VELETRI POWDER FOR SOLUTION FOR INFUSION 1.5MG/VIAL [SIN15406P]

Product Info

VELETRI POWDER FOR SOLUTION FOR INFUSION 1.5MG/VIAL

[SIN15406P]

4.1 Therapeutic indications

Veletri® is indicated for:

Pulmonary Arterial Hypertension.

Veletri® is indicated for the treatment of pulmonary arterial hypertension (PAH) (idiopathic or heritable PAH and PAH associated with connective tissue diseases) in patients with WHO Functional Class III–IV symptoms to improve exercise capacity (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Posology

Veletri® is only indicated for continuous infusion by intravenous route.
Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension.

Short-term (acute) dose ranging:

This procedure should be conducted in a hospital with adequate resuscitation equipment.

A short-term dose-ranging procedure administered via either a peripheral or central venous line is required to determine the long-term infusion rate. The infusion is initiated at 2 ng/kg/min and increased by increments of 2 ng/kg/min every 15 min or longer until maximum haemodynamic benefit or dose-limiting pharmacological effects are elicited.
If the initial infusion rate of 2 ng/kg/min is not tolerated, a lower dose that is tolerated by the patient should be identified.

Long-term continuous infusion:

Long-term continuous infusion of Veletri® should be administered through a central venous catheter. Temporary peripheral i.v. infusions may be used until central access is established. Long-term infusions should be initiated at 4 ng/kg/min less than the maximum tolerated infusion rate determined during short-term dose-ranging. If the maximum tolerated infusion rate is 5 ng/kg/min or less, the long-term infusion should be started at 1ng/kg/min.

Dosage adjustments:

Changes in the long-term infusion rate should be based on persistence, recurrence or worsening of the patient’s symptoms of pulmonary arterial hypertension or the occurrence of adverse reactions due to excessive doses of Veletri®.

In general, the need for increases in dose from the initial long-term dose should be expected over time. Increases in dose should be considered if symptoms of pulmonary arterial hypertension persist, or recur after improving. The infusion rate should be increased by 1 to 2 ng/kg/min increments at intervals sufficient to allow assessment of clinical response; these intervals should be at least 15 min. Following establishment of a new infusion rate, the patient should be observed, and erect and supine blood pressure and heart rate monitored for several hours to ensure that the new dose is tolerated.

During long-term infusion, the occurrence of dose-related pharmacological events similar to those observed during the dose-ranging period may necessitate a decrease in infusion rate, but the adverse reactions may occasionally resolve without dosage adjustment. Dosage decreases should be made gradually in 2 ng/kg/min decrements every 15 min or longer until the dose-limiting effects resolve. Abrupt withdrawal of Veletri® or sudden large reductions in infusion rates should be avoided due to the risk of potentially fatal rebound effect (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Except in life-threatening situations (e.g. unconsciousness, collapse, etc.), infusion rates of Veletri® should be adjusted only under the direction of a physician.

Elderly
There is no specific information on the use of Veletri® in patients over 65 years for pulmonary arterial hypertension. In general, dose selection for an elderly patient should be made carefully, reflecting the greater frequency of decreased hepatic, renal (in the case of pulmonary arterial hypertension) or cardiac function and of concomitant disease or other medicine therapy.

Paediatric population

The safety and efficacy of Veletri® in children have not yet been established.

Method of administration

Veletri® long-term administration is administered via intravenous route through central venous catheter using an ambulatory infusion pump. The patient must be adequately trained in all aspects of care of the central venous catheter, in the aseptic preparation of the Veletri® intravenous injectable solution, and in the preparation and change of the drug delivery reservoir of the infusion pump, and the extension set.

Additional information regarding the potential suitable materials, ambulatory pumps and instructions on connecting the i.v. access systems, to be used for the administration of Veletri® is provided in section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Reduction of the risk of catheter-related blood-stream infection

Particular attention should be given to the recommendations in section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information and the following as this should help to reduce the risk of catheter-related blood-stream infections.

The care of the central venous catheter and the catheter exit site should follow established medical principles.

Only extension sets with an in-line 0.22 micron filter placed between the infusion pump and the central venous catheter must be used. It is recommended to use filters with a hydrophilic polyethersulfone membrane. The extension set and the in-line filter must be changed at least every 48 hours (see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Preparation of Veletri® intravenous injectable solution:

The reconstituted solution should be examined prior to further dilution. Its use is forbidden in the presence of discolouration or particles. Reconstituted solutions should be immediately further diluted to the final concentration.

For further instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Veletri® must not be administered as a bolus injection.

4.3 Contraindications

Veletri® is contraindicated in patients:

• with known hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• with congestive heart failure arising from severe left ventricular dysfunction.

• Veletri® must not be used chronically in patients who develop pulmonary oedema during dose-ranging.