Alpelisib (Piqray)

Alpelisib at a glance

Alpelisib blocks a growth-signalling protein called PI3K. The verified cancer-treatment brand is Piqray. Treatment is generally taken once daily with food and is used alongside the hormone treatment fulvestrant. The two medicines have different jobs and different precautions.

Raised blood sugar, rash and diarrhoea are particularly important with alpelisib. They can need prompt treatment, even in someone who felt well before starting. Regular checks, an early reporting plan and prescribed supportive medicines help the team manage treatment safely.

Vijoice also contains alpelisib, but its prescribing information concerns a different, non-cancer condition and includes different doses and formulations. This guide covers Piqray for cancer treatment. Do not transfer Vijoice tablet-dispersion or granule instructions to Piqray, or substitute one brand yourself. Brand verification here does not establish Indian availability.

How alpelisib works

Cells use signalling pathways to control growth and survival. PI3K is part of one such pathway. A change in the PIK3CA gene can make this pathway unusually active. Alpelisib inhibits the alpha form of PI3K, helping interfere with the signals that support cancer growth.

Fulvestrant acts on hormone signalling rather than PI3K. When prescribed together, the treatments address different signals that the cancer may use. This does not guarantee a response; scans, symptoms and other assessments establish whether the plan is helping you.

PI3K also has normal functions, including helping the body respond to insulin. Blocking it can raise blood glucose, also called blood sugar. This explains why a medicine aimed at cancer may require diabetes medicines and close glucose checks. A treatment-related rise is not evidence that you have done something wrong with your diet.

How the team decides whether it is suitable

Your oncologist considers the diagnosis, hormone-receptor and HER2 results, PIK3CA testing, previous treatments, other health conditions and the applicable prescribing information. A gene result is part of that decision, rather than a guarantee that alpelisib is suitable.

PIK3CA can be tested in tumour tissue or in a blood sample that looks for tumour-derived genetic material. A negative blood result does not always settle the question. The US label recommends testing tumour tissue when the mutation is not detected in plasma. Ask what was tested and whether another sample is needed.

Diabetes, pre-diabetes, previous severe skin reactions, lung problems and medicines already being taken are especially relevant. Safety in people with type 1 diabetes or uncontrolled type 2 diabetes has not been established in the principal trials. This needs specialist assessment, not simply a promise to check sugar more often.

Before treatment starts

Expect a fasting glucose test and HbA1c, which gives an indication of average blood glucose over the preceding months. Your team should address raised glucose before treatment begins. Tell them about diabetes medicines, steroid tablets or injections, recent weight changes, unusual thirst and frequent urination.

Other baseline assessments usually include blood counts, liver and kidney function, blood salts and a review of symptoms and medicines. Pregnancy testing is needed when pregnancy is possible. Tell the team about any previous blistering rash, serious medicine allergy, breathing condition or ongoing bowel problem.

Discuss dental symptoms and any previous or current bone-strengthening medicines, such as bisphosphonates or denosumab. Existing damage to the jawbone requires assessment before starting. European information advises against starting Piqray when osteonecrosis of the jaw is ongoing.

Ask for a written glucose-monitoring plan: whether you need a home meter, when a reading should be fasting, which results require a call and who will act on the readings. Arrange supplies and training before the first dose if home monitoring is planned. Also know how to obtain urgent advice outside normal clinic hours.

The clinician may consider metformin before starting alpelisib to reduce the risk or severity of high glucose. This is an individual decision based on risk, gut tolerance and the clinical situation. It is not mandatory for everyone, and metformin can add nausea, vomiting or diarrhoea. Do not start it yourself. A preventive antihistamine may also be considered to reduce rash.

How to take alpelisib

Daily dose and food

The usual starting Piqray dose in the reviewed labels is 300 mg once daily, supplied as two 150 mg tablets. Take the prescribed dose at approximately the same time each day. US information says with food; European information specifies immediately after food. Taking it straight after a meal follows the European instruction and keeps food linked to the dose.

