FOR HEALTHCARE PROFESSIONALS

About Sandoz® Treprostinil Injection

The first fully substitutable generic for Remodulin® (treprostinil) Injection1,2

Available to treat patients with pulmonary arterial hypertension (PAH; WHO Group 1), Treprostinil Injection offers a known treatment option at a lower price.1,3* Treprostinil Injection is the first FDA-approved generic for Remodulin®.1,2

A therapeutic equivalent for a known molecule2-7

Treprostinil Injection is therapeutically equivalent to Remodulin® 1,3,4,7

•  Same active ingredient
•  Same strengths
•  Same dosage forms

Treprostinil Injection is qualitatively and quantitatively equivalent to Remodulin® 1-4,7

•  Same inactive ingredients
•  Quantitatively the same inactive ingredient amounts

*Sources: AnalySource Online and Red Book Online.

heart and lungs

Therapeutic Equivalence1,3,4

Therapeutic Equivalence Chart

Therapeutic Equivalence: Formulation1,3,4

Therapeutic Equivalence: Formulation Chart

Treprostinil Injection and Remodulin® are both available in strengths of 1, 2.5, 5, and 10 mg/mL.3,4

Each mL also contains 5.3 mg sodium chloride (except for the 10-mg/mL strength, which contains 4.0 mg sodium chloride).3,4


A partnership focused on PAH

Supplied by Sandoz, a division of Novartis

•  A global leader in generics and biosimilar medicines
•  With a supply chain providing trusted quality and supply

Commercial oversight and market support provided by RareGen

•  A team with deep experience in PAH
handshake

References: 1. Data on file, Sandoz Inc. 2. [email protected]: FDA Approved Drug Products. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203649. Accessed October 16, 2018. 3. Treprostinil Injection [package insert]. Princeton, NJ: Sandoz Inc; 2018. 4. Remodulin [package insert]. Research Triangle Park, NC: United Therapeutics Corp; 2018. 5. Orenitram [package insert]. Research Triangle Park, NC: United Therapeutics Corp; 2017. 6. Tyvaso [package insert]. Research Triangle Park, NC: United Therapeutics Corp; 2017. 7. Office of Generic Drugs. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. 38th ed. Rockville, MD: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs; 2018:iv-ADB1. https://www.fda.gov/downloads/drugs/ developmentapprovalprocess/ucm071436.pdf. Accessed October 16, 2018.

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 or renal insufficiency because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic or renal 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 (eg, 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 (≥9% of patients in the treprostinil arm) 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, paresthesias, 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 full Prescribing Information for Treprostinil Injection.

INDICATION

Treprostinil Injection is a prostacyclin vasodilator 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 or renal insufficiency because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic or renal 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 (eg, 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 (≥9% of patients in the treprostinil arm) 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, paresthesias, 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 full Prescribing Information for Treprostinil Injection.