What it is used for
- Treating advanced or metastatic hormone-receptor-positive, HER2-negative breast cancer with a suitable mutation
- Use with fulvestrant after progression on endocrine treatment under an oncology protocol
- Use of a distinct formulation for selected PIK3CA-related overgrowth disorders under specialist authorisation
How it is used
- Take tablets exactly as prescribed by the oncology team and consistently with food
- Swallow tablets whole and do not use one that is broken, cracked or damaged
- Do not replace or change a dose yourself after vomiting or a missed dose; follow the team's instructions
- Take the accompanying endocrine treatment according to its plan and read its leaflet too
- Check blood glucose and attend liver, kidney and other monitoring requested by the team
Possible side effects
- High blood glucose with thirst and frequent urination
- Rash, itching and dry skin
- Diarrhoea, nausea or vomiting
- Mouth ulcers or reduced appetite
- Tiredness, hair loss or altered liver and kidney tests
Who should not use it
- Allergy to alpelisib or any ingredient
- Starting treatment without confirmation of the required mutation for the cancer indication
Before and while using it
- Marked thirst, vomiting, abdominal pain, deep breathing or confusion can indicate dangerous hyperglycaemia or ketoacidosis
- A widespread rash, blisters, peeling, mouth ulcers or fever can indicate a severe skin reaction
- A new cough, breathlessness or low oxygen can indicate lung inflammation
- Severe diarrhoea, blood in stool or abdominal pain can indicate colitis and dehydration
- Monitor wounds and infections because high glucose can delay healing
- Jaw pain or swelling needs assessment, especially with bone-protective medicines
Medicine interactions
- Strong liver-enzyme inducers can lower alpelisib exposure and should be avoided
- BCRP inhibitors can increase exposure to the medicine
- It can alter some medicines dependent on CYP2C9 and these may need monitoring
- Accompanying cancer treatments and glucose-lowering medicines need joint oncology-pharmacy review
Pregnancy and breastfeeding
- It can harm an unborn baby; avoid pregnancy, use effective contraception as directed by oncology and tell them promptly if pregnancy occurs
- Do not breastfeed during treatment or until the oncology team says it is safe
How to store it
- Keep tablets in the original pack as directed, protected from moisture and away from children; do not use a damaged tablet
Get medical help straight away if
- Your face, lips or tongue swell, or you find it hard to breathe.
- You get a severe rash, blistering or peeling skin.
- A side effect worries you or doesn’t go away: contact your doctor or pharmacist.
Questions about this medicine?
Talk to a doctor by video, or send your question by text.
Source: Standard international medicine references
This guide is general information and doesn’t replace advice from your doctor or pharmacist. Don’t start, stop or change a medicine without asking them, and always read the leaflet in the pack.