Cresemba Approved for Invasive Fungal Infections
March 6, 2015 – The U.S. Food and Drug Administration (FDA) approved Cresemba (isavuconazonium), manufacturer by Astellas Pharma, and co-developed with Basilea Pharmaceutica International. Cresemba has initial indications to treat adult patients with two rare types of invasive fungal infections – aspergillosis and mucormycosis. Both types of fungal infections are serious and can be life-threatening for immunocompromised individuals.
Cresemba will be available in both oral capsules and an intravenous (IV) solution, to be administered in 372mg (two capsules or one vial) every eight hours for the first six doses and then dosing will be reduced to 372mg once a day. Oral and IV forms of the drug are bioequivalent, so switching from one to the other does not require dosing adjustments.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.