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Piqray is a brand name for Alpelisib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)- negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine…
Verbatim from this product's EMA label. Tap a section to expand.
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 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. The maximum recommended daily dose of Piqray is 300 mg.
If a dose 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, the dose should be taken at the usual time.
If the patient vomits after taking the 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.
Please 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 1. 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.
Table 1 Recommended dose reduction guidelines for ADRs1 Piqray dose level Dose and schedule Number and strength of tablets Starting dose 300 mg/day continuously 2x 150 mg tablets First dose reduction 250 mg/day continuously 1x 200 mg tablet and 1x 50 mg tablet Second dose reduction 200 mg/day continuously 1x 200 mg tablet 1 Only one dose reduction is permitted for pancreatitis.
Tables 2-5 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.
Summary of the safety profile The safety profile is based on data from 284 patients in the Piqray plus fulvestrant arm of the double- blind, placebo-controlled phase III study. 4%). 1%). 5%). Tabulated list of adverse reactions ADRs from the phase III clinical study and post-marketing experience (Table 7) are listed by MedDRA system organ class.
Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, ADRs are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000); not known (cannot be estimated from the available data).
2) * No grade 4 ADRs were observed # Adverse reactions reported during post-marketing experience. These are derived from spontaneous reports for which it is not always possible to reliably establish frequency or a causal relationship to exposure to the medicinal product.
1 Urinary tract infection: […]
1). 8). Piqray should be permanently discontinued and should not be re-introduced in patients with serious hypersensitivity reactions. Appropriate treatment should be promptly initiated. Severe cutaneous reactions Severe cutaneous reactions have been reported with alpelisib.
1%) patients, respectively. 8). Treatment should not be initiated in patients with a history of severe cutaneous reactions. g. a prodrome of fever, flu-like symptoms, mucosal lesions or progressive skin rash). If signs or symptoms of severe cutaneous reactions are present, Piqray should be interrupted until the aetiology of the reaction has been determined.
A consultation with a dermatologist is recommended. If a severe cutaneous reaction is confirmed, Piqray should be permanently discontinued. It should not be re-introduced in patients who have experienced previous severe cutaneous reactions.
2). Hyperglycaemia Severe hyperglycaemia, in some cases associated with hyperglycaemic hyperosmolar nonketotic syndrome (HHNKS) or ketoacidosis, has been observed in patients treated with Piqray. Some cases of ketoacidosis with fatal outcome have been reported in the post-marketing setting.
9%] with grade 3-4). As hyperglycaemia may occur with a rapid onset after starting treatment, it is recommended to self- monitor frequently in the first 4 weeks and especially within the first 2 weeks of treatment, as clinically indicated.
A specific schedule for fasting glucose monitoring is recommended in Table 6. In the phase III clinical study, patients with a history of diabetes mellitus intensified use of antidiabetic medicinal products while on treatment with Piqray.
g. dietary restrictions and physical activity). Table 6 Schedule of fasting glucose monitoring Recommended schedule for the monitoring of fasting glucose and HbA1c levels in all patients treated with Piqray Recommended schedule of monitoring of fasting glucose and HbA1c levels in patients with diabetes, pre-diabetes, BMI ≥30 or age ≥75 years treated with Piqray At screening, before initiating treatment with Piqray Test for fasting plasma glucose (FPG), HbA1c, and optimise the patient’s level of blood glucose (see Table 2).
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. 4 Table 2 Dose modification and management for hyperglycaemia Fasting glucose (FG) values1 Recommendation Dose modification and management should only be based on fasting glucose (plasma/blood) values.
9 mmol/l No Piqray dose adjustment required. Initiate or intensify oral antidiabetic treatment2. 9 mmol/l No Piqray dose adjustment required. Initiate or intensify oral antidiabetic treatment2. 9 mmol/l within 21 days with appropriate oral antidiabetic treatment2,3, reduce Piqray dose by 1 dose level and follow FG-value-specific recommendations.
8 mmol/l Interrupt Piqray. Initiate or intensify oral antidiabetic treatment2 and consider additional antidiabetic medicinal products such as insulin3 for 1-2 days until hyperglycaemia resolves, as clinically indicated. g. intervention for electrolyte / ketoacidosis / hyperosmolar disturbances).
9 mmol/l within 3 to 5 days under appropriate antidiabetic treatment, resume Piqray at next lower dose level. 9 mmol/l within 3 to 5 days under appropriate antidiabetic treatment, consultation with a healthcare professional with expertise in the treatment of hyperglycaemia is recommended.
9 mmol/l within 21 days following appropriate antidiabetic treatment2,3, permanently discontinue Piqray treatment. 8 mmol/l Interrupt Piqray. g. intervention for electrolyte / ketoacidosis / hyperosmolar disturbances]), re-check within 24 hours and as clinically indicated.
8 mmol/l, then follow FG-value- specific recommendations for <500 mg/dl. 8 mmol/l after 24 hours, permanently discontinue Piqray treatment. 03 CTCAE = Common Terminology Criteria for Adverse Events. 2 Applicable antidiabetic medicinal products, such as metformin, SGLT2 inhibitors or insulin sensitisers (such as thiazolidinediones or dipeptidyl peptidase-4 inhibitors), should be initiated and the respective prescribing information should be reviewed for dosing and dose titration recommendations, including local diabetic treatment guidelines.
Metformin was recommended in the phase III clinical study with the following guidance: Metformin should be initiated at 500 mg once daily. Based on tolerability, the metformin dose may be increased to 500 mg twice daily, followed by 500 mg with breakfast, and 1 000 mg with the evening meal, followed by further increase to 1 000 mg twice daily if needed (see […]
After initiating treatment with Piqray Monitor fasting glucose at weeks 1, 2, 4, 6 and 8 after treatment start and monthly thereafter. Monitor/self-monitor fasting glucose regularly, more frequently in the first 4 weeks and especially within the first 2 weeks of treatment, according to the instructions of a healthcare professional*.
Monitor/self-monitor fasting glucose daily for the first 2 weeks of treatment. Then continue to monitor fasting glucose as frequently as needed to manage hyperglycaemia according to the instructions of a healthcare professional*. HbA1c should be monitored after 4 weeks of treatment and every 3 months thereafter.
If hyperglycaemia develops after initiating treatment with Piqray Monitor fasting glucose regularly, as per local standard of care and at least until fasting glucose decreases to normal levels. During treatment with antidiabetic medication, continue monitoring fasting glucose at least once a week for 8 weeks, followed by once every 2 weeks, and monitor fasting glucose according to the instructions of a healthcare professional with expertise in the treatment of hyperglycaemia.
* All glucose monitoring should be performed at the physician’s discretion as clinically indicated. g. excessive thirst, urinating more often than usual or greater amount of urine than usual, increased appetite with weight loss). g. insulin, dipeptidyl peptidase-4 (DPP-4) inhibitors, SGLT2 inhibitors and sulfonylureas).
9 Oral antidiabetic medication was used in 154 patients. 0%) discontinued study treatment due to hyperglycaemia. 2%) discontinued study treatment due to hyperglycaemia. Out of 164 patients with grade ≥2 hyperglycaemia, 157 had at least 1 grade improvement, median time to improvement from the first event was 8 days (95% CI: 8 to 10 days).
Of the […]