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RIGEL ONECARE Provides Support to Patients Taking VEPPANU

RIGEL ONECARE is fully trained to support patients prescribed VEPPANU, whether their VEPPANU is fulfilled through integrated, in‑office dispensing or specialty pharmacies

RIGEL ONECARE Programs*

Temporary Drug Supply

  • For insurance coverage delays longer than 5 business days
  • Up to 60 days supply and/or insurance coverage determination
  • Patient must have on-label diagnosis

Patient Support Team

  • Will identify the applicable support resources for patients taking VEPPANU
  • Will provide patients taking VEPPANU with adherence and product education calls that are personalized to their desired frequency

Copay or Coinsurance Assistance

  • Pay as little as $0 per prescription fill
  • Subject to an annual cap
  • Must have commercial insurance (Medicare, Medicaid or other government programs are not eligible for copay assistance through RIGEL ONECARE)
  • Covered by most commercial insurance plans

Patient Assistance Program (PAP)

  • Resides in the United States or a US territory
  • Be treated by a licensed US healthcare provider on an outpatient basis
  • Meet income guidelines

Enroll your patients today

Online Enrollment Enrollment Form (English) Enrollment Form (Spanish)

All RIGEL ONECARE programs are subject to eligibility requirements and changes. Criteria above do not represent all criteria for each program. Must be U.S. resident or U.S. territory resident. Restrictions apply.

You and your patients can choose the fulfillment that works best through Rigel's dedicated pharmacy network

Specialty Pharmacy &
Distributor Guide

With VEPPANU financial assistance, eligible patients pay as little as $0†

The VEPPANU copay assistance program can help eligible patients with commercial insurance pay as little as $0 per prescription fill. Enroll your patients now by answering a few eligibility questions.

Sign up!

Eligible patients, age 18 or older and with a valid prescription, may receive VEPPANU at $0 per prescription fill, if they pay through commercial insurance. Full program criteria are not displayed and can be found at VEPPANUcopay.com.

Resources for your practice

Online Enrollment Enrollment Form (English) Enrollment Form (Spanish)

Enroll patients in RIGEL ONECARE for patient support services including benefits verification, prior authorizations, temporary drug supply, and adherence support

Billing and Coding Guide

Find coding and reimbursement information to support appropriate billing and claims submission for VEPPANU

Distribution Guide

Find information on VEPPANU distribution and pharmacy networks, and patient support services

Visit VEPPANUhcp.com for additional resources

Foundations with financial assistance for your patients

These foundations may be able to provide your patients with additional financial support for their treatment

INDICATION

VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative, estrogen receptor 1 (ESR1)– mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

QTc Interval Prolongation

VEPPANU can cause QT (QTc) interval prolongation. Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to and during treatment with VEPPANU. Perform an ECG prior to initiation of treatment with VEPPANU and do not initiate VEPPANU in patients with QTc >470 msec. Repeat ECG approximately 4 weeks after initiating treatment and as clinically indicated. Avoid concomitant use of VEPPANU with strong CYP3A inhibitors or drugs known to prolong the QTc interval.

Embryo-Fetal Toxicity

Based on findings from animal studies and its mechanism of action, VEPPANU 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 VEPPANU and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with VEPPANU and for 2 weeks after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 9% of patients who received VEPPANU. The serious adverse reactions included any fracture (1.3%), fall, hypercalcemia, hepatic injury, pneumonia, musculoskeletal pain (0.6% each), and QTc prolonged (0.3%). Fatal adverse reactions occurred in 1.0% of patients who received VEPPANU, including dyspnea, cerebral ischemia, and unknown cause (one patient each).

Permanent discontinuation of VEPPANU due to an adverse reaction occurred in 2.9% of patients, dosage interruptions of VEPPANU due to an adverse reaction occurred in 14% of patients, and dosage reductions of VEPPANU due to an adverse reaction occurred in 1.9% of patients.

The most common (≥10%) adverse reactions, including laboratory abnormalities, were decreased white blood cells, increased AST, musculoskeletal pain, fatigue, decreased hemoglobin, decreased neutrophils, increased ALT, increased alkaline phosphatase, nausea, decreased blood potassium, increased bilirubin, decreased appetite, electrocardiogram QT prolonged, decreased platelets, and constipation.

