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CRESEMBA 186 MG CAP 14 UD

  • Manufacturer Name : ASTELLAS PHARMA
  • MFG # : 00469052002
  • NDC : 00469052002
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description S
Description -
Description S
DESI Drug Ind -
DESI Drug Ind -; -
DESI Drug Ind -; -
DESI2 Drug Ind -
Drug Category S
Drug Category USES: This medication is used to treat certain serious fungal infections. This medication is known as an azole antifungal. It works by stopping the growth of fungi.
Drug Category USES: This medication is used to treat certain serious fungal infections. This medication is known as an azole antifungal. It works by stopping the growth of fungi.
Drug Type Code COMMON BRAND NAME(S): Cresemba
Drug Type Code COMMON BRAND NAME(S): Cresemba
Drug Type Code 1
FDA Approval Date 04/03/2015
FDA Therap Equiv NR
HCPCS -
HCPCS 1
HCPCS 1
Market Entry Date 04/16/2015
Medical Coverage -
Medical Coverage -
Medical Coverage -
Termination Date (EYE-sa-vue-KOE-na-ZOE-nee-um)
Termination Date -
Termination Date (EYE-sa-vue-KOE-na-ZOE-nee-um)
Unit CAP
Units Per Pkg 14
Active Ingredients 15946 isavuconazonium sulfate 946075134
Active Ingredients 15946 isavuconazonium sulfate 946075134
Active Ingredients 15946 isavuconazonium sulfate 946075134
AHFS Class 8140800 AZOLE ANTIFUNGALS
AHFS Class 8140800 AZOLE ANTIFUNGALS
AHFS Class 8140800 AZOLE ANTIFUNGALS
DEA Class NC
DEA Class NC
DEA Class NC
Dose Form CAPSULE
Dose Form CAPSULE
Dose Form CAPSULE
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 73654 isavuconazonium sulfate ORAL CAPSULE 186 MG
Gen Code and Des 73654 isavuconazonium sulfate ORAL CAPSULE 186 MG
Gen Code and Des 73654 isavuconazonium sulfate ORAL CAPSULE 186 MG
Inactive Ingredients -
Inactive Ingredients -
Inactive Ingredients -
OMP Family -
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 186MG
Strength 186MG
Strength 186MG
Common Brand Name -
Common Brand Name COMMON BRAND NAME(S): Cresemba
Common Brand Name -
Drug Interaction -
Drug Interaction -
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include bosutinib, elacestrant, flibanserin, lomitapide, tolvaptan, among others. Other medications can affect the removal of isavuconazonium from your body, which may affect how isavuconazonium works. Examples include adagrasib, certain azole antifungals (such as itraconazole, ketoconazole), certain HIV protease inhibitors (such as nelfinavir, saquinavir), nefazodone, certain rifamycins (such as rifabutin, rifampin), ritonavir, certain drugs used to treat seizures (such as carbamazepine, phenobarbital), St. John's wort, among others.
Allocation Period Weekly
Allocation Period Weekly
Allocation Period Weekly
Case Quantity 24
Case Quantity 24
Case Quantity 24
Drug Form Pack Size 14
Drug Form Pack Size 14
Drug Form Pack Size 14
Form CAPSULES
Form CAPSULES
Form CAPSULES
Hazard Code -
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
NIOSH Code -
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Retail Pack Quantity 1
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit EA
Unit Size 14
Unit Size 14
Unit Size 14
How to Use -
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually every 8 hours for the first 6 doses (48 hours). Then 12 to 24 hours after the first 6 doses, take this medication once daily. The manufacturer directs not to chew, crush, dissolve, or open the capsule before taking it. However, many similar drugs (immediate-release capsules) can be chewed, crushed, dissolved, or opened. Follow your doctor's directions on how to take this medication. This medication works best when the amount of medicine in your body is kept at a constant level. Take this drug at evenly spaced intervals. Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection. Tell your doctor if your condition does not improve or if it worsens.
How to Use -
Missed Dose 14
Missed Dose MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Missed Dose 14
Notes NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to. Lab and/or medical tests (such as liver function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Notes CAP
Notes CAP
Overdose NR
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose NR
Phonetic Pronunciation -
Phonetic Pronunciation -
Phonetic Pronunciation (EYE-sa-vue-KOE-na-ZOE-nee-um)
Precautions PRECAUTIONS: Before taking isavuconazonium, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, family history of certain heart problems (short QT syndrome, abnormal heart rate/rhythm). This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using isavuconazonium. Isavuconazonium may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 28 days after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. It is unknown if this drug passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Precautions -
Precautions -
Side Effects -
Side Effects SIDE EFFECTS: Dizziness, nausea, vomiting, diarrhea, headache, constipation, cough, and trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: muscle cramps/spasms, weakness, irregular heartbeat, swelling hands/ankles/feet, back pain, mental/mood changes (such as confusion, anxiety). Get medical help right away if you have any very serious side effects, including: fast/irregular/pounding heartbeat, chest pain, fainting, signs of kidney problems (such as change in the amount of urine), seizures. Isavuconazonium may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine. Isavuconazonium can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Tell your doctor right away if you develop any rash. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects -
Storage 04/03/2015
Storage STORAGE: Store in the original container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage 04/03/2015
Uses -
Uses -
Uses USES: This medication is used to treat certain serious fungal infections. This medication is known as an azole antifungal. It works by stopping the growth of fungi.

Frequently Asked Questions(FAQs)

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CRESEMBA 186 MG CAP 14 UD is manufactured by ASTELLAS PHARMA.
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