What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Cresemba (Isavuconazonium)
Prescription Required
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Product Details
Description
Cresemba is a prescription medication for treating certain types of invasive fungal infections, including aspergillosis and mucormycosis, in adults and pediatric patients who are at least 6 years old and weigh at least 16 kg.
Cresemba is available in oral capsules containing 74.5 mg of isavuconazonium sulfate (equivalent to 40 mg of isavuconazole) or 186 mg of isavuconazonium sulfate (equivalent to 100 mg of isavuconazole).
Cresemba’s generic name is isavuconazonium sulfate.
Fact Table
Formula
C35H42F2N8O6S (Isavuconazonium sulfate)
License
US FDA, EMA
Bioavailability
98% (oral)
Legal status
Prescription only (Rx)
Chemical Name
[(2R,3R)-3-[4-[4-[[(1R)-2,2-Difluoro-1-(1H-1,2,4-triazol-1-yl)ethyl]amino]phenyl]-1,3-thiazol-2-yl]oxolan-2-yl]methoxymethylsulfate
Elimination half-life
130 hours
Dosage (Strength)
186 mg capsules, 372 mg powder for injection
Pregnancy
Use only if potential benefit justifies risk
Brands
Cresemba
Protein binding
>99%
PubChem CID
11540082
MedlinePlus
a614047
ChEBI
CHEBI:82720
ATC code
J02AC05
DrugBank
DB06292
KEGG
D10314
Routes of administration
Oral, Intravenous
Directions
Take Cresemba exactly as prescribed. The doctor will prescribe an appropriate dose for you or your child based on age and weight.
Keep Cresemba capsules in their original packaging and stored between 20°C to 25°C (68°F to 77°F). Keep away from children.
If you would like more information about Cresemba, refer to the medication guide that comes with the prescription.
If you have any questions or concerns, talk to your or your child’s doctor or pharmacist.
Ingredients
The active ingredient in Cresemba is isavuconazonium sulfate.
Inactive ingredients in the 74.5 mg capsules include black iron oxide, colloidal silicon dioxide, disodium edetate, gellan gum, hypromellose, magnesium citrate, microcrystalline cellulose, potassium acetate, potassium hydroxide, propylene glycol, purified water, red iron oxide, shellac, sodium lauryl sulfate, stearic acid, strong ammonia solution, talc, and titanium dioxide.
Inactive ingredients in the 186 mg capsules include black iron oxide, colloidal silicon dioxide, disodium edetate, gellan gum, hypromellose, magnesium citrate, microcrystalline cellulose, potassium acetate, potassium hydroxide, propylene glycol, purified water, red iron oxide, shellac, sodium lauryl sulfate, stearic acid, strong ammonia solution, talc, and titanium dioxide.
Contraindications
Patients with any of the following criteria should not take Cresemba:
- Allergy to the medication
- Are also taking strong CYP3A4 inhibitors such as high-dose ritonavir or ketoconazole; ask your doctor whether or not you take any of these medications
- Are also taking strong CYP3A4 inducers, such as rifampin, St. John’s wort, carbamazepine, or long-acting barbiturates; ask your doctor whether or not you take any of these medications
- Familial short QT syndrome
Cautions
- Before you or your child begins Cresemba treatment, inform the doctor of:
- All the prescription and over-the-counter medications you or your child takes
- Your or your child’s allergies
- Your or your child’s current health problems and past medical history
- Your or your child’s pregnancy or breastfeeding status
- Cresemba is associated with the following warnings and precautions:
- Liver problems
- Serious allergic reactions, including anaphylaxis
- Harm to an unborn baby; females with reproductive ability should use effective contraceptive methods during Cresemba treatment and for 28 days after taking the final dose
- Breastfeeding is not recommended during Cresemba treatment
Side Effects
Nausea, vomiting, diarrhea, headache, increased liver enzymes, low blood potassium levels, constipation, shortness of breath, cough, swelling, and back pain are common Cresemba side effects in adults.
Diarrhea, abdominal pain, vomiting, increased liver enzymes, rash, nausea, itching, and headache are common Cresemba side effects in pediatric patients.
Other side effects may occur. Immediately contact a doctor if side effects bother you or your child or they won’t go away.
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Reference
Cresemba. Northbrook, IL: Astellas Pharma US, Inc.; 2023.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 14949
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