What is Tractocile?
Tractocile is a solution for injection or a drip concentrate (slow infusion into a vein), containing the active substance atosiban (7.5 mg per milliliter).
What is Tractocile used for?
Tractocile is used to delay childbirth in pregnant patients aged 18 and over who are between the 24th and 33rd week of pregnancy, if there are signs of an impending (premature) preterm birth. These signals include:
- at least four regular contractions every 30 minutes of at least 30 seconds each;
- cervical dilation (of the cervix) of 1-3 cm and disappearance of the cervix (reduction of its thickness) by at least 50%.
Another essential condition is that the fetus has a normal heart rate.
The medicine can only be obtained with a prescription.
How is Tractocile used?
Treatment with Tractocile should be carried out by physicians experienced in the management of preterm labor and should be started as soon as possible after this diagnosis. Tractocile is given into a vein over a maximum of 48 hours in three phases: an initial injection (6.75 mg), followed by a high-dose drip (300 micrograms / min) over three hours, then by low infusion dosage (100 micrograms / min) for a maximum duration of 45 hours. The total dose of Tractocile given over the entire therapy should not exceed 330 mg. In the event that the contractions recur, it is possible to repeat the treatment with Tractocile up to a maximum of three times during the pregnancy. The patient cannot be treated with Tractocile more than three times during the same pregnancy. There are no data on the need to adjust the dose for patients with kidney or liver problems.
How does Tractocile work?
The active ingredient in Tractocile, atosiban, is an antagonist of oxytocin, a natural hormone, which means it blocks its action. Oxytocin is the hormone responsible for the onset of uterine contractions. By blocking the action of oxytocin, Tractocile prevents uterine contractions and causes uterine relaxation, helping to delay birth.
How has Tractocile been studied?
The effectiveness of Tractocile in delaying preterm birth has been the subject of three main studies involving 742 women between the 23rd and 33rd week of pregnancy. Tractocile was compared with ritodina, terbutaline and salbutamol (all substances belonging to another class of drugs called "beta-agonists", used in cases of premature labor). The main parameter to evaluate the effectiveness was the success of the treatment after one week.
What benefit has Tractocile shown during the studies?
Considering the results of the three main studies as a whole, 60% of the patients treated with Tractocile had not yet given birth one week after starting treatment (201 out of 337), compared to 48% of patients treated with the other comparative drugs (163 out of 342). The number of patients not yet reached the 28th week of pregnancy was too small for the effectiveness of Tractocile to be determined for this group of patients compared to beta-agonists. The greater efficacy of Tractocile compared to beta-agonists could be due to the fact that Tractocile caused fewer unwanted effects, thus allowing the whole treatment to be completed.
What is the risk associated with Tractocile?
The most common side effect seen with Tractocile (or more than one in 10 patients) is nausea. No side effects have been reported in newborns. For the full list of all side effects reported with Tractocile, see the Package Leaflet.
Tractocile should not be used in patients who may be hypersensitive (allergic) to atosiban or any of the other components. It should also not be used in patients who have not reached the 24th or who have passed the 33rd week of pregnancy or with premature rupture of the water, blood loss from the uterus, eclampsia (a dangerous condition that can occur at the end of the pregnancy resulting from the presence of toxins in the blood), preeclampsia (a condition that can lead to eclampsia) or problems with the placenta. For the full list of usage restrictions, see the package leaflet.
Why has Tractocile been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the efficacy demonstrated by Tractocile in delaying preterm birth is equal to the efficacy of beta-agonists and that the best results obtained by Tractocile are due to a better tolerance to this drug. The Committee therefore decided that the benefits of Tractocile are greater than the risks, when given to pregnant patients in order to delay an imminent preterm birth. The Committee therefore recommended that the medicinal product be granted marketing authorization.
More information on Tractocile?
On 20 January 2000, the European Commission issued a marketing authorization for Tractocile, valid throughout the European Union. The authorization was renewed on January 20, 2005. The Marketing Authorization Holder is Ferring Pharmaceuticals A / S.
The full EPAR for Tractocile can be found here.
Last update of this summary: 12-2008
