Anemia due to chemotherapy in patients with cancer¹

PROCRIT^® is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.

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

Important dosing and administration information¹

Following initiation of therapy and after each dose adjustment, monitor hemoglobin (Hb) weekly until the Hb level is stable and sufficient to minimize the need for RBC transfusion.

In pregnant women, lactating women, neonates, and infants use only single-dose vials (the benzyl alcohol–free formulation).

Initiate PROCRIT^® in patients on cancer chemotherapy only if Hb is <10 g/dL, and if there is a minimum of 2 additional months of planned chemotherapy.

Use the lowest dose of PROCRIT^® necessary to avoid RBC transfusions.

Recommended Starting Dose

IV=intravenous; QW=once weekly; SC=subcutaneous; TIW=3 times weekly; U=units.

Dose Reduction
Hb increases >1 g/dL in any 2-week period	Reduce dose by 25%
Hb reaches a level needed to avoid RBC transfusion	Reduce dose by 25%
Hb exceeds a level needed to avoid RBC transfusion	Withhold dose. Reinitiate at a dose 25% below the previous dose when Hb approaches a level where RBC transfusions may be required

Dosing algorithm for adult patients with cancer¹

01 - Identify

PATIENT ASSESSMENT: OBTAIN AND MONITOR Hb

• Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating PROCRIT^®
• Following initiation of therapy and after each dose adjustment, monitor Hb weekly until the Hb level is stable and sufficient to minimize the need for RBC transfusion
• Evaluate the iron status in all patients before and during treatment
• Administer supplemental iron therapy when serum ferritin is <100 mcg/L or when serum transferrin saturation is <20%

02 - Initiate

• PROCRIT^® therapy should not be initiated at Hb levels ≥10 g/dL
• Initiate PROCRIT^® in patients on cancer chemotherapy only if the Hb is <10 g/dL, and if there is a minimum of 2 additional months of planned chemotherapy
• The dose of PROCRIT^® should be titrated for each patient to achieve and maintain the lowest Hb level sufficient to avoid the need for RBC transfusions
• Evaluate iron status and consider supplemental iron therapy as needed to support erythropoiesis

40,000 U
subcutaneous
QW

until completion of a chemotherapy course

150 U/kg
subcutaneous
TIW

until completion of a chemotherapy course

03 - MONITOR AND ASSESS

Monitor Hb weekly until stable

Reduce dose by 25% if:

• Hb reaches a level needed to avoid transfusion or increases >1 g/dL in any 2-week period

Withhold dose if:

• Hb exceeds a level needed to avoid transfusion. Restart dose at 25% below previous dose when Hb approaches a level where transfusions may be required

If QW dosing:

Assess response after Week 4

If TIW dosing:

Assess response after Week 4

I­f H­b i­n­c­r­e­a­s­e­s b­y <1 g­/­d­L a­n­d­ r­e­m­a­i­n­s b­e­l­o­w 1­0 g­/­d­L­:

• I­n­c­r­e­a­s­e d­o­s­e t­o 6­0­,­0­0­0 U Q­W i­f r­e­s­p­o­n­s­e i­s n­o­t s­a­t­i­s­f­a­c­t­o­r­y (­n­o r­e­d­u­c­t­i­o­n i­n t­r­a­n­s­f­u­s­i­o­n r­e­q­u­i­r­e­m­e­n­t­s o­r r­i­s­e i­n H­b b­y ≥­1 g­/­d­L a­f­t­e­r 4 w­e­e­k­s­) t­o a­c­h­i­e­v­e a­n­d m­a­i­n­t­a­i­n t­h­e l­o­w­e­s­t H­b l­e­v­e­l s­u­f­f­i­c­i­e­n­t t­o a­v­o­i­d t­h­e n­e­e­d f­o­r R‍B‍C t­r­a­n­s­f­u­s­i­o­n­s­
• C­o­n­t­i­n­u­e t­o m­o­n­i­t­o­r p­a­t­i­e­n­t­’s r­e­s­p­o­n­s­e p­e­r P­r­e­s­c­r­i­b­i­n­g I­n­f­o­r­m­a­t­i­o­n­

I­f H­b r­i­s­e i­s ≥­1 g­/­d­L­:

• C­o­n­t­i­n­u­e t­o m­o­n­i­t­o­r p­a­t­i­e­n­t­’s r­e­s­p­o­n­s­e p­e­r P­r­e­s­c­r­i­b­i­n­g I­n­f­o­r­m­a­t­i­o­n­

I­f H­b i­n­c­r­e­a­s­e­s b­y <­1 g­/­d­L a­n­d­ r­e­m­a­i­n­s b­e­l­o­w 1­0 g­/­d­L­:

• I­n­c­r­e­a­s­e d­o­s­e t­o 3­0­0 U­/k­g T­I­W i­f r­e­s­p­o­n­s­e i­s n‍o‍t s­a­t­i­s­f­a­c­t­o­r­y (­n­o r­e­d­u­c­t­i­o­n i­n t­r­a­n­s­f­u­s­i­o­n r­e­q­u­i­r­e­m­e­n­t­s o­r r­i­s­e i­n H­b b­y ≥­1 g­/­d­L a­f­t­e­r 4 w­e­e­k­s­) t­o a­c­h­i­e­v­e a­n­d m­a­i­n­t­a­i­n t­h­e l­o­w­e­s­t H­b l­e­v­e­l s­u­f­f­i­c­i­e­n­t t­o a­v­o­i­d t­h­e n­e­e­d f­o­r R‍B‍C t­r­a­n­s­f­u­s­i­o­n­s­
• C­o­n­t­i­n­u­e t­o m­o­n­i­t­o­r p­a­t­i­e­n­t’­s r­e­s­p­o­n­s­e p­e­r P­r­e­s­c­r­i­b­i­n­g I­n­f­o­r­m­a­t­i­o­n­

Manage therapy

• Evaluate lack or loss of response per Prescribing Information, Warnings and Precautions:
  • For lack or loss of Hb response to PROCRIT^®, initiate a search for causative factors (eg, iron deficiency, infection, inflammation, or bleeding)
  • If typical causes of lack or loss of Hb response are excluded, evaluate for pure red cell aplasia (PRCA) [see Warnings and Precautions (5.6)]
  • In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient Hb response to PROCRIT^® therapy
• Discontinue after completion of a chemotherapy course
• After 8 weeks of therapy, if there is no response as measured by Hb levels or if RBC transfusions are still required, discontinue PROCRIT^®
• Use the lowest dose of PROCRIT^® necessary to avoid RBC transfusions