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Piqray

alpelisib
PI3Kα Inhibitor FDA Approved 2019 Novartis
Route
Oral
Half-Life
8.4 hrs
FDA Approved
2019
Manufacturer
Novartis
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1. Indications and Usage

Breast cancer: With fulvestrant for HR+/HER2-/PIK3CA-mutated advanced BC.

2. Dosage and Administration

300 mg daily immediately after food.

3. Dosage Forms and Strengths

Tablets: 50 mg, 150 mg, 200 mg

4. Contraindications

Severe hypersensitivity.

5. Warnings and Precautions
  • Hyperglycemia: 65%. Monitor fasting glucose.
  • Severe Cutaneous Reactions: SJS/DRESS reported.
  • Pneumonitis: Withhold/discontinue.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Hyperglycemia (65%), Diarrhea (58%), Rash (52%), Nausea (45%), Fatigue (42%), Decreased Appetite (36%), Stomatitis (30%), Vomiting (27%)

Hyperglycemia
65%
Diarrhea
58%
Rash
52%
Nausea
45%
Fatigue
42%
Decreased Appetite
36%
Stomatitis
30%
Vomiting
27%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

CYP2C9 Substrates: May increase exposure.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Selective PI3Kα inhibitor blocking downstream AKT phosphorylation in PIK3CA-mutated cells.

Pharmacokinetics

Tmax: 2-4h. t½: 8-9h. Steady state by Day 3.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Piqray Trials on ClinicalTrials.gov ↗ 📚 PubMed: Piqray Clinical Trials ↗
FDA-Approved Tumor Types

Piqray has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Breast Cancer
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Piqray. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Piqray (alpelisib) approved for?

Piqray (alpelisib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Piqray (alpelisib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Piqray (alpelisib) work?

Selective PI3Kα inhibitor blocking downstream AKT phosphorylation in PIK3CA-mutated cells.

What are the most common side effects?

Hyperglycemia (65%), Diarrhea (58%), Rash (52%), Nausea (45%), Fatigue (42%), Decreased Appetite (36%), Stomatitis (30%), Vomiting (27%) Hyperglycemia 65% Diarrhea 58% Rash 52% Nausea 45% Fatigue 42% Decreased Appetite 36% Stomatitis 30% Vomiting 27%

← All Therapies Full Prescribing Information ↗