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Orenitram (treprostinil) dilates (widens) the arteries and decreases the amount of blood clotting platelets in your body. These effects lower blood pressure in the pulmonary artery that leads from the heart to the lungs.
Orenitram is used to treat pulmonary arterial hypertension (PAH). This medicine improves your ability to exercise.
Orenitram may also be used for purposes not listed in this medication guide.
You should not use Orenitram if you have severe liver disease.
You should not use Orenitram if you are allergic to treprostinil, or if you have severe liver disease.
To make sure Orenitram is safe for you, tell your doctor if you have:
diverticulosis (an intestinal disorder); or
liver disease.
It is not known whether Orenitram will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
It is not known whether treprostinil passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
Take Orenitram exactly as prescribed by your doctor. Follow Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Do not crush, chew, or break an extended-release tablet. Swallow the tablet whole. Do not use a broken tablet.
Take with food.
Take your doses at regular intervals to keep a steady amount of the drug in your body at all times.
You should not reduce your dose or stop using Orenitram suddenly. Stopping suddenly may make your condition worse.
Tell your doctor if you need to stop taking Orenitram for any reason. You may need an alternate treatment during that time.
Orenitram is made with a shell that is not absorbed or melted in the body. Part of the tablet shell may appear in your stool. This is a normal side effect of Orenitram and will not make the medication less effective.
Call your doctor if you have new or worsening PAH symptoms such as feeling short of breath (even with mild exertion), tiredness, chest pain, and pale skin.
Use Orenitram regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You will probably have to use this medicine for several months or years to control your condition and keep it from getting worse.
Store at room temperature away from moisture and heat.
Usual Adult Dose of Orenitram for Pulmonary Hypertension:
Oral formulation:
Initial dose: 0.25 mg orally every 12 hours with food
Recommended titration: 0.25 or 0.5 mg 2 times daily every 3 to 4 days (if 0.25 mg 2 times daily increments are not tolerated consider titrating slower)
-The total daily dose can be divided and given every 8 hours with food, titrating by increments of 0.125 mg 3 times daily.
Mean dose: 3.5 mg orally every 12 hours with food.
Maximum dose: Determined by tolerability. The maximum dose studied was 21 mg orally every 12 hours with food.
Infusion:
Initial dose: 1.25 nanogram/kg per minute by continuous infusion. The subcutaneous route is preferred but the drug may be administered by a central intravenous line if the subcutaneous route is not tolerated. The rate may be decreased to 0.625 nanogram/kg/minute if the initial dose is not tolerated by the patient.
Maintenance dose: The infusion rate may be increased in increments of no more than 1.25 nanogram/kg/minute per week for the first 4 weeks, and thereafter by no more than 2.5 nanograms/kg/minute per week. Dosage adjustments should be titrated to a dose where PAH symptoms are improved and adverse effects are minimized (headache, nausea, emesis, restlessness, anxiety, and infusion site pain or reaction). Although doses of up to 100 nanograms/kg/minute have been reported, there is little experience with doses greater than 40 nanograms/kg/minute.
Inhalation:
Use only with the Tyvaso (R) Inhalation System. Administer undiluted, as supplied. A single breath of Tyvaso (R) delivers approximately 6 mcg of Orenitram
Initial dosage: 3 breaths [18 mcg] per treatment session. If 3 breaths are not tolerated, reduce to 1 or 2 breaths. Administer in 4 separate treatment sessions each day approximately four hours apart, during waking hours.
Maintenance dose: Dosage should be increased by an additional 3 breaths at approximately 1-2 week intervals, if tolerated. Titrate to target maintenance dosage of 9 breaths or 54 mcg per treatment session as tolerated.
Usual Pediatric Dose of Orenitram for Pulmonary Hypertension:
Oral formulation: Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Inhalation:
Less than 16 years: Safety and efficacy have not been established.
16 to 18 years:
Initial dose: 1.25 nanogram/kg per minute by continuous infusion. The subcutaneous route is preferred but the drug may be administered by a central intravenous line if the subcutaneous route is not tolerated. The rate may be decreased to 0.625 nanogram/kg/minute if the initial dose is not tolerated by the patient.
Maintenance dose: The infusion rate may be increased in increments of no more than 1.25 nanogram/kg/minute per week for the first 4 weeks, and thereafter by no more than 2.5 nanograms/kg/minute per week. Dosage adjustments should be titrated to a dose where PAH symptoms are improved and adverse effects are minimized (headache, nausea, emesis, restlessness, anxiety, and infusion site pain or reaction). There is little experience with doses greater than 40 nanograms/kg/minute.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Call your doctor if you miss 2 or more doses of Orenitram.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Do not drink alcohol. Alcohol can cause the tablet to release treprostinil too quickly.
