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Piqray Dosage

Generic name: ALPELISIB 150mg
Dosage form: tablet

Medically reviewed by Drugs.com. Last updated on Sep 17, 2020.

2.1 Patient Selection

Select patients for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer with PIQRAY, based on the presence of one or more PIK3CA mutations in tumor tissue or plasma specimens [see Clinical Studies (14)]. If no mutation is detected in a plasma specimen, test tumor tissue. Information on FDA-approved tests for the detection of PIK3CA mutations in breast cancer is available at: http://www.fda.gov/CompanionDiagnostics.

2.2 Dosage and Administration

The recommended dose of PIQRAY is 300 mg (two 150 mg film-coated tablets) taken orally, once daily, with food [see Clinical Pharmacology (12.3)].

Continue treatment until disease progression or unacceptable toxicity occurs [see Dosage and Administration (2.3)].

Patients should take their dose of PIQRAY at approximately the same time each day.

Swallow PIQRAY tablets whole (tablets should not be chewed, crushed or split prior to swallowing). No tablet should be ingested if it is broken, cracked, or otherwise not intact.

If a dose of PIQRAY is missed, it can be taken with food within 9 hours after the time it is usually taken. After more than 9 hours, skip the dose for that day. The next day, take PIQRAY at the usual time.

If the patient vomits after taking the dose, advise the patient not to take an additional dose on that day, and to resume the dosing schedule the next day at the usual time.

When given with PIQRAY, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, and 29, and once monthly thereafter. Refer to the Full Prescribing Information for fulvestrant.

2.3 Dose Modifications for Adverse Reactions

The recommended dose modifications for adverse reactions (ARs) are listed in Table 1.

Table 1: PIQRAY Dose Reduction Guidelines for Adverse Reactions1
1Only one dose reduction is permitted for pancreatitis.
2If further dose reduction below 200 mg once daily is required, discontinue PIQRAY.
PIQRAY Dose Level Dose and Schedule Number and Strength of Tablets
Starting dose 300 mg once daily Two 150 mg tablets
First-dose reduction 250 mg once daily One 200 mg tablet and one 50 mg tablet
Second-dose reduction 200 mg once daily2 One 200 mg tablet

Tables 2, 3, 4, and 5 summarize recommendations for dose interruption, reduction, or discontinuation of PIQRAY in the management of specific ARs.

Cutaneous Adverse Reactions

​If a severe cutaneous adverse reaction (SCAR) is confirmed, permanently discontinue PIQRAY. Do not reintroduce PIQRAY in patients who have experienced previous SCAR during PIQRAY treatment [see Warnings and Precautions (5.2)].

Table 2: Dose Modification and Management for Rash and Severe Cutaneous Adverse Reactions (SCARs)
1Grading according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
2For all grades of rash, consider consultation with a dermatologist.
3Antihistamines administered prior to rash onset may decrease incidence and severity of rash based on the SOLAR-1 trial.
[see Warnings and Precautions (5.1, 5.2)]
Grade1,2 Recommendation3
Grade 1
(< 10% body surface area (BSA) with active skin toxicity)		 No PIQRAY dose adjustment required.
Initiate topical corticosteroid treatment.
Consider adding oral antihistamine to manage symptoms.
If the etiology is SCAR, permanently discontinue PIQRAY.
Grade 2
(10%-30% BSA with active skin toxicity)		 No PIQRAY dose adjustment required.
Initiate or intensify topical corticosteroid and oral antihistamine treatment.
Consider low dose systemic corticosteroid treatment.
If the etiology is SCAR, permanently discontinue PIQRAY.
Grade 3 (e.g., severe rash not responsive to medical management)
(> 30% BSA with active skin toxicity)		 Interrupt PIQRAY.
Initiate or intensify topical/systemic corticosteroid and oral antihistamine treatment.
If the etiology is SCAR, permanently discontinue PIQRAY.
If the etiology is not a SCAR, interrupt dose until recovery to Grade ≤ 1, then resume PIQRAY at same dose level for first occurrence of rash, or at next lower dose level in case of second occurrence.
Grade 4 (e.g., severe bullous, blistering or exfoliating skin conditions)
(any % BSA associated with extensive superinfection, with IV antibiotics indicated; life-threatening consequences)		 Permanently discontinue PIQRAY.

