Treprostinil

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• PAH WHO Group 1 in patients with NYHA Class II-IV symptoms:
• Initial dose for patients new to prostacyclin infusion therapy:
• 1.25 ng/kg/min; increase based on clinical response (increments of 1.25 ng/kg/min per week for the first 4 weeks of treatment, later 2.5 ng/kg/min per week).
• Avoid abrupt cessation.
• ( 2.2 , 2.4 ) Mild to moderate hepatic insufficiency:
• Decrease initial dose to 0.625 ng/kg/min.
• Severe hepatic insufficiency: No studies performed.
• ( 2.5 ) Transition from Epoprostenol:
• Increase the Treprostinil Injection dose gradually as the epoprostenol dose is decreased, based on constant observation of response.
• ( 2.7 ) A d m inistration: Continuous subcutaneous infusion is the preferred mode.
• Use intravenous infusion if subcutaneous infusion is not tolerated.
• ( 2.1 , 2.6 )
• 2.1 General Treprostinil Injection can be administered with or without further dilution with Sterile Diluent for Remodulin ® 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 Injection 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 Remodulin ® , Flolan ® , or Epoprostenol 14 days at room temperature 48 hours at 40°C Sterile Water for Injection 0.9% Sodium Chloride 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 or intravenous 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 Injection 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 x 0.000001 mg/ng For administration of Diluted Treprostinil Injection, the concentration is calculated using the following formula:
• Step 1 Diluted Treprostinil Concentration (mg/mL) = Dose (ng/kg/min) x Weight (kg) x
• 0.00006 Infusion Rate (mL/hour) 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 V olume of Treprostinil Injection (mL) = D il uted Treprostinil Concentration (mg/mL) x T otal 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.
• Subcutaneous Infusion Treprostinil Injection is administered subcutaneously by continuous infusion, via a subcutaneous catheter, using an infusion pump designed for subcutaneous drug delivery.
• The infusion pump should:
• (1) be adjustable to approximately 0.002 mL/hour, (2) have occlusion/no delivery, low battery, programming error and motor malfunction alarms, (3) have delivery accuracy of ±6% or better, (4) be positive pressure-driven, and (5) have a reservoir made of polyvinyl chloride, polypropylene or glass.
• Alternatively, use an infusion pump cleared for use with Treprostinil Injection.
• To avoid potential interruptions in drug delivery, the patient must have immediate access to a backup infusion pump and subcutaneous infusion sets.
• Intravenous Infusion External Intravenous Infusion Pump:
• Treprostinil Injection is administered intravenously by continuous infusion via a surgically placed indwelling central venous catheter using an external infusion pump designed for intravenous drug delivery.
• If clinically necessary, a temporary peripheral intravenous cannula, preferably placed in a large vein, may be used for short term administration of Treprostinil Injection.
• Use of a peripheral intravenous infusion for more than a few hours increases the risk of thrombophlebitis.
• The infusion pump used to administer Treprostinil Injection should:
• (1) have occlusion/no delivery, low battery, programming error and motor malfunction alarms, (2) have delivery accuracy of ±6% or better, (3) be positive pressure driven, and (4) have a reservoir made of polyvinyl chloride, polypropylene or glass.
• Alternatively, use an infusion pump cleared for use with Treprostinil Injection.
• To avoid potential interruptions in drug delivery, the patient must have immediate access to a backup infusion pump and infusion sets.
• Infusion sets with an in-line 0.22 or 0.2 micron pore size filter should be used.
• Implantable Intravenous Infusion Pump:
• Use an implantable intravenous infusion pump approved for use with Treprostinil Injection.
• Refer to the pump manufacturer’s manual for specific instructions regarding preparation, programing, implantation, and refilling.
• 2.7 Patients Requiring Transition from Epoprostenol Transition from epoprostenol to Treprostinil Injection is accomplished by initiating the infusion of Treprostinil Injection and increasing it, while simultaneously reducing the dose of intravenous epoprostenol.
• The transition to Treprostinil Injection should take place in a hospital with constant observation of response (e.g., walk distance and signs and symptoms of disease progression).
• Initiate Treprostinil Injection at a recommended dose of 10% of the current epoprostenol dose, and then escalate as the epoprostenol dose is decreased (see Table 2 for recommended dose titrations).
• Patients are individually titrated to a dose that allows transition from epoprostenol therapy to Treprostinil Injection while balancing prostacyclin-limiting adverse events.
• Treat increases in the patient’s symptoms of PAH first with increases in the dose of Treprostinil Injection.
• Treat side effects normally associated with prostacyclin and prostacyclin analogs first by decreasing the dose of epoprostenol.
• Table 2:
• Recommended Transition Dose Changes S tep Epoprostenol Dose Treprostinil Injection D ose 1 Unchanged 10% Starting Epoprostenol Dose 2 80% Starting Epoprostenol Dose 30% Starting Epoprostenol Dose 3 60% Starting Epoprostenol Dose 50% Starting Epoprostenol Dose 4 40% Starting Epoprostenol Dose 70% Starting Epoprostenol Dose 5 20% Starting Epoprostenol Dose 90% Starting Epoprostenol Dose 6 5% Starting Epoprostenol Dose 110% Starting Epoprostenol Dose 7 0 110% Starting Epoprostenol Dose + additional 5% to 10% increments as needed