Get emergency medical help if you have any signs of an allergic reaction to Orenitram: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
severe headache;
vomiting; or
a light-headed feeling, like you might pass out.
Common Orenitram side effects may include:
headache;
pain in your arms or legs;
diarrhea, nausea; or
flushing (warmth, redness, or tingly feeling).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all your current medicines and any you start or stop using, especially:
gemfibrozil;
blood pressure medication;
a blood thinner - warfarin, Coumadin, Jantoven;
other medicine to prevent blood clots - dalteparin, tinzaparin, Fragmin, Lovenox, and others; or
other forms of treprostinil - Remodulin, Tyvaso.
This list is not complete. Other drugs may interact with treprostinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Orenitram (www.drugs.com/orenitram.html).
Note: This document contains side effect information about treprostinil. Some of the dosage forms listed on this page may not apply to the brand name Orenitram.
For the ConsumerApplies to treprostinil: oral tablet extended release
Other dosage forms:
Along with its needed effects, treprostinil (the active ingredient contained in Orenitram) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking treprostinil:
More common
Get emergency help immediately if any of the following symptoms of overdose occur while taking treprostinil:
Symptoms of overdose
Some side effects of treprostinil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
For Healthcare Professionals
Applies to treprostinil: inhalation solution, injectable solution, oral tablet extended release
GeneralOral tablets: The most frequently reported side effects were headache, diarrhea, nausea, and flushing.
Oral inhalation: The most frequently reported side effects were cough, headache, diarrhea, nausea, dizziness, throat irritation, pharyngolaryngeal pain, and flushing.
Parenteral: The most frequently reported side effects were subcutaneous infusion site pain and reaction, headache, diarrhea, nausea, jaw pain, vasodilation, edema, and hypotension.
LocalVery common (10% or more): Infusion site pain (up to 85%), infusion site reaction (up to 83%), Infusion site bleeding/bruising (33.5%)
Frequency not reported: Induration, erythema, infusion site infection
Postmarketing reports: Subcutaneous infusion site abscess
GastrointestinalVery common (10% or more): Diarrhea (up to 30%), nausea (up to 30%)
Common (1% to 10%): Abdominal discomfort, rectal hemorrhage, melena, vomiting, abdominal pain, dyspepsia
Frequency not reported: Gastrointestinal bleeding
Nervous systemVery common (10% or more): Headache (up to 63%)
Common (1% to 10%): Syncope, paresthesia, dizziness
CardiovascularVery common (10% or more): Flushing (15%), vasodilation (up to 11%)
Common (1% to 10%): Hypotension, tachycardia, palpitation, hypertension, heart failure, bradycardia, hemorrhage
Frequency not reported: Systemic blood pressure decreased, pallor, right ventricular heart failure, supraventricular tachycardia, hematoma
Postmarketing reports: Thrombophlebitis
DermatologicVery common (10% or more): Rash (up to 83.1%), pruritus (up to 13.6%)
Common (1% to 10%): Contact dermatitis, sweating, ecchymosis, cellulitis
Uncommon (0.1% to 1%): Skin ulcer
Postmarketing reports: Angioedema, macular rash, popular rash
MusculoskeletalVery common (10% or more): Pain in extremity (14%), pain in jaw (up to 13.1%)
Common (1% to 10%): Myalgia, back pain
Uncommon (0.1% to 1%): Neck pain, arthralgia, leg cramp, muscle pain
Postmarketing reports: Bone pain, muscle spasm
RespiratoryVery common (10% or more): Cough (54%), throat irritation/pharyngolaryngeal pain (25%)
Common (1% to 10%): Hypoxia, epistaxis, pharyngitis, dyspnea, sinusitis, pulmonary hypertension, rhinitis, hemoptysis
Uncommon (0.1% to 1%): Bronchitis
Frequency not reported: Wheezing, pneumonia
OtherVery common (10% or more): Pain (11.9%)
Common (1% to 10%): Edema, infection, flu syndrome, asthenia, overdose, chest pain, fever, peripheral edema
Uncommon (0.1% to 1%): Viral infection, malaise
Frequency not reported: Infection, fatigue, BUN decreased, LDH decreased, bilirubin decreased, swelling arm
MetabolicCommon (1% to 10%): Hypokalemia, anorexia, dehydration, gout
GenitourinaryCommon (1% to 10%): Urinary tract infection
HematologicCommon (1% to 10%): Anemia
Frequency not reported: Bleeding, thrombocytopenia, WBC decreased, RBC decreased, hemoglobin decreased, hematocrit decreased, eosinophils increased, platelet count increased
PsychiatricCommon (1% to 10%): Insomnia, anxiety, depression
Uncommon (0.1% to 1%): Nervousness
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Orenitram (www.drugs.com/orenitram.html).
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