Important Safety Information


PIQRAY® (alpelisib) tablets is contraindicated in patients with severe hypersensitivity to it or any of its components. Severe Hypersensitivity: Severe hypersensitivity reactions, including anaphy...

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Indication
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, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

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PIK3CA Mutation CDx Testing Program

NeoGenomics Laboratories will conduct tumor tissue and plasma testing using the QIAGEN therascreen® PIK3CA RGQ PCR Kit.1 Appropriate patients may receive one tumor tissue or plasma PIK3CA mutation test at no cost for the purpose of determining whether or not the patient has a PIK3CA mutation and is eligible for alpelisib for an FDA-approved indication, without regard to purchase of any prescribed drug or any other product.

If the patient tests negative for PIK3CA mutation using plasma, eligible patients may also receive one PIK3CA reflex tissue test at no cost.

No patient, health care program, or beneficiary shall be billed for this mutation test. The test shall not be included in a bundled payment to any health care facility including, but not limited to, a hospital. The ordering physician shall not be compensated any fees in connection with this mutation testing, such as for specimen collection, handling, or data reporting. Program is not valid where prohibited by law. Novartis reserves the right to rescind, revoke, or amend the program without notice.

If no mutation is detected in a plasma specimen, retest the patient with tumor tissue.

The QIAGEN therascreen® PIK3CA RGQ PCR Kit has been verified for both tumor tissue and plasma testing with NeoGenomics Laboratories.

Health care professional testing results

Neogenomics PIK3CA mutation CDx testing program HCP sample report

Online Ordering at NeoLINK* is the preferred ordering method when using NeoGenomics Laboratories.

Order tests online through NeoLINK®
Neogenomics ordering process

Schedule your specimen pickup by calling Client Services at 1-866-776-5907, option #1.

Download the PIK3CA CDx Testing Program Brochure

*This is an external website independently operated and not managed by Novartis Pharmaceuticals Corporation. Novartis assumes no responsibility for the site.

For more detailed testing information, please visit our comprehensive PIK3CA Testing Navigator.

For more detailed testing information, please visit our comprehensive PIK3CA Testing Navigator.
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Novartis Oncology Universal Co-Pay Program

Universal co-pay card

Patients may be eligible for immediate co-pay savings on their next prescription of PIQRAY.

• Eligible patients with private insurance may pay $0 per month

• Novartis will pay the remaining co-pay, up to $15,000 per calendar year

Limitations apply. This offer is only available to patients with private insurance. The program is not available for patients who are enrolled in Medicare, Medicaid, or any other federal or state health care program. Novartis reserves the right to rescind, revoke, or amend this program without notice. For full Terms and Conditions, visit Copay.NovartisOncology.com or call 1-877-577-7756.

Encourage your patients to find out if they are eligible to enroll in the Universal Co-pay Program by visiting Copay.NovartisOncology.com or calling 1-877-577-7756.

 

Free Trial Program

The PIQRAY 14-day free trial helps eligible patients start therapy quickly.

A 14-day supply is shipped directly to a patient’s home or another convenient location.

This program is available to all patients prescribed PIQRAY for a US Food and Drug Administration–approved indication without regard to the purchase of PIQRAY or any other product.

Program rules may vary.

Help your patients apply for this program by submitting the Novartis Service Request Form, available at HCP.Novartis.com/Access.

 

Monitoring made accessible for your patients 

Patient Support during COVID-19

Because we understand that in order to continue treatment, your patients need to have required monitoring, which may be difficult to obtain in typical health care settings during these uncertain times, we have instituted a temporary new program.

  • If you have a current or new-start patient for whom you've prescribed select Novartis breast cancer treatment that require monitoring tests (FPG or HbA1c), and you would like to enroll them in the temporary In-Home Monitoring Program, please call 1-844-305-6158 to enroll your patient
  • This service is available for monitoring tests required by the Prescribing Information for select Novartis Oncology breast cancer products only. The program provides such tests at no cost to your patient or any third party, regardless of their insurance coverage. Both physician and patient consent is required

Patient Assistance Now Oncology (PANO)

PANO

PANO is a support center consisting of insurance specialists and case managers who provide access to information regarding an array of services. Consider PANO your first stop for information about Novartis Oncology Patient Support programs. Dedicated support specialists help direct callers to the services that best fit their needs. 

To learn more, call 1-800-282-7630 or visit HCP.Novartis.com/Access.

therascreen is a registered trademark of QIAGEN group.

NeoLINK is a registered trademark of NeoGenomics Laboratories, Inc.

Reference: 1. therascreen® PIK3CA RGQ PCR Kit Instructions for Use. QIAGEN Inc., Germantown, MD; 2019.

Indication

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%. 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, including ketoacidosis, can occur in patients treated with PIQRAY. 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 with PIQRAY, 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. If a patient experiences hyperglycemia after initiating treatment with PIQRAY, monitor fasting glucose as clinically indicated, and at least twice weekly until fasting glucose decreases to normal levels. During treatment with antidiabetic 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 type 2 diabetes were included. Patients with a history of diabetes mellitus may require intensified diabetic 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: Severe diarrhea, including dehydration and 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. Based on the severity of the diarrhea, 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.

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 see full Prescribing Information.