Names and pronunciation
Retacrit
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Drug reference
Retacrit
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Func. class.: Antianemic
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Chem. class.: Amino acid polypeptide
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ACTION: Erythropoietin is a factor controlling the rate of red cell produc- tion; product is developed by recombi- nant DNA technology
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USES: Anemia caused by reduced endogenous erythropoietin production, in end-stage renal disease; to correct hemostatic defect in uremia; anemia due to AZT treatment in patients with HIV or those receiving chemotherapy; reduction of allogenic blood transfusion in surgery patients
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Unlabeled uses: Anemia in premature preterm infants, anemia due to ribavirin and interferon-alfa therapy in hepatitic C
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CONTRAINDICATIONS: Hyper- sensitivity to mammalian-cell–derived products, human albumin; uncontrolled hypertension Precautions: Pregnancy, breastfeeding, children <1 mo, seizure disorder; multidose preserved formulation contains benzyl alco- hol and should not be used in premature infants; porphyria, CV disease, hemodialysis, latex allergy, hypertension, history of CABG
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Black Box Warning: HB >11 g/dL, sur- gery, neoplastic disease Black Box Warning: Blood studies: ferritin, transferrin, serum iron monthly; transferrin sat ≥20%, ferritin ≥100 ng/ mL; Hct 2×/wk until stabilized in target range (30%-36%) then at regular inter- vals; those with endogenous erythropoi- etin levels of <500 units/L respond to product; monitor Hct 2×/wk with chronic renal failure; patients treated with zido- vudine or patients with cancer should be monitored weekly, then periodically after stabilization; death may occur with Hb >12 g/dL; monitor for blood clots • B/P; check for rising B/P as Hct rises, antihypertensives may be needed; hyper- tension may occur rapidly, leading to hy- pertensive encephalopathy, use of antihy- pertensive may be needed • CNS symptoms: coldness, sweating, pain in long bones; for seizures if Hct is increased within 2 wk by 4 points • Hypersensitivity reactions: skin rashes, urticaria (rare), antibody devel- opment does not occur • Pure cell aplasia (PRCA) in absence of other causes; evaluate by testing sera for recombinant erythropoetin antibodies; any loss of response to epoetin should be evaluated • Dialysis patients: thrill, bruit of shunts; monitor for circulation impairment • Seizures: place patient on seizure pre- cautions if increase of 1 g/dL Hct in any 2-wk period, increased B/P; more common in chronic renal failure during the first 90 days of treatment • Pregnancy/breastfeeding: product should be used during pregnancy only when benefits outweigh fetal risk. Multi- dose vials are contraindicated due to the use of benzyl alcohol as a preservative; it is not known whether epoetin alfa is dis- tributed into breast milk
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SIDE EFFECTS CNS: Seizures, coldness, sweating, head- ache, fatigue, dizziness CV: Hypertension, hypertensive enceph- alopathy, HF, edema, DVT, MI, stroke INTEG: Pruritus, rash, injection site reaction MISC: Iron deficiency MS: Bone pain, arthralgia, myalgia RESP: Cough
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INTERACTIONS • Need for increased heparin during hemodialysis
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DOSAGE AND ROUTES Anemia due to chronic kidney dis- ease to decrease the need for red blood cell transfusion • Adults: IV/SUBCUT 50-100 units/kg/ dose or 3 times weekly initially; for pa- tients on dialysis, administer IV. For pa- tients on dialysis, initiate treatment when hemoglobin (Hgb) is less than 10 g/dL • Adolescents 17 years: IV/SUBCUT 50- 100 units/kg/dose 3 times weekly initially; for patients on dialysis, administer IV. For patients on dialysis, initiate treatment when hemoglobin (Hgb) is less than 10 g/ dL. If Hgb approaches or exceeds 11 g/dL, reduce or interrupt the dose • Infants, children, and adolescents 1 mo to 16 yr: 50 units/kg/dose IV or SUB- CUT 3 times weekly initially; for patients on dialysis, administer IV. Initiate treat- ment when hemoglobin (Hgb) is less than 10 g/dL. If Hgb approaches or exceeds 12 g/dL, reduce or interrupt the dose To reduce the need for allogeneic red blood cell transfusions in patients with perioperative hemoglobin more than 10 g/dL to 13 g/dL scheduled to undergo elective, noncardiac, non- vascular surgery who are at high risk for perioperative blood loss and who are NOT willing to donate autol- ogous blood preoperatively • Adults: SUBCUT 300 units/kg/day for 10 days prior to surgery, on the day of surgery, and for 4 days after surgery (15 days total) plus deep vein thrombosis (DVT) prophylaxis Zidovudine-induced anemia in HIV- infected patients with circulating endogenous erythropoietin concen- trations of 500 mUnits/mL or less who are receiving a dose of zidovu- dine of 4200 mg/week or less • Adults: SUBCUT/IV Initially, 100 units/ kg/dose 3 times weekly. If Hgb does not increase after 8 wk, increase by 50-100 units/kg/dose at 4- to 8-wk intervals until Hgb is at