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness in pediatric patients have not been established. Clinical studies of treprostinil did not include sufficient numbers of patients aged ≤16 years to determine whether they respond differently from older patients.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Clinical studies of treprostinil did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
• In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following adverse reactions are discussed elsewhere in labeling:
• Infections associated with intravenous administration [see Warnings and Precautions ( 5.1 )] .
• Most common adverse reactions (incidence >3%) reported in clinical studies with treprostinil:
• subcutaneous infusion site pain and reaction, headache, diarrhea, nausea, jaw pain, vasodilatation, edema, and hypotension.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• Adverse Events with Subcutaneously Administered Treprostinil Patients receiving treprostinil as a subcutaneous infusion reported a wide range of adverse events, many potentially related to the underlying disease (dyspnea, fatigue, chest pain, right ventricular heart failure, and pallor).
• During clinical trials with subcutaneous infusion of treprostinil, infusion site pain and reaction were the most common adverse events among those treated with treprostinil.
• Infusion site reaction was defined as any local adverse event other than pain or bleeding/bruising at the infusion site and included symptoms such as erythema, induration or rash.
• Infusion site reactions were sometimes severe and could lead to discontinuation of treatment.
• Table 3:
• Percentages of Subjects Reporting Subcutaneous Infusion Site Adverse Events R eaction P a i n P l acebo Treprostinil P l acebo Treprostinil Severe 1 38 2 39 Requiring narcotics a NA b NA b 1 32 Leading to discontinuation 0 3 0 7 a based on prescriptions for narcotics, not actual use b medications used to treat infusion site pain were not distinguished from those used to treat site reactions Other adverse events included 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.
• Adverse Reactions during Chronic Dosing Table 4 lists adverse reactions that occurred at a rate of at least 3% more frequent in patients treated with subcutaneous treprostinil than with placebo in controlled trials in PAH.
• Table 4:
• Adverse Reactions in Controlled 12-Week Studies of Subcutaneous Treprostinil and at least 3% more frequent than on Placebo Ad verse Reaction Treprostinil P l acebo (N=236) (N=233) P e rcent of Patients P e rcent of Patients Infusion Site Pain 85 27 Infusion Site Reaction 83 27 Headache 27 23 Diarrhea 25 16 Nausea 22 18 Rash 14 11 Jaw Pain 13 5 Vasodilatation 11 5 Edema 9 3 Reported adverse reactions (at least 3% more frequent on drug than on placebo) are included with the exception of those too general to be informative, and those not plausibly attributable to the use of the drug, because they were associated with the condition being treated or are very common in the treated population.
• While hypotension occurred in both groups, the event was experienced twice as frequently in the treprostinil group as compared to the placebo group (4% in treprostinil treatment group versus 2% in placebo-controlled group).
• As a potent vasodilator, hypotension is possible with the administration of treprostinil.
• The safety of treprostinil was also studied in a long-term, open-label extension study in which 860 patients were dosed for a mean duration of 1.6 years, with a maximum exposure of 4.6 years.
• Twenty-nine (29%) percent achieved a dose of at least 40 ng/kg/min (max: 290 ng/kg/min).
• The safety profile during this chronic dosing study was similar to that observed in the 12-week placebo-controlled study except for the following suspected adverse drug reactions (occurring in at least 3% of patients):
• anorexia, vomiting, infusion site infection, asthenia, and abdominal pain.
• Ad verse Events Attributable to the Drug Delivery System In controlled studies of treprostinil administered subcutaneously, there were no reports of infection related to the drug delivery system.
• There were 187 infusion system complications reported in 28% of patients (23% treprostinil, 33% placebo); 173 (93%) were pump related and 14 (7%) related to the infusion set.
• Eight of these patients (4 treprostinil, 4 placebo) reported non- serious adverse events resulting from infusion system complications.
• Adverse events resulting from problems with the delivery systems were typically related to either symptoms of excess treprostinil (e.g., nausea) or return of PAH symptoms (e.g., dyspnea).
• These events were generally resolved by correcting the delivery system pump or infusion set problem, such as replacing the syringe or battery, reprogramming the pump, or straightening a crimped infusion line.
• Adverse events resulting from problems with the delivery system did not lead to clinical instability or rapid deterioration.
• In addition to these adverse events due to the drug delivery system during subcutaneous administration, the following adverse events may be attributable to the intravenous mode of infusion including arm swelling, paresthesias, hematoma and pain [see Warnings and Precautions ( 5.1 )].
• 6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following events have been identified during post-approval use of treprostinil.
• Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
• The following events have been chosen for inclusion because of a combination of their seriousness, frequency of reporting, and potential connection to treprostinil.
• These events are thrombophlebitis associated with peripheral intravenous infusion, thrombocytopenia, bone pain, pruritus, dizziness, arthralgia, myalgia/muscle spasm, and pain in extremity.
• In addition, generalized rashes, sometimes macular or papular in nature, and cellulitis have been infrequently reported.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Interruption of Therapy Advise patients and caregivers to seek medical attention if they experience signs or symptoms of abrupt withdrawal of therapy or suspect a pump malfunction [see Warnings and Precautions ( 5.2 )] .
• Overdose Inform patients and their caregivers to seek medical attention if they experience signs or symptoms of Treprostinil Injection overdose [see Overdosage ( 10 )] .
• All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
• Manufactured In Croatia By: Pliva Hrvatska d.o.o.
• Zagreb, Croatia Manufactured For: Teva Pharmaceuticals USA, Inc.
• North Wales, PA 19454 Rev.
• A 5/2022

