Treprostinil

TREPROSTINIL- treprostinil injection, solution
Par Pharmaceutical, Inc.

1 INDICATIONS AND USAGE

1.1 Pulmonary Arterial Hypertension

Treprostinil is indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with 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%) [see Clinical Studies (14.1) ].

1.2 Pulmonary Arterial Hypertension in Patients Requiring Transition from Epoprostenol

In patients with PAH requiring transition from epoprostenol, treprostinil is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.

2 DOSAGE AND ADMINISTRATION

2.1 General

Treprostinil Injection can be administered with or without further dilution with Sterile Diluent for Treprostinil or similar approved high-pH glycine diluent (e.g., Sterile Diluent for Flolan or Sterile Diluent for Epoprostenol), Sterile Water for Injection, or 0.9% Sodium Chloride Injection prior to administration. See Table 1 below for storage and administration time limits for the different diluents.

Diluted Treprostinil has been shown to be stable at ambient temperature when stored for up to 14 days using high-pH glycine diluent at concentrations as low as 0.004 mg/mL (4,000 ng/mL).

Table 1. Selection of Diluent
Diluent Storage Limits Administration limits
None See Section 16 16 weeks at 40°C
Sterile Diluents for Treprostinil, Flolan, or Epoprostenol 14 days at room temperature 48 hours at 40°C

Sterile Water for Injection

4 hours at room temperature or 24 hours refrigerated 48 hours at 40°C

2.2 Initial Dose for Patients New to Prostacyclin Infusion Therapy

Treprostinil Injection is indicated for subcutaneous (SC) or intravenous (IV) use only as a continuous infusion. Treprostinil Injection is preferably infused subcutaneously, but can be administered by a central intravenous line if the subcutaneous route is not tolerated because of severe site pain or reaction. The infusion rate is initiated at 1.25 ng/kg/min. If this initial dose cannot be tolerated because of systemic effects, reduce the infusion rate to 0.625 ng/kg/min.

2.3 Initial Dose for Patients Transitioning to an Implantable Intravenous Infusion Pump

The initial dose of Treprostinil should be the same as the current dose the patient is receiving using the external infusion pump at the time of transition.

2.4 Dosage Adjustments

The goal of chronic dosage adjustments is to establish a dose at which PAH symptoms are improved, while minimizing excessive pharmacologic effects of treprostinil injection (headache, nausea, emesis, restlessness, anxiety and infusion site pain or reaction).

The infusion rate should be increased in increments of 1.25 ng/kg/min per week for the first four weeks of treatment and then 2.5 ng/kg/min per week for the remaining duration of infusion, depending on clinical response. Dosage adjustments may be undertaken more often if tolerated. Avoid abrupt cessation of infusion [see Warnings and Precautions (5.2) ]. Restarting a treprostinil injection infusion within a few hours after an interruption can be done using the same dose rate. Interruptions for longer periods may require the dose of treprostinil injection to be re-titrated.

2.5 Patients with Hepatic Insufficiency

In patients with mild or moderate hepatic insufficiency, decrease the initial dose of treprostinil injection to 0.625 ng/kg/min ideal body weight. Treprostinil Injection has not been studied in patients with severe hepatic insufficiency [see Warnings and Precautions (5.3), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].

2.6 Administration

Inspect parenteral drug products for particulate matter and discoloration prior to administration whenever solution and container permit. If either particulate matter or discoloration is noted, do not use.

Preparation

Treprostinil Injection is administered by subcutaneous or intravenous infusion at a calculated rate based on a patient’s dose (ng/kg/min), weight (kg) and the treprostinil injection concentration (mg/mL).

For administration of Undiluted treprostinil injection , the rate is calculated using the following formula:

Undiluted Infusion Rate (mL/hour)

=

Dose (ng/kg/min) x Weight (kg) x 0.00006*

Treprostinil Vial Strength (mg/mL)

* Conversion factor of 0.00006 = 60 min/hour × 0.000001 mg/ng

For administration of Diluted treprostinil , the rate and concentration is calculated using the following formulas:

Step 1

Diluted Treprostinil Concentration

(mg/mL)

=

Dose (ng/kg/min) x weight (kg) x 0.00006

Infusion Rate ( mL/hr)

The volume of treprostinil injection needed to make the required diluted treprostinil concentration for the given reservoir size can then be calculated using the following formula:

Step 2

Volume of Treprostinil Injection

(mL)

=

Diluted Treprostinil Concentration

(mg/mL)

x

Total Volume of Diluted Treprostinil Solution in Reservoir

(mL)

Treprostinil Vial Strength (mg/mL)

The calculated volume of treprostinil injection is then added to the reservoir along with the sufficient volume of diluent to achieve the desired total volume in the reservoir.

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