CRESEMBA (isavuconazonium sulfate) Lighthouse
CRESEMBA (isavuconazonium sulfate) Lighthouse

CRESEMBA® (isavuconazonium sulfate) is indicated for the treatment of invasive aspergillosis and invasive mucormycosis in adults. Usage Specimens for fungal culture and other relevant laboratory studies (including histopathology) to isolate and identify causative organism(s) should be obtained prior to initiating antifungal therapy. Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.

CRESEMBA Support SolutionsSM

CRESEMBA Support SolutionsSM, a component of Astellas Pharma Support SolutionsSM, offers access and reimbursement assistance to help patients and healthcare providers overcome challenges to accessing and paying for CRESEMBA.

CRESEMBA Support Solutions—your resource for access, reimbursement, and patient assistance*

To explore more about each specific service available through CRESEMBA Support Solutions, simply click any of the links below:

CRESEMBA Patient Savings Program

CRESEMBA Patient Savings Card

The CRESEMBA Patient Savings Program is for patients who have commercial/private health insurance, but who may have trouble paying their out-of-pocket costs for CRESEMBA. Eligible patients are responsible for the first $25 per prescription with a maximum savings of $4000 annually.

Print a CRESEMBA Patient Savings Card for your patient

In order to participate in the CRESEMBA Patient Savings Program ("Program"), patient must have prescription drug coverage for CRESEMBA. However, this program is not valid for patients whose prescription claims are reimbursed, in whole or in part, by any state or federal government program, including, but not limited to, Medicaid, Medicare, Medigap, Department of Defense (DoD), Veterans Affairs (VA), TRICARE, CHAMPUS, Puerto Rico Government Health Insurance, or any state patient or pharmaceutical assistance program. Patient must have prescription drug coverage for CRESEMBA. This offer is not valid for cash-paying patients. This Program is void where prohibited by law. Certain rules and restrictions apply. This Program is only valid in the United States.

CRESEMBA Support Solutions patient enrollment

To enroll your patient in CRESEMBA Support Solutions, please complete the CRESEMBA Support Solutions Enrollment Form in its entirety. All required fields are marked with an asterisk.

It is critical that the enrollment form is signed by both the prescribing doctor and the patient or the patient's authorized representative. The enrollment form can be returned via fax to 1-866-317-6235 or completed online at Astellas eService Portal.

Contact CRESEMBA Support Solutions
Phone: 1-800-477-6472
Fax: 1-866-317-6235
Monday through Friday, 9 AM to 8 PM ET
Or visit CRESEMBASupportSolutions.com
CRESEMBA Support Solutions(SM) Logo

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IMPORTANT SAFETY INFORMATION AND USE OF CRESEMBA

CONTRAINDICATIONS

  • CRESEMBA is contraindicated in persons with known hypersensitivity to isavuconazole
  • Coadministration of strong CYP3A4 inhibitors, such as ketoconazole or high-dose ritonavir (400 mg every 12 hours), with CRESEMBA is contraindicated because strong CYP3A4 inhibitors can significantly increase the plasma concentration of isavuconazole
  • Coadministration of strong CYP3A4 inducers, such as rifampin, carbamazepine, St. John's wort, or long acting barbiturates with CRESEMBA is contraindicated because strong CYP3A4 inducers can significantly decrease the plasma concentration of isavuconazole
  • CRESEMBA shortened the QTc interval in a concentration-related manner. CRESEMBA is contraindicated in patients with familial short QT syndrome

WARNINGS AND PRECAUTIONS

Hepatic Adverse Drug Reactions (e.g., elevations in ALT, AST, alkaline phosphatase, total bilirubin) have been reported in clinical trials and were generally reversible and did not require discontinuation of CRESEMBA. Cases of 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 tests at the start and during therapy. Monitor patients who develop liver abnormalities during CRESEMBA therapy for severe hepatic injury. Discontinue if clinical signs and symptoms consistent with liver disease develop that may be attributable to CRESEMBA.

Infusion-Related Reactions including hypotension, dyspnea, chills, dizziness, paresthesia, and hypoesthesia were reported during intravenous administration of CRESEMBA. Discontinue the infusion if these reactions occur.

Serious Hypersensitivity and Severe Skin Reactions, such as anaphylaxis or Stevens Johnson syndrome, have been reported during treatment with other azole antifungal agents. Discontinue CRESEMBA if a patient develops a severe cutaneous adverse reaction. Caution should be used when prescribing CRESEMBA to patients with hypersensitivity to other azoles.

Embryo-Fetal Toxicity: During pregnancy, CRESEMBA may cause fetal harm when administered, and CRESEMBA should only be used if the potential benefit to the patient outweighs the risk to the fetus. Women who become pregnant while receiving CRESEMBA are encouraged to contact their physician.

Drug Interactions: Coadministration of CRESEMBA with strong CYP3A4 inhibitors such as ketoconazole or high-dose ritonavir and strong CYP3A4 inducers such as rifampin, carbamazepine, St. John's Wort, or long-acting barbiturates is contraindicated.

Drug Particulates: Following dilution, CRESEMBA intravenous formulation may form precipitate from the insoluble isavuconazole. Administer CRESEMBA through an in-line filter.

ADVERSE REACTIONS

The most frequently reported adverse reactions among CRESEMBA-treated patients were nausea (26%), vomiting (25%), diarrhea (22%), headache (17%), elevated liver chemistry tests (16%), hypokalemia (14%), constipation (13%), dyspnea (12%), cough (12%), peripheral edema (11%), and back pain (10%).

The adverse reactions which most often led to permanent discontinuation of CRESEMBA therapy during the clinical trials were: confusional state (0.7%), acute renal failure (0.7%), increased blood bilirubin (0.5%), convulsion (0.5%), dyspnea (0.5%), epilepsy (0.5%), respiratory failure (0.5%), and vomiting (0.5%).

INDICATIONS AND USAGE

CRESEMBA is an azole antifungal indicated for patients 18 years of age and older for the treatment of invasive aspergillosis and invasive mucormycosis.

Specimens for fungal culture and other relevant laboratory studies (including histopathology) to isolate and identify causative organism(s) should be obtained prior to initiating antifungal therapy. Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.


Please see full Prescribing Information.

Important Safety Information and Use of Cresemba

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