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