CRESEMBA 100 mg HARD CAPSULES
How to use CRESEMBA 100 mg HARD CAPSULES
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the Patient
Cresemba, hard capsules 40mg
Cresemba, hard capsules 100mg
isavuconazonium
Read the entire package leaflet carefully before starting to take this medicine, as it contains important information for you.
- Keep this package leaflet, as you may need to read it again.
- If you have any further questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed to you only. Do not give it to others, as it may harm them, even if they have the same symptoms as you.
- If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.
Contents of the Package Leaflet
- What is Cresemba and what is it used for
- What you need to know before taking Cresemba
- How to take Cresemba
- Possible side effects
- Storage of Cresemba
- Contents of the pack and further information
1. What is Cresemba and what is it used for
What is Cresemba
Cresemba is an antifungal medicine that contains the active substance isavuconazonium.
How Cresemba works
Isavuconazonium works by killing or stopping the growth of the fungus that causes the infection.
What Cresemba is used for
Cresemba is used in adults and pediatric patients from 6 years of age to treat the following fungal infections:
- invasive aspergillosis, caused by a fungus of 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 isavuconazonium 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 doses of 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 or pharmacist 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 should monitor you for possible side effects.
Monitoring of side effects
Stop taking Cresemba and immediately call your doctor 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 heartbeat or palpitations in the chest: 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 medicine.
Skin problems
Call your doctor immediately if you experience severe skin peeling, mouth, eyes, or genital areas.
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 from 6 years of age and adolescents with a body weight of at least 32 kg, your doctor may prescribe Cresemba 100 mg capsules. Other forms of the medicine are 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 take any other medicines. Some medicines may change the way Cresemba works or Cresemba may change the way other medicines work if 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,
- 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.
A less than 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 any other medicine that decreases the QT interval on the electrocardiogram (ECG),
- aprepitant, used to prevent nausea and vomiting in 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 that the medicines continue to have the desired effect:
- cyclosporine, 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 or 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, mitoxantrone, topotecan, used for different 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 taking this medicine.
Do not take Cresemba if you are pregnant, unless your doctor tells you otherwise. As it is not known whether it may affect or harm the fetus.
Cresemba should not be used during breastfeeding.
Driving and using machines
Cresemba may make you feel confused, tired, or sleepy. It may also cause fainting. Therefore, be very careful when driving or operating machinery.
3. How to take Cresemba
Follow the instructions for taking this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
The recommended dose is as follows:
Adult patients | ||
Loading dose (3 times a day)1 | Maintenance dose (1 time a day)2 | |
Every 8hours during days1 and 2 | Total daily dose during days1 and 2 | |
2 capsules of 100 mg | 6 capsules of 100 mg | 2 capsules of 100 mg |
1 Six administrations in total. 2 Starts between 12 and 24 hours after the last loading dose. |
Pediatric patients from 6 to 18years of age | |||
Body weight (kg) | Loading dose (every 8hours during the first 48hours)1 | Total daily dose during days1 and 2 | Maintenance dose (1 time a day)2 |
From 16 kg to <18 kg | 2 capsules of 40 mg | 6 capsules of 40 mg | 2 capsules of 40 mg |
From 18 kg to <25 kg | 3 capsules of 40 mg | 9 capsules of 40 mg | 3 capsules of 40 mg |
From 25 kg to <32 kg | 4 capsules of 40 mg | 12 capsules of 40 mg | 4 capsules of 40 mg |
≥32 kg to < 37 kg | 1 capsule of 100 mg and2 capsules of 40 mg | 3 capsules of 100 mg and6 capsules of 40 mg | 1 capsule of 100 mg and2 capsules of 40 mg |
≥37 kg | 5 capsules of 40 mg or 2 capsules of 100 mg | 15 capsules of 40 mg or 6 capsules of 100 mg | 5 capsules of 40 mg or 2 capsules of 100 mg |
1 Six administrations in total. 2 Starts between 12 and 24 hours after the last loading dose. |
Use in children and adolescents
The use of Cresemba 100 mg capsules has not been studied in children and adolescents. Your doctor may prescribe Cresemba 100 mg capsules to children and adolescents with a body weight of at least 32 kg.
Other forms of the medicine 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 duration of treatment with Cresemba may be more than 6 months if your doctor considers it necessary.
The 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 the hospital immediately. Take the medicine package with you to show the doctor what you have taken.
It may cause more side effects such as:
- headache, feeling dizzy, agitation, or drowsiness,
- tingling, decreased sensitivity, or tactile sensation,
- problems perceiving things, hot flashes, 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 the next dose, skip the missed dose.
Do not take a double dose to make up for the missed doses.
If you stop taking Cresemba
Do not stop taking Cresemba unless your doctor has told you to do so. It is important to continue treatment with this medicine until your doctor tells you to stop. This is to ensure that the fungal infection has disappeared.
If you have any further questions about 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 immediately call your doctor if you notice any of the following side effects:
- a severe allergic reaction (anaphylaxis) such as 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.
Call your doctor immediately if you notice any of the following side effects:
- severe skin peeling, mouth, eyes, or genital areas.
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
- reduced potassium levels in the blood,
- decreased appetite,
- confusion (delirium),
- headache,
- drowsiness,
- inflamed veins that can cause blood clots,
- sudden shortness of breath or severe respiratory problems,
- nausea, vomiting, diarrhea, and stomach pain,
- changes in blood tests of liver function,
- skin rash, itching,
- kidney failure (symptoms may include swelling of the legs),
- chest pain, feeling tired or sleepy.
