cose decreased,aPTT prolonged, and alopecia (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact NovartisPharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
CYP3A4 Inducers: Avoid coadministration of PIQRAY with a strongCYP3A4 inducer. (7.1)
BCRP Inhibitors: Avoid the use of BCRP inhibitors in patients treated withPIQRAY. If unable to use alternative drugs, closely monitor for increasedadverse reactions. (7.1)
CYP2C9 Substrates: Closely monitor when PIQRAY is coadministeredwith CYP2C9 substrates where decreases in the plasma concentration ofthese drugs may reduce activity. (7.2)
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDAapprovedpatient labeling.
Revised: 5/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
2.2 Dosage and Administration
2.3 Dose Modifications for Adverse Reactions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Severe Hypersensitivity
5.2 Severe Cutaneous Reactions
5.3 Hyperglycemia
5.4 Pneumonitis
5.5 Diarrhea
5.6 Embryo-Fetal Toxicity
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on PIQRAY
7.2 Effect of PIQRAY on Other Drugs
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are notlisted.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
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, PIK3CAmutated,advanced or metastatic breast cancer as detected by an FDA-approved test following progression on orafter an endocrine-based regimen.
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Select patients for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer withPIQRAY, based on the presence of one or more PIK3CA mutations in tumor tissue or plasma specimens [seeClinical Studies (14)]. If no mutation is detected in a plasma specimen, test tumor tissue. Information on FDAapproved
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, withfood [see Clinical Pharmacology (12.3)].
Continue treatment until disease progression or unacceptable toxicity occurs [see Dosage and Administration(2.3)].
Pa
