RRP Task Force
Recommendations for Cidofovir Use
Until more is undestood about the long-term safety profile of cidofovir
in humans, the RRP Task Force is recommending that:
[patients and
doctors]
1) Given the promising results reported in pediatric and adult
patients, cidofovir should be routinely presented as a treatment option
in moderate to severely afflicted RRP patients. i.e.; those patients
whose disease is not improving on surgical therapy alone or in
conjunction with less potentially morbid adjuvant measures and/or
requiring surgical intervention of more than 3 times a year. With
appropriate consent, cidofovir therapy should be a viable option in
patients whose disease severity is resulting in a need for frequent
surgery, worsening airway compromise or severely impaired communication
or those who otherwise may be considered candidates for tracheostomy.
2) Patients with more mild disease, particularly children, should be
discouraged from seeking treatment with cidofovir, until a better
understanding of the long-term implications of the use of this drug
have been established. With appropriate informed consent, cidofovir
could still be utilized on a case-by-case basis, at the discretion of
the prescribing physician, for the more mildly affected patient.
[doctors]
3) As with all surgical procedures, informed consent should be obtained
and documented in the patient's record. At a minimum, this should
include a frank discussion of the nephrotoxic and carcinogenic
potential of this drug.
4) Adverse responses, particularly evidence of
dysplasia or malignant transformation to squamous cell carcinoma,
either locally or remotely, should be reported simultaneously to the
FDA (form 3500 or 3500A) and to the RRP Task Force through email
communication with its Chairman, Craig Derkay, MD.