Isotretinoin

Isotretinoin is a retinoid, which is a type of Vitamin A. It is commonly used for the treatment of severe acne. Retinoids are thought to influence the way in which cells grow and develop, and prevent the production of specific genes that may cause cancer.This page from Great Ormond Street Hospital (GOSH) explains what isotretinoin is, how it is given and some of the possible side effects. 

Isotretinoin is a retinoid, which is a type of Vitamin A. It is commonly used for the treatment of severe acne. 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, which is available as 10mg and 20mg capsules( and 20mg/ml oral liquid if you are on a clinical trial) . There is now also a liquid formulation available as part of a clinical trial for patients with neuroblastoma.
 
Soya allergy - Isotretinoin capsules contains soya. If your child is allergic to soya he or she should not take isotretinoin. Please tell your doctor who will be able to discuss possible alternative treatment with you.

How is it given?

It is given by mouth as a capsule or liquid. 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 to give.
 
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?

Drying of skin, lips and eyes

Moisturisers and lip salves containing vitamin E should be used during treatment with isotretinoin, ideally even before the skin and lips become cracked and dry.

Sensitivity to sunlight

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 they do go out in the sun, always use a good sunblock (SPF 50 or higher and wear a hat). 

Changes in liver function

Isotretinoin may change how well your child’s liver works. These changes may happen rapidly. Blood tests (LFTs) will be taken to monitor your child’s liver function during treatment. Please contact your doctor immediately if your child complains of pain in their right side or the whites of their eyes or their skin develops a yellow tinge.

Increase in blood fats

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

Effects on the unborn child

Isotretinoin must not be given to girls 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. We will also carry out a pregnancy test on a fresh urine sample. If your daughter is sexually active, she must use a reliable form of contraception.

Bone marrow suppression

There will be a temporary reduction in how well your child’s bone marrow works. This is unlikely to have any noticeable effects.

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.

Giving isotretinoin in a mixture at home

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:
  • gloves (disposable or household)
  • 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
  • a plastic medicine pot 
  1. Put the on gloves.
  2. Remove the capsule from the blister pack and put the required number of capsules for each dose into the plastic medicine pot.
  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. 

Note: 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.

  1. Discard the empty capsule in the sharps bin.
  2. Use the kitchen roll to wipe any drug from the gloves and then dispose of the used kitchen roll immediately in the sharps bin.
  3. Repeat for each capsule needed.
  4. After all the required capsules have been snipped, use the teaspoon to place some soft ice cream, yoghurt or mousse onto the dessertspoon.
  5. Using the teaspoon mix the ice cream, yoghurt or mousse with the medicine. 
  6. Give the medicine to your child.
  7. Clean all equipment, including scissors and gloves (if using house-hold gloves) in warm soapy water.
  8. Put the disposable gloves in the sharps bin. Wash your hands thoroughly.
  9. Return the sharps bin to hospital when full.
Note: 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 to give this medicine by mouth. If you have difficulties please ask your nurse or doctor.

Accidental spillages

  • If you accidentally spill the contents of the capsules or mixture on the work surface or floor, wearing gloves, cover the spillage with kitchen paper. Wipe the area with water then clean with household cleaner and water. 
  • If the mixture gets onto your skin, you must wash the area immediately, using plenty of water. If the skin is sore you should contact your GP (family doctor) for advice.
  • If the mixture accidentally gets into your eyes, wash with plenty of running water for at least 10 minutes. If your eyes are sore after this, you should go to your nearest Accident and Emergency (A&E) department.
  • If the mixture is spilt on clothing, the spill should be blotted dry with kitchen paper. Clothing should be removed immediately and washed separately from other items. Used kitchen paper should be disposed of as above.
  • Used paper towels, masks, vomit and dirty disposable nappies should be placed inside two rubbish bags and disposed of along with your normal rubbish.
If any type of spillage occurs you should contact GOSH for advice immediately.

Important

  • Keep all medicines in a safe place where children cannot reach them. 
  • Isotretinoin capsules should be kept in a cool, dry place away from direct sunlight or heat. Keep the capsules in their original packaging. 
  • 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 they are taking isotretinoin. If you are not sure about other medicines, please ask your pharmacist, doctor or nurse.
  • 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. Please see our Special handling requirements information sheet for further details.
  • If you forget to give your child a dose and it is within a few hours of when the dose was due, give it as soon as you remember. Otherwise, do not give this dose but wait until the next dose is due. Do not give a double dose. 
  • If your child vomits straight after taking the dose, inform your doctor or nurse, as your child may need to take another one.
  • If your doctor decides to stop treatment with isotretinoin or the medicine passes its expiry date, return any remaining medicine to the pharmacist. Do not flush it down the toilet or throw it away.
Compiled by: 
The Pharmacy department in collaboration with the Child and Family Information Group.
Last review date: 
October 2019
Ref: 
2019F0213

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.