Patient leaflet - Cresemba 100 mg hard capsules
1. What Cresemba is and what it is used for
What Cresemba is
Cresemba is an anti-fungal medicine that contains the active substance isavuconazole.
How Cresemba works
Isavuconazole works by killing or stopping the growth of the fungus, which causes the infection.
What Cresemba is used for
Cresemba is used in adults and in paediatric patients from 6 years of age to treat the following fungal infections:
- invasive aspergillosis, caused by a fungus in the ‘Aspergillus’ group;
- mucormycosis, caused by a fungus belonging to the ‘Mucorales’ group in patients for whom a treatment with amphotericin B is not appropriate.
2. What you need to know before you take 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 beat problem called ‘familial short QT syndrome’,
if you are using any of the following medicines:
- ketoconazole, used for fungal infections,
- high doses of ritonavir (more than 200 mg every 12 hours), used for HIV,
- rifampicin, rifabutin, used for tuberculosis,
- carbamazepine, used for epilepsy,
- barbiturate medicines like 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 had an allergic reaction to other ‘azole’ anti-fungal treatments in the past, such as ketoconazole, fluconazole, itraconazole, voriconazole or posaconazole,
- if you are suffering from severe liver disease. Your doctor should monitor you for possible side effects.
Look out for side effects
Stop taking Cresemba and tell your doctor straight away if you notice any of the following side effects:
- sudden wheezing, difficulty breathing, swelling of the face, lips, mouth or tongue, severe itching, sweating, dizziness or fainting, fast heartbeat or pounding in the chest – these may be signs of a severe allergic reaction (anaphylaxis).
Changes in your liver function
Cresemba can sometimes affect your liver function. Your doctor may carry out blood tests while you are taking this medicine.
Skin problems
Tell your doctor straight away if you get severe blistering of the skin, mouth, eyes or genitals.
Children and adolescents
Do not give Cresemba capsules to children between the age of one year and 6 years, because this form of the medicine has not been tested in this age group. For children over 6 years and adolescents who wheigh at least 32 kg your doctor may prescribe Cresemba 100 mg capsules. Other forms of this medicine are more suitable for children or adolescents who cannot swallow capsules; ask your doctor or pharmacist.
Other medicines and Cresemba
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Some medicines may affect the way Cresemba works or Cresemba may affect the way they work, if they are taken at the same time.
In particular, do not take this medicine and tell your doctor or pharmacist if you are taking any of the following medicines:
- ketoconazole, used for fungal infections,
- high doses of ritonavir (more than 200 mg every 12 hours), used for HIV,
- rifampicin, rifabutin, used for tuberculosis,
carbamazepine, used for epilepsy,
- barbiturate medicines like 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 tell your doctor or pharmacist if you are taking any of the following medicines:
- rufinamide or other medicines which decrease the QT interval on the heart tracing (ECG),
- aprepitant, used to prevent nausea and vomiting by 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 a dose adjustment or monitoring may be required to check that the medicines are still having the desired effect:
- ciclosporin, tacrolimus and sirolimus, used to prevent rejection of a transplant,
- cyclophosphamide, used for cancer,
- digoxin, used to treat heart failure or an uneven heart beat,
- colchicine, used for gout attack,
- dabigatran etexilate, used to stop 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 against strong 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, mitoxantrone, topotecan, used for different sorts of cancer.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Do not take Cresemba if you are pregnant, unless your doctor tells you otherwise. This is because it is not known if it may affect or harm your unborn baby.
Do not breast-feed if you are taking Cresemba.
Driving and using machines
Cresemba may make you feel confused, tired or sleepy. It can also make you pass out. Therefore, be very careful when driving or operating machinery.
3. How to take Cresemba
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is as follows:
| Adult patients | ||||
Starting dose (three times daily)1 every 8 hours during Days 1 and 2 total daily dose during Days 1 and 2 Two 100 mg capsules Six 100 mg capsules | Usual dose after the first two days: Once per day2 Two 100 mg capsules | |||
1 Six doses in total. 2 This is started 12 to 24 hours after your last starting dose. Paediatric patients aged from 6 years to less than 18 years Bodyweight (kg) Starting dose (three times daily)1 Usual dose after the first two days: Once per day 2 | ||||
| every 8 hours during Days 1 and 2 | total daily dose during Days 1 and 2 | |||
| 16 kg to < 18 kg | Two 40 mg capsules | Six 40 mg capsules | Two 40 mg capsules | |
| 18 kg to < 25 kg | Three 40 mg capsules | Nine 40 mg capsules | Three 40 mg capsules | |
| 25 kg to < 32 kg | Four 40 mg capsules | Twelve 40 mg capsules | Four 40 mg capsules | |
| 32 kg to < 37 kg | One 100 mg capsule and two 40 mg capsules | Three 100 mg capsules and six 40 mg capsules | One 100 mg capsule and two 40 mg capsules | |
| ≥ 37 kg | Five 40 mg capsules or two 100 mg capsules | Fifteen 40 mg capsules or six 100 mg capsules | Five 40 mg capsules or two 100 mg capsules | |
1 Six doses in total. 2 This is started 12 to 24 hours after your last starting dose. | ||||
Use in children and adolescents
The use of Cresemba 100 mg capsules in children and adolescents is not studied. Your doctor may give Cresemba 100 mg capsules to children and adolescents who weigh at least 32 kg.
Other forms of this medicine are suitable for children and adolsecents who cannot swallow capsules; ask your doctor or pharmacist.
