Prescribing information for TOBI:
"Teratogenic Effects - Pregnancy Category D
(SeeWARNINGS).
No reproduction toxicology studies have been conducted with TOBI®. However, subcutaneous administration of tobramycin at doses of 100 or 20
mg/kg/day during organogenesis was not teratogenic in rats or rabbits, respectively. Doses of tobramycin ?40 mg/kg/day were severely maternally toxic to rabbits and precluded the evaluation of teratogenicity. Aminoglycosides can cause fetal harm (e.g., congenital deafness) when administered to a pregnant woman. Ototoxicity was not
evaluated in offspring during nonclinical reproduction toxicity studies with tobramycin. If TOBI®is used during pregnancy, or if the patient becomes pregnant while taking TOBI®, the patient should be apprised of the potential hazard to the fetus. "
Why weren't pregnancy tests done? BECAUSE THEY'RE ALMOST CERTAIN IT COULD HARM THE FETUS.
<b> WARNINGS </b>
"Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides cross the placenta, and streptomycin has been associated with several reports of total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use TOBI® during pregnancy, or become pregnant while taking
TOBI®should be apprised of the potential hazard to the fetus. are pregnant while on TOBI®, you should talk with your doctor about the possibility of TOBI®causing any harm. "
True, TOBI isn't systemically absorbed <i> as much as </i> IV Tobra, but don't be fooled.... TOBI still gets in your blood stream. From the PI:
"Serum Concentrations: The average serum concentration of tobramycin one hour after inhalation of a single 300 mg dose of TOBI®by cystic fibrosis patients was 0.95 mL. After 20 weeks of therapy on the TOBI®regimen, the average serum tobramycin concentration one hour after dosing was 1.05
"Teratogenic Effects - Pregnancy Category D
(SeeWARNINGS).
No reproduction toxicology studies have been conducted with TOBI®. However, subcutaneous administration of tobramycin at doses of 100 or 20
mg/kg/day during organogenesis was not teratogenic in rats or rabbits, respectively. Doses of tobramycin ?40 mg/kg/day were severely maternally toxic to rabbits and precluded the evaluation of teratogenicity. Aminoglycosides can cause fetal harm (e.g., congenital deafness) when administered to a pregnant woman. Ototoxicity was not
evaluated in offspring during nonclinical reproduction toxicity studies with tobramycin. If TOBI®is used during pregnancy, or if the patient becomes pregnant while taking TOBI®, the patient should be apprised of the potential hazard to the fetus. "
Why weren't pregnancy tests done? BECAUSE THEY'RE ALMOST CERTAIN IT COULD HARM THE FETUS.
<b> WARNINGS </b>
"Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides cross the placenta, and streptomycin has been associated with several reports of total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use TOBI® during pregnancy, or become pregnant while taking
TOBI®should be apprised of the potential hazard to the fetus. are pregnant while on TOBI®, you should talk with your doctor about the possibility of TOBI®causing any harm. "
True, TOBI isn't systemically absorbed <i> as much as </i> IV Tobra, but don't be fooled.... TOBI still gets in your blood stream. From the PI:
"Serum Concentrations: The average serum concentration of tobramycin one hour after inhalation of a single 300 mg dose of TOBI®by cystic fibrosis patients was 0.95 mL. After 20 weeks of therapy on the TOBI®regimen, the average serum tobramycin concentration one hour after dosing was 1.05