Sirolimus ointment is an immunosuppressive medication used to treat patients with tuberous sclerosis complex (TSC) who develop facial angiofibroma’s.
Sirolimus Ointment (0.1%–0.5%) in White Soft Paraffin
Sirolimus ointment is available in strengths of 0.1%, 0.2%, or 0.5%, is an immunosuppressive medication used to treat patients with tuberous sclerosis complex (TSC) who develop facial angiofibroma’s.
At a strength of 0.5%, it is also used to treat certain vascular malformations.
Vascular anomalies mean conditions caused by an excess/entanglement of blood and lymphatic vessels causing problems
Topical sirolimus is used in cases where these abnormalities are located on or near the skin’s surface.
The ointment works by obstructing the growth of cells responsible for lesion formation.
While oral sirolimus suppresses the immune system, studies show that in topical formulations at low concentrations, it does not significantly enter the bloodstream. As a result, systemic immune suppression is generally not a concern.
Exceptions to this can be if sirolimus applied areas such as the lips or around the mouth. If this is case the supervising clinician will advise whether blood monitoring of sirolimus levels is required?
Back to topHow is this medicine given?
- A thin coating should be applied to the affected areas once a day in the evening. Allow to air dry for 60 minutes and remove by gentle washing the next morning.
- It is important that you do not touch the ointment directly with your hands. Gloves should be worn. If you are pregnant or think you may be pregnant or are breast feeding it is better to avoid handling this medication if at all possible.
- Use a disposable non-metal applicator to apply ointment. This can be a cotton bud. Try, as far as possible, not to apply to the normal surrounding skin. If contact does occur, wash and dry the area.
- Use extra care when applying ointment around the eyes, nose, and mouth.
- Wash your hands immediately after handling this medicine.
- Waste products, gloves, used paper towels for example, should be placed in a double lined plastic rubbish bin. The double bag should be disposed of as for normal household waste.
- Avoid unnecessary contact with the ointment and minimise contact with any clothing
Accidental contact
Skin
If contact occurs with your skin, you must wash the area immediately, using plenty of water. If the skin is sore, you should contact your clinic doctor or your GP (family doctor), for advice.
Eyes
If contact occurs with your eyes, wash immediately with plenty of water for at least ten minutes. If after this your eyes are sore you should go to your nearest Accident and Emergency (A+E) department.
Surfaces
If you spill any ointment on the work surface or floor, wearing gloves, cover the spillage with kitchen paper.
Wipe up as much as possible and then clean with household cleaner and water. Used kitchen paper, gloves and other items used to clean up the spillage should be double bagged and disposed of with the household waste.
Clothing
If any ointment comes into contact with your clothing, the area 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.
Side-effects
Skin irritation
Skin irritation is possible. If this occurs inform your clinic doctor
Skin protection
It is essential to protect skin from the sun due to the theoretical increase risk of skin cancer associated with the treatment due to its immune suppressive effects. This can be done with shade and suitable tight-weave dark coloured clothing or SPF50 sun cream with a 5* UVA rating, reapplied every 2 hours.
General safety
- Keep all medicines in a safe place where children cannot reach them.
- It is important to give medicines as directed by the doctor, nurse or pharmacist and at the right time.
- Sirolimus ointment has a three-month expiry. It should be stored at room temperature. Return any remaining ointment to your pharmacist.
- If the doctor decides to stop treatment, return any remaining ointment to your pharmacist.
- Sirolimus ointments are specialist treatments that can only be provided by Leeds Teaching Hospitals pharmacies.
- Sirolimus ointments are paraffin-based products.
- If paraffin-based products are covered by a dressing or clothing, there is a danger that smoking, or using a naked flame could cause the dressing or clothing to catch fire. Please speak to your doctor, nurse or pharmacist if you have any questions about this information.
If you are concerned about anything contained within this information, please ring one of the contact numbers below. Ask your doctor, nurse or pharmacist if you have more general queries or concerns.
