Treprostinil (injection): Difference between revisions

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{{Drugbox|
{{DrugProjectFormSinglePage
|IUPAC_name = (1''R'',2''R'',3a''S'',9a''S'')-<nowiki>[[</nowiki>2,3,3a,4,9,9a-hexahydro-2-hydroxy-<br>1-[(3''S'')-3-hydroxyoctyl]-1''H''-benz[f]inden-5-yl]<br>oxy]acetic acid monosodium salt
|authorTag=
| image = Treprostinil_svg.png<!--image is free base, while drugbox data refers to sodium salt-->
 
| CAS_number=
 
| ATC_prefix=B01
 
| ATC_suffix=AC21
<!--Overview-->
| PubChem=130880
 
| DrugBank=
|genericName=
| C = 23 | H = 33 | Na = 1 | O = 5
 
| molecular_weight = relative molecular weight is 412.49 g/mol.
 
| bioavailability= approximately 100%
 
| metabolism = Treprostinil is substantially metabolized by the [[liver]], but the involved enzymes are not currently known. Five metabolites (HU1 through HU5) have been identified thus far.
|aOrAn=
| elimination_half-life= 4 hours
 
| Clearance =
a
| pregnancy_category = B
 
| routes_of_administration=[[Subcutis|Subcutaneous]] or [[intravenous therapy|intravenous infusion]]
|drugClass=
| excretion = Urine (4% as unchanged drug, 64% as metabolites); feces (13%)
 
| legal_status = ?
 
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<!--FDA-Labeled Indications and Dosage (Pediatric)-->
 
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* Intravenous
 
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* Description
 
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====Signs and Symptoms====
 
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: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
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<!--Precautions with Alcohol-->


==Overview==
|alcohol=
'''Treprostinil''' is a synthetic analogue of [[prostacyclin]], used to treat [[pulmonary hypertension]]. Treprostinil is marketed as '''Remodulin®'''.


==Clinical pharmacology==
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
As an analogue of prostacyclin PGI<sub>2</sub>, treprostinil effects [[vasodilation]], which in turn lowers the [[blood pressure]]. Treprostinil also inhibits [[platelet]] aggregation, though the role this phenomenon may play in relation to pulmonary hypertension has yet to be determined.


==Dosage and administration==
<!--Brand Names-->
Treprostinil is administered via a small [[infusion pump]] that the patient must wear at all times. Treprostinil is preferentially given [[Subcutis|subcutaneously]] using an [[infusion set]], but may be given [[Intravenous therapy|intravenously]] via a [[central venous catheter]] if the patient is unable to tolerate the potential pain and discomfort of subcutaneous administration.


Treprostinil, under the trademark Remodulin&reg;, is supplied in 20 mL vials, ranging in concentrations of 1 mg/mL, 2.5 mg/mL, 5 mg/mL, and 10 mg/mL. Treprostinil can be administered subcutaneously as supplied. It must be diluted for intravenous infusion with either sterile water or a 0.9% [[Saline (medicine)|sodium chloride solution]] prior to administration.
|brandNames=


The infusion rate is normally initiated at 1.25 ng/kg/min for new patients, but may be reduced to 0.625 ng/kg/min if the normal rate provokes unwanted side effects in the patient. The infusion rate of trepostinil should be increased no more than 1.25 ng/kg/min per week for the first month, then no more than 2.5 ng/kg/min per week for the remaining duration of infusion. The infusion rate should ideally be high enough to improve symptoms of pulmonary hypertension, while minimizing unpleasant side effects.
* ®<ref>{{Cite web | title =  | url =  }}</ref>


Oral and inhaled forms of treprostinil are currently undergoing [[clinical trial]]s.
<!--Look-Alike Drug Names-->


==Important safety information==
|lookAlike=
<!--Contraindications:-->
Precautions:


* Since treprostinil is a [[vasodilator]], its antihypertensive effect may be compounded by other medications that affect the blood pressure, including [[calcium channel blockers]], [[diuretics]], and other vasodilating agents.
* A® — B®<ref name="www.ismp.org">{{Cite web | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>


* Because of treprostinil's inhibiting effect on platelet aggregation, there is an increased risk of bleeding, especially among patients who are also taking [[anticoagulant]]s.
<!--Drug Shortage Status-->


* It is not known whether treprostinil is excreted in breast milk. Caution is advised when administering this medication to nursing women.
|drugShortage=
}}


* Caution is advised when administering treprostinil to patients who have [[renal failure|impaired kidney]] or [[liver failure|liver function]].
<!--Pill Image-->


Common side effects:
{{PillImage
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
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* 85% of patients report pain or other reaction at the infusion site. Other side effects may include [[headache]], diarrhea, nausea, rash, jaw pain, [[vasodilator|vasodilatation]], [[dizziness]], [[edema]] (swelling), [[pruritus]] (itching), and [[hypotension]].
<!--Label Display Image-->


<!--Serious [[adverse drug reaction]]s have been reported, including:-->
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


Warnings:
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


* Abrupt interruption of the treprostinil infusion can lead to worsening of pulmonary hypertension symptoms, and should be avoided.
<!--Category-->


{{Antithrombotics}}
[[Category:Cardiovascular Drugs]]
{{PAH rx}}
[[Category:Drug]]
{{Prostaglandins}}


[[Category:Prostaglandins]]
[[Category:Prostaglandins]]

Revision as of 18:13, 27 July 2014

Treprostinil (injection)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

Disclaimer

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Treprostinil (injection) is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Treprostinil (injection) in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Treprostinil (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Treprostinil (injection) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Treprostinil (injection) in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Treprostinil (injection) in pediatric patients.

Contraindications

  • Condition1

Warnings

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Treprostinil (injection) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Treprostinil (injection) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Treprostinil (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Treprostinil (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Treprostinil (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Treprostinil (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Treprostinil (injection) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Treprostinil (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Treprostinil (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Treprostinil (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Treprostinil (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Treprostinil (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Treprostinil (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Treprostinil (injection) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Treprostinil (injection) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Treprostinil (injection) in the drug label.

Pharmacology

There is limited information regarding Treprostinil (injection) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Treprostinil (injection)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Treprostinil (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Treprostinil (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Treprostinil (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Treprostinil (injection) in the drug label.

How Supplied

Storage

There is limited information regarding Treprostinil (injection) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Treprostinil (injection) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Treprostinil (injection) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Treprostinil (injection) in the drug label.

Precautions with Alcohol

  • Alcohol-Treprostinil (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)


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