VENTAVIS- iloprost solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

iloprost (UNII: JED5K35YGL) (iloprost - UNII:JED5K35YGL)

Boleh didapati daripada:

Actelion Pharmaceuticals US, Inc.

INN (Nama Antarabangsa):

iloprost

Komposisi:

iloprost 0.01 mg in 1 mL

Laluan pentadbiran:

RESPIRATORY (INHALATION)

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

VENTAVIS is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration. Studies establishing effectiveness included predominately patients with NYHA Functional Class III–IV symptoms and etiologies of idiopathic or heritable PAH (65%) or PAH associated with connective tissue diseases (23%) [see Clinical Studies (14)] . None. Risk Summary Limited published data from case series and case reports with VENTAVIS in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with pulmonary arterial hypertension (see Clinical Considerations) . In animal reproductive studies, administration of continuous intravenous iloprost to pregnant Han-Wistar rats during organogenesis at doses 2-times the recommended human dose on a mg/m2 basis resulted in adverse develo

Ringkasan produk:

VENTAVIS® (iloprost) Inhalation Solution is supplied in cartons of 30×1 mL clear glass single-use ampules as follows: 1 mL ampule containing iloprost 10 mcg per mL (NDC 66215-302-00), carton of 30 (NDC 66215-302-30) 1 mL ampule containing iloprost 20 mcg per mL (NDC 66215-303-00), carton of 30 (NDC 66215-303-30) Storage Store at 20°C to 25°C (68°F to 77°F) Excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature] Keep out of reach of children.

Status kebenaran:

New Drug Application

Ciri produk

VENTAVIS- ILOPROST SOLUTION
ACTELION PHARMACEUTICALS US, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VENTAVIS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VENTAVIS.
VENTAVIS (ILOPROST) INHALATION SOLUTION, FOR ORAL INHALATION USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
VENTAVIS is a prostacyclin mimetic indicated for the treatment of
pulmonary arterial hypertension (PAH)
(WHO Group 1) to improve a composite endpoint consisting of exercise
tolerance, symptoms (NYHA
Class), and lack of deterioration. Studies establishing effectiveness
included predominately patients with
NYHA Functional Class III-IV symptoms and etiologies of idiopathic or
heritable PAH (65%) or PAH
associated with connective tissue diseases (23%). (1.1).
DOSAGE AND ADMINISTRATION
VENTAVIS is intended to be inhaled using the I-neb AAD System.
Patients should receive 6 to 9 doses
(inhalations) per day (minimum of 2 hours between doses during waking
hours) as follows:
Starting dose: 2.5 mcg (2.1).
Uptitrate to 5 mcg if 2.5 mcg is well tolerated (2.1).
Maintenance dose: 5 mcg (2.1).
DELIVERED DOSE FROM AMPULE OF:
Nebulizer
10 mcg/mL
20 mcg/mL
I-neb AAD
2.5 or 5 mcg from one ampule
5 mcg from one ampule
The 20 mcg/mL concentration is for patients who repeatedly experience
extended treatment times
(2.1).
DOSAGE FORMS AND STRENGTHS
1 mL ampules in two concentrations: 10 mcg/mL and 20 mcg/mL (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
Hypotension leading to syncope has been observed. Monitor vital signs
while initiating VENTAVIS.
VENTAVIS should not be administered in patients with systolic blood
pressure below 85 mmHg (5.1).
Pulmonary venous hypertension: Discontinue if pulmonary edema is
present (5.2).
May cause bronchospasm: Patients with a history of hyperreactive
airway disease may be more
sensitive (5.3).
ADVERSE REACTIONS
Most common (≥3% placebo adjusted) adverse reactions are
vasodilation (flushing), cough increased,
headache, tri