Clinically relevant adverse reactions in <10% of patients who received VEPPANU included headache, hot flush, diarrhea, vomiting, bradycardia, and urinary tract infection.

DRUG INTERACTIONS

  • Strong CYP3A Inhibitors: Avoid concomitant use of VEPPANU with strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce VEPPANU dosage.
  • Strong CYP3A Inducers: Avoid concomitant use with strong CYP3A inducers in patients receiving VEPPANU. If concomitant use cannot be avoided, increase VEPPANU dosage.
  • Certain P-gp Substrates: Avoid concomitant use with certain P-gp substrates where minimal increases in concentration may lead to serious adverse reactions.
  • Certain UGT1A9 Substrates: Refer to the Prescribing Information for UGT1A9 substrates where minimal increases in the concentration may lead to serious adverse reactions.

Avoid concomitant use of VEPPANU with other drugs with a known potential to prolong the QTc interval.

LACTATION

Advise lactating women not to breastfeed during treatment with VEPPANU and for 2 weeks after the last dose.

You may report side effects to the FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

Please see full VEPPANU Prescribing Information.

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Call 1-833-RigelOC (1-833-744-3562) Monday-Friday 8 AM to 8 PM ET to contact RIGEL ONECARE

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative, estrogen receptor 1 (ESR1)– mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

QTc Interval Prolongation

VEPPANU can cause QT (QTc) interval prolongation. Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to and during treatment with VEPPANU. Perform an ECG prior to initiation of treatment with VEPPANU and do not initiate VEPPANU in patients with QTc >470 msec. Repeat ECG approximately 4 weeks after initiating treatment and as clinically indicated. Avoid concomitant use of VEPPANU with strong CYP3A inhibitors or drugs known to prolong the QTc interval.

Embryo-Fetal Toxicity

Based on findings from animal studies and its mechanism of action, VEPPANU 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 VEPPANU and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with VEPPANU and for 2 weeks after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 9% of patients who received VEPPANU. The serious adverse reactions included any fracture (1.3%), fall, hypercalcemia, hepatic injury, pneumonia, musculoskeletal pain (0.6% each), and QTc prolonged (0.3%). Fatal adverse reactions occurred in 1.0% of patients who received VEPPANU, including dyspnea, cerebral ischemia, and unknown cause (one patient each).

Permanent discontinuation of VEPPANU due to an adverse reaction occurred in 2.9% of patients, dosage interruptions of VEPPANU due to an adverse reaction occurred in 14% of patients, and dosage reductions of VEPPANU due to an adverse reaction occurred in 1.9% of patients.

The most common (≥10%) adverse reactions, including laboratory abnormalities, were decreased white blood cells, increased AST, musculoskeletal pain, fatigue, decreased hemoglobin, decreased neutrophils, increased ALT, increased alkaline phosphatase, nausea, decreased blood potassium, increased bilirubin, decreased appetite, electrocardiogram QT prolonged, decreased platelets, and constipation.

Clinically relevant adverse reactions in <10% of patients who received VEPPANU included headache, hot flush, diarrhea, vomiting, bradycardia, and urinary tract infection.

DRUG INTERACTIONS

  • Strong CYP3A Inhibitors: Avoid concomitant use of VEPPANU with strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce VEPPANU dosage.
  • Strong CYP3A Inducers: Avoid concomitant use with strong CYP3A inducers in patients receiving VEPPANU. If concomitant use cannot be avoided, increase VEPPANU dosage.
  • Certain P-gp Substrates: Avoid concomitant use with certain P-gp substrates where minimal increases in concentration may lead to serious adverse reactions.
  • Certain UGT1A9 Substrates: Refer to the Prescribing Information for UGT1A9 substrates where minimal increases in the concentration may lead to serious adverse reactions.

Avoid concomitant use of VEPPANU with other drugs with a known potential to prolong the QTc interval.

LACTATION

Advise lactating women not to breastfeed during treatment with VEPPANU and for 2 weeks after the last dose.

You may report side effects to the FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

Please see full VEPPANU Prescribing Information.