Patient Information Leaflet

Cresemba, hard capsules of 40mg

Cresemba, hard capsules of 100mg

isavuconazol

Read 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

1.What is Cresemba and what it is used for

2.What you need to know before starting to use Cresemba

3.How to take Cresemba

4.Possible side effects

5.Storage of Cresemba

6.Contents of the pack and additional information

What is Cresemba

Cresemba is an antifungal medication that contains the active ingredient isavuconazole.

How Cresemba works

Isavuconazole works by killing or preventing the growth of the fungus that causes the infection.

What is Cresemba 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 amphotericin B treatment is not appropriate.

Do not take Cresemba

-if you are allergic to isavuconazole or any of the other components of this medication (listed in section6),

-if you have a heart rhythm problem called ‘short QT syndrome’,

-if you are taking any of the following medications:

• ketoconazole, used for fungal infections,
• high doses of ritonavir (more than 200mg 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 plant-based medication used for depression,
• efavirenz, etravirine, used for HIV,
• nafcillin, used for bacterial infections.

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to take Cresemba:

-if you have had an allergic reaction to another antifungal treatment with ‘azole’, such as ketoconazole, fluconazole, itraconazole, voriconazole, or posaconazole in the past,

-if you have severe liver disease. Your doctor must monitor any possible side effects.

Monitoring of side effects

Stop using Cresemba and call your doctor immediately if you notice any of the following side effects:

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

Changes in liver function

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

Skin problems

Call your doctor immediately if you experience severe skin peeling, mouth, eyes, or genital area.

Children and adolescents

Do not give Cresemba capsules to children between 1 and less than 6years of age, as this medication has not been studied in this age group. Children from 6years and adolescents with a body weight of at least 32kg, your doctor may prescribe Cresemba 100mg capsules.Other forms of the medication are more suitable for children or adolescents who cannot swallow capsules; consult your doctor or pharmacist.

Other medications and Cresemba

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Some medications may modify the way Cresemba acts or Cresemba may modify the way other medications act, if taken at the same time.

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

• ketoconazole, used for fungal infections,
• high doses of ritonavir (more than 200mg 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 plant-based medication used for depression,
• efavirenz, etravirine, used for HIV,
• nafcillin, used for bacterial infections.

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

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

Inform your doctor or pharmacist if you are taking any of the following medications, as it may be necessary to adjust or monitor the dose to ensure that the medications continue to have the desired effect:

• ciclosporin, tacrolimus, and sirolimus, used to prevent transplant rejection,
• cyclophosphamide, used for cancer,
• digoxin, used to treat heart failure or irregular heartbeats,
• colchicine, used to treat gout attacks,
• dabigatran etexilate, used to prevent blood clots after surgery for hip or knee replacement,
• 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,
• mofetil micophenolate (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, mitoxantrone, topotecan, used for different types of cancer.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Do not take Cresemba if you are pregnant, unless your doctor tells you otherwise. As it is unknown whether it may affect or harm the fetus.

Creameba should not be used during breastfeeding.

Driving and operating machinery

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is as follows:

Use in children and adolescents

This medication has not been studied in children and adolescents. Your doctor may prescribe 100 mg capsules of Cresemba to children and adolescents with a body weight of at least 32 kg.

There are other presentations of the medication that are more suitable for children or adolescents who cannot swallow capsules; consult your doctor or pharmacist.

Take this dose until your doctor tells you otherwise. The treatment duration with Cresemba may be longer than 6 months, if your doctor considers it necessary.

The capsules can be taken with or without food. Swallow the capsules whole. Do not crush, chew, 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 to the hospital immediately. Bring the medication packaging with you so the doctor knows what you have taken.

This may cause more side effects such as:

• headache, dizziness, agitation, or somnolence,
• tingling, decreased sensitivity, or tactile sensation,
• difficulty perceiving things, hot flashes, anxiety, joint pain,
• alteration of 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 the next dose, skip the missed dose.

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Cresemba

Do not interrupt treatment with Cresemba unless your doctor has told you to. It is essential to continue treatment with this medication until your doctor tells you to. This is to ensure that the fungal infection has cleared up.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• severe allergic reaction (anaphylaxis) such as, for example, sudden onset of sneezing, difficulty breathing, swelling of the face, lips, mouth, or tongue, intense itching, sweating, dizziness, or fainting, rapid heartbeats, or chest palpitations.

Immediately call your doctor if you observe any of the following adverse effects:

• severe skin blistering, mouth, eyes, or genital area.

Other adverse effects

Call your doctor, pharmacist, or nurse if you observe any of the following adverse effects:

Frequent:may affect up to 1 in 10 people

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

Less frequent:may affect up to 1 in 100 people

• reduced white blood cell count, may increase the risk of infection and fever,
• reduced platelet count, may increase the risk of bleeding or bruising,
• reduced red blood cell count, may cause weakness or shortness of breath or paleness,
• severe reduction in blood cell count, may cause weakness, cause bruising or increase the 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 nutrient absorption from food (malnutrition),
• depression, difficulty sleeping,
• stroke, fainting, or feeling faint, dizziness,
• sensation of tingling, pins and needles, or prickling in the skin (paresthesia),

• mental state alterations (encephalopathy),
• changed taste (dysgeusia),
• sensation of 'giratory' or dizziness (vertigo),

• heart rhythm problems, may be too fast, irregular, or extra heartbeat, this may appear on your electrocardiogram or ECG,
• circulatory problems,
• low blood pressure,
• sneezing, rapid breathing, coughing up blood or sputum with blood, nasal bleeding,
• indigestion,
• constipation,
• swelling (abdominal distension),
• enlarged liver,
• inflammation of the liver,
• skin problems, red spots or purpura on the skin (petechiae), skin inflammation, hair loss,
• back pain,
• swelling of the extremities,
• sensation of weakness, excessive fatigue, drowsiness, feeling unwell (malaise).

Adverse effects with unknown frequency:

• anaphylaxis (severe allergic reaction).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus.You can also report them directly throughtheSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Cresemba

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

Appearance of Cresemba and contents of the pack

Cresemba 40mg hard capsules are brown-red capsules with a cap marked with “CR40” in black ink.

Cresemba 100mg hard capsules are capsules with a brown-red body marked with ”100” in black ink and a white cap marked with "C" in black ink.

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

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

Each capsule is connected to a bag with ’desiccant’ to protect the capsule from moisture.

Do not pierce the blister with the desiccant.

Do not ingest or use the desiccant.

Marketing Authorization Holder:

Basilea Pharmaceutica Deutschland GmbH

Marie-Curie-Strasse 8

79539 Lörrach

Germany

Responsible for manufacturing:

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)

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last update of this leaflet: 08/2024.

Other sources of information

The detailed information about 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 medicines.