Severe chronic ischaemia of lower limbs

Blood pressure and heart rate should be monitored at the start of the infusion and subsequently at every dose increase. During the first 2-3 days, the individually tolerated dose is established. For this reason, treatment should be started at an infusion rate of 0.5 ng/kg/min for 30 minutes. The dose should then be increased at intervals of 30 minutes by 0.5 ng/kg/min to a maximum of 2.0 ng/kg/min. The exact infusion rate should be calculated on the basis of body weight to reach an infusion within the range of 0.5 to 2.0 ng/kg/min (see tables below for use with infusion pump or syringe driver).

Method of administration

Iloprost 100 micrograms/ml concentrate for solution for infusion is NOT ready to use and requires dilution before administration. Depending on the occurrence of adverse effects such as headache and nausea or an undesired blood pressure drop, the infusion rate should be reduced until the optimal tolerated dose is found. If the adverse effects are severe, the infusion should be temporarily interrupted. The treatment course can then be continued with the dose based on the optimal tolerated dose reached in the first 2 to 3 days of treatment.

Depending on the infusion technique used, there are two different methods to dilute the content of the ampoule. One of those two dilutions are 10-fold less concentrated than the other (0.2 micrograms/ml vs 2 micrograms/ml) and may only be administered with an infusion pump. A more concentrated solution may be administered via a syringe driver.

Infusion rates (ml/hour) for different doses using an automatic infusion pump

In general, the ready-to-use infusion solution is administered intravenously using an automatic infusion pump.

In case of an iloprost 100 micrograms/ml concentrate for solution for infusion concentration of 0.2 micrograms/ml, the required infusion rate must be determined according to the below described scheme, to reach a dose within the range of 0.5 to 2.0 ng/kg/min.

The following table (Table 1) can be used to calculate the infusion rate corresponding to the individual weight of the patient and the dose to be administered. Match the patient’s actual body weight on the table, then set the infusion rate on the pump, based on the desired dose in ng/kg/min.

Table 1:

Infusion rates (ml/hour) for different doses using a syringe driver

A syringe driver with a 50 ml injection syringe may also be used to infuse iloprost.

In case of an iloprost concentration of 2 micrograms/ml, the required infusion rate must be determined according to the below described scheme (Table 2), to reach a dose within the range of 0.5 to 2.0 ng/kg/min.

The following table (Table 2) can be used to calculate the infusion rate corresponding to the individual weight of the patient and the dose to be infused. Match the patient’s actual body weight on the table, then set the infusion rate on the syringe driver based on the desired dose to be delivered in ng/kg/min.

Table 2:

The duration of treatment is up to 4 weeks.

The safety and efficacy of iloprost 100 micrograms/ml concentrate for solution for infusion have not been studied after treatment longer than 4 weeks or after repetitive treatment cycles.

Treatment of severe chronic ischemia of the lower limbs

The recommended dosage varies between 0.5 to 2 ng/kg/min for an infusion of 6h /per day depending on the patient’s tolerance.

Continue the treatment in general for four weeks, using the tolerated dose determined during the first two or three days of treatment.

The duration of treatment is usually four weeks. It may be less in case of early efficacy. The efficacy and safety of iloprost 100 micrograms/ml concentrate for solution for infusion has not been established for treatment times of more than four weeks or repeated courses of treatment in this indication. Continuous infusion over several days is not recommended. Although there were no clinical consequences, a tachyphylaxis of the effects on the platelets as well as a hyperaggregability at the stop of the treatment can occur.