AY at approximately the same time each day.
Swallow PIQRAY tablets whole (tablets should not be chewed, crushed or split prior to swallowing). No tabletshould 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. Aftermore 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 toresume 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, and29, 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 Reactions1PIQRAY Dose Level Dose and Schedule Number and Strength of TabletsStarting dose 300 mg once daily Two 150 mg tabletsFirst-dose reduction 250 mg once daily One 200 mg tablet and one 50 mg tabletSecond-dose reduction 200 mg once daily2 One 200 mg tablet
1Only one dose reduction is permitted for pancreatitis.
2If further dose reduction below 200 mg once daily is required, discontinue PIQRAY.
Tables 2, 3, 4, and 5 summarize recommendations for dose interruption, reduction, or discontinuation ofPIQRAY in the management of specific ARs.
Hyperglycemia
Table 2: Dose Modification and Management for Hyperglycemia
Fasting Plasma Glucose
(FPG)/Blood Glucose
Values1
Recommendation
Grade 1
FPG > ULN-160 mg/dL
or > ULN-8.9 mmol/L
No PIQRAY dose adjustment required.
Initiate or intensify anti-diabetic treatment2
.Grade 2
FPG > 160-250 mg/dL or >
8.9-13.9 mmol/L
No PIQRAY dose adjustment required.
Initiate or further intensify anti-diabetic treatment2.
If FPG does not decrease to ≤ 160 mg/dL or 8.9 mmol/L within 21 days under appropriate antidiabetictreatment, reduce PIQRAY dose by 1 dose level and follow FPG value specificrecommendations.
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 forelectrolyte/ketoacidosis/hyperosmolar disturbances).
If FPG decreases to ≤ 160 mg/dL or 8.9 mmol/L within 3 to 5 days under appropriate anti-diabetictreatment, resume PIQRAY at 1 lower dose level.
If FPG does not decrease to ≤ 160 mg/dL or 8.9 mmol/L within 3 to 5 days under appropriate antidiabetictreatment, consultation with a physician with expertise in the treatment of hyperglycemia isrecommended.
If FPG does not decrease to ≤ 160 mg/dL or 8.9 mmol/L within 21 days following appropriate antidiabetictreatment2, permanently discontinue PIQRAY treatment.
Grade 4> 500 mg/dLor ≥ 27.8 mmol/LInterrupt PIQRAY.
Initiate or intensify appropriate anti-diabetic treatment2
(administer intravenous hydration and
consider appropriate treatment (e.g., intervention for electrolyte/ketoacidosis/hyperosmolardisturbances)), re-check FPG within 24 hours and as clinically indicated.
If FPG decreases to &le |
