CRESEMBA 100 MG

Generic Name/API: isavuconazonium sulfate

Manufacturer: Basilea Pharmaceutica International Ltd.

Dosage Forms & Strength & Pack Size:
• CRESEMBA for injection is supplied in a single-dose vial as a
sterile lyophilized powder containing 372 mg of isavuconazonium
sulfate (equivalent to 200 mg of isavuconazole).
• CRESEMBA capsules: 74.5 mg of isavuconazonium sulfate
(equivalent to 40 mg of isavuconazole), 186 mg of
isavuconazonium sulfate (equivalent to 100 mg of isavuconazole).

Storage:
CRESEMBA Capsules
Store CRESEMBA capsules at 20°C to 25°C (68°F to 77°F) in the original packaging to protect from moisture.
Excursions are permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
CRESEMBA for Injection
Store CRESEMBA for injection unreconstituted vials at 2°C to 8°C (36°F to 46°F) in a refrigerator. CRESEMBA for injection is a single-dose vial of unpreserved sterile lyophile.
Following reconstitution of the lyophile with water for injection USP, the reconstituted solution should be used immediately, or stored between 5°C to 25°C (41°F to 77°F) for a maximum of 1 hour prior to preparation of the patient infusion solution [see Dosage and Administration (2.4)]. The prepared infusion solution should be kept for not more than 6 hours at room temperature [20°C to 25°C (68°F to 77°F)] or 24 hours at 2°C to 8°C (36°F to 46°F) prior to use [see Dosage and Administration (2.5)]. For nasogastric tube use, the reconstituted solution should be stored between 5°C to 25°C (41°F to 77°F) and used within 1 hour of reconstitution [see Dosage and Administration (2.6)].

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

CRESEMBA (isavuconazonium sulfate) is an azole antifungal indicated for the treatment of invasive aspergillosis and invasive mucormycosis as follows:

  • CRESEMBA for injection: adults and pediatric patients 1 year of age and older
  • CRESEMBA capsules: adults and pediatric patients 6 years of age and older who weigh 16 kg and greater

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.

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.

Hypersensitivity Reactions: Anaphylactic reactions, with fatal outcome, have been reported during treatment with CRESEMBA. Serious skin reactions, such as Stevens Johnson syndrome, have been reported during treatment with other azole antifungal agents. Discontinue CRESEMBA if anaphylactic or serious skin reactions occur, and initiate supportive treatment as needed.

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.

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