Cresemba 100 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Cresemba, hard capsules 40mg

Cresemba, hard capsules 100mg

isavuconazole

Read all of this leaflet carefully before you start taking this medicine, because 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Cresemba is and what it is used for
2. What you need to know before using Cresemba
3. How to take Cresemba
4. Possible side effects
5. How to store Cresemba
6. Contents of the pack and other information

1. What Cresemba is and what it is used for

What Cresemba is

Cresemba is an antifungal medicine that contains the active substance isavuconazol.

How Cresemba works

Isavuconazol works by killing or stopping the growth of the fungus causing the infection.

What Cresemba is used for

Cresemba is used in adults and pediatric patients aged 6 years and older to treat the following fungal infections:

• invasive aspergillosis, caused by a fungus from the 'Aspergillus' group,
• mucormycosis, caused by a fungus belonging to the 'Mucorales' group, in patients for whom treatment with amphotericin B is not appropriate.

2. What you need to know before taking Cresemba

Do not take Cresemba

• if you are allergic to isavuconazole or any of the other ingredients of this medicine (listed in section 6),
• if you have a heart rhythm problem called ‘short QT syndrome’,
• if you are taking any of the following medicines:
  • ketoconazole, used for fungal infections,
  • high-dose ritonavir (more than 200 mg every 12 hours), used for HIV,
  • rifampicin, rifabutin, used for tuberculosis,
  • carbamazepine, used for epilepsy,
  • barbiturates such as phenobarbital, used for epilepsy and sleep disorders,
  • phenytoin, used for epilepsy,
  • St John’s wort, a herbal medicine used for depression,
  • efavirenz, etravirine, used for HIV,
  • nafcillin, used for bacterial infections.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Cresemba:

• if you have previously had an allergic reaction to another antifungal ‘azole’ treatment, such as ketoconazole, fluconazole, itraconazole, voriconazole, or posaconazole,
• if you have severe liver disease. Your doctor should monitor you for possible adverse effects.

Monitoring for adverse effects

Stop taking Cresemba and contact your doctor immediately if you experience any of the following adverse effects:

• sudden wheezing, difficulty breathing, swelling of the face, lips, mouth, or tongue, severe itching, sweating, dizziness or fainting, rapid heartbeat or palpitations in the chest: these may be signs of a serious allergic reaction (anaphylaxis).

Changes in liver function

Cresemba may sometimes affect liver function. Your doctor may perform blood tests while you are taking this medicine.

Skin problems

Contact your doctor immediately if you develop severe peeling of the skin, mouth, eyes, or genitals.

Children and adolescents

Do not give Cresemba capsules to children between 1 and less than 6 years of age, as this medicine has not been studied in this age group. For children aged 6 years and older and adolescents weighing at least 32 kg, your doctor may prescribe Cresemba 100 mg capsules. Other forms of the medicine may be more suitable for children or adolescents who cannot swallow capsules; consult your doctor or pharmacist.

Other medicines and Cresemba

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines may alter the way Cresemba works, or Cresemba may alter how other medicines work, when taken at the same time.

Specifically, do not take this medicine and inform your doctor or pharmacist if you are taking any of the following medicines:

• ketoconazole, used for fungal infections,
• high-dose ritonavir (more than 200 mg every 12 hours), used for HIV,
• rifampicin, rifabutin, used for tuberculosis,
• carbamazepine, used for epilepsy,
• barbiturates such as phenobarbital, used for epilepsy and sleep disorders,
• phenytoin, used for epilepsy,
• St John’s wort, a herbal medicine used for depression,
• efavirenz, etravirine, used for HIV,
• nafcillin, used for bacterial infections.

Unless your doctor tells you otherwise, do not take this medicine and inform your doctor or pharmacist if you are taking any of the following medicines:

• rufinamide or any other medicine that shortens the QT interval on the electrocardiogram (ECG),
• aprepitant, used to prevent nausea and vomiting during cancer treatment,
• prednisone, used for rheumatoid arthritis,
• pioglitazone, used for diabetes.

