Zidovudine-induced anemia in HIV-infected patients
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Rate of transfusion independence1
Percentage of transfusion-dependent patients who became transfusion independent after PROCRIT®
Percentage of transfusion-dependent patients who became transfusion independent after PROCRIT
  • The safety and efficacy of PROCRIT® were evaluated in 4 placebo-controlled studies enrolling 297 anemic patients (hemoglobin <10 g/dL) with HIV infection receiving concomitant therapy with zidovudine
  • In the subgroup of patients (89/125 PROCRIT® and 88/130 placebo) with prestudy endogenous serum erythropoietin levels ≤500 mU/mL, PROCRIT® reduced the mean cumulative number of units of blood transfused per patient by approximately 40% as compared to the placebo group
  • Among those patients who required RBC transfusions at baseline, 43% of PROCRIT®-treated patients vs 18% of placebo-treated patients were RBC transfusion independent during the second and third months of therapy
  • PROCRIT® therapy also resulted in significant increases in hemoglobin in comparison to placebo
  • When examining the results according to the weekly dose of zidovudine received during Month 3 of therapy, there was a statistically significant reduction (P<0.003) in RBC transfusion requirements in patients treated with PROCRIT® (n=51) compared to placebo-treated patients (n=54) whose mean weekly zidovudine dose was ≤4,200 mg/week
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Selected safety profile
Percentage of transfusion-dependent patients who became transfusion independent after PROCRIT®
Adverse reaction PROCRIT® Placebo (n=153)
Pyrexia 42% 34%
Cough 26% 14%
Rash 19% 7%
Injection site irritation 7% 4%
Urticaria 3% 1%
Respiratory tract congestion 1% Not reported
Pulmonary embolism 1% Not reported
  • Adverse reactions with an incidence of ≥1% in patients treated with PROCRIT®.1
  • From double-blind, placebo-controlled studies of 3 months' duration in approximately 300 zidovudine-treated HIV-infected patients1
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References
  1. PROCRIT® Prescribing Information. Janssen Products, LP.
 
Indications
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Important Safety Information
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