Treatment is normally daily without a planned weekly break. How long it continues depends on benefit and tolerability. If side effects require a reduction, examples in the labels are 250 mg once daily, then 200 mg once daily. These use different tablet strengths; never work out a new dose by breaking tablets or copying another patient's plan.

Swallow tablets whole with water. Do not chew, crush or split them, and do not take a tablet that is cracked or damaged. If swallowing is difficult or you use a feeding tube, contact the oncology pharmacist before the next dose for an appropriate plan. The Piqray labels reviewed do not provide a home dispersion method.

Fulvestrant is given by injection by a healthcare professional. Its appointments continue according to a separate schedule. If either medicine is paused, ask whether the other should continue; do not assume that one change automatically applies to both.

Forgotten doses and vomiting

If you remember within nine hours of the usual time, take the missed dose with food. If more than nine hours have passed, skip that day's dose and take the next one at the normal time the following day. Never double up. If you are uncertain whether a dose was taken, check your record and ask for advice rather than taking another automatically.

If you vomit after taking Piqray, do not take a replacement dose that day. Resume the next day at the usual time unless the team advises otherwise. Repeated vomiting, inability to drink or vomiting with marked thirst, weakness or breathing changes needs urgent assessment.

Storage and practical handling

Keep tablets in their original packaging, safely out of children's reach. Follow the storage instructions on your actual pack. The US label specifies 20–25°C (68–77°F), with permitted excursions to 15–30°C (59–86°F); European information does not require special storage conditions. Protect supplies from excessive heat, moisture and direct sunlight and ask the pharmacist about hot-weather travel.

Do not share tablets or use leftover packs with an outdated dose. Return unused medicine through the pharmacy or treating service. A dose checklist can help, particularly when a caregiver assists or the tablet strengths change.

Monitoring and checking treatment response

Glucose can rise soon after treatment starts, so the first weeks deserve close attention. US prescribing information recommends fasting glucose at least weekly for the first two weeks, then at least every four weeks, with HbA1c every three months. Additional tests depend on your circumstances.

European information recommends fasting glucose at weeks 1, 2, 4, 6 and 8, then monthly, and HbA1c after four weeks and every three months afterwards. It recommends daily fasting-glucose monitoring for the first two weeks in higher-risk groups, including people with diabetes or pre-diabetes, a BMI of at least 30 or age 75 years or older. The schedules differ, so obtain the schedule selected for you.

If glucose rises, checks become more frequent and a diabetes specialist may help. The US label specifies at least twice-weekly fasting checks until glucose normalises, and continued close monitoring when glucose-lowering treatment is used. Do not wait for a planned test if symptoms appear. A normal HbA1c does not exclude a new rapid rise in glucose.

Blood counts, kidney and liver function and other blood chemistry are reviewed as needed. Weight, hydration, skin, bowel symptoms and eating also matter. Planned scans or other cancer assessments measure response; the presence or absence of side effects does not show whether treatment is working.

Common side effects and practical care

Raised blood sugar

Report unusual thirst, passing urine more often or in larger amounts, increased hunger with weight loss, blurred vision or unusual tiredness promptly. High glucose can occur without symptoms, which is why monitoring must continue even when you feel well.

Your team may prescribe metformin or another glucose-lowering treatment, adjust existing diabetes medicines or temporarily interrupt alpelisib. Follow the agreed plan and keep a record of readings and symptoms. Dietary advice and suitable physical activity can help, but do not replace medicine when it is needed. Avoid extreme diets or fasting to try to correct a result yourself.

Rash, itching and dry skin

Tell the team about a new rash early. Mild-looking rashes can spread, and the team needs to distinguish ordinary treatment-related skin changes from a serious reaction. Use gentle, fragrance-free cleansing and moisturising products; avoid irritating acne treatments unless prescribed. Protect skin with clothing, shade and sunscreen.