Tell your doctor or pharmacist if you are taking any of the following medicines, as it may be necessary to adjust or monitor the dose to ensure the medicines remain effective:

• ciclosporin, tacrolimus, and sirolimus, used to prevent transplant rejection,
• cyclophosphamide, used for cancer,
• digoxin, used to treat heart failure or irregular heartbeat,
• colchicine, used to treat gout attacks,
• dabigatran etexilate, used to prevent blood clots after hip or knee replacement surgery,
• clarithromycin, used for bacterial infections,
• saquinavir, fosamprenavir, indinavir, nevirapine, lopinavir/ritonavir combination, used for HIV,
• alfentanil, fentanyl, used for severe pain,
• vincristine, vinblastine, used for cancer,
• mycophenolate mofetil (MMF), used in transplant patients,
• midazolam, used for severe insomnia and stress,
• bupropion, used for depression,
• metformin, used for diabetes,
• daunorubicin, doxorubicin, imatinib, irinotecan, lapatinib, mitoxantrona, topotecan, used for various types of cancer.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Do not take Cresemba if you are pregnant, unless your doctor tells you to. It is unknown whether it may affect or harm the unborn baby.

Cresemba must not be used during breastfeeding.

Driving and using machines

Cresemba may make you feel confused, tired, or drowsy. It may also cause fainting. Therefore, be very careful when driving or operating machinery.

3. How to take Cresemba

Follow exactly the administration instructions for this medicine given to you by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is as follows:

Use in children and adolescents

The use of 100 mg Cresemba capsules has not been studied in children and adolescents. Your doctor may prescribe 100 mg Cresemba capsules to children and adolescents weighing at least 32 kg.

Other formulations of this medicine are more suitable for children or adolescents who cannot swallow capsules; please consult your doctor or pharmacist.

This dose should be taken until your doctor advises otherwise. The duration of treatment with Cresemba may exceed 6 months if your doctor considers it necessary.

The capsules may be taken with or without food. Swallow the capsules whole. Do not chew, crush, dissolve, or open the capsules.

If you take more Cresemba than you should

If you take more Cresemba than you should, consult a doctor or go immediately to the hospital. Take the medicine packaging with you so the doctor knows what you have taken.

This may cause more adverse effects such as:

• headache, dizziness, restlessness, or drowsiness,
• tingling, reduced sensitivity, or impaired tactile sensation,
• difficulty concentrating, hot flushes, anxiety, joint pain,
• altered taste, dry mouth, diarrhea, vomiting,
• palpitations, increased heart rate, increased sensitivity to light.

If you forget to take Cresemba

Take the capsule as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.

Do not take a double dose to make up for missed doses.

If you stop taking Cresemba

Do not stop treatment with Cresemba unless your doctor has instructed you to do so. It is important to continue treatment with this medicine until your doctor advises otherwise. This is to ensure that the fungal infection has been completely eliminated.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

Stop using Cresemba and contact your doctor immediately if you experience any of the following adverse effects:

• a severe allergic reaction (anaphylaxis), for example sudden wheezing, difficulty breathing, swelling of the face, lips, mouth or tongue, intense itching, sweating, dizziness or fainting, rapid heartbeat or palpitations in the chest.

Contact your doctor immediately if you experience any of the following adverse effects:

• severe blistering of the skin, mouth, eyes or genitals.

Other adverse effects

Contact your doctor, pharmacist or nurse if you experience any of the following adverse effects:

Common: may affect up to 1 in 10 people

• reduced potassium levels in the blood,
• decreased appetite,
• confusion (delirium),
• headache,
• drowsiness,
• inflamed veins that may lead to blood clots,
• sudden and severe shortness of breath or breathing problems,
• nausea, vomiting, diarrhoea and stomach pain,
• changes in blood tests indicating liver function,
• skin rash, itching,
• kidney failure (symptoms may include swelling of the legs),
• chest pain, feeling tired or drowsy.

