The use of iloprost in children is not currently licensed in the UK. Medicines are often used outside of their license (off-label) in children because trial data is not available for a specific use. Prescribing medicines ‘off label’ is not necessarily hazardous but should be explained and agreed before use.
How is it given?
Iloprost is available as a 10microgram/ml solution which should be administered via a specific nebuliser called an i-Neb®. The nebuliser changes the solution into a mist which is then inhaled.
Breathing in the mist carries the iloprost directly to the blood vessels in the lungs making them widen. Your doctor, nurse or pharmacist will have explained to you how to give the dose before you leave hospital. When using the nebuliser, always make sure the room is well ventilated and that only a mouthpiece is used rather than a mask.
Who should not take iloprost?
People with the following conditions should discuss taking iloprost with their doctor:
- Hypersensitivity to iloprost or any of its ingredients
- Bleeding disorders
- Recent history of stroke or heart attack
- Pregnancy, possibility of pregnancy, trying to become pregnant or breastfeeding
What are the side effects of iloprost?
If any of these side effects are severe or persist for a long time, please tell the Pulmonary Hypertension team:
- Dizziness or light-headedness (this may be helped by getting up slowly after sitting or lying down)
- Tongue pain or throat irritation
If any of the following side effects occur, please contact the Pulmonary Hypertension team for advice:
- Chest discomfort
- Muscle or jaw pain
- Coughing of blood or blood stained sputum
- Unexplained or prolonged episodes of bleeding
Some people develop an allergic reaction to iloprost, which may be mild or severe. Signs of a mild reaction include skin rashes and itching, high temperature, shivering, redness of the face, a feeling of dizziness or a headache. If you see any of these signs please report them to a doctor or nurse.
Signs of a severe allergic reaction include any of the above, as well as shortness of breath or chest pain. If you are in hospital and your child shows signs of a severe allergic reaction, call a doctor or nurse immediately. If you are at home, call an ambulance immediately. If your child has a severe reaction to iloprost, subsequent treatment will be changed.
Iloprost and other medicines
Some medicines can interact with iloprost and may alter its effects. Always check with your doctor or pharmacist before giving your child any other medicine, including medicines on prescription from your family doctor (GP), medicines bought from a pharmacy (chemist) or any herbal or complementary medicines.
Iloprost should not be taken with the following medicines except upon the advice of your doctor:
- Antihypertensives (blood pressure medicine)
- Anticoagulants and antiplatelets (blood thinning medicine)
- Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen
Please read this information sheet from GOSH alongside the patient information leaflet (PIL) provided by the manufacturer. If you do not have a copy of the manufacturer’s patient information leaflet please talk to your pharmacist. A few products do not have a marketing authorisation (licence) as a medicine and therefore there is no PIL.
For children in particular, there may be conflicts of information between the manufacturer’s patient information leaflet (PIL) and guidance provided by GOSH and other healthcare providers. For example, some manufacturers may recommend, in the patient information leaflet, that a medicine is not given to children aged under 12 years. In most cases, this is because the manufacturer will recruit adults to clinical trials in the first instance and therefore the initial marketing authorisation (licence) only covers adults and older children.
For new medicines, the manufacturer then has to recruit children and newborns into trials (unless the medicine is not going to be used in children and newborns) and subsequently amend the PIL with the approved information. Older medicines may have been used effectively for many years in children without problems but the manufacturer has not been required to collect data and amend the licence. This does not mean that it is unsafe for children and young people to be prescribed such a medicine ‘off-licence/off-label’. However, if you are concerned about any conflicts of information, please discuss with your doctor, nurse or pharmacist.