Important Safety Information:

VIJOICE® (alpelisib) tablets is contraindicated in patients with severe hypersensitivity to alpelisib or any of its ingredients...

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Indication: VIJOICE® (alpelisib) tablets is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.

This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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VIJOICE VIP Program™

VIJOICE VIP Program™ logo

 

The VIJOICE® (alpelisib) tablets VIP ProgramTM, brought to you by Novartis Oncology Patient Support, is a support program made personal for eligible patients taking VIJOICE.

 

About the VIJOICE VIP Program

Care Champion icon

Care Champion

The VIJOICE VIP Program pairs a personal Care Champion with enrolled patients and caregivers.
Each Care Champion is a dedicated specialist with experience in health care.

 

How can the VIJOICE VIP Care Champion help your patient?

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Convenient support, just a phone call away

  • Care Champions schedule personal phone calls and send reminder postcards in advance for organized and timely discussions
  • Program phone support lines are open from 8 AM to 8 PM ET, Monday through Friday
  • Translation services are available in more than 160 languages
Medication and insurance benefits icon

Assistance with access to medication and insurance benefits

  • Insurance benefits verification
  • Help with understanding insurance coverage and financial responsibilities
  • Information about financial assistance that may be available
  • Free trial of medication referral for eligible patients and additional financial assistance*
Information icon

Relevant educational resources and regular topic discussions

  • Education about VIJOICE, including how it works and serious and common side effects
  • Information about the different specialists the patient may see for their condition
  • Questions that may aid with doctor discussions

*Eligible patients can receive a free 28-day supply of VIJOICE. Limitations apply. Call 1-800-282-7630 to determine eligibility.

The VIJOICE VIP Program does not replace the advice and guidance of patients’ health care teams.

 

 

Easy enrollment

You are just 3 steps away from helping your patients receive 1-to-1, personal support:

Step 1: Patient form
Link to Patient PANO Service Request Form icon

Have your patient complete the Patient PANO Service Request Form online at VIJOICE-Support.com.

Step 2: HCP form
Download HCP PANO Service Request Form icon

Download and complete this form:

HCP PANO Service Request Form

Step 3: Enrollment
Fax machine icon

Sign the completed HCP form and fax it to 1-866-253-1410.

Call 1-800-282-7630, and we will be happy to help.

*Patient will have a confirmation number if they already completed the form.
PANO, Patient Assistance Now Oncology.

 

Frequently asked questions

The VIJOICE VIP Program is a support program for eligible patients taking VIJOICE. It is provided for each patient/caregiver enrolled in the program through in-depth and relevant monthly educational calls. Each enrolled patient/caregiver is assigned to a Care Champion who will be their consistent support contact in the program.

Eligible patients must be prescribed VIJOICE for its FDA-approved indication.

The VIJOICE VIP Program provides additional support to your eligible patients and their caregivers throughout their treatment journey. The goal of the program and the Care Champions' support is to help patients access the right resources and have productive conversations with their health care teams.

After completing the enrollment form, the patient will receive an initial communication in the mail welcoming them to the program. A few days later, they will receive a welcome kit that includes materials that will support their Care Champion phone calls. The welcome kit arrives inside a reusable box that the patient can use to organize and store all the materials they receive about their disease. Finally, an initial call is scheduled with their assigned Care Champion who will review the features of the program and introduce some information about VIJOICE. Expectations for scheduling monthly calls will be discussed, and calls will be scheduled at the patient’s convenience.

The program does not cost your patient(s) anything to participate. However, to be eligible, your patient(s) must be prescribed VIJOICE for its FDA-approved indication.

Patient(s) and their caregiver(s) may remain in the program for as long as they like, subject to program eligibility and enrollment requirements. If they would like to leave the program at any time, they simply speak with their Care Champion.

You are just 3 steps away from helping your patients receive 1-to-1 personal support:

  1. Have your patient complete the Patient PANO Service Request Form online at VIJOICE-Support.com.*
  2. Your office downloads and completes the HCP PANO Service Request Form, found here.
  3. Prescribing HCP signs the completed HCP form and faxes it to 1-866-253-1410.
*Patient will have a confirmation number if they already completed the form.

Ensure your patient(s) has completed the online Patient PANO Service Request Form located at VIJOICE-Support.com. The form may be completed online on any electronic device. After submitting the form, your patient will receive a confirmation number for their reference only.

A separate HCP form is needed to complete enrollment. Your office completes the form and prints it, the prescribing HCP signs it, then faxes it to 1-866-253-1410.

