Skip to Content

Join the 'Aspergillosis - Invasive' group to help and get support from people like you.

Aspergillosis - Invasive News

Related terms: Aspergillosis, invasive pulmonary

FDA Medwatch Alert: Noxafil (posaconazole): Drug Safety Communication - Dosing Errors when Switching between Different Oral Formulations; Label Changes Approved

Posted 4 Jan 2016 by Drugs.com

ISSUE: The FDA is cautioning that differences in dosing regimens between the two oral formulations of the antifungal Noxafil (posaconazole) have resulted in dosing errors.  To help prevent additional medication errors, the drug labels were revised to indicate that the two oral formulations cannot be directly substituted for each other but require a change in dose.  Direct mg for mg substitution of the two formulations can result in drug levels that are lower or higher than needed to effectively treat certain fungal infections.  Since the approval of Noxafil delayed-release tablets in November 2013, FDA received eleven reports of the wrong oral formulations being prescribed and/or dispensed to patients.  One case resulted in death, and an additional case resulted in hospitalization.  According to the reports, these outcomes were a result of health care professionals not knowing that the t ... Read more

Related support groups: Candida Infections, Aspergillosis - Invasive, Noxafil, Posaconazole

Cresemba Approved for Serious Fungal Infections

Posted 8 Mar 2015 by Drugs.com

FRIDAY, March 6, 2015 – Cresemba (isavuconazonium sulfate) has been approved by the U.S. Food and Drug Administration to treat rare but serious fungal infections, mostly affecting people with weakened immune systems, the agency said Friday in a news release. The infections are caused by Aspergillus and Mucorales fungi. The new drug, targeting the cell walls of the fungi, is available in oral and intravenous formulations. Cresmba's safety and effectiveness were evaluated in clinical studies involving more than 500 people. The most common side effects included nausea, vomiting, diarrhea, headache, low blood potassium, constipation, shortness of breath, coughing and tissue swelling. More serious adverse effects could include liver problems and allergic reactions. Cresemba is marketed by Astellas Pharma US, based in Northbrook, Ill. More information The FDA has more about this approval. Read more

Related support groups: Fungal Infections, Aspergillosis - Invasive

FDA Approves Cresemba (isavuconazonium sulfate) For Fungal Infections

Posted 6 Mar 2015 by Drugs.com

March 6, 2015 – The U.S. Food and Drug Administration today approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections. Aspergillosis is a fungal infection caused by Aspergillus species, and mucormycosis is caused by the Mucorales fungi. These infections occur most often in people with weakened immune systems. Cresemba belongs to a class of drugs called azole antifungal agents, which target the cell wall of a fungus. Cresemba is available in oral and intravenous formulations. “Today’s approval provides a new treatment option for patients with serious fungal infections and underscores the importance of having available safe and effective antifungal drugs,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Eval ... Read more

Related support groups: Fungal Infections, Aspergillosis, Aspergillosis - Invasive

Ask a Question

Further Information

Related Condition Support Groups

Aspergillosis

Related Drug Support Groups

itraconazole, amphotericin b, Sporanox, voriconazole, AmBisome, amphotericin b lipid complex, Vfend, Abelcet, Noxafil, view more... Cresemba, Cancidas, Fungizone, amphotericin b liposomal, Onmel, posaconazole, Sporanox PulsePak, isavuconazonium, Amphocin, amphotericin b cholesteryl sulfate, Amphotec, caspofungin