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Cresemba 200 mg powder for concentrate for solution for infusion

Last Updated on eMC 01-Mar-2016 View changes  | Basilea Pharmaceutica International Ltd Contact details

Black Triangle icon This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

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Text only version for the visually impaired
Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: EU/1/15/1036/001.



Cresemba 200 mg powder for concentrate for solution for infusion

Package leaflet: Information for the patient

Cresemba 200 mg powder for concentrate for solution for infusion

Isavuconazole

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Cresemba is and what it is used for
2. What you need to know before you use Cresemba
3. How to use 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 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 to treat the following fungal infections:

  • invasive aspergillosis, caused by a fungus in the ‘Aspergillus’ group;
  • mucormycosis, caused by a fungus beloning to the ‘Mucorales’ group in patients for whom a treatment with amphotericin B is not appropriate.

2. What you need to know before you use Cresemba

Do not use 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 (400 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 using 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 using Cresemba and tell your doctor straight away if you notice any of the following side effects:

  • rash, swelling of your lips, mouth, tongue or throat with difficulty breathing - these may be signs of an allergic reaction (hypersensitivity).

Problems while having Cresemba as drip into a vein

Tell your doctor straight away if you notice any of the following side effects:

  • low blood pressure, feel short of breath, nausea, dizziness, headache, tingling, – your doctor may decide to stop the infusion.

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

Cresemba should not be used in children or adolescents younger than 18 years because there is no information on use in this age group.

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 (400 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 for after having a transplant, called ‘immuno-suppressants’,
  • 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, amprenavir, nelfinavir, indinavir, delavirdine, 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. If this happens, do not drive or use machines.

3. How to use Cresemba

Cresemba will be given to you by a doctor or nurse.

Starting dose for the first two days (48 hours)

The recommended dose is one vial three times a day (every 8 hours).

Usual dose after the first two days

This is started 12 to 24 hours after your last starting dose. The recommended dose is one vial once a day.

You will be given 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.

The vial will be given as a drip into a vein by your doctor or nurse.

If you use more Cresemba than you should

If you think you have been given too much Cresemba, talk to your doctor or nurse straight away. 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 use Cresemba

As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed. However, tell your doctor or nurse if you think that a dose has been forgotten.

If you stop using Cresemba

Cresemba treatment will continue for 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 using Cresemba and tell your doctor straight away if you notice any of the following side effects:

  • rash, swelling of your lips, mouth, tongue or throat with difficulty breathing - these may be signs of an allergic reaction (hypersensitivity).

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,
  • hallucinations (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,
  • chest pain, feeling tired or sleepy,
  • problems where the injection was given.

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),
  • 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,
  • 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).

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 website: www.mhra.gov.uk/yellowcard. 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 use 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.

Store in in a refrigerator (2°C to 8°C).

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 vial contains 372.6 mg isavuconazonium sulfate, corresponding to 200 mg isavuconazole.
  • The other ingredients (excipients) are mannitol (E421) and sulfuric acid.

What Cresemba looks like and contents of the pack

Cresemba 200 mg is presented in a single use glass vial as a powder for concentrate for solution for infusion.

Marketing Authorisation Holder:

Basilea Medical Ltd
(c/o Cox Costello & Horne Limited)
Langwood House
63–81 High Street
Rickmansworth
HertfordshireWD3 1 E1Q
United Kingdom

Manufacturer:

Almac Pharma Services Limited
Seagoe Industrial Estate
Craigavon
County Armagh
BT63 5UA
United Kingdom

This leaflet was last revised in

10/2015

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

Company contact details

Basilea Pharmaceutica International Ltd

Company image
Address

Grenzacherstrasse 487, 4005 Basel, Switzerland

Fax

+ 41 61 606 1112

Medical Information e-mail
Medical Information Fax

0800 471 5443

Telephone

+ 41 61 606 1111

Medical Information Direct Line

0800 141 3328

Customer Care direct line

0800 141 3328

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

isavuconazole

Legal categories

POM - Prescription Only Medicine

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