Isotretinoin

Isotretinoin is a retinoid, which is a type of Vitamin A. It is commonly used for the treatment of severe acne. This information sheet from Great Ormond Street Hospital (GOSH) explains what isotretinoin acid is, how it is given and some of the possible side effects.

Retinoids are thought to influence the way in which cells grow and develop, and prevent the production of specific genes that may cause cancer. It is known to be effective in the treatment of a number of different types of cancer. It has recently been shown to improve survival in patients with a stage four neuroblastoma.

Isotretinoin is also called 13-cis-retinoic acid. A commonly used brand of isotretinoin is Roaccutane®, which is available as 10mg and 20mg capsules.

Important: Soya Allergy

Roaccutane® contains soya. If your child is allergic to soya he or she should not take Roaccutane®. Please tell your doctor who will be able to discuss possible alternative treatment with you.

How long should it be taken for?

The dose has been calculated either according to your child’s body weight or surface area. You should give one dose to your child twice a day for 14 days in a row, followed by a break of 14 days. Your doctor or pharmacist will tell you how many capsules this is. This 28-day course is usually repeated five more times. Giving the treatment in this way has been shown to be the best way to achieve maximum effect with the minimum of side effects.

What are the side effects?

Common side effects include dry or peeling skin, cracked lips and dry eyes. Moisturisers and lipsalves containing vitamin E can be helpful when the skin and lips are cracked and dry. Your child’s skin may also become more sensitive to sunlight. Your child should avoid being exposed to sunlight and other forms of ultraviolet light.

If he or she does go out in the sun, always use a good sunblock (SPF 50 or higher and wear a hat). If any of these side effects cause problems for your child, please tell your doctor or nurse. 

There are also several less common side effects. Therefore your child’s blood will be tested regularly for these side effects. All of these are temporary and reversible.

Isotretinoin can cause some mild changes to your child’s liver function. This will not have any noticeable effect and will return to normal when the treatment has finished. Blood tests will be taken to monitor your child’s liver function and doses adjusted if necessary. 

Isotretinoin can cause raised levels of some fats in the blood. This will not have any noticeable effect. Blood tests will be taken and doses adjusted if necessary. Mild bone marrow suppression will not have any noticeable effect.

Isotretinoin must not be given to patients who may be pregnant or are likely to become pregnant in the near future. If your daughter is ten years old or older, we will ask her about her periods and any possibility that she could be pregnant. If your daughter is sexually active, she must use a reliable form of contraception.

Interactions with other medicines

Some medicines can react with isotretinoin, altering how well it works. 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.

Important information

„„You may be able to obtain further supplies from your Shared Care Centre. Ask the pharmacist when you collect your child’s prescription. You cannot get this medicine from your GP or local community pharmacy. 

„„Do not give your child any other medicines that contain Vitamin A, while he or she is taking isotretinoin. If you are not sure about other medicines, please ask your pharmacist, doctor or nurse.

If your child takes too much, you should take him or her to your local Accident and Emergency Department immediately.

If you forget to give your child a dose, do not give a double dose. Inform your doctor or nurse and keep to your child’s regular dose schedule.

„„Keep the capsules in a safe place where children cannot reach them.

Isotretinoin capsules should be stored at room temperature, out of bright sunlight, in their original packaging.

„„You should handle these medicines with care, avoiding touching the capsules where possible. If you are pregnant or think you could be pregnant, please discuss handling instructions with your doctor, nurse or pharmacist.

If your child vomits after taking the dose, inform the doctor or nurse. Do not give them another dose. 

If the medication passes its expiry date or your doctor decides to stop isotretinoin, return any remaining capsules to the pharmacist. Do not flush them away. 

If you accidentally spill the contents of the capsules, wash the area thoroughly with plenty of water. 

If the mixture gets into your eyes, wash with plenty of running water for five to ten minutes. 

„„Vomit and dirty disposable nappies should be placed inside two rubbish bags and disposed of along with your normal rubbish. 

„„This medicine is very thick and sticks to the sides of nasogastric tubes. Even if you usually give medicines to your child through a nasogastric tube you should try and give this medicine by mouth. If you have difficulties please ask your nurse or doctor.

If your child cannot swallow capsules, you can mix the medication with ice cream, yoghurt or similar food like chocolate mousse, as below. You should do this away from bright sunlight.

  1. Assemble all the equipment you will need:
  • non-sterile gloves (disposable or tight fitting household gloves)
  • a small pair of sharp, clean scissors (to be used only for this purpose)
  • a dessert spoon
  • a teaspoon
  • a small tray (this can be plastic or disposable cardboard)
  • small portion of ice cream, yoghurt or chocolate mousse
  • kitchen roll - kept just for this purpose 
  • a sharps bin
  • plastic medicine pot.
  1. Remove the capsule from the blister pack and put the required number of capsules for each dose into the plastic medicine pot.
  2. Put the gloves on.
  3. Place the dessert spoon on a clean surface.
  4. Take a capsule between finger and thumb and hold upright firmly
  5. Working over the tray use the scissors to cut the tip off the capsule and then carefully squeeze the contents on to the dessert spoon. If the capsules are too hard to cut, try putting them (still in their foil packaging) in the plastic medicine pot with some warm water for a minute or two.
  6. Discard the empty capsule in the sharps bin.
  7. Use the kitchen roll to wipe any drug from the gloves and then dispose of the used kitchen roll immediately in the sharps bin.
  8. Repeat for each capsule needed.
  9. After all the required capsules have been snipped, use the teaspoon to place some soft ice cream, yoghurt or mousse onto the dessertspoon.
  10. Using the teaspoon mix the ice cream, yoghurt or mousse with the medicine.
  11. Give the medicine to your child.
  12. Clean all equipment, including scissors and gloves (if using house-hold gloves) in warm soapy water.
  13. Put the disposable gloves in the sharps bin. Wash your hands thoroughly.
  14. Return the sharps bin to hospital when full.
Compiled by: 
The Pharmacy department in collaboration with the Child and Family Information Group.
Last review date: 
December 2015
Ref: 
2015F0213

Disclaimer

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.