Uncommon: may affect up to 1 in 100 people

• reduced white blood cell count, which may increase the risk of infection and fever,
• reduced number of blood cells called 'platelets', which may increase the risk of bleeding or bruising,
• reduced red blood cell count, which may make you feel weak, short of breath or pale,
• severe reduction in the number of blood cells, which may cause weakness, bruising or increased likelihood of infections,
• skin rash, swelling of the lips, mouth, tongue or throat with difficulty breathing (hypersensitivity),
• low blood sugar levels,
• low magnesium levels in the blood,
• low levels of a protein called 'albumin' in the blood,
• poor absorption of nutrients from food (malnutrition),
• low sodium levels in the blood (hyponatremia),
• depression, difficulty sleeping,
• stroke, fainting or feeling faint, dizziness,
• tingling, pins and needles or prickling sensations on the skin (paraesthesia),
• changes in mental state (encephalopathy),
• altered taste (dysgeusia),
• spinning sensation or dizziness (vertigo),
• heart rhythm problems, which may be too fast, irregular, or extra heartbeats, which may appear on your electrocardiogram or ECG,
• circulatory problems,
• low blood pressure,
• wheezing, very rapid breathing, coughing up blood or bloody sputum, nosebleeds,
• indigestion,
• constipation,
• swelling (abdominal distension),
• enlarged liver,
• liver inflammation,
• skin problems, red or purple spots on the skin (petechiae), skin inflammation, hair loss,
• back pain,
• swelling of the limbs,
• feeling of weakness, extreme tiredness, drowsiness, feeling unwell (malaise).

Adverse effects with unknown frequency:

• anaphylaxis (a severe allergic reaction).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are possible adverse effects 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 Cresemba

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cresemba

• The active substance is isavuconazole. Each capsule contains 74.5 mg of isavuconazonium sulfate, equivalent to 40 mg of isavuconazole (for Cresemba 40 mg hard capsules) or 186.3 mg of isavuconazonium sulfate, equivalent to 100 mg of isavuconazole (for Cresemba 100 mg hard capsules).
• The other ingredients are:
• Capsule contents: magnesium citrate (anhydrous), microcrystalline cellulose (E460), talc (E553b), colloidal anhydrous silica, stearic acid.
• Capsule coating for Cresemba 40 mg hard capsules: hypromellose, iron oxide red (E172), titanium dioxide (E171).
• Capsule coating for Cresemba 100 mg hard capsules: hypromellose, iron oxide red (E172) (only in the capsule body), titanium dioxide (E171), gellan gum, potassium acetate, disodium edetate, sodium lauryl sulfate.
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide, black iron oxide (E172).

Appearance of Cresemba and contents of the pack

Cresemba 40 mg hard capsules are reddish-brown coloured capsules with the cap marked "CR40" in black ink.

Cresemba 100 mg hard capsules are reddish-brown coloured capsule bodies marked with "100" in black ink and white caps marked with "C" in black ink.

Cresemba 40 mg hard capsules are available in boxes containing 35 capsules. Each box contains 7 aluminium blisters with 5 capsules each.

Cresemba 100 mg hard capsules are available in boxes containing 14 capsules. Each box contains 2 aluminium blisters with 7 capsules each.

Each capsule is connected to a sachet containing 'desiccant' to protect the capsule from moisture.

Do not pierce the blister with the desiccant.

Do not ingest or use the desiccant.

Marketing Authorisation Holder:

Basilea Pharmaceutica Deutschland GmbH
Marie-Curie-Strasse 8
79539 Lörrach
Germany

Manufacturer:

Almac Pharma Services (Ireland) Limited
Finnabair Industrial Estate
Dundalk
Co. Louth
A91 P9KD
Ireland

Almac Pharma Services Limited
Seagoe Industrial Estate
Craigavon, Co. Armagh
BT63 5UA
United Kingdom (Northern Ireland)

For more information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu. There are also links to other websites about rare diseases and orphan medicinal products.