Please see below for full Important Safety Information and click here for full Prescribing Information for PIQRAY® (alpelisib) tablets.
PIK3CA Testing Navigator brochure
The PIK3CA Testing Navigator brochure provides key information on why, when, and how to test for PIK3CA mutations. It also includes guidance on the PIK3CA Mutation CDx Testing Program through NeoGenomics using the QIAGEN's therascreen® PIK3CA RGQ PCR Kit, as well as information on Foundation Medicine's FoundationOne®CDx and FoundationOne®Liquid CDx.
PIK3CA CDx Testing Program brochure
The PIK3CA CDx Testing Program brochure describes the guidelines for the CDx Testing Program through NeoGenomics using the therascreen® PIK3CA RGQ PCR Kit. It contains information on ordering a tissue or plasma test via NeoLINK®* and also has a printable fax form.
*This is an external website independently operated and not managed by Novartis Pharmaceuticals Corporation. Novartis assumes no responsibility for the site.
PIQRAY is the first and only therapy specifically for advanced breast cancer patients with a PIK3CA mutation. PIQRAY is indicated for postmenopausal women, and men, with HR+/HER2-, PIK3CA-mutated, advanced or metastatic breast cancer (aBC or MBC), in combination with fulvestrant following progression on or after an endocrine-based regimen.1 For more information, click here.
QIAGEN PCR single-gene test2
For ordering instructions on PIK3CA mutation CDx tests, including the QIAGEN therascreen® PIK3CA RGQ PCR Kit, click here.
What sample type is required for the QIAGEN therascreen® PIK3CA RGQ PCR Kit? Can I use primary tumor or metastatic sites? Can I test archival tissue?
For the QIAGEN therascreen® PIK3CA RGQ PCR Kit, primary breast tumor tissue or metastatic tissue specimens may be used, including archival tissue specimens and recent or new biopsies.3 Tumors not originating in the breast are not accepted for this test.4
Plasma derived from peripheral whole blood may also be used for testing.2 If you are ordering through the PIK3CA CDx Testing Program, please contact NeoGenomics Client Services at 1-866-776-5907, or to learn more about ordering click here.
If not, please contact the lab you are ordering the test from.
If PIK3CA mutations are not detected using plasma, retest the patient using tumor tissue. Click here to learn more about false negatives.1
NeoGenomics generally expects to provide results within 1 week of specimen receipt.
For the QIAGEN therascreen® PIK3CA RGQ PCR Kit, QIAGEN expects that decalcified bone metastasis tissue will not be able to be tested using the PIK3CA Mutation CDx test, as it will produce an invalid result.4 For further questions, please contact QIAGEN Customer Service at 1-800-362-7737, or contact the lab that you are ordering from.
If ordering through NeoGenomics, contact NeoGenomics Client Services at 1-866-776-5907 to review specimen collection and preparation requirements and to obtain the specimen shipment kit. If not ordering through NeoGenomics, please contact the laboratory providing testing to obtain specimen collection and preparation requirements and the specimen shipment kit.
For more information on the PIK3CA CDx Testing Program through NeoGenomics, please click here.
PlK3CA mutation CDx testing includes 11 different mutations in the PIK3CA gene as part of the FDA-approved indication. These include: C420R in Exon 7; E542K, E545K/A/D/G and Q546R/E in Exon 9; and H1047R/L/Y in Exon 20. Learn more in our Background tab. Click here.
The QIAGEN therascreen® PIK3CA RGQ PCR Kit runs on the QIAGEN Rotor-Gene Q MDx (US) platform. For technical questions, please contact QIAGEN Customer Service at 1-800-362-7737.
Foundation Medicine NGS multi-gene tests5,6
For ordering instructions on PIK3CA mutation CDx tests, including FoundationOne®CDx or FoundationOne®Liquid CDx, click here.
What sample type is required for FoundationOne®CDx and FoundationOne®Liquid CDx? Can I use primary tissue or metastatic tissue specimens? Can I test archival tissue?
FoundationOne®CDx will test tumor tissue. Primary breast tumor tissue or metastatic tissue specimens may be used for testing and you may use archival tissue. FoundationOne®Liquid CDx will test blood. For more information, please contact Foundation Medicine Client Services at 1-888-988-3639.
For a negative PIK3CA mutation FoundationOne®Liquid CDx plasma result, do I need to confirm with a reflex tissue test?