a concentration to avoid RBC transfusions or a dose of 300 units/kg is reached. If the Hgb is more than 12 g/dL, withhold epoetin and once Hgb is less than 11 g/dL, resume at a dose 25% below the previous dose. Patients receiving zidovu- dine with endogenous serum erythropoietin levels more than 500 mUnits/mL are un- likely to respond to epoetin alfa treatment Anemia in nonmyeloid malignancies where the anemia is due to the effect of chemotherapy and at least 2 additional mo of chemotherapy are planned • Adults: SUBCUT 150 units/kg/dose 3 times weekly or 40,000 units once weekly only when the hemoglobin (Hgb) is less than 10 g/dL and only until the chemo- therapy course is completed. Adjust the dose to maintain the lowest Hgb concen- tration sufficient to avoid RBC transfusions • Children and adolescents 5-17 yr: IV 600 units/kg/dose weekly only when the E hemoglobin (Hgb) is less than 10 g/dL and only until the chemotherapy course is completed. Adjust the dose to maintain the lowest Hgb concentration sufficient to avoid RBC transfusions To reduce the need for allogeneic red blood cell transfusions in patients with perioperative hemoglobin more than 10 g/dL to 13 g/dL scheduled to undergo elective, noncardiac, non- vascular surgery who are at high risk for perioperative blood loss and who are NOT willing to donate autol- ogous blood preoperatively • Adults: SUBCUT 300 units/kg/day for 10 days prior to surgery, on the day of surgery, and for 4 days after surgery (15 days total) plus deep vein thrombosis (DVT) prophylaxis
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Available forms: Injection 2000, 3000, 4000, 10,000, 20,000, 40,000 units/mL
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Administer: • Use 1 single-use vial/dose, once syringe has entered single-dose vial, sterility cannot be guaranteed, do not administer with other product, multidose vials can be stored in re- frigerator up to 21 days once opened, do not use if discolored or particulates are present SUBCUT route • Before injecting, preservative-free, single- dose formulation may be admixed using 0.9% NaCl with benzyl alcohol 0.9% at a 1:1 ratio to reduce injection site discomfort, store solution in refrigerator, protect from light Direct IV route • Additional heparin to lower chance of clots • By direct injection or bolus into IV tubing or venous line at end of dialysis; do not shake vial; can use undiluted or diluted in 0.9% NaCl (1000-40,000 U/ mL); give over ≥1 min • Decrease dose by 25% if Hb increases by 1 g/dL in 2 wk; increase dose if Hb does not increase by 5-6 pts after 8 wk of therapy; suggested target Hb range 30%-36% Solution compatibilities: Do not dilute or administer with other solutions
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Assess: • Renal studies: urinalysis, protein, blood, BUN, creatinine; I&O, electrolytes, report drop in output <50 mL/hr
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Evaluate: • Therapeutic response: increase in reticulocyte count in 2-6 wk, Hb/Hct; increased appetite, enhanced sense of well-being
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • How to take B/P, have patient read the “Medication Guide”; a form must be signed before each cycle • To avoid driving or hazardous activi- ties during beginning of treatment • To take iron supplements, vitamin B12, folic acid as directed • To report immediately chest pain, pain in calves, confusion, inability to speak, numbness in face, arm, leg • Chronic renal failure (anemia): prod- uct does not cure condition, to maintain prescribed diet, medications, dialysis follow-up appointments • Pregnancy/breastfeeding: to report if pregnancy is planned or suspected or if breastfeeding • The reason for treatment, expected results, to notify health care professional of use HIGH ALERT
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PHARMACOKINETICS IV: Metabolized in body, extent of metab- olism unknown, onset of increased retic- ulocyte count 2-6 wk, peak immediate Subcut: Peak 5-24 hr
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• Infants, children, and adolescents 1 mo to 16 yr: 50 units/kg/dose IV or SUB- CUT 3 times weekly initially; for patients on dialysis, administer IV. Initiate treat- ment when hemoglobin (Hgb) is less than 10 g/dL. If Hgb approaches or exceeds 12 g/dL, reduce or interrupt the dose To reduce the need for allogeneic red blood cell transfusions in patients with perioperative hemoglobin more than 10 g/dL to 13 g/dL scheduled to undergo elective, noncardiac, non- vascular surgery who are at high risk for perioperative blood loss and who are NOT willing to donate autol- ogous blood preoperatively
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• Children and adolescents 5-17 yr: IV 600 units/kg/dose weekly only when the E hemoglobin (Hgb) is less than 10 g/dL and only until the chemotherapy course is completed. Adjust the dose to maintain the lowest Hgb concentration sufficient to avoid RBC transfusions To reduce the need for allogeneic red blood cell transfusions in patients with perioperative hemoglobin more than 10 g/dL to 13 g/dL scheduled to undergo elective, noncardiac, non- vascular surgery who are at high risk for perioperative blood loss and who are NOT willing to donate autol- ogous blood preoperatively
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