Tobramycin inhaled products (Tobi, Tobi Podhaler, Bethkis, Kitabis Pak)

Tobramycin inhaled products (Tobi, Tobi Podhaler, Bethkis, Kitabis Pak) are covered only for the FDA‑approved indication—management of cystic fibrosis with Pseudomonas aeruginosa—and off‑label uses are excluded; therapy is contraindicated for patients with aminoglycoside hypersensitivity. Approval requires documented cystic fibrosis diagnosis (diagnostic/genetic testing), microbiologic confirmation of P. aeruginosa (culture or DNA), documentation of no aminoglycoside allergy, is authorized for up to 12 months, and warrants monitoring for bronchospasm, ototoxicity, nephrotoxicity, and neuromuscular effects.

"No off-label compendial uses meet evidence standards (no off-label uses are approved under this policy)."

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