TOBI while pregnant

R

RiRi

Guest
I have a son that does TOBI on 28 days and off 28 days. Some of the med does neb into the air and it just occured to me that I may be taking some of it in. My son is currently off TOBI. I am pregnant and mentioned this to my Md and he got a concerned look on his face. TOBI apparently can cause deafness if passed into the fetus. He stated that it would be hard to determine my TOBI level without being exposed again, which of course we did not want to do. I don't sit directly over my child when he nebs but do move in and out of the room. Anyone had this same issue?

Thanks for the help!

RiRi
 
R

RiRi

Guest
I have a son that does TOBI on 28 days and off 28 days. Some of the med does neb into the air and it just occured to me that I may be taking some of it in. My son is currently off TOBI. I am pregnant and mentioned this to my Md and he got a concerned look on his face. TOBI apparently can cause deafness if passed into the fetus. He stated that it would be hard to determine my TOBI level without being exposed again, which of course we did not want to do. I don't sit directly over my child when he nebs but do move in and out of the room. Anyone had this same issue?

Thanks for the help!

RiRi
 
R

RiRi

Guest
I have a son that does TOBI on 28 days and off 28 days. Some of the med does neb into the air and it just occured to me that I may be taking some of it in. My son is currently off TOBI. I am pregnant and mentioned this to my Md and he got a concerned look on his face. TOBI apparently can cause deafness if passed into the fetus. He stated that it would be hard to determine my TOBI level without being exposed again, which of course we did not want to do. I don't sit directly over my child when he nebs but do move in and out of the room. Anyone had this same issue?

Thanks for the help!

RiRi
 
L

LouLou

New member
RiRi,

If it makes you feel any better I have CF and am pregnant and am on Tobi through orders from my OB and CF doctor. The levels that enter your bloodstream when inhaling Tobi into your lungs are small enough that it is a common practice to keep mothers on Tobi. Now IV Tobra is another story. I haven't heard in recent times of any mother having IV Tobramycin while pregnant due to all the possible problems that could occur and because there are so many other options. I don't think you have anything to worry about. I hope this helps.
 
L

LouLou

New member
RiRi,

If it makes you feel any better I have CF and am pregnant and am on Tobi through orders from my OB and CF doctor. The levels that enter your bloodstream when inhaling Tobi into your lungs are small enough that it is a common practice to keep mothers on Tobi. Now IV Tobra is another story. I haven't heard in recent times of any mother having IV Tobramycin while pregnant due to all the possible problems that could occur and because there are so many other options. I don't think you have anything to worry about. I hope this helps.
 
L

LouLou

New member
RiRi,

If it makes you feel any better I have CF and am pregnant and am on Tobi through orders from my OB and CF doctor. The levels that enter your bloodstream when inhaling Tobi into your lungs are small enough that it is a common practice to keep mothers on Tobi. Now IV Tobra is another story. I haven't heard in recent times of any mother having IV Tobramycin while pregnant due to all the possible problems that could occur and because there are so many other options. I don't think you have anything to worry about. I hope this helps.
 
S

Scarlett81

New member
I'm not judging LouLou here-you know I love you L!!! Everyone has to make the decision that their doc and them feels is best.

But just to show you the flip side, I am not on TOBI and my doctor spent a year with me, weaning me off it before my pregnancy. Basically the jury is still out on how much gets to the fetus. Its one of those situations where there is no proven evidence that says it is that dangerous, but there is also no proven evidence that says that it is safe. My docs personal feeling is, do not take it since it is proven that the medicine tobramycin which TOBI comes from can cause hearing related birth defects. TOBI is that med, its just expressed in a different way, through the lungs so maybe there is not as big a danger to the baby. But I don't want to risk that 'maybe'. And since I have a good relationship with my doc and pretty much take faith in what she says b/c she's shown herself to be very level headed with me, I'm going with her on this one.

The other thing is, she may feel that I really don't need it. For someone else, they may need it. There's also the risk/benefit ratio for a cf mom to consider. Healthy mom-healthy baby. So if the mom feels she needs it to stay healthy, then she needs to make that decision.

