often given with fulvestrant (another anti-cancer medication)
The amount of alpelisib that you will receive depends on many factors, including your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact dosage and schedule.
Important things to remember about the side effects of alpelisib
- Most people will not experience all of the alpelisib side effects listed.
- Alpelisib's side effects are often predictable in terms of their onset, duration, and severity.
- Alpelisib's side effects will improve after therapy is complete.
- Alpelisib's side effects may be quite manageable. There are many options to minimize or prevent the side effects of alpelisib.
The following side effects are common (occurring in greater than 30%) for patients taking alpelisib:
These are less common side effects (occurring in 10-29%) for patients receiving aplelisib:
The following side effects for patients receiving alpelisib are rare but serious:
- A rare but serious possible side effect of alpelisib is severe skin reactions. Immediately contact your doctor's office if you develop unexplained rash, blistering, peeling skin, or red spots on your skin while taking aleplisib
- Alpelisib has also been associated with lung irritation. Let your doctor know if you develop unexplained cough, shortness of breath, or trouble breathing while taking alpelisib.
Not all side effects are listed above. Side effects that are very rare -- occurring in less than about 10 percent of patients -- are not listed here. But you should always inform your health care provider if you experience any unusual symptoms.
When to Contact Your Doctor or Health Care Provider:
Contact your health care provider immediately, day or night if you should experience any of the following symptoms:
- Fever of 100.4°F (38°C) or higher or chills (possible signs of infection).
- Chest pain or heart palpitations
- Inability to pass urine
The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:
- Nausea (interferes with ability to eat and unrelieved with prescribed medication
- Vomiting (vomiting more than 4-5 times in a 24 hour period)
- Diarrhea (4-6 episodes in a 24 hour period)
- Unusual bleeding or bruising
- Black or tarry stools, or blood in stools
- Blood in urine
- Pain or burning with urination
- Extreme fatigue (unable to carry on self-care activities)
- Mouth sores (painful redness, swelling or ulcers)
Always inform your health care provider if you experience any unusual symptoms.
- Before starting alpelisib treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.) Do not take aspirin, products containing aspirin unless your doctor specifically permits this.
- Alpelisib can cause changes in blood sugar levels. Talk to your doctor about signs and symptoms of high or low blood sugar and let your doctor know if you think you experience either. Your doctor may also check your blood sugar before you start alpelisib and while you are being treated with it.
- Do not receive any kind of immunization or vaccination without your doctor's approval while taking alpelisib.
- Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Alpelisib may cause fetal harm when given to a pregnant woman. This drug must not be given to a pregnant woman, a woman who intends to become pregnant, or a woman who wants to continue breastfeeding. If a woman becomes pregnant while taking alpelisib, the medication must be stopped immediately and the women given appropriate counseling. Do not breast feed while taking alpelisib.
- For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking alpelisib. Barrier methods of contraception, such as condoms, are recommended. Contraception should be continued for at least 1 week after the last dose of alpelisib.
Alpelisib Self-Care Tips:
- Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
- You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
- Wash your hands often.
- To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1/2 to 1 teaspoon of salt mixed with 8 ounces of water.
- Avoid contact sports or activities that could cause injury.
- To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
- Follow regimen or anti-diarrhea medication as prescribed by your health care professional.
- Eat foods that may help reduce diarrhea (see managing side effects - diarrhea).
- Avoid sun exposure. Wear SPF 30 (or higher) sunblock and protective clothing.
- In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
- Get plenty of rest.
- Maintain good nutrition.
- Remain active as you are able. Gentle exercise is encouraged such as a daily walk.
- If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
- Acetaminophen or ibuprofen may help relieve discomfort from fever, headache, and/or generalized aches and pains. However, be sure to talk with your doctor before taking it.
Monitoring and Testing While Taking Alpelisib:
You will be checked regularly by your doctor while you are taking alpelisib, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.
How Alpelisib Works:
Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.
Targeted therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells thus leading to fewer side effects. Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.
There are different types of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function of the cancer cell. The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die. There are several types of targeted therapy that focus on the inner parts of the cells. Other targeted therapies target receptors that are on the outside of the cell. Therapies that target receptors are also known as monoclonal antibodies. Antiangiogenesis inhibitors target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.
Researchers agree that targeted therapies are not a replacement for traditional therapies. They may best be used in combination with traditional therapies. More research is needed to identify which cancers may be best treated with targeted therapies and to identify additional targets for more types of cancer.
Alpelisib is a targeted therapy that inhibits (prevents) signaling through the phosphatidylinositol 3-kinase (P13K) pathway by binding to certain phospholipids in the cell membrane. By stopping these signals, alpelisib prevents the cells from signaling for cell growth, reproduction, and survival. P13K inhibitors eventually cause cell death and stop tumor cells from spreading.
Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.