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Dear Health Care Professional:

Wyeth-Ayerst brings to your attention an important change to the safety information for
NEUMEGA ® (oprelvekin) use in the pediatric population. There are no controlled clinical
studies that have established a safe and effective dose of NEUMEGA in children.
Therefore, the administration of NEUMEGA in children, particularly those <12 years of
age, should be restricted to controlled clinical trial settings with closely monitored safety
assessments.

Preliminary data from a safety and pharmacokinetic study in 47 children has identified
papilledema as a dose-limiting adverse reaction in the pediatric population. Among the 16
children in this study who received doses of 100 µg/kg/day, four developed papilledema
(25%; 95% CI: 7-52%). No subject reported visual abnormalities. In the one patient with
adequate follow-up, papilledema was reversible after treatment discontinuation. Although
none of the 9 children who received 75 µg/kg/day developed papilledema, given the small
number studied the true incidence at this dose may be as high as 33%.

Limited pharmacokinetic data are available for pediatric populations receiving doses of 50
µg/kg/day. Adequate pharmacokinetic data for doses of 50 µg/kg/day were obtained for
seven individuals <12 years of age and four individuals >12 and < 17 years of age.
Children (<12 years of age) given doses of 50 µg/kg/day did not achieve effective serum
levels. For adolescents (12 to 16 years of age, N = 2) and young adults ( > 17 years of
age, N = 2) effective serum levels appeared to be achieved.

A copy of the full prescribing information is enclosed. Wyeth-Ayerst is committed to
providing you with current product information. The current labeling does not contain the
information cited above; once these study data are fully analyzed, the labeling will be
changed to provide all currently available information regarding the experience with
administration of NEUMEGA in the pediatric population.

We encourage you to help us in monitoring the safety of NEUMEGA by reporting adverse
events possibly associated with NEUMEGA to us at 1-800-934-5556. Alternatively, you
may report adverse event information directly to FDA's MedWatch reporting system by
phone (1-8OO-FDA-1088), facsimile (1-800-FDA-0178), the MedWatch web site at
www.fda.gov/medwatch , or mailed to MedWatch, HFD-250, 5600 Fishers Lane. Rockville, MD
20852-9787. Both health care professionals and consumers should use the Form 3500 for
reporting adverse events.

Sincerely,

Harold K. Marder, M.D., FAAP
Senior Vice President and Medical Director

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