An antihistamine, prescribed steroid cream or other treatment may help. Do not begin steroid tablets independently: they may affect glucose and need a coordinated plan. Blistering, peeling, mouth or eye sores, fever or a rapidly spreading rash needs the urgent action described below.

Diarrhoea

Record the number of loose stools and whether there is pain, blood, mucus or increased stoma output. Start the anti-diarrhoea medicine supplied by your team according to its instructions and let the team know diarrhoea has begun. Drink fluids regularly unless you have a prescribed restriction; ask which drinks are suitable for your glucose and hydration needs.

Call urgently if diarrhoea persists despite treatment, occurs at night, is accompanied by cramps or makes drinking difficult. Dizziness, reduced urine, marked weakness, blood or mucus in stools needs prompt assessment. Do not keep treating worsening symptoms at home: inflammation of the bowel and dehydration need different or additional care.

Nausea, appetite and mouth discomfort

Use prescribed anti-sickness medicine and report ongoing nausea or vomiting. Small, frequent meals may be easier than large ones, but each Piqray dose still needs food. Ask for dietetic support if weight or intake is falling; managing glucose should not leave you unable to meet your nutritional needs.

A sore mouth can make food and drinks uncomfortable. Use gentle oral care and ask for a suitable mouthwash or pain relief. Report ulcers, white patches, difficulty swallowing or inability to drink. Do not assume every mouth sore is minor, particularly if it occurs with fever or a spreading skin rash.

Tiredness, hair and blood-count changes

Plan rest around essential activities and use manageable activity when you feel able. New or severe tiredness may reflect dehydration, glucose changes or anaemia and should be reported. Hair may thin during treatment; practical hair-care or appearance support is available through many treatment services.

Lower red-cell counts can cause breathlessness or dizziness; lower platelets can cause unusual bruising or bleeding. Contact the team about these changes. Follow their fever and infection instructions, and seek advice if acutely unwell even without a high temperature.

Less common but important side effects

Dangerous glucose emergencies

Very high glucose can lead to severe dehydration and an altered level of consciousness. Ketoacidosis means harmful acids called ketones have built up in the blood; fatal cases have been reported with alpelisib. Vomiting, abdominal pain, deep or rapid breathing, confusion, extreme weakness or unusual drowsiness need emergency assessment, especially with thirst or frequent urination. Do not wait for a home test or a callback.

Severe skin or allergic reactions

Serious skin reactions can affect the skin, mouth, eyes and other organs. Stop taking Piqray and obtain immediate medical advice for a spreading rash with fever, blistering, peeling or sores on the lips, mouth or eyes. Do not restart until a specialist has assessed you. Confirmed severe reactions generally require permanent discontinuation.

Sudden swelling of the face, lips, tongue or throat, trouble breathing, wheezing or collapse can indicate a severe allergy. Seek emergency help immediately and do not take further Piqray. An ordinary rash and a severe allergy need different management; never test a suspected serious reaction by taking another tablet.

Lung inflammation

New or worsening cough, breathlessness or other breathing changes need immediate contact with the treating hospital. Alpelisib can cause pneumonitis, meaning inflammation of lung tissue. Infection and other causes must also be considered. Do not take another Piqray dose while obtaining urgent advice about suspected pneumonitis. Treatment is interrupted during assessment and permanently stopped if confirmed. Severe breathing difficulty is an emergency.

Bowel inflammation, kidney injury and pancreatitis

Colitis is inflammation of the large bowel. Diarrhoea with abdominal pain, blood or mucus should not be assumed to be uncomplicated treatment-related diarrhoea. Urgent assessment may include stool tests and additional treatment.

Fluid loss can damage the kidneys. Reduced urine, dizziness or inability to keep fluids down needs prompt help. Severe persistent upper-abdominal pain, sometimes spreading to the back with vomiting, may indicate pancreatic inflammation and also requires urgent assessment.

Jawbone and eye problems

Report jaw pain, loose teeth, swelling, discharge or a mouth wound that does not heal, especially if you have received bisphosphonates or denosumab. Tell your dentist about all cancer and bone treatments before a procedure. These symptoms need assessment for osteonecrosis, meaning damaged jawbone; they are not simply routine mouth ulcers.