You will take this dose until your doctor tells you otherwise. The duration of treatment with Cresemba may be longer than 6 months if your doctor considers this necessary.
Capsules can 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, talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken.
You may have more side effects such as:
- headache, feeling dizzy, restless or sleepy,
- tingling, reduced sense of touch or sensation in the mouth,
- problems being aware of things, hot flushes, anxiety, joint pain,
- changes in the way things taste, dry mouth, diarrhoea, vomiting,
- feeling your heart beat, faster heart rate, being more sensitive to light.
If you forget to take Cresemba
Take the capsules as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Cresemba
Do not stop taking Cresemba unless you doctor has told you to do so. It is important to keep taking this medicine as long as your doctor tells you. This is to make sure that the fungal infection has gone.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Cresemba and tell your doctor straight away if you notice any of the following side effects:
- a severe allergic reaction (anaphylaxis) such as sudden wheezing, breathing problems, swelling of the face, lips, mouth or tongue, severe itching, sweating, dizziness or fainting, fast heartbeat or pounding in the chest.
Tell your doctor straight away if you notice any of the following side effects:
- severe blistering of the skin, mouth, eyes or genitals.
Other side effects
Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Common: may affect up to 1 in 10 people
- low potassium in your blood,
- decreased appetite,
- confusion (delirium),
- headache,
- sleepiness,
- inflamed veins that could lead to blood clots,
- shortness of breath or sudden and severe difficulty breathing,
- feeling sick (nausea), being sick (vomiting), diarrhoea, stomach pain,
- changes in blood tests of liver function,
- rash, itching,
- kidney failure (symptoms could include swelling of legs),
- chest pain, feeling tired or sleepy.
Uncommon: may affect up to 1 in 100 people
- reduced white blood cells - can increase your risk of infection and fever,
- reduced blood cells called ‘platelets’ - can increase your risk for bleeding or bruising,
- reduced red blood cells - can make you feel weak or short of breath or make your skin pale,
- severe reduction in blood cells - can make you feel weak, cause bruising or make infections more likely,
- rash, swelling of your lips, mouth, tongue or throat with difficulty breathing (hypersensitivity),
- low blood sugar levels,
- low blood levels of magnesium,
- low levels in the blood of a protein called ‘albumin’,
- not getting the right goodness from your diet (malnutrition), - low blood levels of sodium (hyponatraemia),
- depression, difficulty sleeping,
- seizure, fainting or feeling faint, dizziness,
- sensation of tingling, tickling, or pricking of the skin (paraesthesia),
- altered mental state (encephalopathy),
- changes in taste (dysgeusia),
- feeling of ‘spinning’ or being dizzy (vertigo),
- heart beat problems - may be too fast or uneven, or extra heart beats – this may show in your heart tracing (electrocardiogram or ECG),
- problems with the blood circulation,
- low blood pressure,
- wheezing, very fast breathing, coughing up blood or blood-stained sputum, nose bleeding,
- indigestion,
- constipation,
- feeling bloated (abdominal distension),
- enlarged liver,
- inflammation of the liver,
- problems with the skin, red or purple spots on the skin (petechiae), inflamed skin (dermatitis), hair loss,
- back pain,
- swelling of the extremities,
- feeling weak, very tired, or sleepy or generally out of sorts (malaise).
Side effects with frequency not known:
anaphylaxis (a severe allergic reaction).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Cresemba
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original packaging in order to protect from moisture.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Cresemba contains
- The active substance is isavuconazole. Each capsule contains either 74.5 mg isavuconazonium sulfate, corresponding to 40 mg isavuconazole (for Cresemba 40 mg hard capsules) or 186.3 mg isavuconazonium sulfate, corresponding to 100 mg isavuconazole (for Cresemba 100 mg hard capsules).
The other ingredients are:
- Capsule content: magnesium citrate (anhydrous), microcrystalline cellulose (E460), talc (E553b), anhydrous colloidal silica, stearic acid.
- Caspule shell for Cresemba 40 mg hard capsules: hypromellose, red iron oxide (E172), titanium dioxide (E171).
- Capsule shell for Cresemba 100 mg hard capsules: hypromellose, red iron oxide (E172) (capsule body only), titanium dioxide (E171), gellan gum, potassium acetate, disodium edetate, sodium laurilsulfate.
- Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide, black iron oxide (E172).
What Cresemba looks like and contents of the pack
Cresemba 40 mg hard caspsules are reddish-brown capsules with a cap marked with “CR40” in black ink.
Cresemba 100 mg hard capsules are capsules with a reddish-brown body marked with “100” in black ink and a white cap marked with “C” in black ink.
Cresemba 40 mg hard capsules are available in cartons that contain 35 capsules. Each carton contains seven aluminium blisters with 5 capsules each.
Cresemba 100 mg hard capsules are available in cartons that contain 14 capsules. Each carton contains 2 aluminium blisters, with 7 capsules each.
Each capsule pocket is connected to a pocket that contains ‘desiccant’ to protect the capsule from moisture.
Do not puncture the blister containing the desiccant.
Do not swallow or use the desiccant.
Marketing Authorisation Holder:
Basilea Medical Ltd.
Onslow House
Onslow Street
Guildford
GU1 4TL
United Kingdom
Manufacturer:
Almac Pharma Services (Ireland) Limited
Finnabair Industrial Estate
Dundalk
Co. Louth
A91 P9KD
Ireland
For any information about this medicine, please contact: Medical Information, Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS.
Telephone 01304 616161.
This leaflet was last revised in 07/2025.
Package leaflet: