PROCRIT® Efficacy and Safety: Zidovudine

Anemia due to zidovudine in patients with HIV infection¹

PROCRIT^® is indicated for the treatment of anemia due to zidovudine administered at ≤ 4200 mg/week in patients with HIV infection with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL.

PROCRIT^® has not been shown to improve quality of life, fatigue, or patient well-being.

PROCRIT^® is not indicated for use:

In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy
In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure
In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion
In patients scheduled for surgery who are willing to donate autologous blood
In patients undergoing cardiac or vascular surgery
As a substitute for red blood cell (RBC) transfusions in patients who require immediate correction of anemia

Rate of transfusion independence¹

Percentage of transfusion-dependent patients who became transfusion independent after PROCRIT^®

Procrit 43% (21 of 50 patients). Placebo 18% (9 of 50 patients)

In the subgroup of patients (89/125 PROCRIT^® and 88/130 placebo) with prestudy endogenous serum erythropoietin levels ≤500 mUnits/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

Study design¹

PATIENTS	DESIGN	TREATMENT
297 zidovudine-treated, anemic patients (hemoglobin <10 g/dL) with HIV infection	4 placebo-controlled studies; patients treated up to 12 weeks	PROCRIT^® administered at doses between 100 and 200 U/kg SC TIW

PATIENTS	297 zidovudine-treated, anemic patients (hemoglobin <10 g/dL) with HIV infection
DESIGN	4 placebo-controlled studies; patients treated up to 12 weeks
TREATMENT	PROCRIT^® administered at doses between 100 and 200 U/kg SC TIW

HIV=human immunodeficiency virus; SC=subcutaneously; TIW=3 times weekly; U=units.

Selected safety profile¹

WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

Expand the Important Safety Information at the bottom of the page to see the complete Boxed Warnings.

Adverse reactions with an incidence of ≥1% in patients treated with PROCRIT^® were:

Adverse reactions in zidovudine-treated patients with HIV infection¹

ADVERSE REACTION	PROCRIT^® (n=144)	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

From double-blind, placebo-controlled studies of 3 months’ duration in approximately 300 zidovudine-treated patients with HIV infection¹

MENU

Zidovudine-induced anemia in patients with HIV infection

Anemia due to zidovudine in patients with HIV infection¹

Rate of transfusion independence¹

Study design¹

Selected safety profile¹

Reference

MENU

Zidovudine-induced anemia in patients with HIV infection

Anemia due to zidovudine in patients with HIV infection1

Rate of transfusion independence1

Study design1

Selected safety profile1

Reference

Anemia due to zidovudine in patients with HIV infection¹

Rate of transfusion independence¹

Study design¹

Selected safety profile¹