For U.S. Healthcare Professionals Only

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FOR U.S. HEALTHCARE PROFESSIONALS ONLY

IPSEN CARES PATIENT SUPPORT PROGRAM OFFERINGS

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Resources to support your patients' access to TAZVERIK®

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Patient Assistance Program (PAP)

Patients may be eligible to receive a limited supply of free medication if they are uninsured or underinsured (based on program eligibility criteria).

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Bridge Supply Program

Helping existing commercial patients access medication should they experience change or delay in drug coverage.

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Patient Assistance Program (PAP)

Patients may be eligible to receive a limited supply of free medication if they are uninsured or underinsured (based on program eligibility criteria).

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Quick Start Program

New commercial patients may be eligible to receive a limited supply of free medication.

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Quick Start Program

New commercial patients may be eligible to receive a limited supply of free medication.

copay assistance program

Co-Pay Assistance Program

Patients with commercial health insurance may be eligible to receive co-payment assistance from Ipsen to help reduce out-of-pocket costs for TAZVERIK®*

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Bridge Supply Program

Helping existing commercial patients access medication should they experience change or delay in drug coverage.

copay assistance program

Co-Pay Assistance Program

Patients with commercial health insurance may be eligible to receive co-payment assistance from Ipsen to help reduce out-of-pocket costs for TAZVERIK®*

Are you a healthcare professional or pharmacy looking to enroll your patient in the Ipsen Cares Co-Pay Assistance Program?

Your commercially-insured patients may be eligible to receive co-pay assistance. Note that only patients’ prescribers and specialty pharmacies can register patients for this program.

FOR HEALTHCARE PROFESSIONALS ONLY

Note: All patient support is subject to eligibility criteria and program terms and conditions.

*This offer is not valid for cash-paying patients or patients currently enrolled in Medicare, Medicaid, or any other federal or state or healthcare program. Limitations apply. Void where prohibited.

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If you are interested in learning more about any of the support offerings mentioned, including eligibility requirements, visit ipsencares.com or contact Ipsen Cares at 1-866-435-5677, Monday through Friday (8 AM – 8 PM ET).

See the dosing schedule for patients

taking TAZVERIK.

DOSING & ADMINISTRATION

Find helpful materials to download

about TAZVERIK.

RESOURCES

IMPORTANT SAFETY INFORMATION AND INDICATION

Warnings and Precautions

  • Secondary Malignancies

The risk of developing secondary malignancies is increased following treatment with TAZVERIK. Across clinical trials of 758 adults who received TAZVERIK 800 mg twice daily as monotherapy, myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or B-cell acute lymphoblastic leukemia (B-ALL) occurred in 1.7% of patients. One pediatric patient developed T-cell lymphoblastic lymphoma (T-LBL). Monitor patients long-term for the development of secondary malignancies.

  • Embryo-Fetal Toxicity

Based on findings from animal studies and its mechanism of action, TAZVERIK can cause fetal harm when administered to pregnant women. There are no available data on TAZVERIK use in pregnant women to inform the drug-associated risk. Administration of tazemetostat to pregnant rats and rabbits during organogenesis resulted in dose-dependent increases in skeletal developmental abnormalities in both species beginning at maternal exposures approximately 1.5 times the adult human exposure (area under the plasma concentration time curve [AUC0‑45h]) at the 800 mg twice daily dose.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAZVERIK and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TAZVERIK and for 3 months after the final dose.

Adverse Reactions

In 62 clinical study patients with epithelioid sarcoma receiving TAZVERIK 800 mg twice daily: Serious adverse reactions occurred in 37% of patients who received TAZVERIK. Serious adverse reactions occurring in ≥3% were hemorrhage, pleural effusion, skin infection, dyspnea, pain, and respiratory distress. The most common (≥20%) adverse reactions were pain (52%), fatigue (47%), nausea (36%), decreased appetite (26%), vomiting (24%), and constipation (21%).

Drug Interactions

Avoid coadministration of strong or moderate CYP3A inhibitors with TAZVERIK. If coadministration of moderate CYP3A inhibitors cannot be avoided, reduce TAZVERIK dose.

Avoid coadministration of moderate and strong CYP3A inducers with TAZVERIK, which may decrease the efficacy of TAZVERIK.

Coadministration of TAZVERIK with CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and reduced efficacy of CYP3A substrates.

Lactation

Because of the potential risk for serious adverse reactions from TAZVERIK in the breastfed child, advise women not to breastfeed during treatment with TAZVERIK and for one week after the final dose.

To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATION

TAZVERIK is indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

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

Please see full Prescribing Information.