Alpelisib Tablet: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Alpelisib Tablet (brand names Piqray and Vijoice) is a targeted cancer medicine belonging to the PI3K inhibitor class. Piqray is used for certain PIK3CA-mutated breast cancers in men and postmenopausal women, while Vijoice is used for PIK3CA-Related Overgrowth Spectrum (PROS). It is only used for tumors or conditions with a confirmed PIK3CA mutation. It is taken as a tablet, usually once daily with food.

What is Alpelisib Tablet

Alpelisib (brand names Piqray and Vijoice) is a targeted cancer tablet. Piqray is used to treat certain types of breast cancer in men and postmenopausal women, and Vijoice is used to treat a condition called PROS (PIK3CA-Related Overgrowth Spectrum). Alpelisib is only used for tumors with a PIK3CA mutation, which is confirmed by an FDA-approved test.

Alpelisib Tablet uses

• Breast cancer in men and postmenopausal women that is PIK3CA-mutated, advanced or metastatic, hormone receptor (HR)-positive, HER2-negative, and has progressed on or after hormone-based treatment, used together with fulvestrant
• PIK3CA-Related Overgrowth Spectrum (PROS) with severe symptoms in patients who need ongoing treatment and are 2 years or older

Benefits of Alpelisib Tablet

• Targets cancer cells with specific PIK3CA mutations
• May slow cancer cell growth
• May help delay disease progression
• May help control advanced breast cancer
• May improve disease control when combined with appropriate hormone therapy

How Alpelisib Tablet works

Alpelisib blocks a protein pathway called PI3K, which cancer or overgrown cells use to grow and divide. In PIK3CA-mutated breast cancer, blocking this pathway slows cancer growth. In PROS, blocking this pathway reduces abnormal cell growth and may improve symptoms.

Alpelisib Tablet dosage

Take the tablets with food, at the same time each day. Swallow the tablet whole; do not crush, chew, or break it, and do not use a cracked or broken tablet. If you are taking Vijoice and cannot swallow the tablets whole, they may be dissolved in water and the mixture drunk right away, following your doctor's instructions. If you vomit shortly after taking a dose, do not take another dose that day; wait until your next scheduled dose. Alpelisib is usually taken together with fulvestrant on its own separate injection schedule; keep the two schedules separate. Treatment is usually continued until the disease gets worse or side effects become unacceptable. Your blood sugar and other blood tests will need to be checked regularly during treatment.

Available forms and strengths

• Tablet

Side effects of Alpelisib Tablet

Common

• Nausea, vomiting
• Loss of appetite, weight loss
• Feeling weak or tired
• Mouth sores
• Rash
• Hair loss
• Abnormal blood tests
• High blood sugar
• Diarrhea
• Low white blood cell count
• Higher liver enzyme levels
• Change in how things taste
• Headache
• Itchy or dry skin
• Stomach pain
• Swelling in arms or legs
• Heartburn
• Dry mouth

Serious

• Severe allergic reaction: hives, difficulty breathing, swelling of face, lips, or throat, fast heartbeat
• Severe skin reaction: fever, sore throat, burning eyes, skin pain, red or purple rash with blistering and peeling
• Serious drug reaction affecting many body parts: rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, yellowing of skin or eyes
• Chest pain, cough, feeling short of breath
• Severe or ongoing diarrhea
• Blisters or ulcers in the mouth, red or swollen gums, trouble swallowing
• Pale skin, unusual tiredness, cold hands and feet
• Little or no urination
• High blood sugar symptoms: increased thirst, increased urination, dry mouth, fruity breath odor, confusion, hunger, weight loss
• Serious lung problems: trouble breathing, dry cough, chest pain
• Pancreatitis: severe stomach pain spreading to the back, fever, nausea, vomiting
• Colitis: stomach pain, mucus or blood in stool

Warnings and precautions

• Alpelisib can cause severe diarrhea, which can be life-threatening if it leads to dehydration or kidney damage. Call your doctor right away if diarrhea is severe.
• This medicine can cause dangerously high blood sugar, sometimes leading to a serious condition called ketoacidosis. Blood sugar should be checked before and regularly during treatment.
• Serious skin reactions can occur, including blistering and peeling skin.
• Lung problems such as inflammation of the lungs can develop during treatment.
• This medicine may harm an unborn baby, based on animal studies.
• This medicine may decrease fertility in both men and women.
• Alpelisib can harm an unborn baby. Women should not use it while pregnant and should use effective birth control during treatment and for at least 1 week after the last dose. 
• Men should use condoms and effective birth control if their partner could become pregnant, for at least 1 week after the last dose. Tell your doctor right away if pregnancy occurs.
• Do not breastfeed while using alpelisib and for at least 1 week after the last dose. If also taking fulvestrant, breastfeeding may need to be avoided for up to 1 year after the last dose.
• Tell your doctor if you have kidney disease before starting this medicine.
• Caution is advised in patients with severe liver impairment.

Storage

• Store Vijoice at 68°F to 77°F (20°C to 25°C); excursions permitted between 15°C and 30°C (59°F and 86°F)
• Store Piqray at room temperature between 68°F to 77°F (20°C to 25°C)
• Keep this medication in the container it came in, tightly closed, and out of reach of children
• Store it at room temperature and away from excess heat and moisture (not in the bathroom)
• Do not flush this medication down the toilet; dispose of unneeded medication through a medicine take-back program

When to see a doctor

• Get emergency help for signs of a severe allergic reaction: hives, warmth or tingling, difficulty breathing, fast heartbeats, or swelling of the face or throat.
• Seek medical help right away for chest pain, cough, or shortness of breath.
• Call your doctor at once for severe or ongoing diarrhea.
• Get medical help for signs of very high blood sugar: increased thirst, increased urination, dry mouth, fruity breath odor, confusion, hunger, or weight loss.
• Call your doctor if you have blisters or ulcers in your mouth, red or swollen gums, or trouble swallowing.
• Call your doctor if you have pale skin, unusual tiredness, or cold hands and feet.
• Call your doctor if you have little or no urination.
• Get emergency care for watery or bloody diarrhea with stomach pain.
• Get emergency help for trouble swallowing or breathing, rash, hives, flushing, fever, or fast heartbeat.
• If an overdose is suspected, seek emergency medical attention or contact your local poison control center right away.

Alternatives

• Ribociclib
• Everolimus
• Capivasertib