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CRESEMBA
Overview
What is CRESEMBA?
CRESEMBA contains isavuconazonium sulfate, which is the prodrug of isavuconazole, an azole antifungal drug. Isavuconazonium sulfate drug substance is an amorphous, white to yellowish-white powder. The chemical name of isavuconazonium sulfate is glycine, -methyl-, [2-[[[1-[1-[(2,3)-3-[4-(4-cyanophenyl)-2-thiazolyl]-2-(2,5-difluorophenyl)-2-hydroxybutyl]-4-1,2,4-triazolium-4-yl]ethoxy]carbonyl]methylamino]-3-pyridinyl]methyl ester, sulfate (1:1). The empirical formula is CHFNOS·HSO, the molecular weight is 814.84 and the structural formula is:
CRESEMBA (isavuconazonium sulfate) capsules are available for oral administration. Each CRESEMBA capsule contains 186 mg isavuconazonium sulfate, equivalent to 100 mg isavuconazole. The inactive ingredients include magnesium citrate, microcrystalline cellulose, talc, colloidal silicon dioxide, stearic acid, hypromellose, red iron oxide, titanium dioxide, purified water, gellan gum, potassium acetate, disodium edetate, sodium laurylsulfate, shellac, propylene glycol, strong ammonia solution, potassium hydroxide and black iron oxide.
CRESEMBA (isavuconazonium sulfate) for injection is available for intravenous administration. CRESEMBA for injection is a white to yellow sterile lyophilized powder containing 372 mg isavuconazonium sulfate, equivalent to 200 mg isavuconazole, per vial. Inactive ingredients included in each vial are 96 mg mannitol and sulfuric acid for pH adjustment.
What does CRESEMBA look like?
What are the available doses of CRESEMBA?
Each CRESEMBA capsule contains 186 mg isavuconazonium sulfate (equivalent to 100 mg of isavuconazole). Capsules are opaque and elongated, and have a Swedish orange (reddish-brown) body imprinted with the Astellas logo in black ink and a white cap imprinted with “766” in black ink.
Each single-dose vial of CRESEMBA for injection contains 372 mg isavuconazonium sulfate (equivalent to 200 mg of isavuconazole). CRESEMBA for injection is supplied in a single-dose vial as a sterile lyophilized white to yellow powder.
What should I talk to my health care provider before I take CRESEMBA?
How should I use CRESEMBA?
CRESEMBA is an azole antifungal indicated for patients 18 years of age and older for the treatment of invasive aspergillosis.
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What interacts with CRESEMBA?
Sorry No Records found
What are the warnings of CRESEMBA?
Sorry No Records found
What are the precautions of CRESEMBA?
Sorry No Records found
What are the side effects of CRESEMBA?
Sorry No records found
What should I look out for while using CRESEMBA?
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What might happen if I take too much CRESEMBA?
During clinical studies, total daily CRESEMBA doses higher than the recommended dose regimen were associated with an increased rate of adverse reactions. At supratherapeutic doses (three times the recommended maintenance dose) evaluated in a thorough QT study, there were proportionally more treatment-emergent adverse reactions than in the therapeutic dose group (maintenance dose) for the following: headache, dizziness, paresthesia, somnolence, disturbance in attention, dysgeusia, dry mouth, diarrhea, oral hypoesthesia, vomiting, hot flush, anxiety, restlessness, palpitations, tachycardia, photophobia and arthralgia. Treatment-emergent adverse reactions leading to discontinuation of study drug occurred in 7 of 39 (17.9%) subjects in the supratherapeutic dose group.
Isavuconazole is not removed by hemodialysis. There is no specific antidote for isavuconazole. Treatment should be supportive with appropriate monitoring.
