Vijoice Is the First FDA-Approved Treatment for Severe PROS

Vijoice (Alpelisib) is a prescription PI3K inhibitor manufactured by Novartis that treats severe PIK3CA-Related Overgrowth Spectrum (PROS) in patients aged 2 years and older. It received FDA accelerated approval in April 2022, making it the first and only systemic therapy specifically approved for this group of rare genetic overgrowth conditions.

If you've been prescribed Vijoice or are researching it for a loved one, this guide covers everything you need to know—from what it treats and how to take it, to what it costs and who shouldn't use it.

What Is Vijoice?

Here are the key facts:

• Brand name: Vijoice
• Generic name: Alpelisib
• Drug class: PI3K inhibitor (phosphatidylinositol 3-kinase inhibitor) / kinase inhibitor
• Manufacturer: Novartis Pharmaceuticals Corporation
• FDA approval: April 2022 (accelerated approval)
• Controlled substance: No — Vijoice is not a controlled substance
• Related brand: Piqray (same active ingredient, Alpelisib, but approved for a different condition — PIK3CA-mutated breast cancer)

Alpelisib works by selectively blocking the PI3K-alpha enzyme, which is overactive in people with PIK3CA mutations. By inhibiting this enzyme, Vijoice reduces the abnormal cell growth and tissue overgrowth that characterizes PROS. For a detailed explanation, see how Vijoice works: mechanism of action explained.

What Is Vijoice Used For?

Vijoice is FDA-approved for:

• Treatment of adult and pediatric patients (2 years and older) with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy

PROS is an umbrella term for a group of rare conditions caused by somatic (non-inherited) mutations in the PIK3CA gene. These mutations cause tissues to grow excessively, leading to overgrowth of bone, fat, blood vessels, lymphatic tissue, or skin. Conditions that fall under the PROS umbrella include:

• CLOVES syndrome
• Klippel-Trenaunay syndrome (KTS)
• Fibroadipose hyperplasia
• Megalencephaly-capillary malformation (MCAP)
• Other PIK3CA-related overgrowth conditions

Before Vijoice, the main systemic treatment option was off-label use of Sirolimus (Rapamune), an mTOR inhibitor. Surgery and sclerotherapy remain options for localized overgrowth. For information on alternatives, see our guide on alternatives to Vijoice.

How Is Vijoice Taken?

Dosage Forms

Vijoice comes in two forms:

• Film-coated tablets: Available in 50 mg, 125 mg, and 200 mg strengths
• Oral granules: 50 mg per packet — designed for patients who cannot swallow tablets, mixed with soft food like applesauce or yogurt

Typical Dosing

• Children (ages 2 to under 18): 50 mg once daily is the typical starting dose. After 24 weeks, your doctor may increase the dose to 125 mg daily for patients 6 years and older, based on response and tolerability.
• Adults (18 and older): 250 mg once daily

How to Take It

• Take once daily with food, at about the same time each day
• Swallow tablets whole — do not split or chew
• If you can't swallow tablets, they can be dispersed in water to make an oral suspension
• Oral granules (50 mg packets) should be mixed with soft food like applesauce or yogurt

Your doctor will determine the right dose based on your age, weight, and how well you tolerate the medication. Do not adjust your dose without medical guidance.

Who Should Not Take Vijoice?

Vijoice is not appropriate for everyone. You should not take Vijoice if you have:

• A history of severe allergic reaction to Alpelisib or any inactive ingredient in Vijoice

Additionally, special caution is needed for:

• Pregnant patients: Vijoice can harm a developing fetus. Pregnancy must be ruled out before starting treatment. Effective contraception is required during treatment and for at least 1 week after the last dose.
• Breastfeeding patients: Breastfeeding is not recommended during treatment and for 1 week after the last dose.
• Patients with diabetes: Vijoice can cause significant hyperglycemia. Patients with diabetes or pre-diabetes need closer blood sugar monitoring.
• Children under 2 years: Safety and effectiveness have not been established in this age group.

For detailed side effect information, read our full guide: Vijoice side effects: what to expect and when to call your doctor.

How Much Does Vijoice Cost?

Vijoice is an expensive specialty medication:

• Cash price: Approximately $31,754 per 28-day supply (all strengths priced similarly)
• Generic available: No — there is no generic version of Alpelisib for PROS
• Insurance coverage: Most commercial and Medicaid plans cover Vijoice with prior authorization. Documentation of PIK3CA mutation, severe PROS requiring systemic therapy, and specialist prescribing is typically required.

Financial Assistance Options

• Novartis Oncology Universal Co-Pay Program: Eligible commercially insured patients may pay as little as $0 per prescription, with Novartis covering up to $15,000 per calendar year. Call 1-877-577-7756 or visit Copay.NovartisOncology.com.
• Novartis Patient Assistance Foundation (NPAF): Provides free medication to eligible uninsured or underinsured patients. Call 1-800-277-2254 or visit pap.novartis.com.
• Patient Access Network Foundation (PAN): May offer additional copay assistance.

For a complete breakdown of savings options, see how to save money on Vijoice.

Final Thoughts

Vijoice represents a major advance for patients with severe PROS. As the only FDA-approved systemic treatment for this group of rare overgrowth disorders, it offers a targeted option where previously there were only off-label treatments and surgery. If you think Vijoice might be right for you or your child, start by consulting with a specialist in medical genetics or vascular anomalies—our guide on finding a doctor who can prescribe Vijoice can help.

Need help locating this medication? Medfinder can help you find pharmacies with Vijoice in stock.