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1 Indications And Usage Mycamine ® Is Indicated For: • Treatment Of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis And Abscesses In Adult And Pediatric Patients 4 Months Of Age And Older [see Clinical Studies ( 14.1 ) And Use In Specific Populations ( 8.4 )]. • Treatment Of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis And Abscesses Without Meningoencephalitis And/or Ocular Dissemination In Pediatric Patients Younger Than 4 Months Of Age [see Use In Specific Populations ( 8.4 )] . • Treatment Of Esophageal Candidiasis In Adult And Pediatric Patients 4 Months Of Age And Older [see Clinical Studies ( 14.2 )] . • Prophylaxis Of Candida Infections In Adult And Pediatric Patients 4 Months Of Age And Older Undergoing Hematopoietic Stem Cell Transplantation [see Clinical Studies ( 14.3 )] . Limitations Of Use • The Safety And Effectiveness Of Mycamine Have Not Been Established For The Treatment Of Candidemia With Meningoencephalitis And/or Ocular Dissemination In Pediatric Patients Younger Than 4 Months Of Age As A Higher Dose May Be Needed [see Use In Specific Populations ( 8.4 )] . • Mycamine Has Not Been Adequately Studied In Patients With Endocarditis, Osteomyelitis And Meningoencephalitis Due To Candida . • The Efficacy Of Mycamine Against Infections Caused By Fungi Other Than Candida Has Not Been Established. Mycamine ® Is An Echinocandin Indicated In Adult And Pediatric Patients For ( 1 ): • Treatment Of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis And Abscesses In Adult And Pediatric Patients 4 Months Of Age And Older. • Treatment Of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis And Abscesses Without Meningoencephalitis And/or Ocular Dissemination In Pediatric Patients Younger Than 4 Months Of Age. • Treatment Of Esophageal Candidiasis In Adult And Pediatric Patients 4 Months Of Age And Older. • Prophylaxis Of Candida Infections In Adult And Pediatric Patients 4 Months Of Age And Older Undergoing Hematopoietic Stem Cell Transplantation (hsct). Limitations Of Use • The Safety And Effectiveness Of Mycamine Have Not Been Established For The Treatment Of Candidemia With Meningoencephalitis And/or Ocular Dissemination In Pediatric Patients Younger Than 4 Months Of Age As A Higher Dose May Be Needed. ( 1 , 2.3 , 8.4 ) • Mycamine Has Not Been Adequately Studied In Patients With Endocarditis, Osteomyelitis Or Meningoencephalitis Due To Candida. ( 1 ) • The Efficacy Of Mycamine Against Infections Caused By Fungi Other Than Candida Has Not Been Established. ( 1 )
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