How should I store and handle CRESEMBA?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Lisinopril Tablets, USP 2.5 mg are white, oval shaped, convex tablets, debossed “4209” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 5 mg are white, capsule shaped, convex, bisected tablets, debossed “42/10” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 10 mg are white, round, convex tablets, debossed “3972” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 20 mg are white, round, convex tablets, debossed “3973” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 30 mg are white, round, convex tablets, debossed “3974” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 40 mg are white, round, convex tablets, debossed “4214” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 2.5 mg are white, oval shaped, convex tablets, debossed “4209” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 5 mg are white, capsule shaped, convex, bisected tablets, debossed “42/10” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 10 mg are white, round, convex tablets, debossed “3972” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 20 mg are white, round, convex tablets, debossed “3973” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 30 mg are white, round, convex tablets, debossed “3974” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 40 mg are white, round, convex tablets, debossed “4214” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 2.5 mg are white, oval shaped, convex tablets, debossed “4209” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 5 mg are white, capsule shaped, convex, bisected tablets, debossed “42/10” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 10 mg are white, round, convex tablets, debossed “3972” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 20 mg are white, round, convex tablets, debossed “3973” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 30 mg are white, round, convex tablets, debossed “3974” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 40 mg are white, round, convex tablets, debossed “4214” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 2.5 mg are white, oval shaped, convex tablets, debossed “4209” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 5 mg are white, capsule shaped, convex, bisected tablets, debossed “42/10” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 10 mg are white, round, convex tablets, debossed “3972” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 20 mg are white, round, convex tablets, debossed “3973” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 30 mg are white, round, convex tablets, debossed “3974” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 40 mg are white, round, convex tablets, debossed “4214” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 2.5 mg are white, oval shaped, convex tablets, debossed “4209” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 5 mg are white, capsule shaped, convex, bisected tablets, debossed “42/10” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 10 mg are white, round, convex tablets, debossed “3972” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 20 mg are white, round, convex tablets, debossed “3973” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 30 mg are white, round, convex tablets, debossed “3974” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 40 mg are white, round, convex tablets, debossed “4214” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 2.5 mg are white, oval shaped, convex tablets, debossed “4209” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 5 mg are white, capsule shaped, convex, bisected tablets, debossed “42/10” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 10 mg are white, round, convex tablets, debossed “3972” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 20 mg are white, round, convex tablets, debossed “3973” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 30 mg are white, round, convex tablets, debossed “3974” on one side and “V” on the reverse side; and supplied as follows:Lisinopril Tablets, USP 40 mg are white, round, convex tablets, debossed “4214” on one side and “V” on the reverse side; and supplied as follows:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Isavuconazonium sulfate is the prodrug of isavuconazole, an azole antifungal .
Non-Clinical Toxicology
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Theophylline interacts with a wide variety of drugs. The interaction may be pharmacodynamic, i.e., alterations in the therapeutic response to theophylline or another drug or occurrence of adverse effects without a change in serum theophylline concentration. More frequently, however, the interaction is pharmacokinetic, i.e., the rate of theophylline clearance is altered by another drug resulting in increased or decreased serum theophylline concentrations. Theophylline only rarely alters the pharmacokinetics of other drugs.
The drugs listed in Table II have the potential to produce clinically significant pharmacodynamic or pharmacokinetic interactions with theophylline. The information in the “Effect” column of Table II assumes that the interacting drug is being added to a steady-state theophylline regimen. If theophylline is being initiated in a patient who is already taking a drug that inhibits theophylline clearance (e.g., cimetidine, erythromycin), the dose of theophylline required to achieve a therapeutic serum theophylline concentration will be smaller. Conversely, if theophylline is being initiated in a patient who is already taking a drug that enhances theophylline clearance (e.g., rifampin), the dose of theophylline required to achieve a therapeutic serum theophylline concentration will be larger. Discontinuation of a concomitant drug that increases theophylline clearance will result in accumulation of theophylline to potentially toxic levels, unless the theophylline dose is appropriately reduced. Discontinuation of a concomitant drug that inhibits theophylline clearance will result in decreased serum theophylline concentrations, unless the theophylline dose is appropriately increased.
The drugs listed in Table III have either been documented not to interact with theophylline or do not produce a clinically significant interaction (i.e., <15% change in theophylline clearance).
The listing of drugs in Tables II and III are current as of February 9, 1995. New interactions are continuously being reported for theophylline, especially with new chemical entities. . Before addition of a newly available drug in a patient receiving theophylline, the package insert of the new drug and/or the medical literature should be consulted to determine if an interaction between the new drug and theophylline has been reported.
The Effect Of Other Drugs On Theophylline Serum Concentration Measurements:
Hepatic adverse drug reactions (e.g., elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin) have been reported in clinical trials. The elevations in liver-related laboratory tests were generally reversible and did not require discontinuation of CRESEMBA. Cases of more severe hepatic adverse drug reactions including hepatitis, cholestasis or hepatic failure including death have been reported in patients with serious underlying medical conditions (e.g., hematologic malignancy) during treatment with azole antifungal agents, including CRESEMBA.
Evaluate liver-related laboratory tests at the start and during the course of CRESEMBA therapy. Monitor patients who develop abnormal liver-related laboratory tests during CRESEMBA therapy for the development of more severe hepatic injury. Discontinue CRESEMBA if clinical signs and symptoms consistent with liver disease develop that may be attributable to CRESEMBA.
The following are discussed in more detail in other sections of the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of CRESEMBA cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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