treprostinil inhaled (Rx)

Brand and Other Names:Tyvaso
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

inhalation solution

  • 600mcg/mL
  • ~6mcg delivered for single breath inhaled

Pulmonary Arterial Hypertension

Indicated for treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability

Initial

  • 18 mcg (3 breaths) per treatment session QID
  • If 3 breaths not tolerated, decrease to 1-2 breaths and later increase to 3 breaths as tolerated

Maintenance

  • If tolerated, increase by 3 breaths/dose (18 mcg) q1-2Weeks
  • Target maintenance: 54 mcg (9 breaths) per treatment session QID
  • If adverse effects preclude titration to target dose, continue at highest tolerated dose
  • If effects diminish over minimum recommended dosing interval of 4 hr, treatment timing can be adjusted for planned activities

Pulmonary Hypertension Associated with ILD

Indicated for treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability

Initial

  • 18 mcg (3 breaths) per treatment session QID
  • If 3 breaths not tolerated, decrease to 1-2 breaths and later increase to 3 breaths as tolerated

Maintenance

  • If tolerated, increase by 3 breaths/dose (18 mcg) q1-2Weeks
  • Target maintenance: 54 mcg (9 breaths) per treatment session QID
  • If adverse effects preclude titration to target dose, continue at highest tolerated dose
  • If effects diminish over minimum recommended dosing interval of 4 hr; treatment timing can be adjusted for planned activities

Dosage Modifications

Renal impairment

  • No dose adjustments required in patients with renal impairment
  • Drug is not cleared by dialysis

Hepatic impairment

  • Titrate dose slowly
  • Plasma clearance may be reduced with hepatic insufficiency
  • Patients with hepatic insufficiency may be at increased risk of dose-dependent adverse reactions owing to increased systemic exposure

<18 years: Safety and efficacy not established

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Adverse Effects

>10%

Cough (54%)

Headache (41%)

Throat irritation/pharyngolaryngeal pain (25%)

Nausea (19%)

Flushing (15%)

1-10%

Syncope (6%)

Postmarketing Reports

Angioedema

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Warnings

Contraindications

None

Cautions

Efficacy of treprostinil inhaled has not been established in patients with significant underlying lung disease (eg, asthma or chronic obstructive pulmonary disease); monitor patients with acute pulmonary infections to detect any worsening of lung disease and loss of drug effect

May produce symptomatic hypotension in patients with low systemic arterial pressure

Titrate slowly in patients with hepatic or renal insufficiency

Inhibits platelet aggregation and increases the risk of bleeding

Drug interaction overview

  • Oral treprostinil is a CYP2C8 substrate
  • It is unclear if systemic exposure of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8
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Pregnancy & Lactation

Pregnancy

Limited case reports of treprostinil insufficient to inform a drug-associated risk of adverse developmental outcomes; however, there are risks to mother and fetus associated with pulmonary arterial hypertension associated with an increased risk of maternal and fetal mortality; in animal studies, no adverse reproductive and developmental effects observed

Animal data

  • Animal reproductive studies have shown an adverse effect on fetus; in rats, administration to pregnant rats during period of organogenesis at doses greater than or equal to 10 mg/kg/day (approximately 15 times the human exposure at the dose of 3.5 mg BID on an AUC basis) resulted in decreased pregnancy rate, increased post-implantation loss, and decreased fetal viability and growth
  • In rabbits, teratogenicity and decreased fetal viability and growth were observed at doses greater than or equal to 1.5 mg/kg/day (approximately 7 times the human exposure at dose of 3.5 mg BID on an AUC basis)

Clinical considerations

  • Pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality

Lactation

Data are not available regarding presence in human milk, effects on breastfed infants, or effects on milk production

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Prostacyclin analog; elicits direct vasodilation of both pulmonary and systemic arterial vascular beds; decreases ventricular afterload; also inhibits platelet aggregation

Absorption

Bioavailability: ~64% (18 mcg inhalation); ~72% (36 mcg inhalation)

Peak plasma concentration: 0.91-1.3 ng/mL (54 mcg inhalation)

Peak plasma time: 0.12-0.25 hr (54 mcg inhalation)

AUC: 0.81-0.97 ng·hr/mL (54 mcg inhalation)

Distribution

Protein bound: 91%

Vd: 14 L/70 kg IBW (parenteral infusion)

Metabolism

Substantially metabolized by the liver, primarily by CYP2C8

Elimination

Half-life (SC): 4 hr

Excretion (SC): Urine 79%; feces 13%

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Administration

Incompatibilities

Do not mix with other medications in the inhalation system

Compatibility with other medications has not been studied

Oral Inhalation Preparation

Only use with Tyvaso Inhalation System, which consists of an ultrasonic, pulsed delivery device and its accessories

Follow instructions for operating inhalation system and for device cleaning after last daily treatment session

Avoid potential interruptions in drug delivery because of equipment malfunction, by having a back-up inhalation system device

Prepare inhalation system for use each day according to instructions for use

One ampule of treprostinil contains a sufficient volume of medication for all 4 treatment sessions/day

Before first treatment session, twist the top off a single ampule and squeeze entire contents into medicine cup

Between each treatment session, cap device and store upright with remaining medication inside

At end of each day, discard medicine cup and any remaining medication

Oral Inhalation Administration

Avoid skin or eye contact; rinse with water if contact occurs

Do not orally ingest

Inhale orally via Tyvaso Inhalation System in 4 daily treatment session ~4 hr apart during waking hours

Each session will take 2-3 minutes

Missed dose: Take as soon as possible and adjust remainder of daily scheduled doses to be 4 hr apart

Storage

Store ampules in foil packs at 25ºC (77ºF); excursions are permitted between 15-30ºC (59-86ºF); protect from light

Once foil pack is opened, ampules should be used within 7 days

Following transfer of solution to inhalation device, solution should remain in device for ≤24 hr; discard unused portion

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Images

No images available for this drug.
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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.