Hyperglycemia

Table 3: Dose Modification and Management for Hyperglycemia
Abbreviation: ULN, upper limit of normal.
1FPG/Fasting Blood Glucose/Grade levels reflect hyperglycemia grading according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.
2Initiate applicable anti-diabetic medications, including metformin and insulin sensitizers (such as thiazolidinediones or dipeptidyl peptidase-4 inhibitors), and review respective prescribing information for dosing and dose titration recommendations, including local diabetic treatment guidelines. Metformin was recommended in the SOLAR-1 trial with the following guidance: Initiate metformin 500 mg once daily. Based on tolerability, metformin dose may be increased to 500 mg twice daily, followed by 500 mg with breakfast, and 1000 mg with dinner, followed by further increase to 1000 mg twice daily if needed [see Warnings and Precautions (5.3)].
3As recommended in the SOLAR-1 trial, insulin may be used for 1-2 days until hyperglycemia resolves. However, this may not be necessary in the majority of PIQRAY-induced hyperglycemia, given the short half-life of PIQRAY and the expectation of glucose levels normalizing after interruption of PIQRAY.
[see Warnings and Precautions (5.3)]
Fasting Plasma Glucose (FPG)/Fasting Blood Glucose Values1 Recommendation
Dose modifications and management should only be based on fasting glucose values (FPG or fasting blood glucose).
Grade 1
Fasting glucose > ULN -160 mg/dL or > ULN -8.9 mmol/L		 No PIQRAY dose adjustment required.
Initiate or intensify anti-diabetic treatment2.
Grade 2
Fasting glucose > 160-250 mg/dL or > 8.9-13.9 mmol/L		 No PIQRAY dose adjustment required.
Initiate or further intensify anti-diabetic treatment2.
If fasting glucose does not decrease to ≤ 160 mg/dL or 8.9 mmol/L within 21 days under appropriate anti-diabetic treatment, reduce PIQRAY dose by 1 dose level and follow fasting glucose value specific recommendations.
Grade 3
> 250-500 mg/dL or > 13.9-27.8 mmol/L		 Interrupt PIQRAY.
Initiate or intensify oral anti-diabetic treatment2 and consider additional anti-diabetic medications3 for 1-2 days until hyperglycemia improves.
Administer intravenous hydration and consider appropriate treatment (e.g., intervention for electrolyte/ketoacidosis/hyperosmolar disturbances).
If fasting glucose decreases to ≤ 160 mg/dL or 8.9 mmol/L within 3 to 5 days under appropriate anti-diabetic treatment, resume PIQRAY at 1 lower dose level.
If fasting glucose does not decrease to ≤ 160 mg/dL or 8.9 mmol/L within 3 to 5 days under appropriate anti-diabetic treatment, consultation with a physician with expertise in the treatment of hyperglycemia is recommended.
If fasting glucose does not decrease to ≤ 160 mg/dL or 8.9 mmol/L within 21 days following appropriate anti-diabetic treatment2, permanently discontinue PIQRAY treatment.
Grade 4
> 500 mg/dL or ≥ 27.8 mmol/L		 Interrupt PIQRAY.
Initiate or intensify appropriate anti-diabetic treatment2 (administer intravenous hydration and consider appropriate treatment (e.g., intervention for electrolyte/ketoacidosis/hyperosmolar disturbances)), re-check fasting glucose within 24 hours and as clinically indicated.
If fasting glucose decreases to ≤ 500 mg/dL or 27.8 mmol/L, follow fasting glucose value specific recommendations for Grade 3.
If fasting glucose is confirmed at > 500 mg/dL or 27.8 mmol/L, permanently discontinue PIQRAY treatment.

Diarrhea

Table 4: Dose Modification and Management for Diarrhea
1Grading according to CTCAE Version 5.0.
[see Warnings and Precautions (5.5)]
Grade1 Recommendation
Grade 1 No PIQRAY dose adjustment is required. Initiate appropriate medical therapy and monitor as clinically indicated.
Grade 2 Initiate or intensify appropriate medical therapy and monitor as clinically indicated. Interrupt PIQRAY dose until recovery to Grade ≤ 1, then resume PIQRAY at same dose level.
Grade 3 and 4 Initiate or intensify appropriate medical therapy and monitor as clinically indicated. Interrupt PIQRAY dose until recovery to Grade ≤ 1, then resume PIQRAY at the next lower dose level.

Other Toxicities

Table 5: Dose Modification and Management for Other Toxicities (Excluding Hyperglycemia, Rash, and Diarrhea)
1Grading according to CTCAE Version 5.0.
2For Grade 2 and 3 pancreatitis, interrupt PIQRAY dose until recovery to Grade < 2 and resume at next lower-dose level. Only one dose reduction is permitted. If toxicity reoccurs, permanently discontinue PIQRAY treatment.
3For Grade 2 total bilirubin elevation, interrupt PIQRAY dose until recovery to Grade ≤ 1 and resume at the same dose if resolved in ≤ 14 days or resume at the next lower dose level if resolved in > 14 days.
Grade1 Recommendation
Grade 1 or 2 No PIQRAY dose adjustment is required. Initiate appropriate medical therapy and monitor as clinically indicated2,3.
Grade 3 Interrupt PIQRAY dose until recovery to Grade ≤ 1, then resume PIQRAY at the next lower dose level.
Grade 4 Permanently discontinue PIQRAY.

Refer to the Full Prescribing Information of fulvestrant for dose modification guidelines in the event of toxicity and for other relevant safety information.

Further information

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