European information also lists inflammation inside the eye, called uveitis. New eye pain, redness, light sensitivity or vision changes requires prompt medical assessment. Do not drive if vision is affected.

Other medicines, supplements and vaccinations

Have the full medicine list checked, including non-prescription products, vitamins and herbal preparations. Strong enzyme-inducing medicines, including rifampicin, carbamazepine, phenytoin and St John's wort, can reduce alpelisib exposure and should generally be avoided with it. The prescribing clinicians should arrange alternatives where necessary.

Some medicines block a transport protein called BCRP and may increase alpelisib exposure. US information recommends avoiding these when possible; European information advises caution and monitoring. Pantoprazole is an example listed in European information, so even familiar stomach medicines should be checked.

Acid-reducing medicines are not prohibited as a whole: the labels allow their use when Piqray is taken with food. This does not remove the need to check an individual medicine for other interactions. Do not assume spacing medicines by a few hours solves every interaction. Tell the pharmacist if you take warfarin or another medicine that needs precise blood-level or effect monitoring; the current European information also describes transporter interactions that need individual assessment. Do not change these medicines yourself.

Steroids can raise glucose, including steroids used to manage side effects. Do not stop a prescribed steroid suddenly; the team should coordinate the glucose plan. Ask about flu, COVID-19 and travel vaccines. Suitability and timing, especially for live vaccines, depend on your immune function and the whole treatment plan.

Everyday life during treatment

Build the daily dose around a reliable meal and record doses and glucose readings if asked. Tell the team if work hours, fasting practices or poor appetite make the routine difficult. They can help agree a workable plan without compromising food instructions or monitoring.

Keep activity comfortable and realistic. Take breaks when tired and avoid driving or operating machinery if you have fatigue, dizziness, blurred vision or feel unsafe. Ask for help with transport if blood tests or appointments are frequent early in treatment.

Before travelling, plan enough medicine, glucose supplies if needed, access to care and protection from heat. Discuss time-zone changes with the pharmacist. Inform dentists and other clinicians about treatment, and agree any interruption around procedures with the oncology team. Worries about scans, side effects or changing roles at home also deserve support; bring them into clinic discussions.

Fertility, contraception, pregnancy and breastfeeding

Alpelisib can harm a developing baby. Pregnancy status should be checked before treatment when pregnancy is possible. Effective contraception is required during treatment and for at least one week after the last alpelisib dose. Men with a partner who can become pregnant should use condoms and effective contraception during treatment and for one week afterwards; European information also specifies condoms with a pregnant or possibly pregnant partner.

Do not breastfeed during alpelisib treatment or for at least one week afterwards. These are alpelisib-specific minimum periods, not permission to stop precautions after a combination regimen. Fulvestrant's US label requires effective contraception and no breastfeeding for one year after its last dose. European Faslodex information requires contraception for two years afterwards; it prohibits breastfeeding during treatment without specifying the same post-treatment interval. Obtain a written plan covering every medicine and the supplied products rather than choosing the shortest interval.

Human fertility effects are not fully known; animal studies suggest possible impairment in both sexes. Discuss future parenthood and preservation options before starting if relevant. Do not assume missed periods or reduced fertility prevents pregnancy. Inform the team promptly about a pregnancy or possible pregnancy during the precaution period.

After treatment stops or changes

Continue the tests and symptom follow-up arranged by your team. Glucose often improves after alpelisib is stopped, so diabetes treatment may need reassessment; obtain instructions rather than continuing, stopping or reducing it automatically. Keep reporting new symptoms after the final tablet.

A temporary pause should include clear restart conditions and the intended dose. Do not restart because diarrhoea or a rash seems better without checking. Continue the contraception and breastfeeding precautions required by all medicines in the plan, and return unused supplies when treatment ends permanently.

Frequently asked questions