Piqray Dosage/Direction for Use

Treatment with PIQRAY should be initiated by a physician experienced in the use of anticancer therapies.
Patients with HR-positive, HER2-negative advanced breast cancer should be selected for treatment with PIQRAY, based on the presence of a PIK3CA mutation in tumour or plasma specimens, using a validated test. If a mutation is not detected in a plasma specimen, test tumour tissue if available.
The safety and efficacy of alpelisib in combination with a GnRH agonist in pre- or peri-menopausal women has not been established.
There was no treatment benefit demonstrated in patients without PIK3CA mutations, in the phase III clinical study (see Pharmacology: Pharmacodynamics under Actions).
Adult Dose: Recommended Dosage: The recommended dose of PIQRAY is 300 mg (two 150 mg film-coated tablets) taken orally, once daily. PIQRAY should be taken immediately following food, at approximately the same time each day (see Pharmacology: Pharmacodynamics under Actions and Interactions). The maximum recommended daily dose of PIQRAY is 300 mg. If patient vomits after taking the PIQRAY dose, the patient should not take an additional dose on that day, and should resume the usual dosing schedule the next day, at the usual time.
When co-administered with PIQRAY, the recommended dose of fulvestrant is 500 mg administered intramuscularly on days 1, 15 and, 29, and once monthly thereafter. Refer to the full product information of fulvestrant.
Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs. Dosing modifications may be necessary to improve tolerability.
Missed dose: If a dose of PIQRAY is missed, it can be taken immediately following food and within 9 hours after the time it is usually administered. After more than 9 hours, the missed dose should be skipped for that day. On the next day, PIQRAY should be taken at its usual time.
Dose modifications: The recommended daily dose of PIQRAY is 300 mg. Management of severe or intolerable adverse drug reactions may require temporary dosing interruption, reduction, and/or discontinuation of PIQRAY. If dosing reduction is required, the dosing reduction guidelines for adverse drug reactions (ADRs) are listed in Table 3. A maximum of 2 dosing reductions are recommended, after which the patient should be discontinued from treatment with PIQRAY. Dosing reduction should be based on the worst preceding toxicity. (See Table 3.)

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Tables 4, 5, 6 and 7 summarize recommendations for dosing interruption, reduction or discontinuation of PIQRAY in the management of specific ADRs. Clinical judgement of the treating physician, including confirmation of laboratory values if deemed necessary, should guide the management plan of each patient based on the individual benefit/risk assessment for treatment with PIQRAY.
Hyperglycaemia: Consultation with a Healthcare Professional (HCP) with experience in the management of hyperglycemia should be considered and lifestyle changes as per local guidelines, including exercise and dietary advice should be recommended/reinforced (e.g. small frequent meals, low carbohydrate, high fiber, low processed food intake, three macronutrient balanced meals and 2 optional small snacks rather than one large meal).
Fasting Plasma Glucose (FPG) and/or HbA1c (hemoglobin A1c) test should be performed before initiating treatment with PIQRAY. Glucose levels should be corrected in patients with abnormal glucose levels which are in the range of pre-diabetic or diabetic before initiating PIQRAY, and should be closely monitored to enable early detection and early treatment of hyperglycemia.
After initiating treatment with PIQRAY, Fasting Glucose (FG; either plasma or blood) should be monitored at least once per week in the first 2 weeks, followed by every 4 weeks and as clinically indicated. HbA1c should be monitored every 3 months as clinically indicated.
If patient experiences hyperglycemia after initiating treatment with PIQRAY, FG should be monitored as clinically indicated, and at least twice weekly until FG decreases to ≤8.9 mmol/L. During treatment with anti-diabetic medication, monitoring of FG should be continued at least once a week for 8 weeks, followed by once every 2 weeks and as clinically indicated. Dosing modifications and management guidelines for hyperglycaemia are described in Table 4.
Rash: Oral antihistamine administration may be considered prophylactically, at the time of initiation of treatment with PIQRAY. Based on the severity of rash, PIQRAY may require dose interruption, reduction, or discontinuation as described in Table 5 (see Adverse Reactions).
Diarrhoea: Refer to Table 6 for dosing modifications and management guidelines.
Other toxicities: Refer to Table 3 for the dosing modification and management for other toxicities (excluding hyperglycaemia and rash).
Fulvestrant: For dose modification guidelines in the event of toxicity or for any other relevant safety information, refer to the fulvestrant product information. (See Tables 4, 5, 6 and 7.)

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Special populations: Renal impairment: Based on population pharmacokinetic analysis, no dose adjustment is necessary in patients with mild or moderate renal impairment (see Pharmacology: Pharmacodynamics under Actions). Caution should be used in patients with severe renal impairment as there is no experience with PIQRAY in this population (see Pharmacology: Pharmacodynamics under Actions).
Hepatic impairment: Based on a hepatic impairment study in non-cancer subjects with impaired hepatic function, no dose adjustment is necessary in patients with mild, moderate and severe hepatic impairment (Child-Pugh class A, B or C, respectively) (see Pharmacology: Pharmacodynamics under Actions).
Refer to the product information of fulvestrant for dose modifications related to hepatic impairment.
Paediatric use: The safety and efficacy of PIQRAY in paediatric patients have not been established.
Use in the elderly: No dosage regimen adjustment is required in patients 65 years or above (see Pharmacology: Pharmacodynamics under Actions).
Administration: PIQRAY tablets should be swallowed whole (tablets should not be chewed, crushed or split prior to swallowing). Tablets that are broken, cracked or otherwise not intact should not be ingested.