Cayston Update ****WARNING: MUCUS PICTURES*******

*********WARNING: MUCUS PICTURES***************

After about 2 doses of Cayston, I coughed up this sucker (see below. that finger is my index finger, btw)

I am definitely a plug-cougher-upper, but rarely do I get suckers this big. The last one of this size was when I was on prednisone in February/March.

So, is it related to Cayston? I'm not sure. But that's the only thing that has changed.

Now that I've been on Cayston for 3 days, my mucus has definitely thinned, decreased in quantity and lightened in color. So we'll see how things continue to go :)

First dose of Cayston

Well, I'm happy to report that I'm in the middle of my very first dose of Cayston.

Here is what I see as the good, the bad, and the ugly:


The Good

• Unique class of nebulized antibiotic for the CF population
• FDA approved (although I don't have much issue with my Colistin not being FDA approved for nebbing - we CFer's do things off label all the time... actually since my FEV1 is greater than 75% my use of Cayston is off label....)
• Used through the eFlow (you all know what a fan I have been of the eFlow... been using it since 2006)
• Pretty quick nebulzation time

The Bad

• Tastes a bit like TOBI - I haven't been on TOBI since about 2004 and I don't miss the taste. Oh well - not that big of a deal
• Stuff has to be refrigerated (but technically the PI says once the meds have been removed from the fridge, meds can remain at room temp for 28 days)
• Stuff has to be mixed (Just one extra step I'll have to do in my car during my mid-day dose.... more on that later)

The Ugly

• I nearly sliced my finger open trying to get the metal flap and metal ring off the cayston vial. WOW FDA and GILEAD - you thought this was safe?! Good grief
• 3x a day dose.... WOW. Yes, 4 hours apart is OK. Sure, I get that. But wow - for those of us who work (and even those who don't), this is a very difficult routine to get in to. I have put reminders in my iPhone and work Blackberry to doubly remind me mid-day to do my Cayston. Or else I'll forget. BLEH

Given this is my 1st dose, I might have more to add to the Good and the Bad, depending upon how the med makes me feel :) I"ll keep you posted.

Overall, I'm super happy that the CF Community has another option to treat PA!

Gilead's Head-to-Head Study Of Cayston Vs. TIS In Cystic Fibrosis Patients Achieves Co-Primary Efficacy Endpoint Of Non-inferiority

Gilead's Head-to-Head Study Of Cayston Vs. TIS In Cystic Fibrosis Patients Achieves Co-Primary Efficacy Endpoint Of Non-inferiority -
6/18/2010 12:51 PM ET

(RTTNews) - Gilead Sciences, Inc. (GILD: News ) said Friday that its head-to-head Phase III clinical trial of Cayston compared to tobramycin inhalation solution in cystic fibrosis patients with Pseudomonas aeruginosa achieved one of its co-primary endpoints of non-inferiority for mean percent change in forced expiratory volume in one second percent predicted after 28 days of treatment.

Patients receiving Cayston had a mean increase in FEV1 percent predicted from baseline to Day 28 of 8.35% compared to 0.55% for patients receiving tobramycin inhalation solution, which meets the statistical definition of superiority. Safety results were similar across both arms of the study, with lower incidence of cough in patients receiving Cayston.

Cayston was approved by the U.S. Food and Drug Administration in February 2010 and by the Australian Therapeutic Goods Administration in January 2010. Cayston received conditional marketing authorizations in the European Union and Canada in September 2009. These conditional approvals are contingent upon results from this Phase III study.

Gilead said it plans to begin submitting data from this study to regulatory agencies later this year.

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by RTT Staff Writer

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FDA panel: Gilead Sciences drug to treat deadly lung infection appears safe and effective

FDA panel: Gilead Sciences drug to treat deadly lung infection appears safe and effective

On 3:50 pm EST, Thursday December 10, 2009

WASHINGTON (AP) -- Federal health advisers are recommending the use of an experimental Gilead Sciences drug to treat a form of lung infection.
A Food and Drug Administration panel voted 15-2 in favor of the safety and effectiveness of the inhalable drug Cayston.
Cayston is intended to treat chronic lung infections in patients with cystic fibrosis -- an often fatal disease that affects the lungs and digestive system. Lung infections are the biggest killer of people with the disease.
The drug is designed to be given three times per day for 28 days.
The same panel of experts voted unanimously that Gilead has identified the appropriate dose for Cayston.
The FDA is not required to follow the group's advice, though it often does.

Euope approves Aztreonam

Gilead Sciences Inc. said Wednesday that European regulators gave conditional marketing approval to Cayston, a treatment for a type of chronic lung infection in patients with cystic fibrosis.

Cayston is intended to treat chronic lung infections caused by the bacterium Pseudomonas aeruginosa. ( news - people ) said those lung infections are the biggest killer of people with cystic fibrosis.

The drug will be available in some EU countries in early 2010, Gilead said.

The company said Cayston, or aztreonam lysine, is intended to be given three times per day for 28 days to treat the infection. Cayston was approved conditionally because it addresses an unmet medical need, Gilead said, and could receive full approval after a current late-stage clinical trial is complete.

Gilead said the drug has been approved in Canada. The Food and Drug Administration has asked Gilead to run another study before requesting approval.