 

Novartis Oncology Universal Co-pay Program

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

  • Eligible patients with private insurance may pay $0 per month
  • Novartis will pay the remaining co-pay, up to $15,000 per calendar year, per product*

Novartis Universal Co-pay Card

*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 Novartis Oncology Universal Co-pay Program by visiting Copay.NovartisOncology.com or calling 1-877-577-7756.

 

Free Trial Program

The VIJOICE 28-day free trial helps eligible patients start therapy quickly. This 1-time trial is available to all patients prescribed VIJOICE for a US Food and Drug Administration–approved indication without regard to the purchase of VIJOICE or any other product. Certain patients may be eligible to obtain 1 more free fill. Program rules may vary.

Help your patients apply for this program by submitting the Novartis Service Request Form.

INDICATION

VIJOICE® (alpelisib) tablets is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.

This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

VIJOICE is contraindicated in patients with severe hypersensitivity to alpelisib or any of its ingredients.

Severe Hypersensitivity. Severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have occurred in adult patients treated with alpelisib in the oncology setting and may occur in patients treated with VIJOICE. VIJOICE is not approved for use in the oncology setting. Permanently discontinue VIJOICE 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), have occurred in adult patients treated with alpelisib in the oncology setting and may occur in patients treated with VIJOICE. If signs or symptoms of SCARs occur, interrupt VIJOICE until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended. If a SCAR is confirmed, permanently discontinue VIJOICE. If a SCAR is not confirmed, VIJOICE may require dose modifications, topical corticosteroids, or oral antihistamine treatment.

Hyperglycemia. Severe hyperglycemia, in some cases associated with hyperglycemic hyperosmolar nonketotic syndrome (HHNKS) or fatal cases of ketoacidosis, has occurred in adult patients treated with alpelisib in the oncology setting and may occur in patients treated with VIJOICE.

In the EPIK-P1 study, grade 1 or 2 hyperglycemia was reported in 12% of patients treated with VIJOICE.

Before initiating treatment with VIJOICE, test fasting plasma glucose (FPG), HbA1c, and optimize blood glucose. After initiating treatment with VIJOICE, 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 with VIJOICE in patients with risk factors for hyperglycemia, such as obesity (body mass index ≥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 with VIJOICE, monitor fasting glucose as clinically indicated and at least twice weekly until fasting glucose decreases to normal levels. During treatment with antihyperglycemic 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 provider with expertise in the treatment of hyperglycemia, and counsel patients on lifestyle changes.

The safety of VIJOICE in patients with type 1 and uncontrolled type 2 diabetes has not been established. Patients with a history of diabetes mellitus may require intensified hyperglycemic treatment. Closely monitor patients with diabetes.

Interrupt, reduce the dose of, or permanently discontinue VIJOICE based on severity.

Pneumonitis. Severe pneumonitis, including acute interstitial pneumonitis and interstitial lung disease, has occurred in adult patients treated with alpelisib in the oncology setting and may occur in patients treated with VIJOICE.

In patients who have new or worsening respiratory symptoms or are suspected to have developed pneumonitis, interrupt VIJOICE 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 examinations and in whom infectious, neoplastic, and other causes have been excluded by means of appropriate investigations.

Permanently discontinue VIJOICE in all patients with confirmed pneumonitis.

Diarrhea. Severe diarrhea, including cases resulting in dehydration and acute kidney injury, has occurred in adult patients treated with alpelisib in the oncology setting and may occur in patients treated with VIJOICE. In the EPIK-P1 study, 16% of patients experienced grade 1 diarrhea during treatment with VIJOICE. Interrupt, reduce the dose of, or permanently discontinue VIJOICE based on severity.

Embryo-Fetal Toxicity. Based on findings in animals and its mechanism of action, VIJOICE 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 VIJOICE 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 VIJOICE and for 1 week after the last dose.

The most common adverse reactions (all grades, incidence ≥10%) were diarrhea (16%), stomatitis (16%), and hyperglycemia (12%).

The most common laboratory abnormalities (all grades, incidence ≥20%) were decreased calcium (corrected) (60%), decreased phosphate (59%), increased glucose (56%), increased HbA1c (38%), increased creatinine (31%), increased bilirubin (29%), decreased magnesium (26%), increased potassium (24%), decreased leukocyte (22%), decreased lymphocyte (20%), and decreased hemoglobin (20%).

Please see full Prescribing Information for VIJOICE® (alpelisib) tablets.