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS 20 mL vial containing 20 mg treprostinil (1 mg per mL). 20 mL vial containing 50 mg treprostinil (2.5 mg per mL). 20 mL vial containing 100 mg treprostinil (5 mg per mL). 20 mL vial containing 200 mg treprostinil (10 mg per mL).
• Treprostinil Injection is supplied in 20 mL vials containing 20 mg, 50 mg, 100 mg, or 200 mg of treprostinil (1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 mg/mL).
• ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Treprostinil Injection is supplied in 20 mL multidose vials as sterile, clear, colorless to pale yellow solutions in Water for Injection, individually packaged in cartons.
• Unopened vials of Treprostinil Injection are stable until the date indicated when stored at 25°C (77°F), with excursions permitted to 2° to 30°C (36° to 86°F).
• A single vial of Treprostinil Injection should be used for no more than 30 days after the initial introduction into the vial.
• Treprostinil Injection is supplied as:
• 20-mL vial containing 20 mg treprostinil (1 mg treprostinil per mL), carton of 1 (NDC 0703-0666-01). 20-mL vial containing 50 mg treprostinil (2.5 mg treprostinil per mL), carton of 1 (NDC 0703-0676-01). 20-mL vial containing 100 mg treprostinil (5 mg treprostinil per mL), carton of 1 (NDC 0703-0686-01). 20-mL vial containing 200 mg treprostinil (10 mg treprostinil per mL), carton of 1 (NDC 0703-0696-01).
• KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Quoted from the official label, section “How Supplied”.

What is in it

• Treprostinil Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration.
• Treprostinil Injection is supplied in 20 mL multidose vials in four strengths, containing 20 mg, 50 mg, 100 mg, or 200 mg (1 mg/mL, 2.5 mg/mL, 5 mg/mL, or 10 mg/mL) of treprostinil.
• Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL strength which contains 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate, and Water for Injection.
• Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2.
• Treprostinil is chemically stable at room temperature and neutral pH.
• Treprostinil is (1 R ,2 R ,3a S ,9a S )-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]- 1 H -benz[ f ]inden-5-yl]oxy]acetic acid.
• Treprostinil has a molecular weight of 390.52 and a molecular formula of C 23 H 34 O 5 .
• The structural formula of treprostinil is: formula

Quoted from the official label, section “Description”.

Ingredients people check for

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Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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