Ventavis

/ Bayer

Adults Dose per inhalation session: At initiation of Ventavis treatment the first inhaled dose should be 2.5 micrograms iloprost (as delivered at the mouthpiece of the nebulizer). 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 micrograms 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 nebulizer, the duration of an inhalation session is approximately 4 to 10 minutes.
Duration of treatment: Long term treatment. Additional information on special populations Children and adolescents The experience in children and adolescents (patients below 18 years of age) is limited Therefore, Ventavis is not recommended for use in this population Patients with hepatic impairment Iloprost elimination is reduced in patients with hepatic dysfunction. 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. A n 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. The elimination is reduced in patients with renal failure requiring dialysis.
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Treatment of patients with primary pulmonary hypertension or secondary pulmonary hypertension due to connective tissue disease or drug-induced, in moderate or severe stages of the disease. Treatment of moderate or severe secondary pulmonary hypertension due to chronic pulmonary thromboembolism, where surgery is not possible.

Hypersensitivity to iloprost or to any of the excipients. Conditions where the effects 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 medicdbal 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. Pregnancy, lactation.
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Should not be initiated in patients with systolic arterial hypotension less than 85 mmHg. Acute pulmonary infections, chronic obstructive pulmonary disease and severe asthma should be carefully monitored. Should not be used as the first treatment option in thromboembolic pulmonary hypertension if surgery is feasible. Should signs of pulmonary edema occur when administered in patients with pulmonary hypertension, the possibility of associated pulmonary veno-occlusive disease should be considered. The treatment should be stopped. The pulmonary vasodilatory effect is of short duration (one to two hours). Patients who experience syncope in association with pulmonary hypertension should avoid any exceptional straining, for example during physical exertion. Before physical exertion it might be useful to inhale (in accordance to total daily dose). The occurrence of exertional syncope reflects the therapeutic gaps, and the need to adapt and/or change the therapy should be considered. A change of therapy should be considered also if syncope worsens due to the underlying disease, or in case of deterioration or worsening of right heart failure. Elimination is reduced in patients with hepatic dysfunction and in patients with renal failure requiring dialysis. A cautious initial dose titration using dosing intervals of at least 3 hours is recommended. Should not be used in patients below 18 years of age. Care should be exercised during initiation of therapy until any effects on the individual have been determined. Ability to drive or operate machines may be seriously affected in patients experiencing hypotensive symptoms such as dizziness.
Pregnancy and lactation: Women of child-bearing potential should use effective contraception measures during treatment. The drug must not be administered to nursing mothers.
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Summary of the safety profile: The adverse drug reactions (ADRs) reported below are based on pooled clinical trial data from phase II and III clinical trials involving 131 patients taking the medication and on data from postmarketing surveillance. In addition to local effects resulting from administration of iloprost by inhalation such as cough, adverse reactions with iloprost are related to the pharmacological properties of prostacyclins. The most frequently observed adverse reactions (≥ 20 %) in clinical trials include vasodilatation (including hypotension), headache, and cough. The most serious adverse reactions were hypotension, bleeding events, and bronchospasm.
Tabulated list of adverse reaction: The adverse drug reactions observed with Ventavis are represented in the table below. They are classified according to System Organ Class. The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions. Adverse drug reactions from clinical trials are classified according to their frequencies. Frequency groupings are defined according to the following convention: very common: = 1/10 and common: = 1/100 to < 1/10.
The ADRs identified only during post marketing surveillance, and for which a frequency could not be estimated, are listed under “not known”. Within each frequency grouping, undesirable effects are presentedVasodilation, hypotension, increased cough, headache, trismus, syncopes.
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May increase the antihypertensive activity of beta-receptor blockers, calcium antagonists, vasodilators and ACE inhibitors. Use with anticoagulants (such as heparin, coumarin-type anticoagulants), or other inhibitors of platelet aggregation (such as acetylsalicylic acid, NSAIDs, phosphodiesterase inhibitors and nitro vasodilators) may increase the risk of bleeding.
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There are insufficient data from the use of Ventavis in pregnant women. Therefore, women of child bearing potential should use effective contraceptive measures during treatment with Ventavis. If a pregnancy occurs, Ventavis should only be used following careful risk-benefit evaluation. It is not known whether iloprost/metabolites are excreted in human milk. Therefore women should not breast-feed during treatment with Ventavis.

Symptoms: No case of overdose has been reported. In the event of an overdose, hypotensive reaction might be anticipated as well as headache, flushing, nausea, vomiting, and diarrhea. An increase of blood pressure, bradycardia or tachycardia and limb or back pain might be possible.
Therapy: A specific antidote is not known. Interruption of the iloprost administration, monitoring and symptomatic measures are recommended.