Just great this is the only protease that I am not resistant to and is part
of my current regimen, now what?????????????/
Gary Stein
September 2004
Dear Health Care Professional:
This letter is intended to inform you that GlaxoSmithKline will be
discontinuing the sale
and distribution of AGENERASE® (amprenavir) 150 mg Capsules by the end of
2004.
This action is not the result of any safety or efficacy issues regarding the
product.
AGENERASE 50 mg Capsules and 15 mg/mL Oral Solution will continue to be
available.
GlaxoSmithKline has taken this action because the clinical demand for
AGENERASE
150 mg capsules has diminished significantly. Additionally, in the recent
treatment
recommendations by the Department for Health and Human Services (DHHS),
AGENERASE is no longer recommended as a component of a preferred or
alternative
initial regimen.
Because of this discontinuation, you should consider not initiating
treatment with
AGENERASE 150 mg Capsules in your patients with HIV infection. If you are
aware of
a patient receiving AGENERASE 150 mg Capsules, please notify the prescribing
health
care provider (if someone other than yourself) and the patient regarding
this
announcement. We encourage you or the prescribing health care provider to
discuss
appropriate alternative treatment regimens with your patients currently
receiving
AGENERASE 150 mg Capsules.
AGENERASE is indicated in combination with other antiretroviral agents for
the
treatment of HIV-1 infection. The following points should be considered when
initiating
therapy with AGENERASE: in a study of NRTI-experienced, protease
inhibitor-naive
patients, AGENERASE was found to be significantly less effective than
indinavir. Mild
to moderate gastrointestinal adverse events led to discontinuation of
AGENERASE
primarily during the first 12 weeks of therapy. There are no data on
response to therapy
with AGENERASE primarily during the first 12 weeks of therapy. There are
limited
data on response to therapy with AGENERASE in protease inhibitor-experienced
patients.
Because of the potential risk of toxicity from the large amount of the
excipient propylene
glycol contained in AGENERASE Oral Solution, that formulation is
contraindicated in
infants and children below the age of 4 years, pregnant women, patients with
hepatic or
renal failure, and patients treated with disulfiram or metronidazole.
AGENERASE Oral
Solution should be used only when other protease inhibitor formulations are
not
therapeutic options. Amprenavir is a sulfonamide, and patients with a known
sulfonamide
allergy should be treated with caution. Caution should be exercised when
administering
IMPORTANT
PRESCRIBING
INFORMATION
AGENERASE to patients with hepatic impairment. In patients receiving
protease
inhibitors (including amprenavir), hyperglycemia, diabetes mellitus, acute
hemolytic
anemia and spontaneous bleeding in hemophiliacs have been reported. Severe
and lifethreatening
drug interactions could occur, and skin reactions including Stevens-Johnson
syndrome have occurred with amprenavir. Redistribution/accumulation of body
fat has
been observed in patients receiving antiretroviral therapy. The causal
relationship,
mechanism, and long-term consequences of these events are currently unknown.
Please
consult the enclosed full prescribing information for AGENERASE Capsules and
AGENERASE Oral Solution.
GlaxoSmithKline is committed to providing you with current product
information for the
management of your patients with HIV infection. The medical community can
assist us
in monitoring the safety of our products by reporting adverse events to
GlaxoSmithKline's Customer Response Center at 1-888-825-5249 or to the FDA
MEDWATCH program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178,
by
modem at 1-800-FDA-7737, via www.FDA.gov/medwatch, or by mail to:
MEDWATCH HF-2
FDA
5600 Fisher's Lane
Rockville, MD 20857
If you have any questions or want additional medical information, please
contact our
Customer Response Center at 1-888-825-5249.
Sincerely,
Douglas J. Manion, M.D.
Vice President, Clinical Development and Medical Affairs
--
Gary Stein
ge.stein@verizon.net
