Tyvaso

What is Tyvaso?

Tyvaso (treprostinil) is a prostacyclin mimetic used for the treatment of pulmonary arterial hypertension, pulmonary hypertension associated with interstitial lung disease.

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Treprostinil

Treprostinil2

What are the uses of this medicine?

Tyvaso is indicated for the treatment of:

• pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability.
• pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability.

How does this medicine work?

• Treprostinil is a prostacyclin analogue.
• The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds and inhibition of platelet aggregation.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Tyvaso dosage adjustments may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn. Tyvaso dosage adjustments may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn.
• No pharmacokinetic interactions between treprostinil and bosentan were observed.
• No pharmacokinetic interactions between treprostinil and sildenafil were observed.

Is this medicine FDA approved?

• The inhaled form of treprostinil was approved by the FDA in July 2009 and is marketed as the trade name Tyvaso.
• The inhaled form is used with a proprietary inhalation device supplied by the manufacturer.

How should this medicine be used?

Recommended dosage:

• Administer undiluted, as supplied.
• A single breath of Tyvaso delivers approximately 6 mcg of treprostinil.
• Administer in 4 separate treatment sessions each day approximately 4 hours apart, during waking hours.

Initial Dosage:

• Therapy should begin with 3 breaths of Tyvaso (18 mcg of treprostinil) per treatment session 4 times daily.
• If 3 breaths are not tolerated, reduce to 1 or 2 breaths and subsequently increase to 3 breaths, as tolerated.

Maintenance Dosage:

• Dosage should be increased by an additional 3 breaths per treatment session, 4 times daily at approximately 1- to 2-week intervals.
• Titrate to target maintenance doses of 9 to 12 breaths per treatment session, 4 times daily.

Administration:

• Tyvaso must be used only with the Tyvaso Inhalation System.
• Patients should follow the instructions for use for operation of the Tyvaso Inhalation System and for daily cleaning of the device components after the last treatment session of the day.
• Do not mix Tyvaso with other medications in the Tyvaso Inhalation System.
• The Tyvaso Inhalation System should be prepared for use each day according to the instructions for use.
• One ampule of Tyvaso contains a sufficient volume of medication for all 4 treatment sessions in a single day.
• At the end of each day, the medicine cup and any remaining medication must be discarded.
• The device must be cleaned each day according to the instructions for use.
• Avoid skin or eye contact with Tyvaso solution.
• Do not orally ingest the Tyvaso solution.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Sterile solution for oral inhalation: 2.9 mL ampule containing 1.74 mg treprostinil (0.6 mg per mL).

This medicine is available in fallowing brand namesː

• Tyvaso

What side effects can this medication cause?

The most common side effects of this medicine include:

• cough
• headache
• nausea
• dizziness
• flushing
• throat irritation
• pharyngolaryngeal pain
• diarrhea
• syncope

What special precautions should I follow?

• Tyvaso may cause symptomatic hypotension.
• Tyvaso inhibits platelet aggregation and increases the risk of bleeding.
• Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Tyvaso dosage adjustments may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• flushing
• headache
• hypotension
• nausea
• vomiting
• diarrhea

Management of overdosage:

• Provide general supportive care until the symptoms of overdose have resolved.

Can this medicine be used in pregnancy?

• Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• treprostinil

Inactive ingredients:

• sodium chloride
• trisodium citrate dihydrate
• sodium hydroxide
• hydrochloric acid
• water

Who manufactures and distributes this medicine?

Tyvaso manufactured for: United Therapeutics Corp. Research Triangle Park, NC

What should I know about storage and disposal of this medication?

• Ampules of Tyvaso are stable until the date indicated when stored in the unopened foil pouch at 20-25°C (68-77°F) with excursions permitted to 15-30°C (59-86°F) .
• Once the foil pack is opened, ampules should be used within 7 days.
• Because Tyvaso is light-sensitive, unopened ampules should be stored in the foil pouch.

• Dailymed label info on Tyvaso
• FDA Tyvaso

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