TYVASO

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TREPROSTINIL AS SODIUM SALT

Available from:

RAFA LABORATORIES LTD

ATC code:

B01AC21

Pharmaceutical form:

SOLUTION FOR INHALATION

Composition:

TREPROSTINIL AS SODIUM SALT 1.74 MG / 2.9 ML

Administration route:

INHALATION

Prescription type:

Required

Manufactured by:

UNITED THERAPEUTICS CORPORATION, USA

Therapeutic group:

TREPROSTINIL

Therapeutic area:

TREPROSTINIL

Therapeutic indications:

Treatment of pulmonary arterial hypertension in patients with NYHA class III symptoms, to increase walk distance.Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability.

Authorization date:

2015-11-30

Patient Information leaflet

PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is sold with a doctor's prescription only
TYVASO
INHALATION SOLUTION
ACTIVE INGREDIENT:
Each ampule (2.9 mL) contains 1.74 mg of Treprostinil as sodium salt.
Each mL contains 0.6 mg of Treprostinil.
For the list of the other ingredients, please see section 6.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further questions,
refer to your doctor or pharmacist.
This medicine has been prescribed for treating your illness. Do not
pass it on to others. It may
harm them, even if it seems to you that their illness is similar to
yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for treatment of pulmonary arterial
hypertension (PAH - high blood
pressure in the arteries of the lungs) and for increasing the distance
you can walk.
Pulmonary hypertension associated with interstitial lung disease
(PH-ILD; WHO Group 3) to
improve exercise ability.
THERAPEUTIC GROUP: synthetic analog of prostacyclin, platelet
aggregation inhibitor.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
Do not use if you are sensitive (allergic) to the active ingredient or
to any of the other
ingredients the medicine contains (for the list of the other
ingredients, please see
section 6).
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
•
Do not allow the inhalation solution to come into contact with the
eyes or skin. If such an
accidental contact occurs, rinse the place immediately with water.
•
The medicine is intended to be inhaled through the mouth.
BEFORE THE TREATMENT WITH TYVASO, TELL YOUR DOCTOR IF:
•
You suffer or have suffered in the past from lung diseases (e.g.
asthma or COPD) or a lung
infection.
•
You suffer or have suffered in the past from impaired function of the
liver or kidneys.
•
You suffer or have suffered in the past from low blood pressure.
•
You suffer or have suffered in the past from bleeding problem

Summary of Product characteristics

1
Tyvaso January 2023
FULL PRESCRIBING INFORMATION
TYVASO
®
SOLUTION FOR INHALATION
FOR ORAL INHALATION ONLY
COMPOSITION
: Sterile solution for oral inhalation: each ampule contains 1.74 mg
treprostinil (as
sodium) in 2.9 mL (0.6 mg/ mL)
For a full list of ingredients see section 11.
1
INDICATIONS AND USAGE
1.1 Treatment of pulmonary arterial hypertension in patients with NYHA
class III symptoms, to increase
walk distance.
The effects diminish over the minimum recommended dosing interval of 4
hours; treatment timing can
be adjusted for planned activities.
While there are long-term data on use of treprostinil by other routes
of administration, nearly all
controlled clinical experience with inhaled treprostinil has been on a
background of bosentan (an
endothelin receptor antagonist) or sildenafil (a phosphodiesterase
type 5 inhibitor). The controlled
clinical experience was limited to 12 weeks in duration
_[see Clinical Studies (14)]_
.
1.2 Pulmonary hypertension associated with interstitial lung disease
(PH-ILD; WHO Group 3) to
improve exercise ability.
The study establishing effectiveness predominately included patients
with etiologies of idiopathic
interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary
fibrosis (IPF), combined pulmonary
fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue
disease (22%)
_[see _
_Clinical Studies (14)]_
.
2
DOSAGE AND ADMINISTRATION
2.1
USUAL DOSAGE IN ADULTS
Tyvaso is intended for oral inhalation using the Tyvaso Inhalation
System, which consists of an
ultrasonic, pulsed delivery device and its accessories.
Tyvaso is dosed in 4 separate, equally spaced treatment sessions per
day, during waking hours. Each
treatment session will take 2 to 3 minutes. The treatment sessions
should be approximately 4 hours apart.
_INITIAL DOSAGE: _
2
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.