1 mg, 5 mg, 10 mg film-coated tablets
osilodrostat

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, which means that the body produces too much of the hormone et cortisol. Too much cortisol in the body leads to various symptoms such as weight gain (especially around the waist), around the face (“moon face”), easy bruising, irregular menstruation, increased hair growth on the body and face, and a general feeling of being weak, tired or ill.

How Isturisa works

Isturisa blocks the most important enzyme that produces cortisol in the adrenal glands. This reduces the overproduction of cortisol and reduces the symptoms of Cushing’s syndrome.

2. What you need to know before using 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 cautions

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 disease or disorder of the heart rhythm, e.g. irregular heartbeats or so-called prolonged QT syndrome (prolonged QT interval ).
  • if you have liver disease. Your doctor may need to change the dose of Isturisa.

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

Sampling before and during treatment

Your doctor will take samples of your blood and/or urine before starting treatment and at regular intervals during treatment. This is done to detect any abnormal magnesium, calcium, or potassium values, and also to measure the amount of cortisol. Depending on what the test results show, your doctor may need to change your dose.

This medicine may have an undesirable effect on heart function (so-called QT prolongation). Your doctor will therefore check this by taking an ECG before you start treatment and during treatment.

If your Cushing’s syndrome is caused by a benign tumor (called an adenoma ) in the pituitary gland, your doctor may consider stopping your treatment if a scan of the pituitary gland shows that the adenoma has grown to surround areas.

Children and young people

This medicine is not recommended for patients under 18 years of age. There are insufficient data on use 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 tell your doctor if you are taking any of the following medicines:

  • drugs that may have an unwanted effect on heart function (so-called QT prolongation). These include drugs used for abnormal heart rhythms such as quinidine , sotalol, amiodarone , medicines for allergy s ( antihistamine s), antidepressants such as amitriptyline and drugs for mental disorders (antipsychotics), antibiotics including the following types: macrolide s, fluoroquinolone s or imidazole and other medicines for Cushing’s disease (pasireotide, ketoconazole )
  • theophylline (used for breathing problems) or tizanidine (used to treat muscle pain and muscle cramps).

Pregnancy, breastfeeding and fertility

This medicine should not be used during pregnancy or breastfeeding unless your doctor tells you to. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Contraceptive

Women who may become pregnant should use an effective contraceptive during treatment and for at least one week after the last dose. Before you start taking Isturisa, ask your doctor if you need to use contraception.

Driving and using machines

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

How to take Isturisa

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

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

Your doctor may change your dose one after you start treatment. It depends on how you respond to the treatment. The maximum recommended dose is 30 mg twice daily.

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 do not feel well (eg feel weak, unsteady, tired, or nauseous or if you have to vomit) or if someone else has accidentally taken your medicine, contact a doctor or hospital immediately to get advice. 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, wait until it is time for the next dose and take it at the scheduled time.

If you stop taking Isturisa

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious. Pay special attention to the following:

  • Tell your doctor immediately if you get a heart disease or a heart rhythm disorder, e.g. rapid and irregular heartbeat, even when you are at rest, palpitations, temporary unconsciousness or fainting (may be a sign of so-called QT prolongation, a side effect that can occur in up to 1 in 10 people)).
  • Tell your doctor immediately if you get two or more of the following symptoms: weakness, instability, fatigue, loss of appetite, nausea and vomiting. This may indicate adrenal insufficiency (low cortisol levels) a side effect that may occur in more than 1 in 10 people. Adrenal insufficiency can occur if Isturisa leads to an excessive reduction in the amount of cortisol . It is more likely to occur during periods of increased stress. Your doctor will correct this by using a hormone preparation or by changing the dose of Isturisa.

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

  • vomiting
  • nausea
  • diarrhea
  • abdominal pain
  • fatigue
  • fluid retention leading to swelling ( edema ), especially around the ankles
  • abnormal blood test values ​​(high testosterone levels, high levels of adrenocorticotropic hormone; ACTH, low potassium)
  • decreased appetite
  • dizziness
  • headache
  • rash
  • low blood pressure ( hypotension ).

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

  • rapid heartbeat ( tachycardia )
  • general malaise
  • abnormal results on liver samples
  • fainting
  • heavy hair growth on the face and / or body ( hirsutism )
  • acne.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

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 blister after EXP. The expiration date is the last day of the specified month.

Store below 25 ° C.

Store in the original package. Moisture sensitive.

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 to protect the environment.

6. Contents of the pack and other information

Content declaration

  • The active substance is osilodrostat. Each film-coated tablet contains 1 mg osilodrostat, 5 mg osilodrostat or 10 mg osilodrostat.
  • The other ingredients are
    • Tablet core: microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, colloidal anhydrous silica.
    • 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.

What the medicine looks like and contents of the pack

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

The 1 mg tablets are light yellow, round, and marked with “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 with “Y2” on one side and “NVR” on the other side. The approximate diameter is 7.1 mm.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Record Rare Diseases

Real Estate Le Wilson

70 avenue du Général de Gaulle

92800 Puteaux

France

Manufacturer

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nuremberg

Germany

Record Rare Diseases

Real Estate Le Wilson

70 avenue du Général de Gaulle

92800 Puteaux

France

Record Rare Diseases

Eco River Parc

30 rue des Peupliers

92000 Nanterre

France

Contact the representative of the marketing authorization holder to find out more about this medicin

Belgium / Belgique / BelgienRecordatiTel: +32 2 46101 36 LithuaniaRecordati AB.Tel: + 46 8 545 80 230Sweden
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Muhammad Nadeem

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