FOR HEALTHCARE PROFESSIONALS

Getting Started

A specialty pharmacy service provider you know and trust

You and your patients will be in familiar and capable hands with access to a specialty pharmacy (SP) provider with years of experience servicing patients who have been prescribed Remodulin® (treprostinil) Injection.

The SP that supplies Sandoz Treprostinil Injection can provide

•  A familiar and established pulmonary arterial hypertension (PAH) care team
•  Support for generic substitution in accordance with applicable law and prescriber’s instructions
•  Benefits investigation research to help patients understand their insurance and out-of-pocket costs
•  Consultations to support medication initiation and titration, and injection site management and care

Your patients can receive support through

•  In-home training on the safe and effective use of Treprostinil Injection and associated pumps and supplies
•  Ongoing clinical counseling and education from licensed pharmacists and nurses

Accredo Health Group, Inc.

Phone 1-866-344-4874

Fax 1-800-711-3526

Your patients can receive support through

•  In-home training on the safe and effective use of Treprostinil Injection and associated pumps and supplies
•  Ongoing clinical counseling and education from licensed pharmacists and nurses

Financial assistance for your patients

Treprostinil Injection co-payment assistance may be available for patients who qualify.* Your patients may pay as little as $0 per prescription filled for Treprostinil Injection.

about how to help your patients receive co-payment support or financial assistance that may be available.

Sample Treprostinil Injection co-pay savings card

*Sandoz Treprostinil Injection Savings Program Eligibility

The Sandoz Treprostinil Injection Savings Program provides annual support for patient cost-sharing for prescriptions filled with Sandoz Treprostinil Injection. Your commercially insured patients may pay a co-pay as low as $0 out-of-pocket per Treprostinil Injection prescription filled. Your patient pays the first co-pay for their Treprostinil Injection and Sandoz will pay the balance of their cost-sharing. This program is not health insurance. This program is for commercially-insured patients only; uninsured cash-paying patients are not eligible. Patients are not eligible if prescriptions are paid, in whole or in part, by any state or federally funded programs, including but not limited to Medicare (including Part D, even in the coverage gap) or Medicaid, Medigap, VA, DOD, or TriCare, or private indemnity, or HMO insurance plans that reimburse your patient for the entire cost of their prescription drugs, or where prohibited by law. Card may not be combined with any other rebate, coupon, or offer. Card has no cash value. Sandoz reserves the right to rescind, revoke, or amend this offer without further notice.


Get started with Treprostinil Injection

Completing the referral for Treprostinil Injection is a straightforward process.

Simply collect the necessary clinical information, complete the referral form, and fax the form and supporting documentation to your selected SP. Download the referral form, or talk with your sales representative.


Remind your patients to answer the phone at initiation and throughout treatment.

Delays can occur if the SP has trouble reaching the patient.


IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

•  Chronic intravenous (IV) infusions delivered using an external infusion pump with an indwelling central venous catheter are associated with the risk of bloodstream infections (BSIs) and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion is the preferred mode of administration.
•  Do not abruptly lower the dose or withdraw dosing.
•  Treprostinil injection may cause symptomatic hypotension.
•  Titrate slowly in patients with hepatic insufficiency because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic function.
•  Treprostinil injection inhibits platelet aggregation and increases the risk of bleeding.

ADVERSE REACTIONS

During clinical trials with SC infusion of treprostinil, infusion site pain and infusion site reaction (e.g., erythema, induration, or rash) were the most common adverse events and occurred in majority of those treated with treprostinil. Infusion site reactions were sometimes severe and led to discontinuation of treatment. Rash and hypotension (14% and 4%, respectively) were also commonly reported with SC infusion of treprostinil. Other common adverse events (≥3% more than placebo) included headache, diarrhea, jaw pain, edema, vasodilatation, and nausea, and these are generally considered to be related to the pharmacologic effects of treprostinil, whether administered subcutaneously or intravenously. The adverse reactions reported with treprostinil IV included bloodstream infections, arm swelling, paresthesia, hematoma, and pain.

DRUG INTERACTIONS

Treprostinil injection dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn.

USE IN SPECIFIC POPULATIONS

•  Safety and effectiveness of Treprostinil injection in pediatric patients have not been established.
•  It is unknown if geriatric patients respond differently than younger patients. Caution should be used when selecting a dose for geriatric patients.
•  There are no adequate and well-controlled studies with Treprostinil injection in pregnant women.
•  It is not known whether Treprostinil injection is excreted in human milk.

Please see accompanying full for additional safety information.

INDICATION

Treprostinil injection is a prostacyclin mimetic indicated for

•  Treatment of pulmonary arterial hypertension (PAH), World Health Organization (WHO) Group 1 to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with New York Heart Association (NYHA) Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).
•  Patients who require transition from epoprostenol to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

•  Chronic intravenous (IV) infusions delivered using an external infusion pump with an indwelling central venous catheter are associated with the risk of bloodstream infections (BSIs) and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion is the preferred mode of administration.
•  Do not abruptly lower the dose or withdraw dosing.
•  Treprostinil injection may cause symptomatic hypotension.
•  Titrate slowly in patients with hepatic insufficiency because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic function.
•  Treprostinil injection inhibits platelet aggregation and increases the risk of bleeding.

ADVERSE REACTIONS

During clinical trials with SC infusion of treprostinil, infusion site pain and infusion site reaction (e.g., erythema, induration, or rash) were the most common adverse events and occurred in majority of those treated with treprostinil. Infusion site reactions were sometimes severe and led to discontinuation of treatment. Rash and hypotension (14% and 4%, respectively) were also commonly reported with SC infusion of treprostinil. Other common adverse events (≥3% more than placebo) included headache, diarrhea, jaw pain, edema, vasodilatation, and nausea, and these are generally considered to be related to the pharmacologic effects of treprostinil, whether administered subcutaneously or intravenously. The adverse reactions reported with treprostinil IV included bloodstream infections, arm swelling, paresthesia, hematoma, and pain.

DRUG INTERACTIONS

Treprostinil injection dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn.

USE IN SPECIFIC POPULATIONS

•  Safety and effectiveness of Treprostinil injection in pediatric patients have not been established.
•  It is unknown if geriatric patients respond differently than younger patients. Caution should be used when selecting a dose for geriatric patients.
•  There are no adequate and well-controlled studies with Treprostinil injection in pregnant women.
•  It is not known whether Treprostinil injection is excreted in human milk.

Please see accompanying full for additional safety information.

INDICATION

Treprostinil injection is a prostacyclin mimetic indicated for

•  Treatment of pulmonary arterial hypertension (PAH), World Health Organization (WHO) Group 1 to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with New York Heart Association (NYHA) Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).
•  Patients who require transition from epoprostenol to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition.