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, tumour tissue should be tested if available.
Posology: The recommended dose is 300 mg alpelisib (2x 150 mg film-coated tablets) taken once daily on a continuous basis. Piqray should be taken immediately after food, at approximately the same time each day (see Pharmacology: Pharmacokinetics under Actions). The maximum recommended daily dose of Piqray is 300 mg.
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 dose should be skipped for that day. On the next day, Piqray should be taken at the usual time. If the 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.
Piqray should be co-administered with fulvestrant. The recommended dose of fulvestrant is 500 mg administered intramuscularly on days 1, 15 and 29, and once monthly thereafter. Refer to the full prescribing information of fulvestrant.
Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs. Dose modifications may be necessary to improve tolerability.
Dose modifications: Management of severe or intolerable adverse drug reactions (ADRs) may require temporary dose interruption, reduction, and/or discontinuation of Piqray. If dose reduction is required, the dose reduction guidelines for ADRs are listed in Table 2. A maximum of 2 dose reductions are recommended, after which the patient should be permanently discontinued from treatment with Piqray. Dose reduction should be based on the worst preceding toxicity. (See Table 2.)

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Tables 3-6 summarise the recommendations for dose interruption, reduction or discontinuation of Piqray in the management of specific ADRs. The 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 experienced in the treatment of hyperglycaemia should always be considered and is recommended for patients who are pre-diabetic or those with fasting glucose (FG) >250 mg/dl or 13.9 mmol/l, body mass index (BMI) ≥30 or age ≥75 years.
Consultation with a diabetologist or a healthcare professional experienced in the treatment of hyperglycaemia should always take place for patients with diabetes.
In patients with risk factors for hyperglycemia, monitor fasting glucose more closely and as clinically indicated (see Precautions). (See Table 3.)

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Baseline diabetic and pre-diabetic status, baseline BMI ≥30 and baseline age ≥75 years have been found to be risk factors for hyperglycaemia in patients treated with alpelisib. These risk factors were present in 74.7% of patients with any grade of hyperglycaemia and in 86.2% of patients with grade 3 or 4 hyperglycaemia (see Precautions).
Rash: Oral antihistamine administration may be considered prophylactically, at the time of initiation of treatment with Piqray. Additionally, antihistamines are recommended to manage symptoms of rash.
Topical corticosteroid treatment should be initiated at the first signs of rash and oral corticosteroids should be considered for moderate to severe rashes. Based on the severity of rash, Piqray may require dose interruption, reduction or discontinuation as described in Table 4 (see Adverse Reactions). (See Table 4.)

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Diarrhoea: See Table 5.

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Other toxicities: See Table 6.

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Special populations: Elderly: No dose regimen adjustment is required in patients aged 65 years or above (see Pharmacology: Pharmacokinetics under Actions). There are limited data in patients aged ≥75 years, and especially for those ≥85 years.
Renal impairment: Based on population pharmacokinetic analysis, no dose adjustment is necessary in patients with mild or moderate renal impairment (see Pharmacology: Pharmacokinetics under Actions). Caution should be used in patients with severe renal impairment as there is no experience with Piqray in this population.
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 or severe hepatic impairment (Child-Pugh class A, B or C, respectively) (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Piqray in children aged 0-18 years have not been established. No data are available.
Method of administration: Piqray is for oral use. The tablets should be swallowed whole. They should not be chewed, crushed or split prior to swallowing. Tablets that are broken, cracked or otherwise not intact should not be ingested.