Treprostinil

Name: Treprostinil

What Is Treprostinil?

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.

Treprostinil is used to treat pulmonary arterial hypertension (PAH). This medicine improves your ability to exercise and can help prevent your condition from getting worse.

Treprostinil may also be used for purposes not listed in this medication guide.

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.

Treprostinil is used to treat pulmonary arterial hypertension (PAH). This medicine improves your ability to exercise and can help prevent your condition from getting worse.

Treprostinil may also be used for purposes not listed in this medication guide.

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.

Treprostinil is used to treat pulmonary arterial hypertension (PAH). This medicine improves your ability to exercise.

Treprostinil may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use treprostinil if you have severe liver disease.

You should not use treprostinil if you are allergic to it.

To make sure treprostinil is safe for you, tell your doctor if you have:

  • kidney disease;
  • liver disease;
  • if you are using epoprostenol (Flolan); or
  • if you take medicine to treat high blood pressure (hypertension).

FDA pregnancy category B. Treprostinil is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether treprostinil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

You should not use treprostinil if you are allergic to it.

To make sure treprostinil inhalation is safe for you, tell your doctor if you have:

  • asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;
  • an infection in your lungs, including pneumonia;
  • kidney disease;
  • liver disease;
  • low blood pressure;
  • a bleeding or blood clotting disorder;
  • if you take a blood thinner (warfarin, Coumadin, Jantoven); or
  • if you take medicine to treat high blood pressure (hypertension).

FDA pregnancy category B. Treprostinil is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether treprostinil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

You should not use treprostinil if you are allergic to it, or if you have severe liver disease.

To make sure treprostinil is safe for you, tell your doctor if you have:

  • diverticulosis (an intestinal disorder);
  • kidney disease;
  • liver disease;
  • if you take a blood thinner (warfarin, Coumadin, Jantoven) or other medicine to prevent blood clots (Fragmin, Lovenox, and others); or
  • if you take medicine to treat high blood pressure (hypertension).

It is not known whether treprostinil 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.

Treprostinil Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • pain, swelling, redness, bleeding, or a hard lump where your catheter is placed;
  • swelling in your hands or feet; or
  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • mild irritation or swelling around the catheter;
  • headache or jaw pain;
  • dizziness;
  • diarrhea, nausea;
  • itching; or
  • flushing (warmth, redness or tingling).

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.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • easy bruising or bleeding (nosebleeds, bleeding gums), or any bleeding that will not stop;
  • unexpected vaginal bleeding;
  • coughing up blood or vomit that looks like coffee grounds; or
  • blood in your urine or stools, black or tarry stools.

Common side effects may include:

  • cough, sore throat;
  • pain or irritation in your throat after use;
  • dizziness;
  • nausea, diarrhea;
  • headache; or
  • flushing (warmth, redness or tingling).

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.

Get emergency medical help if you have signs of an allergic reaction: 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 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.

Treprostinil Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication, there are no specific foods that you must exclude from your diet when receiving this medication.

 

What is treprostinil?

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.

Treprostinil is used to treat pulmonary arterial hypertension (PAH). This medicine improves your ability to exercise.

Treprostinil may also be used for purposes not listed in this medication guide.

What should I avoid while taking treprostinil?

Do not drink alcohol. Alcohol can cause the tablet to release treprostinil too quickly.

Before Using treprostinil

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For treprostinil, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to treprostinil or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of treprostinil in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of treprostinil in the elderly. However, elderly patients are more likely to have liver or heart problems, which may require caution and an adjustment in the dose for patients receiving treprostinil.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking treprostinil, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using treprostinil with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Defibrotide

Using treprostinil with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aceclofenac
  • Acemetacin
  • Alipogene Tiparvovec
  • Alteplase, Recombinant
  • Amtolmetin Guacil
  • Anagrelide
  • Apixaban
  • Ardeparin
  • Argatroban
  • Aspirin
  • Bemiparin
  • Betrixaban
  • Bivalirudin
  • Bromfenac
  • Bufexamac
  • Celecoxib
  • Certoparin
  • Choline Salicylate
  • Citalopram
  • Clonixin
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Desirudin
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dipyridamole
  • Dipyrone
  • Droxicam
  • Edoxaban
  • Enoxaparin
  • Eptifibatide
  • Escitalopram
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Fluoxetine
  • Flurbiprofen
  • Fluvoxamine
  • Fondaparinux
  • Heparin
  • Ibuprofen
  • Indomethacin
  • Ketoprofen
  • Ketorolac
  • Lepirudin
  • Levomilnacipran
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Morniflumate
  • Nabumetone
  • Nadroparin
  • Naproxen
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Parnaparin
  • Paroxetine
  • Phenindione
  • Phenprocoumon
  • Phenylbutazone
  • Piketoprofen
  • Piracetam
  • Piroxicam
  • Pixantrone
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Protein C
  • Reviparin
  • Rivaroxaban
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sertraline
  • Sodium Salicylate
  • Sulindac
  • Tenoxicam
  • Tiaprofenic Acid
  • Tinzaparin
  • Tolfenamic Acid
  • Tolmetin
  • Valdecoxib
  • Vilazodone
  • Vortioxetine
  • Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of treprostinil. Make sure you tell your doctor if you have any other medical problems, especially:

  • Hypotension (low blood pressure) or
  • Stomach or bowel problems (eg, diverticulosis, ulcers) or
  • Stroke, history of—Use with caution. May make these conditions worse.
  • Liver disease, mild—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Liver disease, moderate to severe—Should not be used in patients with this condition.

