In 1993, the Public Health Service Task Force recommended use
of Mycobutin * (rifabutin) at a daily dose of 300 mg for
prophylaxis
for disseminated Mycobacterium avium complex (MAC) infection in
patients with human immunodeficiency virus (HIV) infection and less
than 100 CD4+ T-lymphocytes/uL (1). However, uveitis (an
inflammatory eye condition characterized by pain, redness, and
possible temporary or permanent loss of vision) has been associated
with rifabutin therapy.
Uveitis has occurred among participants in several trials for
treatment and prophylaxis of MAC in which rifabutin was
administered at daily doses of 300-900 mg per day in combination
with other agents, particularly clarithromycin and/or fluconazole
{2-4; C. Benson, Rush-Presbyterian St. Luke's hospital, Chicago,
personal communication, 1994). Patients who developed uveitis have
had mild to severe symptoms that resolved after treatment with
corticosteroid and/or mydriatic eye drops; in some severe cases,
however, resolution of symptoms occurred after several weeks.
Uveitis occurred an average of 2-4 months after initiation of
treatment for MAC (2).
Uveitis is rare when rifabutin is used as a single agent at
300 mg/day for prophylaxis of MAC in HIV-infected persons, even
with the concomitant use of fluconazole or macrolide antibiotics.
However, if higher doses of rifabutin are administered in
combination with these agents, clinicians should be alert to the
possibility of uveitis. Patients should be instructed to report
symptoms of uveitis (i.e., pain, redness, and loss of vision) to
their physician.
For patients with uveitis, temporary discontinuation of
rifabutin and ophthalmologic evaluation are recommended. In most
mild cases, using rifabutin again is acceptable; however, if signs
or symptoms recur, use of rifabutin should be discontinued.
Physicians are encouraged to report cases of uveitis to the
Food and Drug Administration's MedWatch Program, telephone (800)
332-1088 ({301} 738-7553).
Reported by: Div of Antiviral Drug Products, Center for Drug
Evaluation and Research, Food and Drug Administration, Rockville,
Maryland. Div of HIV/AIDS, National Center for Infectious Diseases,
CDC.
References
CDC. Recommendations on prophylaxis and therapy for disseminated
Mycobacterium avium complex for adults and adolescents infected
with human immunodeficiency virus. MMWR 1993;42(no. RR-9):14-20.
Shafran S, Deschenes J, Miller M, et al. Uveitis and
pseudojaundice during a regimen of clarithromycin, rifabutin, and
ethambutol. N Engl J Med 1994;330:438-9.
Trapnell CB, Narang PK, Li R, et al. Fluconazole increases
rifabutin absorption in HIV positive patients on stable zidovudine
therapy {Abstract no. PO B31-2212}. Vol 1. IX International
Conference on AIDS/HIV STD World Congress, Berlin, 1993.
Siegal F, Eilbott D, Burger H, et al. Dose-limiting toxicity of
rifabutin in AIDS-related complex: syndrome of
arthralgia/arthritis. AIDS 1990;4:433-41.
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