Isturisa 5 mg film-coated tablets

Patient Information Leaflet

Introduction

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

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Isturisa is and what it is used for
2. What you need to know before taking 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 to treat endogenous Cushing's syndrome in adults, a condition in which the body produces too much of a hormone called cortisol. Excess cortisol can cause a variety of symptoms such as weight gain (especially around the waist), a rounded "moon" face, easy bruising, irregular menstrual periods, excess hair on the body and face, and general feelings of weakness, fatigue, or discomfort.

How Isturisa works

Isturisa blocks the main enzyme responsible for producing cortisol in the adrenal glands. This results in a reduction of excessive cortisol production and improvement of the symptoms of endogenous Cushing's syndrome.

2. What you need to know before taking Isturisa

Do not take Isturisa:

• if you are allergic to osilodrostat or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Isturisa.

Tell your doctor if you are in any of the following situations before taking Isturisa:

• if you have a heart condition or a heart rhythm disorder, such as irregular heartbeat, including a condition called QT prolongation (prolonged QT interval).
• if you have liver disease; your doctor may need to adjust the dose of Isturisa.

Contact your doctor immediately if you experience two or more of these symptoms during treatment with Isturisa. These may indicate adrenal insufficiency (low cortisol levels):

• weakness
• dizziness
• fatigue
• loss of appetite
• nausea
• vomiting

These symptoms may persist for months after stopping treatment with Isturisa. Contact your doctor, as you may require additional treatment and/or monitoring.

Monitoring before and during treatment

Your doctor will perform blood and/or urine tests before starting treatment and regularly during treatment. These tests are to detect any possible changes in levels of magnesium, calcium, and potassium, and also to measure cortisol levels. Depending on the results, your doctor may adjust your dose.

This medicine may have an undesirable effect (called QT prolongation) on heart function. Therefore, your doctor will also monitor this effect by performing an electrocardiogram (ECG) before starting treatment and during treatment.

If your Cushing’s Syndrome is due to a benign tumour (called an adenoma) in the pituitary gland, your doctor may consider stopping treatment if imaging of the pituitary gland shows that the adenoma has expanded into surrounding areas.

Children and adolescents

This medicine is not recommended for patients under 18 years of age due to lack of data in this patient group.

Other medicines and Isturisa

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines. It is especially important that you mention any of the following medicines:

• medicines that may have an undesirable effect (called QT prolongation) on heart function. These include medicines used for abnormal heart rhythm such as quinidine, sotalol, and amiodarone; allergy medicines (antihistamines); antidepressants such as amitriptyline and medicines for mental disorders (antipsychotics); antibiotics, including the following types: macrolides, fluoroquinolones, or imidazoles; and other medicines for Cushing’s disease (pasireotide, ketoconazole)
• theophylline (used to treat breathing problems) or tizanidine (used to treat muscle pain and muscle spasms).

Pregnancy and breastfeeding

This medicine should not be used during pregnancy or breastfeeding unless your doctor has instructed you to do so. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Contraception

Women of childbearing potential must use an effective method of contraception during treatment and for at least one week after the last dose. Discuss the need for contraception with your doctor before starting treatment with Isturisa.

Driving and using machines

Dizziness and fatigue may occur during treatment with Isturisa. Do not drive or operate machinery if you experience these symptoms.

Isturisa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially “sodium-free”.

3. How to take Isturisa

Follow exactly the instructions for using this medicine as given by your doctor.

If in doubt, consult your doctor or pharmacist again.

The usual starting dose is two 1 mg tablets twice daily (approximately every 12 hours). Patients of Asian origin and patients with liver disease may require a lower starting dose (one 1 mg tablet twice daily).

After starting treatment, your doctor may adjust your dose depending on your response to treatment. The highest recommended dose is 30 mg twice daily.

Isturisa tablets are taken orally and may be taken with or without food.

If you take more Isturisa than you should

If you have taken more Isturisa than you should and feel unwell (for example, weak, dizzy, tired, nauseous, or have vomiting), or if someone else accidentally takes your medicine, contact a doctor or hospital immediately. You may require medical treatment.

If you forget to take Isturisa

Do not take a double dose to make up for forgotten doses. Instead, wait until the time of your next dose and take it as scheduled.

If you stop taking Isturisa

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some adverse effects may be serious. Pay special attention to the following:

• Immediately inform your doctor if you experience a heart problem or irregular heartbeat, such as rapid and irregular beats, even at rest, palpitations, pre-syncope, or fainting (this may be a sign of a condition called QT prolongation, an adverse effect that may affect up to 1 in 10 people).
• Immediately inform your doctor if you have two or more of these symptoms: weakness, dizziness, tiredness (fatigue), loss of appetite, nausea, vomiting. This may indicate adrenal insufficiency (low cortisol levels), an adverse effect that may affect more than 1 in 10 patients. Adrenal insufficiency occurs when Isturisa reduces cortisol levels too much. It is more likely to occur during periods of increased stress. Your doctor will correct this condition by using a hormonal medicine or adjusting the dose of Isturisa.

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

• low cortisol levels (adrenal insufficiency)
• vomiting
• nausea
• diarrhoea
• abdominal pain
• tiredness (fatigue)
• fluid retention leading to swelling (oedema), especially in the ankles
• blood test abnormalities (increased testosterone levels, increased adrenocorticotropic hormone levels, also known as ACTH, low potassium levels)
• decreased appetite
• dizziness
• rapid heartbeat (tachycardia)
• myalgia (muscle pain)
• arthralgia (joint pain)
• headache
• rash
• low blood pressure (hypotension)
• excessive growth of facial or body hair (hirsutism)
• acne

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

• general feeling of being unwell (malaise)
• abnormal results in liver function tests
• fainting (syncope)
• abnormal electrical activity of the heart affecting heart rhythm.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 CAD/EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Isturisa

• The active substance is osilodrostat. Each film-coated tablet contains 1 mg of osilodrostat, 5 mg of osilodrostat or 10 mg of osilodrostat.

• The other components are:

  • In the tablet core: microcrystalline cellulose, mannitol, sodium croscarmellose (see section 2 “Isturisa contains sodium”), magnesium stearate, colloidal anhydrous silica.
  • In the coating: hypromellose, titanium dioxide (E171), iron oxides (E172, see below), macrogol and talc.
    • Isturisa 1 mg film-coated tablets contain yellow iron oxide and red iron oxide.

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

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

Appearance of Isturisa and contents of the pack

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

The 1 mg tablets are light yellow, round, unmarked on one side and engraved with a “1” on one face. The approximate diameter is 6.1 mm.

The 5 mg tablets are yellow, round, unmarked on one side and engraved with a “5” on one face. The approximate diameter is 7.1 mm.

The 10 mg tablets are light orange-brown, round, unmarked on one side and engraved with a “10” on one face. The approximate diameter is 9.1 mm.

Marketing Authorisation Holder

Recordati Rare Diseases

Tour Hekla

52 avenue du Général de Gaulle

92800 Puteaux

France

Manufacturer

Millmount Healthcare Ltd

Block 7, City North

Business Campus, Stamullen,

Co. Meath, K32 YD60,

Ireland

Recordati Rare Diseases

Tour Hekla

52 avenue du Général de Gaulle

92800 Puteaux

France

Recordati Rare Diseases

Eco River Parc

30 rue des Peupliers

92000 Nanterre

France

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet: 12/2024

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu