Find similar products:
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PLGB 15266/0029.
Isturisa, INN-osilodrostat
Isturisa 1 mg film-coated tablets
Isturisa 5 mg film-coated tablets
Isturisa 10 mg film-coated tablets
osilodrostat
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What Isturisa is and what it is used for
2. What you need to know before you take Isturisa
3. How to take Isturisa
4. Possible side effects
5. How to store Isturisa
6. Contents of the pack and other information
Isturisa is a medicine that contains the active substance osilodrostat.
Isturisa is used in adults to treat endogenous Cushing’s syndrome, a condition in which the body produces too much of a hormone called cortisol. Too much cortisol may lead to a variety of symptoms such as weight gain (particularly around the waist), a moon-shaped face, bruising easily, irregular periods, excessive body and facial hair, and generally feeling weak, tired or unwell.
Isturisa blocks the main enzyme that makes cortisol in the adrenal glands. The effect of this is to decrease the over-production of cortisol and improve the symptoms of endogenous Cushing’s syndrome.
Talk to your doctor or pharmacist before taking Isturisa.
If any of the following apply to you, tell your doctor before taking Isturisa:
Contact your doctor immediately if you have two or more of these symptoms during your treatment with Isturisa. This may indicate that you have adrenal insufficiency (low cortisol levels):
After Isturisa discontinuation, these symptoms may persist for months. You should contact with your doctor since you may need additional monitoring and/or treatment.
Your doctor will test your blood and/or urine before you start treatment and regularly during treatment. This is to detect any possible abnormalities in your magnesium, calcium and potassium levels and also to measure the levels of cortisol. Depending on the results, your doctor may change your dose.
This medicine may have an unwanted effect (called QT prolongation) on the function of the heart. Your doctor will therefore also check for this effect by performing an electrocardiogram (ECG) before you start treatment and during treatment.
If your Cushing’s syndrome is caused by a benign tumour (called adenoma) in the pituitary gland, your doctor may consider stopping your treatment if a pituitary scan shows that the adenoma has expanded into neighbouring regions.
This medicine is not recommended for patients aged under 18 years. This is because there is a lack of data in these patients.
Tell your doctor if you are taking, have recently taken or might take any other medicines. It is particularly important that you mention any of the following medicines:
This medicine should not be used during pregnancy or breast-feeding, unless your doctor has advised you to do so. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Women who could become pregnant should use an effective method of contraception during treatment and for at least one week after the last dose. Ask your doctor about the need for contraception before you start taking Isturisa.
Dizziness and tiredness may occur during treatment with Isturisa. Do not drive or operate machines if you get these symptoms.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The usual starting dose is two 1 mg tablets twice a day (about every 12 hours). Patients of Asian ancestry and patients with liver disease may need a lower starting dose (one 1 mg tablet twice a day).
After you have started treatment, your doctor may change your dose. This will depend on how you respond to the treatment. The highest recommended dose is 30 mg twice a day.
Isturisa tablets are taken by mouth and can be taken with or without food.
If you have taken more Isturisa than you should and you feel unwell (for example if you feel weak, light-headed, tired or sick, or if you have to vomit), or if someone else accidentally takes your medicine, contact a doctor or hospital for advice immediately. Medical treatment may be needed.
Do not take a double dose to make up for a forgotten dose. Instead, just wait until it is time for your next dose and take that at the scheduled time.
Do not stop taking Isturisa unless your doctor tells you to. If you stop your treatment with Isturisa, your symptoms may come back.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be serious. Please take particular note of the following:
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system : Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Isturisa is available in packs containing 60 film-coated tablets.
The 1 mg tablets are pale yellow, round, unscored and debossed with ‘1’ on one side. The approximate diameter is 6.1 mm.
The 5 mg tablets are yellow, round, unscored and debossed with ‘5’ on one side. The approximate diameter is 7.1 mm.
The 10 mg tablets are pale orange brown, round, unscored and debossed with ‘10’ on one side. The approximate diameter is 9.1 mm.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 12/2024