Cresemba 200 mg polvo para concentrado para solucion para perfusion

Prospect: information for the patient

Cresemba 200mg powder for concentrate for solution for infusion

isavuconazol

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section4.

1.What is Cresemba and for what it is used

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

3.How to use Cresemba

4.Possible adverse effects

5.Storage of Cresemba

6.Contents of the package 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 patients 1 year of age 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 use Cresemba

-if you are allergic to isavuconazonium or any of the other ingredients of this medicine (listed in section6),

-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 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 medicine used for depression,
• efavirenz, etravirine, used for HIV,
• nafcillin, used for bacterial infections.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use 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 heartbeats or palpitations in the chest: these may be signs of a severe allergic reaction (anaphylaxis).

Problems with Cresemba and its intravenous administration (infusion)

Call your doctor immediately if you notice any of the following side effects:

• low blood pressure, difficulty breathing, nausea, dizziness, headache, numbness, your doctor will decide whether to stop the infusion.

Changes in liver function

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

Skin problems

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

Children and adolescents

Do not administer Cresemba to children under 1year of age, as there is no information on its use in this age group.

Other medicines and Cresemba

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. Some medicines may modify the way Cresemba works or Cresemba may modify the way other medicines work, if 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 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 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 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 medicines, as it may be necessary to adjust or monitor the dose to ensure that the medicines 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 heart rhythm,
• 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, combination lopinavir/ritonavir, 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 medicine.

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 drowsy, tired or sleepy. It may also cause dizziness. Be careful when driving or operating machinery.

Crebensa will be administered under the direction of a doctor or nurse.

The recommended dose is as follows:

This dose should be administered until your doctor tells you otherwise. The duration of treatment with Crebensa may be longer than 6 months, if your doctor considers it necessary.

Your doctor or nurse will administer the vial in the form of an infusion into a vein.

If you use more Crebensa than you should

If you think you have been given too much Crebensa, consult your doctor or nurse immediately. It may cause more side effects such as:

• headache, dizziness, agitation or drowsiness,
• tingling, decreased sensitivity or tactile sensation,
• difficulty perceiving things, hot flashes, anxiety, joint pain,
• alteration of taste, dry mouth, diarrhea, vomiting,
• palpitations, elevated heart rate, increased sensitivity to light.

If you forget to take Crebensa

Since this medication will be administered under close medical supervision, it is unlikely that you will forget a dose. However, inform your doctor or nurse if you think you have forgotten a dose.

If you interrupt treatment with Crebensa

Treatment with Crebensa will continue for the time your doctor indicates. This is to ensure that the fungal infection has disappeared.

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 side effects:

• severe allergic reaction (anaphylaxis) such as 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 side effects:

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

Other side effects

Call your doctor, pharmacist, or nurse if you observe any of the following side 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 problem,
• 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,
• problems at the injection site.

Rare: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 risk 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,
• malabsorption of nutrients from food (malnutrition),
• depression, difficulty sleeping,
• stroke, fainting, or feeling faint, dizziness,
• sensation of tingling, prickling, or pinching in the skin (paresthesia),

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

• cardiac rhythm problems, may be too fast, or irregular, or extra heartbeats, which 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 (distension) of the abdomen,
• enlargement of the liver size,
• 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, much fatigue, drowsiness, feeling unwell (malaise).

Side effects with unknown frequency:

• anaphylaxis (severe allergic reaction).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side 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.

Store in refrigerator (between 2 °C and 8 °C).

Medicines should not be disposed of through drains. Ask your pharmacist how to dispose of the containers 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 vial contains 372.6 mg of isavuconazonium sulfate, corresponding to 200 mg of isavuconazole.
• The other components (excipients) are: mannitol (E421) and sulfuric acid.

Appearance of Cresemba and contents of the container

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

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 medication 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 medication 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 drugs.

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This information is intended only for healthcare professionals:

Cresemba 200 mg powder for concentrate for solution for infusion should be reconstituted and diluted before infusion.

Reconstitution

To reconstitute a vial of powder for concentrate for solution for infusion, 5 ml of water for injections should be added to the vial. The reconstituted concentrate contains 40 mg of isavuconazole per ml. The vial should be shaken until the powder is completely dissolved. The reconstituted solution should be visually inspected for any particles and color changes. The reconstituted concentrate should be transparent and free of visible particles. It should be diluted before administration.

Dilution

Adults and pediatric patients with a body weight of more than 37 kg:

After reconstitution, the entire content of the reconstituted concentrate should be transferred from the vial to a infusion bag containing 250 ml of sodium chloride 0.9% solution or glucose 5% solution. The infusion solution contains approximately 0.8 mg of isavuconazole per ml.

Pediatric patients with a body weight of less than 37 kg:

The final concentration of the infusion solution should be in the range of 0.4 to 0.8 mg/ml of isavuconazole.Concentrations above this range should be avoided, as they may cause irritation at the infusion site.

To obtain the final concentration, the appropriate volume of the reconstituted concentrate should be withdrawn from the vial according to the posological recommendations for pediatric patients (see section 3) and added to an infusion bag containing the appropriate amount of diluent. The appropriate volume of the infusion bag is calculated as follows:

[Required dose (mg)/final concentration (mg/ml)] – Volume of concentrate (ml)

The concentrate can be diluted with sodium chloride 0.9% solution or glucose 5% solution.

Administration

After re-dilution, the diluted solution may show fine white to translucent isavuconazole particles that do not sediment (but should be removed by in-line filtration). The diluted solution should be gently mixed, or the bag may be rolled to minimize particle formation. Avoid excessive agitation and shaking of the solution.The infusion solution should be administered through an infusion device with an in-line filter (pore size 0.2 μm to 1.2 μm) made of sulfonated polyether (PES). Infusion pumps that should be placed before the infusion device may be used. Regardless of the size of the infusion solution container used, the entire volume of the container should be administered to ensure that the complete dose has been administered.

Isavuconazole should not be administered by infusion in the same line or cannula as other intravenous products.

Stability has been demonstrated for 24 hours at 2 °C to 8 °C, or 6 hours at room temperature.

From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, the storage time in use and the conditions prior to use are the responsibility of the user and are normally not to exceed 24 hours at 2 °C to 8 °C, unless the reconstitution and dilution have been performed in validated and controlled aseptic conditions.

If possible, intravenous administration of isavuconazole should be performed within 6 hours after reconstitution and dilution at room temperature. If this is not possible, after dilution, the infusion solution should be refrigerated immediately, and infusion should be performed within 24 hours.

A line intravenous should be flushed with sodium chloride 0.9% solution or glucose 5% solution.

This medicinal product is for single use only. Dispose of partially used vials.