Since you don't have to worry about that, and its not your health at risk here, I'd have him do his nebs in a well-ventilated room in the house, far away from where you will be at the time. Maybe stick an airpurifier in the room with him. Play it safe. You never know. Then you can say at least that you took all the precautions you could at the time. That's just my opinion.
 
S

Scarlett81

New member
I'm not judging LouLou here-you know I love you L!!! Everyone has to make the decision that their doc and them feels is best.

But just to show you the flip side, I am not on TOBI and my doctor spent a year with me, weaning me off it before my pregnancy. Basically the jury is still out on how much gets to the fetus. Its one of those situations where there is no proven evidence that says it is that dangerous, but there is also no proven evidence that says that it is safe. My docs personal feeling is, do not take it since it is proven that the medicine tobramycin which TOBI comes from can cause hearing related birth defects. TOBI is that med, its just expressed in a different way, through the lungs so maybe there is not as big a danger to the baby. But I don't want to risk that 'maybe'. And since I have a good relationship with my doc and pretty much take faith in what she says b/c she's shown herself to be very level headed with me, I'm going with her on this one.

The other thing is, she may feel that I really don't need it. For someone else, they may need it. There's also the risk/benefit ratio for a cf mom to consider. Healthy mom-healthy baby. So if the mom feels she needs it to stay healthy, then she needs to make that decision.

Since you don't have to worry about that, and its not your health at risk here, I'd have him do his nebs in a well-ventilated room in the house, far away from where you will be at the time. Maybe stick an airpurifier in the room with him. Play it safe. You never know. Then you can say at least that you took all the precautions you could at the time. That's just my opinion.
 
S

Scarlett81

New member
I'm not judging LouLou here-you know I love you L!!! Everyone has to make the decision that their doc and them feels is best.

But just to show you the flip side, I am not on TOBI and my doctor spent a year with me, weaning me off it before my pregnancy. Basically the jury is still out on how much gets to the fetus. Its one of those situations where there is no proven evidence that says it is that dangerous, but there is also no proven evidence that says that it is safe. My docs personal feeling is, do not take it since it is proven that the medicine tobramycin which TOBI comes from can cause hearing related birth defects. TOBI is that med, its just expressed in a different way, through the lungs so maybe there is not as big a danger to the baby. But I don't want to risk that 'maybe'. And since I have a good relationship with my doc and pretty much take faith in what she says b/c she's shown herself to be very level headed with me, I'm going with her on this one.

The other thing is, she may feel that I really don't need it. For someone else, they may need it. There's also the risk/benefit ratio for a cf mom to consider. Healthy mom-healthy baby. So if the mom feels she needs it to stay healthy, then she needs to make that decision.

Since you don't have to worry about that, and its not your health at risk here, I'd have him do his nebs in a well-ventilated room in the house, far away from where you will be at the time. Maybe stick an airpurifier in the room with him. Play it safe. You never know. Then you can say at least that you took all the precautions you could at the time. That's just my opinion.
 
L

LouLou

New member
I agree with you Amy and Christian 100%. Another thing I was thinking was that you should make sure to be administering the TOBI in a Pari LC Plus nebulizer cup because with the dual valves very little mist escapes.

If I could do my pregnancy without Tobi I would have. There are risks but like Christian said it's the healthy mommy = healthy baby risk/benefit ratio my doctors are working with here.
 
L

LouLou

New member
I agree with you Amy and Christian 100%. Another thing I was thinking was that you should make sure to be administering the TOBI in a Pari LC Plus nebulizer cup because with the dual valves very little mist escapes.

If I could do my pregnancy without Tobi I would have. There are risks but like Christian said it's the healthy mommy = healthy baby risk/benefit ratio my doctors are working with here.
 
L

LouLou

New member
I agree with you Amy and Christian 100%. Another thing I was thinking was that you should make sure to be administering the TOBI in a Pari LC Plus nebulizer cup because with the dual valves very little mist escapes.

If I could do my pregnancy without Tobi I would have. There are risks but like Christian said it's the healthy mommy = healthy baby risk/benefit ratio my doctors are working with here.
 
N

NoExcuses

New member
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
 
N

NoExcuses

New member
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
 
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