Isturisa - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Isturisa 1 mg film-coated tablets

Isturisa 5 mg film-coated tablets

Isturisa 10 mg film-coated tablets

osilodrostat

'VThis medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

• 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

1. What Isturisa is and what it is used for

What Isturisa is

Isturisa is a medicine that contains the active substance osilodrostat.

What Isturisa is used for

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.

How Isturisa works

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.

2. What you need to know before you take Isturisa

Do not take Isturisa:

• – if you are allergic to osilodrostat or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Isturisa.

If any of the following apply to you, tell your doctor before taking Isturisa:

• – if you have a heart disorder or a heart rhythm disorder, such as an irregular heartbeat, including

a condition called prolonged QT syndrome (QT interval prolongation).

• – if you have a liver disease; your doctor may need to change your dose of 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): – weakness

• – light-headedness

• – tiredness

• – lack of appetite

• – nausea (feeling sick)

• – vomiting

Tests before and during 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.

Children and adolescents

This medicine is not recommended for patients aged under 18 years. This is because there is a lack of data in these patients.

Other medicines and Isturisa

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:

• – medicines that may have an unwanted effect (called QT prolongation) on the function of the

heart. These include medicines used for abnormal heart rhythm such as quinidine, sotalol and amiodarone; medicines used for allergies (antihistamines); antidepressants such as amitriptyline and drugs for mental health disorders (antipsychotics); antibiotics, including the following types: macrolides, fluoroquinolones or imidazole; and other medicines for Cushing’s disease (pasireotide, ketoconazole)

• – theophylline (used to treat breathing problems) or tizanidine (used to treat muscle pain and

muscle cramps)

Pregnancy and breast-feeding

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.

Contraception

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.

Driving and using machines

Dizziness and tiredness may occur during treatment with Isturisa. Do not drive or operate machines if you get these symptoms.

3. How to take Isturisa

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 take more Isturisa than you should

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.

If you forget to take Isturisa

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.

If you stop taking Isturisa

Do not stop taking Isturisa unless your doctor tells you to. If you stop your treatment with Isturisa, your symptoms may come back.

4. Possible side effects

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:

• – Tell your doctor immediately if you experience a heart disorder or heart rhythm disorder, such

as a fast and irregular heartbeat, even when you are at rest, heart palpitations, blackouts or fainting (this could be a sign of a condition called QT prolongation, a side effect that may affect up to 1 in 10 people).

• – Tell your doctor immediately if you have two or more of these symptoms: weakness,

light-headedness, tiredness (fatigue), lack of appetite, nausea (feeling sick), vomiting. This may indicate that you have adrenal insufficiency (low cortisol levels), a side effect that may affect more than 1 in 10 people. Adrenal insufficiency occurs when Isturisa lowers the amount of cortisol too much. It is more likely to occur during periods of increased stress. Your doctor will correct this by using a hormone medicine or by adjusting the dose of Isturisa.

Very common side effects (may affect more than 1 in 10 people):

• – vomiting

• – nausea (feeling sick)

• – diarrhoea

• – abdominal pain

• – tiredness (fatigue)

• – build-up of fluid leading to swelling (oedema), particularly of your ankles

• – abnormal blood tests (increased levels of testosterone, increased levels of adrenocortico­trophic

hormone, also known as ACTH, low levels of potassium)

• – decreased appetite

• – dizziness

• – headache

• – rash

• – low blood pressure (hypotension)

Common side effects (may affect up to 1 in 10 people):

• – fast heartbeat (tachycardia)

• – general feeling of being unwell (malaise)

• – abnormal results of liver function tests

• – fainting (syncope)

• – excessive facial or body hair growth (hirsutism)

• – acne

Reporting of side effects

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 listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Isturisa

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.

6. Contents of the pack and other information

What Isturisa contains

• – The active substance is osilodrostat. Each film-coated tablet contains 1 mg osilodrostat, 5 mg

osilodrostat or 10 mg osilodrostat.

• – The other ingredients are:

• – In the tablet core: microcrystalline cellulose, mannitol, croscarmellose sodium,

magnesium stearate, colloidal anhydrous silica.

• – In the film coating: hypromellose, titanium dioxide (E171), iron oxides (E172, see

below), macrogol and talc.

• – Isturisa 1 mg film-coated tablets contain iron oxide yellow and iron oxide red.

• – Isturisa 5 mg film-coated tablets contain iron oxide yellow.

• – Isturisa 10 mg film-coated tablets contain iron oxide yellow, iron oxide red and

What Isturisa looks like and contents of the pack

Isturisa is available in packs containing 60 film-coated tablets.

The 1 mg tablets are pale yellow, round and marked “Y1” on one side and “NVR” on the other side.

The approximate diameter is 6.1 mm.

The 5 mg tablets are yellow, round and marked “Y2” on one side and “NVR” on the other side. The approximate diameter is 7.1 mm.

The 10 mg tablets are pale orange brown, round and marked “Y3” on one side and “NVR” on the other side. The approximate diameter is 9.1 mm.

Marketing Authorisation Holder Recordati Rare Diseases

Immeuble Le Wilson

70 avenue du Général de Gaulle

92800 Puteaux

France

Manufacturer

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nuremberg

Germany

Recordati Rare Diseases

Immeuble Le Wilson

70 avenue du Général de Gaulle

92800 Puteaux

France

Recordati Rare Diseases

Eco River Parc

30 rue des Peupliers

92000 Nanterre

France

Eesti Recordati AB. Tel: + 46 8 545 80 230 Rootsi	Norge Recordati AB. Tlf: + 46 8 545 80 230 Sverige
EMáSa Recordati Hellas Tql: +30 210 6773822	Österreich Recordati Rare Diseases Germany GmbH Tel: +49 731 140 554 0 Deutschland
España Recordati Rare Diseases Spain S.L.U. Tel: + 34 91 659 28 90	Polska Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Francja
France Recordati Rare Diseases Tél: +33 (0)1 47 73 64 58	Portugal Jaba Recordati S.A. Tel: +351 21 432 95 00
Hrvatska Recordati Rare Diseases Tél: +33 (0)1 47 73 64 58 Francuska	Romania Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Franta
Ireland Recordati Rare Diseases Tél: +33 (0)1 47 73 64 58 France	Slovenija Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Francija
Ísland Recordati AB. Simi: + 46 8 545 80 230 Sví^jóó	Slovenská republika Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Francúzsko
Italia Recordati Rare Diseases Italy Srl Tel: +39 02 487 87 173	Suomi/Finland Recordati AB. Puh/Tel : +46 8 545 80 230 Sverige
Kúnpog Recordati Rare Diseases TnX : +33 1 47 73 64 58 raXXía	Sverige Recordati AB. Tel : +46 8 545 80 230

Latvija Recordati AB. Tel: + 46 8 545 80 230 Zviedrija

United Kingdom Recordati Rare Diseases UK Ltd. Tel: +44 (0)1491 414333

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

35