Mutation)
16 HOW SUPPLIED/STORAGE AND HANDLING
PIQRAY (alpelisib) 50 mg, 150 mg, and 200 mg film-coated tablets [see Dosage Forms and Strengths (3)].
300 mg daily dose: Each carton contains 2 blister packs. Each blister pack contains a 14-day supply of 28tablets (28 tablets, 150 mg alpelisib per tablet). NDC 0078-0708-02250 mg daily dose: Each carton contains 2 blister packs. Each blister pack contains a 14-day supply of 28tablets (14 tablets, 200 mg alpelisib per tablet and 14 tablets, 50 mg alpelisib per tablet). NDC 0078-0715-02200 mg daily dose: Each carton contains 1 blister pack. Each blister pack contains a 28-day supply of 28 tablets
(28 tablets, 200 mg alpelisib per tablet). NDC 0078-0701-84Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USPontrolled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Severe Hypersensitivity
Inform patients of the signs and symptoms of hypersensitivity. Advise patients to contact their healthcare
provider immediately for signs and symptoms of hypersensitivity [see Warnings and Precautions (5.1)].
Severe Cutaneous Reactions
Inform patients of the signs and symptoms of severe cutaneous reactions. Advise patients to contact their
healthcare provider immediately for signs and symptoms of severe cutaneous reactions [see Warnings and
Precautions (5.2)].
Hyperglycemia
Advise patients of the possibility of developing hyperglycemia and the need to monitor blood glucoseperiodically during therapy. Advise patients to contact their healthcare provider immediately for signs andsymptoms of hyperglycemia [see Warnings and Precautions (5.3)].
Pneumonitis
Inform patients of the possibility of developing pneumonitis and to immediately contact their healthcareprovider if they experience respiratory problems [see Warnings and Precautions (5.4)].
Diarrhea
Advise patients that PIQRAY may cause diarrhea, which may be severe in some cases. Inform patients to startantidiarrheal treatment, increase oral fluids, and notify their healthcare provider if diarrhea occurs while takingPIQRAY [see Warnings and Precautions (5.5)].
Embryo-Fetal ToxicityInform pregnant women and females of reproductive potential of the potential risk to a fetus. Advisefemales to inform their healthcare provider of a known or suspected pregnancy [see Warnings andPrecautions (5.6) and Use in Specific Populations (8.1)].
Advise females of reproductive potential to use effective contraception during treatment with PIQRAYand for 1 week after the last dose [see Use in Specific Populations (8.3)].
Advise male patients with female partners of reproductive potential to use condoms and effectivecontraception during treatment with PIQRAY and for 1 week after the last dose [see Use in SpecificPopulations (8.3)].
Refer to the Full Prescribing Information of fulvestrant for pregnancy and contraception information.
Lactation
Advise women not to breastfeed during treatment with PIQRAY and for 1 week after the last dose [see Use inSpecific Populations (8.2)]. Refer to the Full Prescribing Information of fulvestrant for lactation information.
Infertility
Advise males and females of reproductive potential that PIQRAY may impair fertility [see Use in SpecificPopulations (8.3)]. Refer to the Full P |
