TRYVIO PATIENT SUPPORT TERMS & CONDITIONS
Free trial terms and conditions
This offer is not contingent on a purchase of any kind. The free trial may be redeemed for a single, one-time-only, 30-day supply (maximum 30 tablets) of TRYVIO. Patients must be new to TRYVIO and must not have previously filled a prescription for TRYVIO. A patient must be under the care of a licensed US physician. Patients must have a valid prescription(s) for TRYVIO. This offer may be used by cash-paying patients, patients with commercial insurance, and patients who are eligible for or participate in federal healthcare programs such as Medicaid, Medicare, or any similar federal or state programs only when patients, pharmacists, and prescribers agree not to seek reimbursement from health insurance, health savings or flexible spending accounts, or any third party, including state or federally funded programs for the free trial of TRYVIO received by the patient through this offer. Patients eligible for the free trial may not count the free trial as an expense incurred for determining out-of-pocket costs for any plan, including true out-of-pocket costs (“TrOOP”), under Medicare Part D. This offer is limited to one per patient and is nontransferable. This free trial offer cannot be combined with any other free trial, coupon, discount, prescription savings card or other offer. No substitutions are permitted. This offer is not health insurance, nor is it provided for the purpose of financial assistance. This offer is restricted to residents of the United States. Void where prohibited by law, taxed or restricted. Not valid in California or Massachusetts, if an AB-rated generic equivalent becomes available for the product. This offer may be changed or discontinued at any time without notice. Patients are responsible for applicable taxes, if any. By redeeming this free trial voucher, you acknowledge that you are an eligible patient and that you understand and agree to comply with the terms and conditions of this offer.
Tryvio savings card terms of use and restrictions
Eligibility Requirements: Patients may be eligible if: (1) the patient is insured by commercial insurance and their prescription insurance coverage does not cover the full cost of the prescription; (2) patient does not have prescription insurance coverages through a state or federal healthcare program, including but not limited to Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), or Department of Defense (DOD) programs; patients who move from commercial insurance plans to state or federal healthcare programs will no longer be eligible; (3) patient is 18 years of age or older; (4) patient is a resident of the United States.
Terms of Use: Eligible commercially insured patients with a valid prescription for TRYVIO (aprocitentan) 12.5 mg who present this savings card at participating pharmacies may pay as little as $10 for a 30-day supply. Maximum savings limit applies; patient out-of-pocket expenses may vary. The patient is responsible for applicable taxes—void where prohibited by law, taxed, or restricted. Other restrictions may apply. Patients, pharmacists, and prescribers cannot seek reimbursement from health insurance or any third party for any part of the benefit received by the patient through this offer. All copay payments are for the benefit of the patient only. Idorsia reserves the right to rescind, revoke, or amend this offer, eligibility, and terms of use at any time without notice. Must present offer along with a valid prescription at the time of purchase.
Restrictions: This offer is not valid for cash-paying patients. This offer is nontransferable, no substitutions are permissible, and the offer cannot be applied with any other financial assistance program, free trial, discount, prescription savings card, or other offers. The savings card for TRYVIO is not health insurance. The savings card may not be sold, purchased, or traded. ConnectiveRx manages this program on behalf of Idorsia.
For Healthcare Professionals Only: Pharmacist Instructions for a Patient with an Eligible Third Party: For Insured/Covered Patients: Submit the claim to the primary Third-Party Payer first, then submit the balance due to SS&C as a Secondary Payer COB with patient responsibility amount and a valid Other Coverage Code of 08. Patient pays $10 for a 30-day supply. The pharmacist will receive reimbursement from SS&C.
For any questions regarding SS&C online processing, please call the Help Desk at 844-373-0987.
IMPORTANT SAFETY INFORMATION & INDICATION
- TRYVIO is contraindicated for use during pregnancy because it may cause fetal harm if used by pregnant patients. Therefore in patients who can become pregnant, exclude pregnancy prior to initiation of TRYVIO.
- Advise use of effective contraception before the start of TRYVIO, during treatment and for one month after stopping treatment.
- When pregnancy is detected, discontinue TRYVIO as soon as possible.
CONTRAINDICATIONS
TRYVIO is contraindicated:
- in patients who are pregnant.
- in patients who are hypersensitive to aprocitentan or any of its excipients.
WARNINGS AND PRECAUTIONS
Embryo-Fatal Toxicity
Based on data from animal reproduction studies with endothelin receptor antagonists (ERAs), TRYVIO may cause fetal harm when administered during pregnancy and is contraindicated for use in patients who are pregnant. The available human data for endothelin receptor antagonists do not establish the presence or absence of fetal harm related to the use of TRYVIO. Counsel patients who can become pregnant about the potential risk to a fetus. Obtain a pregnancy test prior to initiation of treatment with TRYVIO. Advise patients who can become pregnant to use effective contraception during treatment, and for one month after the final dose of TRYVIO. When pregnancy is detected, discontinue TRYVIO as soon as possible.
Hepatotoxicity
Elevations of aminotransferases and hepatotoxicity are known effects of ERAs, including TRYVIO. Elevations in alanine transaminase (ALT) or aspartate aminotransferase (AST) of greater than 5-fold upper limit of normal (ULN) were observed rarely in patients treated with aprocitentan in the clinical trial, including cases with positive rechallenge. To reduce the risk of potential serious hepatotoxicity, measure serum aminotransferase levels and total bilirubin prior to initiation of treatment and repeat during treatment periodically and as clinically indicated.
Do not initiate TRYVIO in patients with elevated aminotransferases (>3 × ULN) or moderate to severe hepatic impairment. Advise patients with symptoms suggesting hepatotoxicity (nausea, vomiting, right upper quadrant pain, fatigue, anorexia, scleral icterus, jaundice, dark urine, fever, or itching) to immediately stop treatment with TRYVIO and seek medical attention.
If sustained, unexplained, clinically relevant aminotransferase elevations occur, or if elevations are accompanied by an increase in bilirubin >2 × ULN, or if clinical symptoms of hepatotoxicity occur, discontinue TRYVIO.
Fluid Retention
Fluid retention and peripheral edema are known effects of ERAs, including TRYVIO. Edema/fluid retention was reported in 9% of TRYVIO-treated patients compared with 18% of patients receiving aprocitentan 25 mg (twice the recommended dose) and 2% on placebo in the clinical trial, requiring additional diuretic use in some patients. Older age and chronic kidney disease are risk factors for edema/fluid retention with TRYVIO. TRYVIO has not been studied in patients with heart failure New York Heart Association stage III–IV, unstable cardiac function, or with NTproBNP ≥500 pg/mL. TRYVIO is not recommended in these patients.
Monitor for signs and symptoms of fluid retention, weight gain, and worsening heart failure. If clinically significant fluid retention develops, treat appropriately, and consider discontinuation of TRYVIO.
Hemoglobin Decrease
Decreases in hemoglobin concentration and hematocrit have occurred following administration of other ERAs and were observed in the clinical trial with TRYVIO. Hemoglobin decreases usually presented early, stabilized thereafter, and were reversible after discontinuation. A decrease in hemoglobin of >2 g/dL from baseline was observed in 7% of patients compared to 1% of placebo patients. A decrease to below 10.0 g/dL was observed in 3% of TRYVIO-treated patients compared to 0 patients taking placebo. Initiation of TRYVIO is not recommended in patients with severe anemia. Measure hemoglobin prior to initiation of treatment and periodically during treatment as clinically indicated.
Decreased Sperm Counts
TRYVIO, like other ERAs, may have an adverse effect on spermatogenesis. Counsel men about potential effects on fertility.
MOST COMMON ADVERSE REACTIONS
The most common adverse reactions (more frequent than placebo and ≥ 2% in TRYVIO-treated patients) are edema/fluid retention and anemia.
USE IN SPECIFIC POPULATIONS
Lactation
There are no data on the presence of aprocitentan in human milk, the effects on the breastfed infant, or the effect on milk production. Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with TRYVIO.
Renal Impairment
TRYVIO is not recommended in patients with kidney failure (eGFR <15 mL/min) or on dialysis. Patients with renal impairment are at increased risk of edema/fluid retention.
Hepatic Impairment
TRYVIO is not recommended in patients with moderate and severe hepatic impairment (Child-Pugh class B and C) because these patients may be at increased risk for poor outcomes from hepatotoxicity.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information including BOXED Warning and Medication Guide.
INDICATION
TRYVIO is an endothelin receptor antagonist indicated for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Lowering blood pressure reduces the risk of fatal and non fatal cardiovascular events, primarily strokes and myocardial infarctions.