Tyvaso

Generic Name: treprostinil (Inhalation route)

tre-PROS-ti-nil

Commonly used brand name(s)

In the U.S.

  • Tyvaso

Available Dosage Forms:

  • Solution

Therapeutic Class: Vasodilator

Pharmacologic Class: Prostaglandin

Uses For Tyvaso

Treprostinil inhalation is used to treat the symptoms of pulmonary arterial hypertension. This is the high blood pressure that occurs in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs. Treprostinil works by blocking a hormone (a naturally occurring substance), that is found in the blood and lungs in large quantities of the people with pulmonary arterial hypertension. Treprostinil helps by increasing the supply of blood to the lungs and reducing the workload of the heart.

Slideshow: Flashback: FDA Drug Approvals 2013

This medicine is available only with your doctor's prescription.

Before Using Tyvaso

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 inhalation 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 inhalation in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems which may require caution and an adjustment in the dose for patients receiving treprostinil inhalation.

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 this medicine, 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 this medicine 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.

  • Alipogene Tiparvovec
  • Alteplase, Recombinant
  • Apixaban
  • Aspirin
  • Dipyridamole
  • Eptifibatide
  • Fluoxetine
  • Levomilnacipran
  • Pixantrone
  • Vortioxetine

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

  • Asthma or
  • Bleeding problems or
  • Chronic obstructive pulmonary disease (COPD) or
  • Hypotension (low blood pressure) or
  • Lung infection—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of Tyvaso

Treprostinil inhalation should be taken when you wake up and also before any physical activity, but not more than every 4 hours. Do not change your dose without talking to your doctor.

Treprostinil is breathed into your lungs with Tyvaso® Inhalation System. This system consists of the Tyvaso® Inhalation System device and its accessories. Carefully follow your doctor's instructions for using the medicine and operating and cleaning the equipment. Do not put other medicines into this equipment.

Do not drink this medicine. Do not allow the inhalation solution to come into contact with your skin or eyes. If it does, rinse it off with water right away.

To avoid missing a dose or any possible problems with the drug delivery device you are using, you should have a back-up with Tyvaso® Inhalation System device.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For inhalation dosage form (solution):
    • For pulmonary arterial hypertension:
      • Adults—At first, 18 micrograms (mcg) or three breaths, per treatment session at least 4 hours apart, 4 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 9 breaths per treatment session, 4 times a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Protect the medicine from direct light. Keep your medicine in the unopened foil pouch until you are ready to use it. Once the foil pack is opened, the ampules should be used within 7 days.

Precautions While Using Tyvaso

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly.

It is very important that your doctor check your blood pressure regularly while you are taking this medicine. You may also need to monitor your blood pressure at home. If you notice any changes to your recommended blood pressure, call your doctor right away.

Patients may have a drop in blood pressure, and may become dizzy, lightheaded, or faint. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. You should stand up slowly when you get out of a chair or bed.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Your doctor may adjust the doses of all the medicines you are taking or monitor you carefully for side effects.

Tyvaso Side Effects

Along with its needed effects, a medicine 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:

More common
  • Cough
  • fainting
  • feeling of warmth
  • redness of the face, neck, arms and occasionally, upper chest
  • sore throat
Incidence not known
  • Bloody nose
  • chest pain
  • coughing or spitting up blood
  • difficulty in breathing or troubled breathing
  • fever or chills
  • sneezing
  • tightness in the chest

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

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

Some side effects 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 cramps, discomfort or pain
  • back pain
  • constipation
  • indigestion
  • loss of appetite
  • muscle, jaw, or bone pain
  • swollen mouth and tongue
  • unpleasant taste
  • urge to have bowel movement

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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