Source: Gilead website
February 15, 2012
Important Information Regarding the Availability of Cayston®
To the CF Community,
Gilead Sciences, Inc., the manufacturer of Cayston, is facing significant and unanticipated challenges manufacturing enough Cayston to meet demand in the United States.
Gilead is committed to patient care. To that end, we have consulted with physicians who specialize in the treatment of cystic fibrosis and members of the patient advocacy community to make them aware of the shortage and to get their input on our process for managing this situation.
Patients who are currently active on Cayston therapy are our first priority, and every effort is being made to avoid any interruptions in their therapy. This group of patients includes only those who have received 2 or more courses of Cayston in the last 6 months or 1 or more courses in the last 2 months. For all other patients, pharmacies will continue to accept prescriptions for Cayston, but they will not be filled until Gilead can ensure that there is sufficient supply. Patients and their providers should discuss alternative treatment options to Cayston while this supply shortage is in effect. For an individual patient who has no feasible alternative to Cayston, their healthcare provider may request an exception. These cases will be considered on a case-by-case basis through a separate medical review process.
Gilead takes this issue very seriously, and we are working urgently to resolve the supply shortage. However, at this time, we do not know how long the shortage will last.
Guidance for Patients
- Patients who are currently taking Cayston should complete their course of Cayston as prescribed by their healthcare providers.
- Patients who have received 2 or more courses of Cayston in the last 6 months or 1 or more courses in the last 2 months will be able to continue receiving refills unless there are further changes in our supply.
- Patients should call their specialty pharmacy when their next refill of Cayston is due. Pharmacies will continue to fill prescriptions in accordance with when a patient is due to initiate their next course of treatment.
- Patients who do not meet the requirements as defined above should discuss alternative treatment options with their providers.
- If an individual patient has a significant clinical need for Cayston with no feasible alternatives, their healthcare provider can request an exception for that patient. This will be considered through a separate medical review process and communicated back to the patient’s healthcare provider.
- Once the supply issue is resolved, we will inform the CF community about timing for Cayston availability so that patients and their healthcare providers can determine the next steps in their care.
- Cayston will not be available in hospitals.
Treatment alternatives
Our goal is to maintain the supply of Cayston to patients currently active on Cayston therapy, but we cannot guarantee it. As such, Gilead recommends that patients and their healthcare providers consider alternative treatment options until the Cayston shortage is resolved. Please be aware that there are no equivalent forms of aztreonam for inhalation solution approved by the FDA that can be used in place of Cayston.
Actions we are taking
At Gilead, the welfare of patients is our highest priority. We are very conscious of the potential impact of this shortage on people living with CF. We are actively working to qualify new and expand existing manufacturing sites to increase the production of Cayston. We are committed to keeping the CF community informed of our progress as updates become available.
Updates and inquiries about the Cayston drug supply
To stay up-to-date about the availability of Cayston:
- Register for e-mail updates at www.Cayston.com/supply.html
- Call the Cayston Access Program at 1-877-7CAYSTON between the hours of 8AM-8PM ET
Thank you for your support as we work through this issue.
Sincerely,
Noreen R. Henig, MD
Sr. Director, Medical Affairs
Respiratory and PAH Therapeutics
Gilead Sciences, Inc.