VENTAVIS SOLUTION FOR INHALATION [SIN13140P]

Product Info

VENTAVIS SOLUTION FOR INHALATION

[SIN13140P]

4.1 Indications

Treatment of moderate or severe stages of

• Idiopathic pulmonary arterial hypertension [IPAH] and familial pulmonary arterial hypertension [FPAH]

• Pulmonary arterial hypertension [APAH] associated with connective tissue disease, and pulmonary arterial hypertension associated with drugs or toxins

• Pulmonary hypertension due to chronic thrombotic and/or embolic disease where surgery is not possible

4.2 Dosage and method of administration

4.2.1 Method of administration

The ready-to-use Ventavis 10 microgram / mL nebuliser solution is administered with a suitable inhalation device (nebuliser) as recommended in the section “Instructions for use/handling”.

Previous therapy should be adjusted to individual needs (see section “Interaction with other medicinal products and other forms of interaction” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2.2 Dosage regimen

Adults

At initiation of Ventavis 10 microgram / mL treatment the first inhaled dose should be 2.5 microgram iloprost (as delivered at the mouthpiece). If this dose is well tolerated, dosing should be increased to 5.0 microgram and maintained at that dose. In case of poor tolerability of the 5.0 microgram dose, the dose should be reduced to 2.5 microgram.

The dose per inhalation session should be administered 6 to 9 times per day according to the individual need and tolerability.

Depending on the desired dose at the mouthpiece and on the nebuliser, the duration of an inhalation session is approximately 4 to 10 minutes.

Duration of treatment

Long term treatment.

The duration of treatment depends on clinical status and is left to the physician's discretion. Should patients deteriorate on this treatment intravenous prostacyclin treatment should be considered.

4.2.3 Additional information on special populations

Patients with hepatic impairment
Iloprost elimination is reduced in patients with hepatic dysfunction (see section “Pharmacokinetic Properties” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Caution should be used during therapy in patients with Child-Pugh class B or more severe hepatic impairment. It should also be used with caution in patients with mild to moderate hepatic impairment. To avoid undesired accumulation over the day, special caution has to be exercised with these patients during initial dose titration. Initially, doses of 2.5 micrograms should be administered with dosing intervals of 3–4 hours (corresponds to administration of max. 6 times per day). Thereafter, dosing intervals may be shortened cautiously based on individual tolerability. If a further increase in the dose up to 5.0 micrograms is indicated, again dosing intervals of 3–4 hours should be chosen initially and shortened according to individual tolerability. An accumulation of iloprost following treatment over several days is not likely due to the overnight break in administration of the medicinal product.

Patients with renal impairment
There is no need for dose adaptation in patients with a creatinine clearance > 30 mL/min (as determined from serum creatinine using the Cockroft and Gault formula). Patients with a creatinine clearance of ≤30 mL/min were not investigated in the clinical trials with Ventavis. Based on data with intravenously administered iloprost the elimination is reduced in patients with renal failure requiring dialysis. For dosing recommendations, see “Patients with hepatic impairment”.

Children and adolescents (below 18 years of age)
Currently only sporadic reports of use in children and adolescents are available. Until further data become available. Ventavis should not be used in patients below 18 years of age (see section, “Special warnings and precautions for use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

• Pregnancy

• Lactation

• Conditions where the effects of Ventavis on platelets might increase the risk of hemorrhage (e.g. active peptic ulcers, trauma, intracranial hemorrhage)

• Severe coronary heart disease or unstable angina

• Myocardial infarction within the last six months

• Decompensated cardiac failure if not under close medical supervision

• Severe arrhythmias

• Suspected pulmonary congestion

• Cerebrovascular events [e.g. transient ischemic attack, stroke] within the last 3 months

• Pulmonary hypertension due to venous occlusive disease

• Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension

• Hypersensitivity to iloprost or to any of the excipients