Uncommon: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 make you feel weak or short of breath or pale,
- severe reduction in the number of blood cells, may make you feel weak, 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,
- malnutrition,
- low sodium levels in the blood (hyponatremia),
- depression, difficulty sleeping,
- stroke, fainting, or feeling faint,
- tingling, numbness, or prickling sensation in the skin (paresthesia),
- changes in mental status (encephalopathy),
- altered taste (dysgeusia),
- 'spinning' sensation or dizziness (vertigo),
- heart rhythm problems, may be too fast or irregular, or extra heartbeat, this may appear on your electrocardiogram or ECG,
- circulatory problems,
- low blood pressure,
- wheezing, rapid breathing, coughing up blood or bloody sputum, nosebleeds,
- indigestion,
- constipation,
- 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 weak, very tired, sleepy, feeling unwell.
Frequency not known:
- anaphylaxis (a severe allergic reaction).
Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report side effects directly through the national reporting system included in Appendix V. By reporting side 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 which is stated on the label after EXP. The expiry date is the last day of the month indicated.
Do not store above 30°C.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Package Contents and Additional Information
Composition of Cresemba
- The active ingredient is isavuconazole. Each capsule contains 74.5 mg of isavuconazonium sulfate, corresponding to 40 mg of isavuconazole (for Cresemba 40 mg hard capsules) or 186.3 mg of isavuconazonium sulfate, corresponding to 100 mg of isavuconazole (for Cresemba 100 mg hard capsules).
- The other ingredients are:
- Capsule content: magnesium citrate (anhydrous), microcrystalline cellulose (E460), talc (E553b), colloidal anhydrous silica, stearic acid.
- Capsule 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) (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 Package Contents
Cresemba 40 mg hard capsules are brown-red capsules with the cap marked with “CR40” in black ink.
Cresemba 100 mg hard capsules are capsules with the brown-red 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 boxes with 35 capsules. Each box contains 7 aluminum blisters with 5 capsules each.
Cresemba 100 mg hard capsules are available in boxes with 14 capsules. Each box contains 2 aluminum blisters with 7 capsules each.
Each capsule is connected to a bag with a ‘desiccant’ to protect the capsule from moisture.
Do not puncture 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
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)
You can request more information about this medication by contacting the local representative of the marketing authorization holder:
Belgium Pfizer SA/NV Tel: + 32 (0)2 554 62 11 | Lithuania Pfizer Luxembourg SARL, Lithuanian branch Tel: + 3705 2514000 |
| Luxembourg Pfizer SA/NV Tel: + 32 (0)2 554 62 11 |
Czech Republic Pfizer s.r.o. Tel: + 420-283-004-111 | Hungary Pfizer Kft. Tel.: + 36 1 488 37 00 |
Denmark Unimedic Pharma AB Tlf.: + 46 (0) 10-130 99 50 | Malta Vivian Corporation Ltd. Tel: + 35621 344610 |
Germany PFIZER PHARMA GmbH Tel: + 49 (0)30 550055-51000 | Netherlands Pfizer bv Tel: + 31 (0)800 63 34 636 |
Estonia Pfizer Luxembourg SARL, Estonian branch Tel: + 372 666 7500 | Norway Unimedic Pharma AB Tlf: + 46 (0) 10-130 99 50 |
Greece Pfizer ΕΛΛΑΣ A.E. Τηλ: + 30 210 67 85 800 | Austria Pfizer Corporation Austria Ges.m.b.H. Tel: + 43 (0)1 521 15-0 |
Spain Pfizer S.L. Tel: + 34 91 490 99 00 | Poland Pfizer Polska Sp. z o.o. Tel.: + 48 22 335 61 00 |
France Pfizer Tél: + 33 (0)1 58 07 34 40 | Portugal Laboratórios Pfizer, Lda. Tel: + 351 21 423 5500 |
Croatia Pfizer Croatia d.o.o. Tel: + 385 1 3908 777 | Romania Pfizer România S.R.L. Tel: + 40 (0) 21 20 728 00 |
Ireland Pfizer Healthcare Ireland Unlimited Company Tel: + 1800 633 363 (toll free) + 44 (0)1304 616161 | Slovenia Pfizer Luxembourg SARL Pfizer, branch for pharmaceutical activities, Ljubljana Tel: + 386 (0) 1 52 11 400 |
Iceland Unimedic Pharma AB Sími: + 46 (0) 10-130 99 50 | Slovak Republic Pfizer Luxembourg SARL, organizational unit Tel: + 421-2-3355 5500 |
Italy Pfizer S.r.l. Tel: + 39 06 33 18 21 | Finland Unimedic Pharma AB Puh/Tel: + 46 (0) 10-130 99 50 |
Cyprus Pfizer ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH) Τηλ: + 357 22 817690 | Sweden Unimedic Pharma AB Tel: + 46 (0) 10-130 99 50 |
Latvia Pfizer Luxembourg SARL, Latvian branch Tel: + 371 670 35 775 |
Date of the Last Revision of this Leaflet:
Other Sources of Information
Detailed information about this medication is available on the European Medicines Agency website: https://www.ema.europa.eu. There are also links to other websites about rare diseases and orphan medicines.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to CRESEMBA 100 mg HARD CAPSULESDosage form: INJECTABLE PERFUSION, 200 mg (equivalent to 372.6 mg isavuconazole sulfate)Active substance: isavuconazoleManufacturer: Basilea Pharmaceutica Deutschland GmbhPrescription requiredDosage form: CAPSULE, 40 mgActive substance: isavuconazoleManufacturer: Basilea Pharmaceutica Deutschland GmbhPrescription requiredDosage form: CAPSULE, 100 mgActive substance: itraconazoleManufacturer: Esteve Pharmaceuticals S.A.Prescription required
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