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Cresemba 372 Mg Sdv

  • Manufacturer Name : ASTELLAS PHARMA
  • MFG # : 00469042001
  • NDC : 00469042001
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind A1
DESI2 Drug Ind A1
Drug Category -
Drug Category -
Drug Type Code S
Drug Type Code S
FDA Approval Date 04/15/2015
FDA Approval Date 04/15/2015
FDA Therap Equiv EA
FDA Therap Equiv EA
HCPCS isavuconazonium inj, 1 mg
HCPCS isavuconazonium inj, 1 mg
Market Entry Date -
Market Entry Date -
Medical Coverage J1833
Medical Coverage J1833
Termination Date 1
Termination Date 1
Unit 1
Unit 1
Units Per Pkg 03/06/2015
Units Per Pkg 03/06/2015
Active Ingredients 15946 isavuconazonium sulfate 946075134
Active Ingredients 15946 isavuconazonium sulfate 946075134
AHFS Class 8140800 AZOLE ANTIFUNGALS
AHFS Class 8140800 AZOLE ANTIFUNGALS
DEA Class NC
DEA Class NC
Dose Form VIAL (EA)
Dose Form VIAL (EA)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 73653 isavuconazonium sulfate INTRAVEN VIAL 372 MG
Gen Code and Des 73653 isavuconazonium sulfate INTRAVEN VIAL 372 MG
Inactive Ingredients -
Inactive Ingredients -
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 372MG
Strength 372MG
Common Brand Name COMMON BRAND NAME(S): Cresemba
Common Brand Name COMMON BRAND NAME(S): Cresemba
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.
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
Case Quantity 60
Case Quantity 60
Drug Form Pack Size 1
Drug Form Pack Size 1
Form SINGLE DOSE VIAL
Form SINGLE DOSE VIAL
Hazard Code UN3077 ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S.
Hazard Code UN3077 ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S.
Listed Chemical -
Listed Chemical -
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.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 30 Refrige./DoNot Freez
Temp Zone 30 Refrige./DoNot Freez
Unit EA
Unit EA
Unit Size -
Unit Size -
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist. This medication is given by injection into a vein 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, it will be given once daily. This medication should be injected slowly over 1 hour. If you are using this medication at home, learn all preparation and usage instructions from your health care professional. You should use an in-line filter with this medication. It is normal for this product to have white particles in the liquid. Before using, check this product visually for other particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely. If you are giving this medication through a nasogastric tube, ask your health care professional for detailed instructions on how to properly mix and give it. This medication works best when the amount of medicine in your body is kept at a constant level. Use this drug at evenly spaced intervals. Continue to use 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 HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist. This medication is given by injection into a vein 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, it will be given once daily. This medication should be injected slowly over 1 hour. If you are using this medication at home, learn all preparation and usage instructions from your health care professional. You should use an in-line filter with this medication. It is normal for this product to have white particles in the liquid. Before using, check this product visually for other particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely. If you are giving this medication through a nasogastric tube, ask your health care professional for detailed instructions on how to properly mix and give it. This medication works best when the amount of medicine in your body is kept at a constant level. Use this drug at evenly spaced intervals. Continue to use 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.
Missed Dose MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
Missed Dose MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
Notes NOTES: Lab and/or medical tests (such as liver function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Notes NOTES: Lab and/or medical tests (such as liver function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
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 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.
Phonetic Pronunciation (EYE-sa-vue-KOE-na-ZOE-nee-um)
Phonetic Pronunciation (EYE-sa-vue-KOE-na-ZOE-nee-um)
Precautions PRECAUTIONS: Before using 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: Before using 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.
Side Effects SIDE EFFECTS: 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. Symptoms of an infusion reaction that may occur during isavuconazonium treatment include dizziness, fainting, trouble breathing, chills, numb/tingling skin, changes in your sense of touch. Your doctor will monitor you closely and will stop your treatment if a reaction occurs. 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 SIDE EFFECTS: 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. Symptoms of an infusion reaction that may occur during isavuconazonium treatment include dizziness, fainting, trouble breathing, chills, numb/tingling skin, changes in your sense of touch. Your doctor will monitor you closely and will stop your treatment if a reaction occurs. 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.
Storage STORAGE: Consult the product instructions and your pharmacist for storage details. 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 STORAGE: Consult the product instructions and your pharmacist for storage details. 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.
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.
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.

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Cresemba 372 Mg Sdv is manufactured by ASTELLAS PHARMA.
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