Administration

Avoid treatment interruptions or rapid large dosage reductions with use of inhalation, IV, or SubQ formulations. Immediate access to medication, a back-up inhalation device, or pump and infusion sets is essential to prevent treatment interruptions.

Inhalation: Do not mix with other medications. For inhalation only via the Tyvaso Inhalation System. Prior to the first treatment session of each day, transfer the entire contents of one ampule into the medicine chamber; one ampule contains sufficient volume of medication for all 4 treatment sessions in a single day. Between each session, the device should be capped and stored upright with the remaining medication inside. At the end of each day, the medicine chamber and any remaining medication must be discarded. Avoid contact of solution with eyes or skin; wash hands after handling.

IV infusion: IV use is recommended when SubQ infusion is not tolerated or when the benefit outweighs the potential risks of an indwelling central venous catheter. Solution must be diluted in SWFI, NS, Remodulin sterile diluent, or Flolan sterile diluent prior to use and administered by continuous infusion using a central indwelling catheter and infusion pump. The ambulatory infusion pump should be small and lightweight; have occlusion/no delivery, low battery, programming error, and motor malfunction alarms; have ± 6% accuracy of the programmed rate; and be positive pressure driven. The reservoir should be made of polyvinyl chloride, polypropylene, or glass. Peripheral infusion may be used temporarily until central line is established. Infusion sets with an in-line 0.22 or 0.2 micron filter should be used for central and peripheral administration.

Oral: Administer with food (minimum of 250 calories containing 30% to 50% fat) (Lim 2013; Pugliese 2016). Swallow tablets whole; do not crush, split or chew; use only intact tablets.

SubQ infusion (preferred): Administer undiluted via continuous SubQ infusion using an appropriately designed infusion pump. The ambulatory infusion pump should be small and lightweight; be able to adjust infusion rates in ~0.002 mL/hour increments; have occlusion/no delivery, low battery, programming error, and motor malfunction alarms; have ± 6% accuracy of the programmed rate; and be positive pressure driven. The reservoir should be made of polyvinyl chloride, polypropylene, or glass. Proactively manage infusion-site reactions based on individual patient needs and by combining multiple strategies, including improved dosing strategies (eg, more rapid dose escalation), appropriate site selection, less frequent infusion site changes (eg, every 2 to 5 weeks [Skoro-Sajer 2007]), and analgesic care (pharmacologic and nonpharmacologic) when pain occurs. Rotate infusion site when patient experiences continued site pain, itching, erythema, drainage, or bleeding; decreased site pain and need for site changes or discontinuation due to site pain may be reduced in patients who are managed proactively in this manner (Mathier 2010; Skoro-Sajer 2008; White 2013).

For the Consumer

Applies to treprostinil: oral tablet extended release

Other dosage forms:

  • inhalation solution
  • injection solution

Along with its needed effects, treprostinil 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
  • Decreased urine
  • dry mouth
  • increased thirst
  • irregular heartbeat
  • muscle pain or cramps
  • nausea or vomiting
  • pain in the jaw, arms, or legs
  • unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking treprostinil:

Symptoms of overdose
  • Blurred vision
  • confusion
  • diarrhea
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • headache, severe
  • sweating

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
  • Abdominal or stomach discomfort
  • diarrhea
  • feeling of warmth
  • headache
  • redness of the face, neck, arms, and occasionally, upper chest

For Healthcare Professionals

Applies to treprostinil: inhalation solution, injectable solution, oral tablet extended release

General

Oral 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.[Ref]

Local

Very 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[Ref]

Gastrointestinal

Very 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[Ref]

Nervous system

Very common (10% or more): Headache (up to 63%)
Common (1% to 10%): Syncope, paresthesia, dizziness[Ref]

Cardiovascular

Very 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[Ref]

Dermatologic

Very 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[Ref]

Musculoskeletal

Very 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[Ref]

Respiratory

Very 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[Ref]

Other

Very 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[Ref]

Metabolic

Common (1% to 10%): Hypokalemia, anorexia, dehydration, gout[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Hematologic

Common (1% to 10%): Anemia
Frequency not reported: Bleeding, thrombocytopenia, WBC decreased, RBC decreased, hemoglobin decreased, hematocrit decreased, eosinophils increased, platelet count increased[Ref]

Psychiatric

Common (1% to 10%): Insomnia, anxiety, depression
Uncommon (0.1% to 1%): Nervousness[Ref]

Some side effects of treprostinil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Liver Dose Adjustments

Extended-release tablets:
-Mild liver dysfunction (Child-Pugh Class A): Initiate at 0.125 mg orally twice a day with 0.125 mg twice a day dose increments every 3 to 4 days
-Moderate liver dysfunction (Child-Pugh Class B): Avoid use
-Severe liver dysfunction (Child-Pugh Class C): Contraindicated

Oral inhalation: Titrate dose slowly in patients with liver dysfunction

Parenteral:
-Mild to moderate liver dysfunction: Decrease initial subcutaneous or IV dose to 0.625 ng/kg/min ideal body weight
-Severe liver dysfunction: Data not available

Dose Adjustments

No adjustment recommended, however, doses should be titrated slowly in patients with renal insufficiency.

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