Colistimethate Sodium and Denileukin Diftitox

• Generic Name: colistimethate
• Dosage Forms: n.a.
• Other Brand Names: Coly Mycin M

Treatment of acute or chronic infections caused by certain susceptible gram-negative bacteria (e.g., Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa).

Used only when the causative agent is susceptible and other more effective and less toxic anti-infectives are contraindicated or ineffective.

May be useful alone or in conjunction with other anti-infectives for treatment of infections caused by multiple-drug resistant gram-negative bacteria, such as respiratory tract infections in cystic fibrosis patients caused by multiple-drug resistant Ps. aeruginosa.

Not indicated for infections caused by Proteus or Neisseria.

Administered by oral inhalation via nebulization in adult and pediatric cystic fibrosis patients for early treatment of Ps. aeruginosa respiratory tract infections and for suppressive therapy in those colonized with Ps. aeruginosa.

Safety and efficacy not established and the drug is not labeled by FDA for administration via nebulization. Adverse respiratory effects (e.g., bronchoconstriction) have occurred with this route and there has been at least one fatality in a patient who self-administered a nebulizer treatment using a premixed solution of the drug. (See Respiratory Effects under Cautions.)

• Generic Name: denileukin diftitox
• Dosage Forms: n.a.
• Other Brand Names: Ontak

Treatment of persistent or recurrent cutaneous T-cell lymphoma (CTCL) in patients whose malignant cells express the CD25 component of the IL-2 receptor (designated an orphan drug by FDA for this use).

Safety and efficacy in patients with CTCL whose malignant cells do not express the CD25 component of the IL-2 receptor not established but currently being studied.