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Piqray 200mg Tablet
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Indications & Clinical Uses
- Piqray 200 mg tablets contain the active substance alpelisib, a PI3K (phosphatidylinositol-3-kinase) inhibitor.
- Piqray is used in combination with the hormonal therapy fulvestrant to treat hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer in adults whose disease has progressed on or after an endocrine-based regimen.
- Before starting treatment, an FDA-approved test must confirm a PIK3CA mutation in a tumour or blood (plasma) sample, since Piqray only works against PIK3CA-mutated tumours.
- It is taken as two tablets (150 mg each) once daily with food, swallowed whole.
- Piqray is prescribed and monitored by a cancer specialist; it is not for use alone and is not a first-line treatment.
- This information is based on the US prescribing information; the combination-partner and PIK3CA-testing requirement are broadly consistent between the US and EU labels.
Side Effects
- High blood sugar (hyperglycaemia) is very common, affecting most patients, and can occasionally become severe, leading to diabetic-coma-like states (hyperglycaemic hyperosmolar syndrome) or ketoacidosis; regular blood glucose and HbA1c monitoring is required throughout treatment.
- Diarrhoea affects more than half of patients and can occasionally be severe enough to cause dehydration or kidney injury.
- A skin rash is also very common; a small number of patients develop severe skin reactions such as Stevens-Johnson syndrome or DRESS, which need urgent medical review.
- Severe hypersensitivity reactions, including anaphylaxis with breathing difficulty, flushing, fever or a fast heartbeat, have occurred and require immediate emergency treatment and permanent discontinuation.
- Severe lung inflammation (pneumonitis) has also been reported, causing new or worsening cough, breathlessness or fever.
- Other common effects include nausea, tiredness, mouth sores, decreased appetite and hair thinning.
- Seek urgent help for severe rash, breathing problems, facial swelling, or signs of very high blood sugar.
Precautions & Warnings
- Piqray is contraindicated in anyone with a history of severe hypersensitivity to alpelisib.
- Fasting blood glucose and HbA1c must be checked before starting and monitored regularly during treatment, and pre-existing diabetes should be well controlled first; some patients are started on metformin alongside Piqray to reduce the risk of high blood sugar.
- Liver function, and any signs of skin reaction, diarrhoea or breathing changes should be reported promptly, since dose interruption, reduction or permanent stopping may be needed.
- Piqray can cause fetal harm, so females of reproductive potential must use effective contraception during treatment and for one week after the last dose, and breastfeeding is not recommended during treatment or for one week afterwards.
- There is no boxed warning on the current US FDA label for Piqray, but the Warnings and Precautions section covers hyperglycaemia, severe hypersensitivity /anaphylaxis, severe cutaneous reactions and pneumonitis in detail, and these are the most clinically important risks of treatment.
Avoid Interactions
- Piqray should not be taken with strong CYP3A4 inducers, such as rifampicin, carbamazepine, phenytoin or St John's Wort, because they substantially reduce alpelisib levels and can make treatment ineffective.
- Avoid BCRP-inhibiting medicines where possible, as they can increase alpelisib exposure and side effects; if one must be used, monitoring for increased adverse reactions is advised.
- Because Piqray can raise blood sugar, using it with corticosteroids or other medicines that raise glucose needs closer monitoring, and diabetes medicines may need dose adjustment.
- Piqray is taken with food, and consistent meal timing helps keep drug levels steady.
- Tell the healthcare provider and pharmacist about all prescription and over-the-counter medicines, herbal products and supplements before starting Piqray, and about any new medicine started during treatment, so interactions can be checked.
References
Frequently Asked Questions
Piqray (alpelisib) treats HR-positive, HER2-negative, PIK3CA-mutated advanced breast cancer in adults, given with fulvestrant after the disease has progressed on hormone therapy. A tumor or blood test must confirm the PIK3CA mutation before starting. It is not used alone as a first treatment.
Take Piqray as two 150 mg tablets (300 mg total) once daily, with food, at about the same time each day. Swallow tablets whole; do not chew, crush or split them. If a dose is missed by more than 9 hours, skip it and take the next dose as scheduled.
High blood sugar affects most people taking Piqray and is monitored with regular blood tests. Diarrhoea and rash are also very common. Seek urgent help for severe rash, breathing trouble, or a fast heartbeat with flushing, since severe allergic reactions and lung inflammation have occurred.
Avoid strong CYP3A4 inducers such as rifampicin, carbamazepine, phenytoin and St John's Wort, which reduce Piqray's effect, and BCRP-inhibiting medicines where possible. Tell your doctor about every medicine and supplement you take, since Piqray can also raise blood sugar levels.
Before starting, you need a fasting blood glucose and HbA1c test, and a PIK3CA mutation test on tumor tissue or blood. During treatment, glucose is checked weekly for 2 weeks then monthly, and HbA1c every 3 months, to catch high blood sugar early.
No. Piqray can harm an unborn baby, so anyone who could become pregnant must use effective contraception during treatment and for one week after the last dose. Breastfeeding is not recommended during treatment or for one week after stopping Piqray.
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