ISTURISA 10 mg FILM-COATED TABLETS

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

Consult your doctor or pharmacist before taking Isturisa.

If you are in any of the following situations, inform your doctor before taking Isturisa:

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

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

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

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

Checks before and during treatment

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

This medicine may have an unwanted effect (called QT prolongation) on the heart. Your doctor will therefore also check this effect by performing an electrocardiogram (ECG) before starting treatment and during treatment.

If your Cushing's syndrome is due to a benign tumor (called an adenoma) in the pituitary gland, your doctor may consider stopping treatment if the pituitary gland scan shows that the adenoma has expanded into surrounding areas.

Children and adolescents

This medicine is not recommended for patients under 18 years of age. This is due to the 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 especially important that you mention any of the following medicines:

• medicines that may have an unwanted effect (called QT prolongation) on the heart. These include medicines used for irregular heartbeat such as quinidine, sotalol, and amiodarone; medicines for allergies (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 respiratory problems) or tizanidine (used to treat muscle pain and muscle cramps).

Pregnancy and breastfeeding

This medicine must not be used during pregnancy and breastfeeding unless your doctor has told you to do so. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Contraception

Women who can become pregnant must use an effective contraceptive method during treatment and for at least one week after the last dose. Consult your doctor about the need for contraception before starting treatment with Isturisa.

Driving and using machines

Dizziness and fatigue may occur during treatment with Isturisa. Do not drive or use machines if you have these symptoms.

Isturisa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Isturisa

Follow the instructions for administration of this medicine exactly as told by your doctor.

In case of doubt, consult your doctor or pharmacist again.

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

After starting treatment, your doctor may change the dose. This will depend on how you respond to treatment. The highest recommended dose is 30 mg twice a day.

Isturisa tablets are taken orally 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 do not feel well (for example, you feel weak, dizzy, tired, nauseous, or have vomiting), or if someone else has taken your medicine by mistake, contact a doctor or hospital immediately. You may need 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 the next dose and take it when it is due.

If you stop taking Isturisa

Do not stop taking Isturisa unless your doctor tells you to. If you stop taking Isturisa, the 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.Pay special attention to the following:

• Tell your doctor immediately if you have a heart condition or an irregular heart rhythm, such as rapid and irregular heartbeats, even at rest, palpitations, lipotimias, or fainting (this may 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, dizziness, fatigue, loss of appetite, nausea, vomiting. This may indicate that you have adrenal insufficiency (low cortisol levels), a side effect that may affect more than 1 in 10 patients. Adrenal insufficiency occurs when Isturisa decreases cortisol levels too much. It is more likely to occur during periods of increased stress. Your doctor will correct this situation using a hormonal medicine or adjusting the dose of Isturisa.

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

• low cortisol levels (adrenal insufficiency)
• vomiting
• nausea
• diarrhea

• abdominal pain
• fatigue
• fluid accumulation, which leads to swelling (edema), especially in the ankles
• changes in blood tests (increased testosterone levels, increased adrenocorticotropic hormone levels, also known as ACTH, low potassium levels)
• decreased appetite
• dizziness
• rapid heartbeat (tachycardia)
• muscle pain (myalgia)
• joint pain (arthralgia)
• headache
• rash
• low blood pressure (hypotension)
• excessive hair growth on the face or body (hirsutism)
• acne

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

• general feeling of being unwell (malaise)
• abnormal liver function tests
• fainting (syncope)
• abnormal heart rhythm.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. 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 Appendix V. By reporting side 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 blister after EXP. The expiry date refers to the last day of the month shown.

Do not store above 25°C.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 of osilodrostat, 5 mg of osilodrostat, or 10 mg of osilodrostat.
• The other ingredients are:
• • In the tablet core: microcrystalline cellulose, mannitol, sodium croscarmellose (see section 2 "Isturisa contains sodium"), magnesium stearate, anhydrous colloidal 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 pack contents

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

The 1 mg tablets are light yellow, round, not scored, and have a "1" engraved on one side. The approximate diameter is 6.1 mm.

The 5 mg tablets are yellow, round, not scored, and have a "5" engraved on one side. The approximate diameter is 7.1 mm.

The 10 mg tablets are light orange-brown, round, not scored, and have a "10" engraved on one side. 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

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:12/2024

Other sources of information

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