A negative result from a plasma specimen does not mean that the patient’s tumor is negative for genomic findings. Patients who are negative for PIK3CA mutation should be reflexed to routine biopsy and their tumor mutation status confirmed using an FDA-approved tumor tissue test, if feasible to receive a tissue sample for that patient.
Foundation Medicine generally expects to provide results in 12 days or less from specimen receipt.
PlK3CA mutation CDx testing includes 11 different mutations in the PIK3CA gene as part of the FDA-approved indication. These include: C420R in Exon 7; E542K, E545K/A/D/G and Q546R/E in Exon 9; and H1047R/L/Y in Exon 20. Click here.
To obtain the shipment kit for FoundationOne®CDx or FoundationOne®Liquid CDx, please contact Foundation Medicine Client Services at 1-888-988-3639.
What is the cost of FoundationOne®CDx and FoundationOne®Liquid CDx tests? Are they covered by the patient’s insurance? Is financial assistance available?
To find out the cost of FoundationOne®CDx or FoundationOne® Liquid CDx and if these tests are covered by the patient's insurance, please contact Foundation Medicine Client Services at 1-888-988-3639 or the appropriate insurance provider. To learn more click here.
For technical information about FoundationOne®CDx or FoundationOne®Liquid CDx, please contact Foundation Medicine Client Services at 1-888-988-3639.
PIQRAY® (alpelisib) tablets 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, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
Important Safety Information
PIQRAY is contraindicated in patients with severe hypersensitivity to it or any of its components.
Severe Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, can occur in patients treated with PIQRAY. Severe hypersensitivity reactions were manifested by symptoms including, but not limited to, dyspnea, flushing, rash, fever, or tachycardia. The incidence of grade 3 and 4 hypersensitivity reactions was 0.7%. Angioedema has been reported in the postmarketing setting in patients treated with PIQRAY. Advise patients of the signs and symptoms of severe hypersensitivity reactions. Permanently discontinue PIQRAY in the event of severe hypersensitivity.
Severe Cutaneous Adverse Reactions (SCARs): SCARs, including Stevens-Johnson syndrome (SJS), erythema multiforme (EM), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur in patients treated with PIQRAY. In the SOLAR-1 study, SJS and EM were reported in 0.4% and 1.1% of patients, respectively. DRESS was reported in patients in the postmarketing setting. If signs or symptoms of SCARs occur, interrupt PIQRAY until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended.
If a SCAR is confirmed, permanently discontinue PIQRAY. Do not reintroduce PIQRAY in patients who have experienced previous SCARs during PIQRAY treatment. If it is not confirmed, PIQRAY may require dose modifications, topical corticosteroids, or oral antihistamine treatment.
Advise patients of the signs and symptoms of SCARs (eg, a prodrome of fever, flu-like symptoms, mucosal lesions, progressive skin rash, or lymphadenopathy).
Hyperglycemia: Severe hyperglycemia, in some cases associated with hyperglycemic hyperosmolar non-ketotic syndrome (HHNKS) or ketoacidosis has occurred in patients treated with PIQRAY. Fatal cases of ketoacidosis have occurred in the postmarketing setting.
Hyperglycemia was reported in 65% of patients treated with PIQRAY. Grade 3 (FPG >250-500 mg/dL) and grade 4 (FPG >500 mg/dL) hyperglycemia were reported in 33% and 3.9% of patients, respectively. Ketoacidosis was reported in 0.7% of patients (n=2) treated with PIQRAY.
Before initiating treatment with PIQRAY, test fasting plasma glucose (FPG), HbA1c, and optimize blood glucose. After initiating treatment, monitor fasting glucose (FPG or fasting blood glucose) at least once every week for the first 2 weeks, then at least once every 4 weeks, and as clinically indicated. Monitor HbA1c every 3 months and as clinically indicated. Monitor fasting glucose more frequently for the first few weeks during treatment in patients with risk factors for hyperglycemia such as obesity (BMI ≥30), elevated FPG, HbA1c at the upper limit of normal or above, use of concomitant systemic corticosteroids, or age ≥75.
If a patient experiences hyperglycemia after initiating treatment, monitor fasting glucose as clinically indicated, and at least twice weekly until fasting glucose decreases to normal levels. During treatment with anti-hyperglycemic medication, continue monitoring fasting glucose at least once a week for 8 weeks, followed by once every 2 weeks and as clinically indicated. Consider consultation with a health care practitioner with expertise in the treatment of hyperglycemia and counsel patients on lifestyle changes.
The safety of PIQRAY in patients with type 1 and uncontrolled type 2 diabetes has not been established as these patients were excluded from the SOLAR-1 trial. Patients with a medical history of controlled type 2 diabetes were included. Patients with a history of diabetes mellitus may require intensified hyperglycemic treatment. Closely monitor patients with diabetes.
Based on the severity of the hyperglycemia, PIQRAY may require dose interruption, reduction, or discontinuation. Advise patients of the signs and symptoms of hyperglycemia (eg, excessive thirst, urinating more often than usual or higher amount of urine than usual, or increased appetite with weight loss).
Pneumonitis: Severe pneumonitis, including acute interstitial pneumonitis and interstitial lung disease, can occur in patients treated with PIQRAY. Pneumonitis was reported in 1.8% of patients treated with PIQRAY.
In patients who have new or worsening respiratory symptoms or are suspected to have developed pneumonitis, interrupt PIQRAY immediately and evaluate the patient for pneumonitis. Consider a diagnosis of noninfectious pneumonitis in patients presenting with nonspecific respiratory signs and symptoms such as hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams and in whom infectious, neoplastic, and other causes have been excluded by means of appropriate investigations.
Permanently discontinue PIQRAY in all patients with confirmed pneumonitis. Advise patients to immediately report new or worsening respiratory symptoms.
Diarrhea or Colitis: Severe diarrhea, resulting in dehydration and in some cases in acute kidney injury, can occur in patients treated with PIQRAY. Most patients (58%) experienced diarrhea during treatment with PIQRAY. Grade 3 diarrhea occurred in 7% (n=19) of patients. Colitis has been reported in the postmarketing setting in patients treated with PIQRAY. Monitor patients for diarrhea and additional symptoms of colitis, such as abdominal pain and mucus, or blood in the stool. Based on the severity of the diarrhea or colitis, PIQRAY may require dose interruption, reduction, or discontinuation. Advise patients to start antidiarrheal treatment, increase oral fluids, and notify their health care provider if diarrhea occurs while taking PIQRAY. For patients with colitis, additional treatment, such as enteric-acting and/or systemic steroids, may be required.
Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, PIQRAY can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with PIQRAY and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use condoms and effective contraception during treatment with PIQRAY and for 1 week after the last dose. Refer to the full Prescribing Information of fulvestrant for pregnancy and contraception information.
The most common adverse reactions (all grades, incidence ≥20%) were diarrhea (58%), rash (52%), nausea (45%), fatigue (42%), decreased appetite (36%), stomatitis (30%), vomiting (27%), weight decreased (27%), and alopecia (20%). The most common grade 3/4 adverse reactions (incidence ≥2%) were rash (20%), diarrhea (7%), fatigue (5%), weight decreased (3.9%), nausea (2.5%), stomatitis (2.5%), and mucosal inflammation (2.1%).
The most common laboratory abnormalities (all grades, incidence ≥20%) were glucose increased (79%), creatinine increased (67%), lymphocyte count decreased (52%), gamma-glutamyl transferase (GGT) increased (52%), alanine aminotransferase (ALT) increased (44%), hemoglobin decreased (42%), lipase increased (42%), calcium decreased (27%), glucose decreased (26%), and activated partial thromboplastin time (aPTT) prolonged (21%). The most common grade 3/4 laboratory abnormalities (incidence ≥5%) were glucose increased (39%), GGT increased (11%), lymphocyte count decreased (8%), lipase increased (7%), and potassium decreased (6%).
Please click here for full Prescribing Information.
therascreen is a registered trademark of QIAGEN Group.
NeoLINK is a registered trademark of NeoGenomics Laboratories.
Foundation Medicine, FoundationOne CDx, and FoundationOne Liquid CDx are registered trademarks of Foundation Medicine, Inc.
References: 1. Piqray [prescribing information]. East Hanover, NJ. Novartis Pharmaceuticals, Corp. 2022. 2. therascreen® PIK3CA RGQ PCR Kit Instructions for Use. Germantown, MD: QIAGEN; May 2019. 3. Data on file. Novartis Pharmaceuticals, Corp; 2018. 4. PIK3CA Mutation CDx tissue & plasma. Accessed November 11, 2020. https://www.neogenomics. com/pik3ca#tissue-requirements. 5. FoundationOne®CDx technical information. Foundation Medicine, Inc. 6. FoundationOne®Liquid CDx technical information. Foundation Medicine, Inc.